Active ingredients: Risperidone
Risperdal 1, 2, 3 and 4 mg film-coated tablets
Risperdal 1 and 2 mg orodispersible tablets
Risperdal 1 mg / ml oral drops, solution
Risperdal package inserts are available for pack sizes: - Risperdal 1, 2, 3 and 4 mg film-coated tablets, Risperdal 1 and 2 mg orodispersible tablets, Risperdal 1 mg / ml oral drops, solution
- Risperdal 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for injection for intramuscular use
Why is Risperdal used? What is it for?
Risperdal belongs to a group of medicines called "antipsychotics". Risperdal is used for:
- treatment of schizophrenia, a condition in which you can see, hear or feel things that are not present, believe things that are not true, or feel unusually suspicious or confused
- treatment of mania, a condition in which one can feel very excited, euphoric, agitated, electrified or hyperactive. Mania occurs during a disease called "bipolar disorder"
- short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia, which harms themselves or others. Non-pharmacological alternatives should have been adopted prior to treatment
- short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (aged 5 years and over) and adolescents with conduct disorder.
Risperdal can help relieve the symptoms of the disease and stop it from returning.
Contraindications When Risperdal should not be used
Do not take Risperdal if:
- You are allergic (hypersensitive) to risperidone or any of the other ingredients of this medicine.
If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Risperdal.
Precautions for use What you need to know before you take Risperdal
Talk to your doctor or pharmacist before taking Risperdal if:
- He has a heart problem. Examples include an irregular heart rhythm, or if you tend to have low blood pressure or if you are taking blood pressure medicines. Risperdal can cause a drop in blood pressure. Your dose may need to be adjusted
- Do you know of any factors that can put you at risk of stroke, such as high blood pressure, cardiovascular disorders or circulatory disorders of the brain
- She happened to have involuntary movements of the tongue, mouth and face
- Have had a condition whose symptoms included fever, muscle stiffness, sweating or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome)
- He has Parkinson's disease or dementia
- You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
- He is diabetic
- Suffers from epilepsy
- He's a boy and he has happened to have a prolonged or painful erection.
- Has difficulty controlling body temperature or excessive warming
- You have kidney problems
- You have liver problems
- You have an abnormally high level of the hormone prolactin in your blood or you have a possible prolactin-dependent tumor
- You or someone else in your family has a history of blood clots (thrombi), as antipsychotic medications have been associated with the formation of blood clots
If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Risperdal.
Since dangerously low numbers of a certain type of white blood cells needed to fight infections in the blood have been observed very rarely in patients who have taken RISPERDAL, your doctor may check the white blood cell count in your blood.
Risperdal can cause weight gain. Significant weight gain can negatively affect your health. Your doctor should check your weight regularly.
Since diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking Risperdal, the doctor should check for elevated blood glucose levels.
Blood glucose levels should be monitored regularly in patients with pre-existing diabetes mellitus.
During an "eye operation" due to clouding of the lens (cataract), the pupil (the black circle in the center of your eye) may not increase in size as needed. Also, the iris (the colored part of the eye) can become flabby during surgery, which can cause damage to the eye. If you are planning to have eye surgery, be sure to tell your ophthalmologist that you are taking this medicine.
Elderly with dementia
There is an increased risk of stroke in elderly patients with dementia. If your dementia is caused by stroke you should not take risperidone.
During treatment with risperidone you should see your doctor frequently. If you or your caregiver notice a sudden change in your mental state or a "sudden weakness or numbness of the face, arms or legs, particularly on one side only, or an incomprehensible way of speaking, even if for a short time of time, you need to seek immediate medical attention.These may be signs of a stroke.
Children and Teenagers
Before starting treatment for the behavior disorder, other causes for the aggressive behavior must have been ruled out.
If fatigue occurs during treatment with risperidone, changing the timing of the drug may improve attention difficulties.
Before starting treatment, your body weight, or that of your child, should be measured and monitored closely during treatment.
Interactions Which drugs or foods may change the effect of Risperdal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to tell your doctor or pharmacist if you are taking any of the following:
- Medicines that work on your brain to help you calm down (benzodiazepines), or some pain medicines (opiates), allergy medicines (some antihistamines), because risperidone may increase the sedative effects of all these medicines
- Medicines that can change the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm problems, medicines for allergies (antihistamines), some antidepressants or other medicines for mental problems
- Medicines which cause a slow heart rate Medicines which cause low potassium in the blood (such as some diuretics)
- Medicines to treat high blood pressure Risperdal can cause low blood pressure
- Medicines for Parkinson's disease (such as levodopa)
- Medicines to urinate (diuretics), used for heart problems or for swelling of parts of the body, due to a buildup of too many fluids (such as furosemide or chlorothiazide). Risperdal taken alone or with furosemide may increase the risk of stroke or death in elderly patients with dementia.
The following medicines may reduce the effect of risperidone
- Rifampicin (a medicine to treat some infections)
- Carbamazepine, phenytoin (medicines for epilepsy)
- Phenobarbital If you start or stop taking such medicines, you may need a different dose of risperidone.
The following medicines may increase the effect of risperidone
- Quinidine (used for some heart diseases)
- Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
- Medicines known as beta blockers (used to treat high blood pressure)
- Phenothiazines (used to treat psychosis or as a sedative)
- Cimetidine, ranitidine (stomach acid blockers)
If you start or stop taking such medicines, you may need a different dose of risperidone.
If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Risperdal.
Risperdal with food, drink and alcohol
You can take this medicine with or without food. During treatment with Risperdal you should avoid drinking alcohol.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide if you can use it.
- The following symptoms may occur in newborn babies born to mothers who have taken Risperdal during the last trimester (the last three months of their pregnancy): shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems and difficulty in eating. . If your baby shows any of these symptoms, contact your doctor.
- Risperdal may increase the levels of a hormone called 'prolactin' which can affect fertility (see Possible side effects).
Driving and using machines
Dizziness, tiredness and vision problems may occur during treatment with Risperdal. Do not drive or use any tools or machines without first talking to your doctor.
Risperdal contains lactose or aspartame
Risperdal film-coated tablets contain lactose, a type of sugar. If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.
Risperdal 2 mg film-coated tablets contain sunset yellow aluminum lake (E110) which may cause allergic reactions.
Risperdal orodispersible tablets contain aspartame (E951), a source of phenylalanine. It can be harmful to you if you have phenylketonuria.
Dosage and method of use How to use Risperdal: Dosage
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist. The recommended dose is as follows:
For the treatment of schizophrenia
Adults
- The usual starting dose is 2 mg per day, which can be increased to 4 mg per day from the second day
- The dose may then be increased by your doctor depending on how you respond to the treatment
- Most people feel better with daily doses of between 4 and 6 mg
- The total daily dose can be divided into one or two administrations. Your doctor will tell you what is best for you.
Senior citizens
- The starting dose will generally be 0.5 mg twice a day
- The dose can then be gradually increased by your doctor to 1-2 mg twice a day
- Your doctor will tell you which modality is best for you.
For the treatment of mania
Adults
- The usual starting dose will be 2 mg once a day
- The dose can then be gradually adjusted by your doctor, depending on your response to treatment
- Most people will feel better with doses between 1 and 6 mg once a day.
Senior citizens
- The starting dose will generally be 0.5 mg twice a day
- The dose can then be gradually adjusted by your doctor up to 1 - 2 mg twice a day, depending on your response to treatment. 5
For the treatment of persistent aggression in people with Alzheimer's dementia
Adults (including the elderly)
The usual starting dose will be 0.25 mg twice a day
- The dose can then be gradually adjusted by your doctor, depending on your response to treatment
- Most people will feel better on 0.5mg twice a day. Some patients may need 1 mg twice a day
- The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks.
Children and adolescents
- Children and adolescents under 18 should not be treated with Risperdal for schizophrenia or mania
For the treatment of conduct disorder
The dose will depend on the weight of the child:
For children weighing less than 50 kg:
- The starting dose will generally be 0.25 mg once a day
- The dose can be increased every other day in 0.25 mg increments per day
- The maintenance dose is usually between 0.25 mg and 0.75 mg once daily
For children weighing 50 kg or more:
- The starting dose will generally be 0.5 mg once a day
- The dose can be increased every other day in 0.5 mg increments per day
- The maintenance dose is usually between 0.5 mg and 1.5 mg once daily
The duration of treatment in patients with conduct disorder should not exceed 6 weeks.
Children under the age of 5 should not be treated with Risperdal for conduct disorder.
Patients with kidney or liver problems
Regardless of the condition being treated, all initial and subsequent doses of risperidone should be halved. Dose increases should occur more slowly in these patients. Risperidone should be used with caution in this patient group.
Risperdal film-coated tablets
- You should swallow the tablet with a glass of water.
- The score line is only to help you break the tablet if you have difficulty swallowing it whole.
Risperdal orodispersible tablets
- Remove the tablet from the blister only when you are ready to take the medicine Open the foil of a blister to see the tablet
- Do not push the tablet through the foil, as it can break
- Remove the tablet from the blister with dry hands
- Place the tablet immediately on the tongue
- The tablet will begin to break down within seconds.
- It is therefore possible to swallow it with or without water.
Risperdal oral drops, solution
The drops are supplied with a syringe (pipette). This should be used to help you measure the exact amount of medicine you need.
Follow these procedures:
- Remove the child resistant cap. Press the screw cap down and turn it counterclockwise at the same time
- Insert the syringe into the bottle
- Holding the lower ring still, pull the upper ring upwards, up to the mark corresponding to the quantity in milliliters or mg to be taken
- Holding the bottom ring, pull the entire syringe out of the bottle
- Empty the contents of the syringe into any soft drink, except tea. Slide the top ring down
- Close the bottle
- Rinse the syringe with some water.
Overdose What to do if you have taken an overdose of Risperdal
If you use more Risperdal than you should
- Consult your doctor immediately. Take the medicine pack with you
- In the event of an overdose, you may feel sleepy or tired or have strange body movements, problems with standing and walking, dizziness caused by low blood pressure, or abnormal heart beat or fits.
If you forget to take Risperdal
- If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.
- Do not take a double dose (two doses together) to make up for a forgotten dose.
If you stop taking Risperdal
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may recur. If your doctor decides to stop this medicine, your dose may be gradually decreased over a few days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Risperdal
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if:
- You think you have blood clots (thrombi) in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which can travel along the blood vessels to the lungs, causing chest pain and difficulty in breathing. If you notice any of these symptoms, consult your doctor immediately.
- You have dementia and notice a sudden change in your mental state or a "sudden weakness or numbness of the face, arms or legs, especially on one side, or if your language is incomprehensible, even if for a short time. They can." be the signs of a stroke.
- You have fever, muscle stiffness, sweating or a reduced level of consciousness (a disorder called Neuroleptic Malignant Syndrome). Immediate medical treatment may be needed.
- He is male and has a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be required.
- He has involuntary rhythmic movements of the tongue, mouth and face. Risperidone may need to be discontinued
- Have a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash or drop in blood pressure.
The following side effects may occur:
Very common (affects more than 1 user in 10):
- Difficulty falling asleep or staying asleep
- Parkinsonism: This condition can include: slow or impaired body movements, a feeling of muscle stiffness or tension (making movements jerky), and sometimes even a feeling of movement that freezes and then restarts. Other signs of parkinsonism include slow shuffling walking, a tremor at rest, increased saliva and / or drooling, and a loss of facial expression.
- Feeling sleepy or less alert
- Headache.
Common (affects 1 to 10 users in 100):
- Pneumonia, chest infection (bronchitis), cold symptoms, sinusitis
- Urinary tract infection
- Ear infection, feeling like you have the flu
- Risperdal may increase the levels of a hormone called 'prolactin' found in a blood test (which may or may not cause symptoms). When symptoms of a high prolactin level occur, these may include: (in men) breast swelling, difficulty in getting or maintaining erections or other sexual dysfunction; (in women) breast discomfort, loss of milk from the breasts, missing menstrual periods or other problems with your period
- Weight gain, increased appetite, decreased appetite
- Sleep disturbances, irritability, depression, anxiety, agitation
- Dystonia: This is a condition that involves slow or prolonged involuntary muscle contraction. While it can involve any part of the body (resulting in abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue, or jaw.
- Dizziness
- Dyskinesia: This is a condition that involves involuntary muscle movements and can include repetitive, spastic or twisted movements or spasms.
- Tremor (shaking)
- Blurred vision, eye infection or conjunctivitis
- Rapid heart rate, high blood pressure, shortness of breath
- Sore throat, cough, nosebleed, stuffy nose
- Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache
- Rash, redness of the skin
- Muscle spasms, bone or muscle pain, back pain, joint pain
- Urinary incontinence (lack of control)
- Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain
- Fall.
Uncommon (affects 1 to 10 users in 1000):
- Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, infection of a single area of skin or part of the body, viral infection, inflammation of the skin caused by mites.
- A decrease in a type of white blood cell in the blood which serves to protect the body from infection
- Reduction in the number of white blood cells, reduction in platelets (blood cells that help stop bleeding), anemia, reduction in the number of red blood cells, increase in eosinophils (particular white blood cells) in the blood
- Allergic reaction
- Diabetes or worsening of diabetes, high blood sugar, excessive water intake, weight loss, loss of appetite resulting in malnutrition and low body weight
- Increased cholesterol in the blood
- Euphoria (mania), confusion, decreased sexual drive, nervousness, nightmares
- Tardive dyskinesia (twitching or jerking movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue Risperdal
- Sudden loss of blood supply to the brain (stroke or "mini" stroke),
- Failure to respond to stimuli, loss of consciousness, reduced level of consciousness
- Convulsions (fits), fainting
- An urgent need to move a part of the body, balance disturbances, abnormal coordination, dizziness when standing up, attention disturbance, speech problems, loss or abnormal sense of taste, decreased sensitivity of the skin to pain and touch, a tingling, prickling or numb feeling of the skin
- Hypersensitivity of the eyes to light, dry eyes, increased tearing, redness of the eyes
- Sensation of spinning (vertigo), ringing in the ears, ear pain
- Atrial fibrillation (an abnormal heart rhythm), an interruption in cardiac conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the heart's QT interval, slow heart rate, abnormal electrical tracing of the heart (electrocardiogram or ECG ), a feeling of racing or throbbing in the chest (palpitations)
- Low blood pressure, low blood pressure when standing up (as a result, some patients taking Risperdal may feel faint, dizzy or faint when suddenly standing up or sitting down), hot flashes
- Pneumonia caused by inhalation of food, lung congestion, airway congestion, croaking sounds in the lungs, wheezing, voice problems, respiratory tract disorder
- Stomach or bowel infection, fecal incontinence, hard stools, difficulty swallowing, excessive passing of gas or air
- Hives, itching, hair loss, skin thickening, eczema, dry skin, skin discoloration, acne, flaking and itchy scalp or skin, skin disorder, skin injury
- An increase in blood levels of CPK (creatine phosphokinase), an enzyme that is sometimes released when there is muscle damage
- Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
- Frequent urination, inability to urinate, pain when urinating
- Erectile dysfunction, ejaculation disorders
- Loss of menstrual periods, missed periods or problems with your period (females),
- Breast development in men, breast milk loss, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
- Swelling of the face, mouth, eyes or lips
- Chills, increased body temperature
- Change in the way you walk
- Feeling thirsty, feeling unwell, chest pain, feeling out of sorts, discomfort
- Increased liver transaminases in the blood, increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood
- Procedural pain
Rare (affects 1 to 10 users in 10,000):
- Infection
- Inappropriate secretion of the hormone that controls urine volume
- Sugar in the urine
- Low blood sugar, high levels of triglycerides (a fat)
- Lack of emotion, inability to reach orgasm
- Neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever and severe muscle stiffness)
- Problems with the blood vessels in the brain
- Coma due to uncontrolled diabetes
- Shaking of the head
- Glaucoma (increased pressure inside the eyeball). Problems with eye movement, eye rotation, eyelid margin crusting
- Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you take or have taken RISPERDAL. be sure to tell your doctor if you take or have taken this medicine
- Dangerously low number of a certain type of white blood cell needed to fight infections,
- Severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes a drop in blood pressure
- Dangerously excessive water intake
- mbe, blood clots in the lungs
- Breathing problems during sleep (sleep apnea), fast and shallow breathing
- Inflammation of the pancreas
- Colon occlusion
- Swollen tongue, chapped lips, drug rash
- Dandruff
- Breakdown of muscle fibers and muscle pain (rhabdomyolysis)
- A delay in the menstrual cycle, enlarged mammary glands, breast enlargement, discharge from the breasts
- Increase in insulin levels (a hormone that controls blood sugar levels)
- Priapism (a prolonged and painful erection that may require surgical treatment)
- Hardening of the skin
- Very low body temperature, a decrease in body temperature, cold arms and legs
- Drug withdrawal syndrome
- Yellowing of the skin and eyes (jaundice)
Very rare (affects less than 1 user in 10,000):
- Life-threatening complications of uncontrolled diabetes
- Severe allergic reaction with swelling which can involve the throat and lead to breathing difficulties
- Lack of bowel muscle movement which causes blockage
The following side effects have been seen with the use of another medicine called paliperidone which is very similar to risperidone, so these effects can also be expected with Risperdal: fast heart rate when standing up.
Additional side effects in children and adolescents
In general, the type of side effects in children are expected to be similar to that seen in adults.
The following side effects have been reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling sleepy or less alert, fatigue, headache, increased appetite, vomiting, common cold symptoms, congestion nasal, abdominal pain, dizziness, cough, fever, tremor, diarrhea and urinary incontinence (loss of control).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https: // www. aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, carton or bottle. The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Risperdal film-coated tablets
Blisters: Store in the original package to protect from light.
Risperdal orodispersible tablets
Store in the original package to protect the medicine from moisture
Risperdal oral drops, solution
Do not freeze.
Store in the original package to protect from light and moisture.
Once the bottle is opened, any unused product must be discarded after 3 months.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Contents of the pack and other information
What Risperdal contains
The active ingredient is risperidone
Each Risperdal film-coated tablet contains 1 mg, 2 mg, 3 mg or 4 mg of risperidone.
The other ingredients are:
Risperdal 1 mg film-coated tablets
Tablet core: lactose monohydrate, corn starch, microcrystalline cellulose (E460), hypromellose (E464), magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate. Coating: hypromellose (E464), propylene glycol (E490).
Risperdal 2 mg film-coated tablets
Core of the tablet: lactose monohydrate, corn starch, microcrystalline cellulose (E460), hypromellose (E464), magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate. Coating: hypromellose (E464), propylene glycol (E490), talc (E553B), titanium dioxide (E171), sunset yellow-aluminum lake (E110).
Risperdal 3 mg film-coated tablets
Core of the tablet: lactose monohydrate, corn starch, microcrystalline cellulose (E460), hypromellose (E464), magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate. Coating: hypromellose (E464), propylene glycol (E490), talc (E553B), titanium dioxide (E171), quinoline yellow (E104).
Risperdal 4 mg film-coated tablets
Core of the tablet: lactose monohydrate, corn starch, microcrystalline cellulose (E460), hypromellose (E464), magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate. Coating: hypromellose (E464), propylene glycol (E490), talc (E553B), titanium dioxide (E171), quinoline yellow (E104), indigotindisulfonate-aluminum lake (E132).
Each Risperdal orodispersible tablet contains 1 mg or 2 mg of risperidone.
The other ingredients are:
Risperdal 1 mg square orodispersible tablets
Polacrilex resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame E951, red iron oxide E172, peppermint oil.
Risperdal 2 mg square orodispersible tablets
Polacrilex resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame E951, red iron oxide E172, peppermint oil, Xanthan gum. 1 ml of
Risperdal oral drops, solution contains 1 mg of risperidone
The other ingredients are: tartaric acid, benzoic acid, sodium hydroxide, purified water.
Description of what Risperdal looks like and contents of the pack
Risperdal film-coated tablets are packed in PVC / LDPE / PVDC aluminum blister foil and in HDPE bottles with PP screw cap.
Risperdal orodispersible tablets are packaged in film / sheet or sheet / sheet blister.
Risperdal film-coated tablets
- Risperidone 0.5 mg tablets are red-brown, oblong, biconvex, scored
- Risperidone 1 mg tablets are white, oblong, biconvex, scored
- Risperidone 2 mg tablets are orange, oblong, biconvex, scored
- Risperidone 3 mg tablets are yellow, oblong, biconvex, scored
- Risperidone 4 mg tablets are green, oblong, biconvex, scored
- Risperidone 6 mg tablets are white, round
The film-coated tablets have one side debossed RIS 0.5, RIS 1, RIS 2, RIS 3 and RIS 4, RIS 6 respectively. Additionally JANSSEN can be engraved on the reverse side
Risperdal film-coated tablets are available in the following pack sizes:
0.5 mg: in blisters containing 20 or 50 tablets and bottles containing 500 tablets
1 mg: in blisters containing 6, 20, 50, 60, or 100 tablets and bottles containing 500 tablets
2 mg: on blisters containing 10, 20, 50, 60, or 100 tablets and bottles containing 500 tablets
3 mg: in blisters containing 20, 50, 60, or 100 tablets
4 mg: in blisters containing 10, 20, 30, 50, 60, or 100 tablets 6 mg: in blisters containing 28, 3 or 60 tablets
Not all pack sizes may be marketed.
Risperdal orodispersible tablets
- Risperdal 1 mg orodispersible tablets are light coral colored, square and biconvex
- Risperdal 2 mg orodispersible tablets are coral colored, square and biconvex
- The orodispersible tablets are scored on one side of R1 and R2 respectively
Packaging:
1 mg: packs containing 28, 56 orodispersible tablets
2 mg: packs containing 28, 56 orodispersible tablets
Not all pack sizes may be marketed.
Oral drops, solution
The drops are packaged in amber glass bottles with a child resistant cap containing 30 or 100 ml of clear, colorless liquid. A graduated pipette is also provided.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
RISPERDAL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Film-coated tablets
Each film-coated tablet contains 1 mg of risperidone
Each film-coated tablet contains 2 mg of risperidone
Each film-coated tablet contains 3 mg of risperidone
Each film-coated tablet contains 4 mg of risperidone
Excipients with known effects:
Each 1 mg film-coated tablet contains 131 mg of lactose monohydrate
Each 2 mg film-coated tablet contains 130 mg lactose monohydrate and 0.05 mg sunset yellow-E110 aluminum lake
Each 3 mg film-coated tablet contains 195 mg of lactose monohydrate
Each 4 mg film-coated tablet contains 260 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
Orodispersible tablets
Each orodispersible tablet contains 1 mg of risperidone
Each orodispersible tablet contains 2 mg of risperidone
Excipients with known effects:
Each 1 mg orodispersible tablet contains 0.5 mg aspartame (E951)
Each 2 mg orodispersible tablet contains 0.75 mg of aspartame (E951)
For the full list of excipients, see section 6.1.
Oral drops, solution
1 ml of solution contains 1 mg of risperidone
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
• Risperidone 1 mg tablets are white, oblong, biconvex, with fracture line
• Risperidone 2 mg tablets are orange, oblong, biconvex, scored
• Risperidone 3 mg tablets are yellow, oblong, biconvex , with fracture line
• Risperidone 4 mg tablets are green, oblong, biconvex, scored
The score line on the tablet is intended to make it easier to break and to swallow the tablet more easily and not to divide it into equal doses.
The film-coated tablets have RIS 1, RIS 2, RIS 3 and RIS 4 debossed on one side respectively.
Additionally JANSSEN can be engraved on the reverse side.
Orodispersible tablets
• Risperidone 1 mg tablets are light coral colored, square and biconvex
• Risperidone 2 mg orodispersible tablets are coral colored, square and biconvex
• The orodispersible tablets are scored on one side R1 and R2 respectively
Oral drops, solution.
The solution is clear and colorless.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Risperdal is indicated for the treatment of schizophrenia.
Risperdal is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorder.
Risperdal is indicated for the short-term (up to 6 weeks) treatment of persistent aggression in patients with moderate to severe Alzheimer's dementia who are unresponsive to non-pharmacological approaches, and when there is a risk of harm to themselves or to the others.
Risperdal is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with below average intellectual functioning or with mental retardation, diagnosed according to to the DSM-IV criteria, in which the severity of aggressive or other disruptive behaviors requires drug treatment.
Pharmacological treatment must be an integral part of a more comprehensive therapeutic program, which includes psychosocial and educational intervention. It is recommended that risperidone be prescribed by specialists in child neurology and child and adolescent psychiatry, or by physicians experienced in the treatment of conduct disorder in children and adolescents.
04.2 Posology and method of administration
Schizophrenia
Adults
Risperdal can be given once or twice a day.
Patients should be started on risperidone 2 mg / day. The dose could be increased to 4 mg from the second day. Thereafter, the dose can remain unchanged or be further customized according to the patient's needs. Most patients will benefit from a daily dose of 4 to 6 mg. For some patients, slower titration and lower initial and maintenance doses may be more appropriate.
Administration of doses higher than 10 mg / day did not show greater efficacy than lower doses and could cause an increase in the incidence of extrapyramidal symptoms. The safety of dosages above 16 mg / day has not been evaluated, therefore they are not recommended.
Senior citizens
It is recommended to start treatment by administering 0.5 mg twice a day. This dosage can be individually adjusted in increments of 0.5 mg twice daily up to 1-2 mg twice daily.
Pediatric patients
Risperidone is not recommended for use in children below 18 years with schizophrenia due to a lack of data on efficacy.
Manic Episodes in Bipolar Disorder
Adults
Risperdal should be administered once daily, starting with a 2 mg dose of risperidone. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in increments of 1 mg / day. Risperidone can be administered in flexible doses over a range of 1-6 mg per day to optimize efficacy and tolerability in each patient. In patients with manic episodes, daily doses greater than 6 mg of risperidone have not been studied.
As with all symptomatic treatments, the continued use of Risperdal should be evaluated and justified periodically.
Senior citizens
It is recommended to start treatment by administering 0.5 mg twice a day. This dose can be individually adjusted in increments of 0.5 mg twice daily up to 1-2 mg twice daily. Since clinical experience in the elderly is limited, use with caution.
Pediatric patients
Risperidone is not recommended for use in children / adolescents with schizophrenia below 18 years of age due to a lack of data on efficacy.
Persistent aggression in patients with moderate to severe Alzheimer's dementia
It is recommended to start treatment by administering 0.25 mg twice daily. This dose can be individually adjusted, if necessary, by increments of 0.25 mg twice daily, every other day only. For most patients, the optimal dose is 0.5 mg twice a day. Some patients, however, may benefit from doses up to 1 mg twice daily.
Risperdal should not be used for more than 6 weeks in patients with persistent aggression in Alzheimer's dementia. During the course of treatment, patients should be evaluated frequently and regularly, and the need for continued therapy reexamined.
Conduct disorder
Children and adolescents from 5 to 18 years of age
In patients weighing ≥50 kg, it is recommended to initiate treatment by administering 0.5 mg once daily. This dose can be individually adjusted, if necessary, by increments of 0.5 mg once daily, every other day only. For most patients, the optimal dose is 1 mg once a day. Some patients, however, may benefit from a 0.5 mg / day dose, while others may need a 1.5 mg / day dose. In patients with weight
As with all symptomatic treatments, the continued use of Risperdal should be evaluated and justified periodically.
Risperdal is not recommended in children under 5 years of age because there is no experience in children under 5 years of age with this disorder.
Renal and hepatic insufficiency
Patients with renal insufficiency have a reduced ability to eliminate the active antipsychotic fraction compared to adults with normal renal function. Patients with hepatic insufficiency have increases in the plasma concentration of the free fraction of risperidone.
Irrespective of the indication, in patients with renal or hepatic insufficiency, the starting dose and subsequent increments should be halved and dose adjustment should be made more slowly.
Risperdal should be used with caution in these patient groups.
Method of administration
Risperdal is for oral use. Food does not affect the absorption of Risperdal.
In case of discontinuation of therapy, a gradual withdrawal is recommended. Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia, have been reported very rarely after abrupt discontinuation of high doses of antipsychotics (see section 4.8). Recurrence of psychotic symptoms may also occur, and involuntary movement disorders (such as akathisia, dystonia and dyskinesia) have been reported.
Switching from other antipsychotics.
If clinically appropriate, it is recommended that previous therapy be gradually withdrawn while Risperdal is initiated. Similarly, when it is considered clinically appropriate to switch from depot antipsychotics, treatment with Risperdal is initiated in place of the next scheduled injection. The need for continued administration of anti-parkinson drugs should be reassessed periodically.
Risperdal orodispersible tablets:
Do not open the blister until you are ready for administration. Open the foil of the blister to expose the tablet. Do not push the tablet through the foil, as it may break. Remove the tablet from the blister with dry hands.
Immediately place the tablet on the tongue. The tablet begins to break down within seconds. If desired, water can be used.
Risperdal oral solution:
For instructions on handling Risperdal oral solution see section 6.6
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
Elderly patients with dementia
Increased mortality in elderly patients with dementia
In a meta-analysis of 17 controlled clinical trials of atypical antipsychotics, including Risperdal, there was an increase in mortality compared to placebo in elderly patients with dementia treated with atypical antipsychotics. In placebo-controlled clinical trials with oral Risperdal in this population, an incidence of mortality of 4.0% was observed in patients treated with Risperdal versus 3.1% in patients who received placebo. (95% exact confidence interval) was 1.21 (0.7, 2.1). The mean age (range) of the deceased patients was 86 years (range 67-100). Data from two large observational studies also showed that even in elderly patients with dementia treated with conventional antipsychotics the risk of death is slightly increased. compared to untreated patients. There are insufficient data to actually estimate the precise magnitude of the risk and the cause of the increased risk is unknown. It is unclear to what extent the increased mortality found in observational studies can be attributed to the antipsychotic drug rather than to some patient characteristics.
Concomitant use of furosemide
In placebo-controlled clinical trials of Risperdal in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide and risperidone (7.3%; mean age 89 years, range 75-97), compared with patients treated only with risperidone (3.1%; mean age 84 years, range 70-96) or only with furosemide (4.1%; mean age 80 years, range 67-90). The increased mortality in patients treated with furosemide and risperidone was observed in two of the four clinical studies. The concomitant use of risperidone with other diuretics (mainly thiazide diuretics used at low doses) was not associated with similar observations.
No pathophysiological mechanisms have been identified to explain this observation, nor has any compatible pattern for causes of death been observed. Nonetheless, care should be taken and the risks and benefits of this combination, or combinations with other potent diuretics, should be considered before deciding to use it. No increased incidence of mortality was observed among patients taking other diuretics concomitantly with risperidone. Regardless of treatment, dehydration was an overall risk factor for mortality, and therefore should be carefully avoided in elderly patients with dementia.
Adverse Cerebrovascular Events (EACV)
An approximately 3-fold increased risk of cerebrovascular adverse events was observed in randomized placebo-controlled clinical trials in dementia patients treated with some atypical antipsychotics. Pooled data from six placebo-controlled clinical trials with Risperdal mainly conducted in elderly patients (> 65 years) with dementia showed that ACVs (severe and non-serious, associated) occurred in 3.3% (33/1009) of patients treated with risperidone and in 1.2% (8/712) of those treated with placebo. The odds ratio (exact 95% confidence interval) was 2.96 (1.34 - 7.50). The mechanism for this increased risk is unknown. An increased risk cannot be excluded for other antipsychotics or other patient populations. Risperdal should be used with caution in patients with stroke risk factors.
The risk of EACV was significantly higher in patients with vascular or mixed dementia than in those with Alzheimer's dementia. Therefore, patients with forms of dementia other than Alzheimer's should not be treated with risperidone.
Physicians are advised to weigh the risks and benefits of using Risperdal in elderly patients with dementia, taking into account the individual patient's predictive risk factors for stroke. Patients / caregivers should be advised to report signs and symptoms immediately of potential EACV, such as "sudden weakness or numbness in the face, arms or legs, as well as speech or vision problems." All alternative treatments, including discontinuation of treatment, should be considered without further delay.
Risperdal is to be used only in the short term for the treatment of persistent aggression in patients with moderate to severe Alzheimer's dementia, as a supplement to non-pharmacological approaches, which have shown limited or ineffective efficacy and when there is a potential risk. for the patient to harm himself or others.
Patients should be re-evaluated periodically and the need for continued treatment should be reassessed.
Orthostatic hypotension
In relation to the alpha-blocking activity of risperidone, hypotension (orthostatic) phenomena may occur, especially during the initial dose adjustment phase. Clinically significant hypotension has been observed in the postmarketing phase with the concomitant use of risperidone and antihypertensive treatment. . Risperdal should be administered with caution in patients with known cardiovascular disease (e.g. heart failure, myocardial infarction, conduction disturbances, dehydration, hypovolaemia or cerebrovascular disease) and gradual dose adjustment as recommended is recommended (see section 4.2). In case of hypotension, a dose reduction should be considered.
Leukopenia, neutropenia and agranulocytosis
Events of leukopenia, neutropenia and agranulocytosis have been reported with the use of antipsychotic agents, including Risperdal. Agranulocytosis has been reported very rarely (clinically significant history of low white blood cell count (WBC) or with drug induced leukopenia / neutropenia should be monitored during the first months of therapy and discontinuation of Risperdal should be considered at the first sign of clinically significant WBC decrease in the absence of other causative factors. Patients with clinically significant neutropenia should be closely monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.Patients with severe neutropenia (absolute neutrophil count
Tardive dyskinesia / Extrapyramidal symptoms (DT / SEP)
Medicinal products with dopamine receptor antagonism properties have been associated with the induction of tardive dyskinesia, characterized by rhythmic involuntary movements, predominantly of the tongue and / or face. The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia. If signs and symptoms of tardive dyskinesia occur, the possibility of discontinuing any antipsychotic treatment should be considered.
Neuroleptic malignant syndrome (NMS)
Neuroleptic Malignant Syndrome, characterized by hyperthermia, muscle stiffness, autonomic instability, altered state of consciousness and elevated serum creatinophosphokinase levels, has been reported with the administration of antipsychotic drugs. Additional signs may include myoglobinuria (rhabdomyolysis) and renal failure. In this case, all antipsychotics, including Risperdal, should be discontinued.
Parkinson's disease and Lewy body dementia
Before prescribing antipsychotics, including Risperdal, to patients with Parkinson's disease or Lewy body dementia (DLB), physicians should evaluate the benefit / risk ratio. The disease can get worse with risperidone. Both groups of patients may be at increased risk for Neuroleptic Malignant Syndrome, as well as more sensitive to antipsychotic drugs; these patients were excluded from clinical trials. The increase in this sensitivity can manifest itself with confusion, sedation, postural instability with frequent falls, as well as extrapyramidal symptoms.
Hyperglycemia and diabetes mellitus
Hyperglycaemia, diabetes mellitus and exacerbation of pre-existing diabetes have been reported during treatment with Risperdal.
In some cases, previous weight gain has been reported which may be a predisposing factor. The association with ketoacidosis has been reported very rarely and rarely with diabetic coma. Adequate clinical monitoring according to guidelines is advised with the use of antipsychotics. Patients treated with any atypical antipsychotic, including oral Risperdal, should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus should be monitored regularly for worsening glucose control.
Weight gain
Significant increase in body weight has been reported with the use of Risperdal. Weight should be monitored regularly.
Hyperprolactinemia
Tissue culture studies suggest that cell growth in human breast cancers may be stimulated by prolactin. Although a clear association with the administration of antipsychotics has not been demonstrated so far in clinical and epidemiological studies, caution is recommended in patients with a relevant clinical history. Risperdal should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with potentially prolactin-dependent tumors.
Prolongation of the QT interval
QT interval prolongation has been reported very rarely in the postmarketing setting. As with other antipsychotics, caution should be exercised when prescribing risperidone to patients with known cardiovascular disease, family history of QT interval prolongation, bradycardia or electrolyte imbalances ( hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in the concomitant use of medicinal products known to cause QT prolongation.
Convulsions
Risperdal should be used with caution in patients with a history of seizures or other conditions that may lower the seizure threshold.
Priapism
Priapism may occur with Risperdal, due to its alpha-adrenergic receptor blocking activity.
Body thermoregulation
Antipsychotic medicinal products have been shown to impair the body's ability to reduce core body temperature. Due caution is advised when prescribing Risperdal to patients who may experience conditions that may contribute to an increase in body temperature. internal, for example, intense physical activity, exposure to extreme heat, concomitant administration of drugs with anticholinergic activity, or predisposition to dehydration.
Antiemetic effect
An antiemetic effect was observed in preclinical studies with risperidone. This effect, if it occurs in humans, may mask the signs and symptoms of overdose of certain medicines or of conditions such as intestinal obstruction, Reye's syndrome and brain tumor.
Renal and hepatic impairment
Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than adults with normal renal function. Patients with hepatic impairment have an increased plasma concentration of the free fraction of risperidone (see section 4.2).
Venous thromboembolism
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Patients treated with antipsychotic drugs often have acquired risk factors for VTE; Before and during treatment with Risperdal, all possible risk factors for VTE must be identified and preventive measures undertaken.
Intraoperative Floppy Iris Syndrome
Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in patients treated with medicinal products with alpha1a-adrenergic antagonist effect, including Risperdal (see section 4.8).
IFIS may increase the risk of ocular complications during and after the operation. Current or past use of medicinal products with alpha1a-adrenergic antagonist effect should be made known to the ophthalmic surgeon prior to surgery. The potential benefit of discontinuing alpha1 blocker therapy prior to cataract surgery has not been established and must be weighed against the risk of discontinuing antipsychotic therapy.
Pediatric population
Before prescribing risperidone to a child or adolescent with a conduct disorder, the physical and social causes of their aggressive behavior, such as pain or inappropriate environmental demands, should be carefully evaluated.
In this population it is necessary to constantly monitor the sedative effect of risperidone, for the possible consequences on the ability to learn. Changing the time when risperidone is administered can improve the impact of sedation on the attention span of children and adolescents. .
Risperidone has been associated with mean increases in body weight and body mass index (BMI). Baseline body weight measurement prior to treatment and regular monitoring of body weight are recommended. the open-label extension phase of the long-term studies, fell within the predicted age patterns.
The effects of long-term risperidone treatment on sexual maturity and height have not been adequately studied.
Because of the potential effects of prolonged hyperprolactinaemia on the growth and sexual maturation of children and adolescents, regular clinical evaluation of endocrine function, including examination of height, weight, sexual maturation, monitoring, should be considered. menstrual function and other effects potentially related to prolactin.
Evaluation of extrapyramidal symptoms and other movement disorders should also be conducted regularly during treatment with risperidone.
For specific dosing recommendations in children and adolescents, see section 4.2.
Excipients
The film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The orodispersible tablets contain aspartame. Aspartame is a source of phenylalanine, potentially dangerous for people with phenylketoinuria.
The 2 mg film-coated tablets contain sunset yellow (E110). It can cause allergic reactions.
04.5 Interactions with other medicinal products and other forms of interaction
Pharmacodynamic interactions
Drugs known to cause QT interval prolongation
As with other antipsychotics, caution is advised when prescribing risperidone in combination with medications known to cause QT interval prolongation, such as, antiarrhythmics (eg, quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), tricyclic antidepressants (eg amitriptyline), tetracyclic antidepressants (e.g. maprotiline), some antihistamines, other antipsychotics, some antimalarials (e.g. quinine and mefloquine) and with drugs that induce electrolyte imbalances (hypokalaemia, hypomagnesaemia), bradycardia, or those that inhibit hepatic metabolism of risperidone This is an indicative and non-exhaustive list.
Centrally acting drugs and alcohol
Risperidone should be used with caution in combination with other centrally acting substances, especially including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.
Levodopa and dopamine agonists
Risperdal may antagonize the effect of levodopa and other dopamine agonists. If this combination is deemed necessary, particularly in the final stage of Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Drugs with hypotensive effect
Clinically significant hypotension has been observed post-marketing with the concomitant use of risperidone and antihypertensive treatment.
Paliperidone
The combination of oral Risperdal with paliperidone is not recommended, because paliperidone is the active metabolite of risperidone and their combination may result in cumulative exposure to the active antipsychotic fraction.
Pharmacokinetic interactions
Food does not affect the absorption of Risperdal.
Risperidone is metabolised primarily via CYP2D6, and to a lesser extent by CYP3A4. Both risperidone and its active metabolite 9-hydroxyrisperidone are substrates of P-glycoprotein (P-gp). Substances which modify CYP2D6 activity, or which are potent inhibitors or inducers of CYP3A4 and / or P-gp activity, may affect the pharmacokinetics of the active antipsychotic fraction of risperidone.
Strong CYP2D6 inhibitors
Concomitant administration of Risperdal with a strong CYP2D6 inhibitor may increase the plasma concentrations of risperidone, but to a lesser extent those of the active antipsychotic fraction. High doses of a potent CYP2D6 inhibitor may increase concentrations of the active antipsychotic fraction of risperidone (e.g. paroxetine, see below). Other CYP 2D6 inhibitors, such as quinidine, are expected to affect the plasma concentrations of risperidone in a similar way. When concomitant treatment with paroxetine, quinidine or another strong CYP2D6 inhibitor, especially at high doses, is initiated or discontinued, the physician should re-evaluate the dose of Risperdal.
CYP3A4 and / or P-gp inhibitors
Concomitant administration of Risperdal with a strong CYP3A4 and / or P-gp inhibitor may substantially increase the plasma concentrations of the risperidone active antipsychotic fraction. When concomitant itraconazole or another strong CYP3A4 and / or P-gp inhibitor is initiated or discontinued, the physician should re-evaluate the dose of Risperdal.
CYP3A4 and / or P-gp inducers
Concomitant administration of Risperdal with a strong CYP3A4 and / or P-gp inducer may decrease the plasma concentrations of the risperidone active antipsychotic fraction. When concomitant treatment with carbamazepine or another strong CYP3A4 and / or P-gp inducer is initiated or discontinued, the physician should re-evaluate the dose of Risperdal. CYP3A4 inducers exert their effect in a time-dependent manner and may take at least 2 weeks to reach maximum effect after their introduction. Conversely, upon discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
Medicinal products with high plasma protein binding
When Risperdal is taken together with highly plasma protein binding medicinal products, no clinically relevant shift of either medicinal product from plasma proteins occurs.
When administering concomitant medicinal products, the Summary of Product Characteristics should be consulted regarding information on metabolism and the possible need for dose adjustments.
Pediatric population
Interaction studies have only been conducted in adults. The relevance of the results of these studies in pediatric patients is unknown.
The combined use of psychostimulants (eg, methylphenidate) with Risperdal in children and adolescents did not alter the pharmacokinetics and efficacy of Risperdal.
Examples
Examples of medicines that have the potential to interact or have been shown not to interact with risperidone are listed below:
Effect of other medicinal products on risperidone pharmacokinetics
RisperdalAntibacterials:
• Erythromycin, a moderate CYP3A4 inhibitor and a P-gp inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.
• Rifampicin, a strong CYP3A4 inducer and a P-gp inducer, reduced the plasma concentrations of the active antipsychotic fraction.
Anticholinesterases:
• Donepezil and galantamine, both substrates of CYP2D6 and CYP3A4, do not show a clinically relevant effect on the pharmacokinetics of risperidone and the active antipsychotic fraction.
Antiepileptics:
• Carbamazepine, a strong CYP3A4 inducer and a P-gp inducer, has been shown to reduce the plasma concentrations of the active antipsychotic fraction of risperidone. Similar effects can be observed e.g. with phenytoin and phenobarbital, which are also inducers of the hepatic enzyme CYP 3A4, as well as the glycoprotein PRisperdal.
• Topiramate modestly reduced the bioavailability of risperidone, but not that of the active antipsychotic fraction. Therefore this interaction is unlikely to be of clinical significance.
Antifungals:
• Itraconazole, a potent CYP3A4 inhibitor and a P-gp inhibitor, at a dose of 200 mg / day increased the plasma concentrations of the active antipsychotic fraction by approximately 70%, with risperidone doses of 2-8 mg / day .
• Ketoconazole, a potent CYP3A4 inhibitor and P-gp inhibitor, at a dose of 200 mg / day increased the plasma concentrations of risperidone and decreased the plasma concentrations of 9-hydroxyrisperidone.
Antipsychotics:
• Phenothiazines may increase the plasma concentrations of risperidone, but not those of the active antipsychotic fraction.
Antivirals:
• Protease inhibitors: data from formal studies are not available; however, since ritonavir is a potent inhibitor of CYP3A4 and a weak inhibitor of CYP2D6, ritonavir and ritonavir-boosted protease inhibitors potentially increase concentrations of the active antipsychotic fraction of risperidone.
Beta blockers:
• Some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Calcium channel blockers:
• Verapamil, a moderate CYP3A4 inhibitor and a P-gp inhibitor, increases the plasma concentration of risperidone and the active antipsychotic fraction.
Gastrointestinal medications:
• H2 receptor antagonists: cimetidine and ranitidine, both weak inhibitors of CYP2D6 and CYP3A4, increased the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction.
SSRIs and tricyclic antidepressants:
• Fluoxetine, a potent inhibitor of RisperdalCYP2D6, increases the plasma concentration of risperidone but to a lesser extent that of the active antipsychotic fraction.
• Paroxetine, a potent CYP2D6 inhibitor, increases the plasma concentration of risperidone but, at doses up to 20 mg / day, less than that of the active antipsychotic fraction. However, higher doses of paroxetine may increase the concentrations of the active antipsychotic fraction of risperidone.
• Tricyclic antidepressants may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of Risperdaldi risperidone or the active antipsychotic fraction.
• Sertraline, a weak inhibitor of CYP2D6, and fluvoxamine, a weak inhibitor of CYP3A4, at doses up to 100 mg / day are not associated with clinically significant changes in concentrations of the risperidone active antipsychotic fraction. However, doses above 100 mg / day of sertraline or fluvoxamine may increase concentrations of the risperidone active antipsychotic fraction.
Effect of risperidone on the pharmacokinetics of other medicinal products
Antiepileptics:
• Risperidone does not exhibit a clinically relevant effect on the pharmacokinetics of valproate and topiramate.
Antipsychotics:
• Aripiprazole, a substrate of CYP2D6 and CYP3A4: Oral or injectable risperidone did not affect the pharmacokinetics of the sum of aripiprazole and its active metabolite, dehydroaripiprazole.
Digitalis glycosides:
• Risperidone does not show a clinically relevant effect on the pharmacokinetics of digoxin.
Lithium:
• Risperidone does not show a clinically relevant effect on lithium pharmacokinetics.
Concomitant use of risperidone and furosemide
• See section 4.4 regarding increased mortality in elderly patients with dementia treated in combination with furosemide.
Risperdal
04.6 Pregnancy and lactation
Pregnancy
There are insufficient data on the use of risperidone in pregnant women. Risperidone has not shown teratogenic effects in animal studies, but other types of reproductive toxicity have been found (see section 5.3). The potential risk to humans is not it's known.
Infants exposed to antipsychotics (including Risperdal) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and / or withdrawal symptoms which may vary in severity and duration after birth. Cases of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or nutritional disturbances have been reported. Therefore infants must be carefully monitored.
Risperdal should not be used during pregnancy unless clearly necessary. If during pregnancy it is necessary to discontinue treatment, discontinuation should not occur suddenly.
Feeding time
In animal studies, risperidone and 9-hydroxy-risperidone are excreted in milk. Risperidone and 9-hydroxy-risperidone have also been shown to be excreted in breast milk in small amounts. There are no data available on adverse reactions in breastfed infants. Therefore, the benefit of breastfeeding must be weighed against the potential risk to the baby.
Fertility
As with other drugs that antagonize the dopamine D2 receptor, Risperdal increases prolactin levels.
Hyperprolactinaemia can suppress hypothalamic GnRH, resulting in decreased secretion of pituitary gonadotropin. This, in turn, can inhibit reproductive function by compromising gonadal steroidogenesis in both female and male patients.
No relevant effects were observed in non-clinical studies.
04.7 Effects on ability to drive and use machines
Risperdal may slightly or moderate interfere with the ability to drive and use machines due to potential effects on the nervous system and vision (see section 4.8). Therefore, patients should be advised not to drive or operate machinery until their individual sensitivity is known.
04.8 Undesirable effects
The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 10%) are: parkinsonism, sedation / somnolence, headache and insomnia.
ADRs that appear to be dose related include parkinsonism and akathisia.
The following ADRs are all those reported in clinical trials and postmarketing experience with risperidone by frequency category estimated from Risperdal clinical trials. The following terms and related frequencies apply: very common (≥1 / 10), common (from ≥1 / 100 y
Within each frequency class, undesirable effects are reported in descending order of severity.
a L "hyperprolactinemia can cause in some cases gynecomastia, menstrual disturbances, amenorrhea, galactorrhea.
b Diabetes mellitus was reported in 0.18% of subjects treated with risperidone compared to 0.11% in the placebo group in placebo-controlled clinical trials. The overall incidence of all clinical studies was 0.43% in all subjects treated with risperidone.
c Not observed in Risperdal clinical trials but observed in post-marketing experience with risperidone.
d Extrapyramidal disorders may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, ptyalism with saliva loss, jerky stiffness, bradykinesia, hypokinesia, mask facies, muscle tension, akinesia, nuchal stiffness, muscle stiffness, parkinsonian gait and glabellar reflex abnormal, parkinsonian tremor at rest), akathisia (akathisia, restlessness, hyperkinesia and restless legs syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis and myoclonia), dystonia.
Dystonia includes dystonia, hypertonia, torticollis, involuntary muscle contractions, muscle contracture, blepharospasm, oculogyrus, paralysis of the tongue, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurotonus, lingual spasm and trismus. It is important to note that a broader spectrum of symptoms are included, not necessarily of extrapyramidal origin. Insomnia includes: initial insomnia, central insomnia; seizures includes: grand mal convulsions; menstrual disorders includes: irregular menstruation, oligomenorrhea; edema includes: generalized edema, peripheral edema, plastic edema.
Undesirable effects reported with paliperidone formulations
Paliperidone is the active metabolite of risperidone, therefore, the adverse ration profiles of these compounds (including both oral and injectable formulations) are relevant to each other. In addition to the adverse reactions mentioned above, the following adverse reactions have been reported with the use of paliperidone products and can be expected with Risperdal.
Cardiac disorders: postural orthostatic tachycardia syndrome.
Class effects
Very rare cases of QT interval prolongation have been reported postmarketing with risperidone, like other antipsychotics. Other cardiac class effects reported with antipsychotics that prolong QT interval include ventricular arrhythmia, ventricular fibrillation, tachycardia ventricular, sudden death, cardiac arrest and torsades de pointes.
Venous thromboembolism
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic drugs (frequency not known).
Weight gain
Pooled data from placebo-controlled clinical trials lasting 6-8 weeks compared the proportions of adult schizophrenia patients treated with Risperdal and placebo who met a weight gain criterion ≥7% body weight, revealing greater statistically significant incidence of weight gain for Risperdal (18%), compared to placebo (9%). From the pooled analysis of 3-week placebo-controlled clinical trials in adult patients with acute mania, the incidence of ≥7% weight gain at the endpoint was comparable between the Risperdal treatment groups (2 , 5%) and placebo (2.4%), showing slightly higher in the active drug control group (3.5%).
In long-term clinical trials, in a population of children and adolescents with conduct and other disruptive behavior disorders, weight gain averaged 7.3 kg after 12 months of treatment. normal children aged between 5 and 12 years, ranging from 3 to 5 kg per year. From 12 to 16 years, this entity of weight gain ranging from 3 to 5 kg per year is maintained for girls, while boys gain about 5 kg per year.
Learn more about special populations
Adverse drug reactions, reported at a higher incidence in elderly patients with dementia or in pediatric patients than in adult patient populations, are described below:
Elderly patients with dementia
In elderly patients with dementia, transient ischemic attack and cerebrovascular accident were reported as ADRs in clinical trials at a frequency of 1.4% and 1.5%, respectively. In addition, the following ADRs have been reported with a frequency of ≥5% in elderly patients with dementia and with at least twice the frequency seen in other adult populations: urinary tract infection, peripheral edema, lethargy and cough.
Pediatric population
In general, the type of adverse reactions in children are expected to be similar to that seen in adults. The following ADRs were reported with a frequency of ≥5% in pediatric patients (5 to 17 years) and at least twice as often as observed in clinical trials in adults: somnolence / sedation, fatigue, headache, increased appetite , vomiting, upper respiratory infections, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhea and enuresis.
The long-term effects of risperidone treatment on sexual maturation and height have not been adequately studied (see subsection 4.4 "Children and adolescents").
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Symptoms
Generally, the signs and symptoms reported have been those resulting from an enhancement of the known pharmacological effects of risperidone. These include somnolence and sedation, tachycardia and hypotension, and extrapyramidal symptoms. In overdose, QT prolongation and seizures have been reported. Torsades de pointes have been reported in association with the combined overdose of Risperdal and paroxetine.
In the event of an acute overdose, consideration should be given to the possibility of multiple drugs being involved.
Treatment
Establish and maintain a patent airway and ensure adequate oxygenation and ventilation. Consider performing gastric lavage (after intubation if the patient is unconscious) and administering activated charcoal together with a laxative only when the patient is drug has not been taken for more than one hour. Cardiovascular monitoring should be started immediately, which must include continuous electrocardiographic monitoring, to detect possible arrhythmias.
There is no specific antidote to Risperdal. Therefore appropriate general supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures, such as IV fluids and / or sympathomimetic agents. In case of severe extrapyramidal symptoms, an anticholinergic drug should be given. Careful monitoring and clinical supervision continue until the patient.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other antipsychotics, ATC code: N05AX08.
Mechanism of action
Risperidone is a selective monoaminergic antagonist with unique properties of their kind. It possesses a "high affinity for 5-HT2 serotonergic receptors and D2 dopaminergic receptors. Risperidone also binds to alpha1-adrenergic receptors and, to a lesser extent, to H1-histaminergic and alpha2-adrenergic receptors. Risperidone has no affinity for receptors. Although risperidone is a potent D2 antagonist, believed to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classic antipsychotics. The central balanced antagonism between serotonin and dopamine can reduce the risk of extrapyramidal side effects and extend the therapeutic activity to the improvement of the negative and affective symptoms of schizophrenia.
Pharmacodynamic effects
Clinical efficacy
Schizophrenia
The efficacy of risperidone in the short-term treatment of schizophrenia was established in four clinical trials, lasting 4-8 weeks, enrolling over 2,500 patients meeting DSM-IV criteria for schizophrenia. In a 6-week study. , placebo-controlled, which included titration of risperidone in doses up to 10 mg / day administered twice daily, risperidone was superior to placebo in total scale score Brief Psychiatric Rating Scale - (BPRS). In an 8-week, placebo-controlled clinical study of four fixed doses of risperidone (2, 6, 10, and 16 mg / day, given twice daily), all four risperidone treatment groups had demonstrated superiority over placebo in the PANSS total score (Positive and Negative Syndrome Scale). In an 8-week dose comparison clinical study involving five fixed doses of risperidone (1, 4, 8, 12, and 16 mg / day administered twice daily), treatment groups with 4, Risperidone 8 and 16 mg / day were superior to the risperidone 1 mg dose group in the PANSS total score. In a 4-week, placebo-controlled, placebo-controlled clinical trial of two fixed doses of risperidone (4 and 8 mg / day administered once daily), both risperidone dose groups were shown to be superior. to placebo in several measures of the PANSS scale, including the total PANSS scale and a measure of response (> 20% reduction in the PANSS total score). In a long-term clinical study, outpatients primarily meeting DSM-IV criteria for schizophrenia and who had remained clinically stable for at least 4 weeks with an antipsychotic were randomized to risperidone in doses of 2 to 8 mg / die or haloperidol for 1-2 years of observation, to observe any relapses. Over this time, risperidone-treated patients had a significantly longer time to relapse than those on haloperidol.
Manic episodes in bipolar disorder
The efficacy of risperidone monotherapy in the acute treatment of manic episodes associated with bipolar I disorder was demonstrated in three, double-blind, placebo-controlled monotherapy trials in approximately 820 patients with bipolar I disorder, based on DSM-IV criteria. In the three studies, risperidone 1 to 6 mg / day (starting dose of 3 mg in two studies and 2 mg in the other) was significantly superior to placebo in "endpoint previously established primary, i.e., change from baseline in YMRS total score (Young Mania Rating Scale) at Week 3. The outcome of secondary efficacy were generally consistent with outcome primary. The percentage of patients with a ≥50% reduction in YMRS score from baseline to "endpoint week 3 was significantly higher for the risperidone group than for the placebo group.
One of the three clinical trials included a haloperidol treatment arm and a 9-week double-blind maintenance phase. Efficacy was maintained throughout the maintenance therapy period, which lasted 9 weeks. The change in YMRS total scale from baseline showed continuous and comparable improvement between the two risperidone and haloperidol treatment groups at Week 12.
The efficacy of risperidone in combination with mood stabilizers in the treatment of acute mania was demonstrated in one of two double-blind, 3-week clinical trials conducted in approximately 300 patients meeting DSM-IV criteria for bipolar I disorder. In a 3-week clinical study, risperidone 1 to 6 mg / day, starting dose of 2 mg / day, in combination with lithium or valproate, was superior to lithium or valproate monotherapy in theendpoint previously established primary, i.e., the change from baseline in YMRS total score at Week 3. In a second 3-week study, risperidone 1 to 6 mg / day, with a starting dose of 2 mg / day, combined with lithium, valproate, or carbamazepine was not superior to lithium, valproate, or carbamazepine monotherapy in reducing the YMRS total score. One possible explanation for the failure of this clinical study was the induction of clearance of risperidone and 9-hydroxy-risperidone by carbamazepine, which generated subtherapeutic levels of risperidone and 9-hydroxy-risperidone. When the carbamazepine treatment group was excluded in one "analysis post-hoc, risperidone in combination with lithium or valproate was superior to lithium or valproate monotherapy in reducing the YMRS total score.
Persistent aggression in dementia
The efficacy of risperidone in treating the behavioral and psychological symptoms of dementia (Behavioral and Psychological Symptoms of Dementia - BPSD), which include behavioral disturbances such as aggression, agitation, psychosis, activity and affective disorders, has been demonstrated in three double-blind, placebo-controlled clinical trials conducted in 1,150 elderly patients with moderate to severe dementia. One of the studies included fixed risperidone doses of 0.5, 1, and 2 mg / day. Two flexible-dose studies involved treatment groups with risperidone doses in the range of 0.5 - 4 mg / day and 0.5 - 2 mg / day, respectively. Risperidone demonstrated statistically significant and clinically important therapeutic efficacy. in treating aggression and less consistent for agitation and psychosis of elderly patients with dementia (as measured by the scale Behavioral Pathology in Alzheimer's Disease [BEHAVE-AD -] and from Cohen Mansfield Agitation Inventory [CMAI]). The therapeutic effect of risperidone was independent of the MMSE test score (Mini-Mental State Examination) (and therefore the severity of dementia), the sedative properties of risperidone, the presence or absence of psychosis and the type of dementia, Alzheimer's, vascular or mixed (see also section 4.4).
Pediatric population
Conduct disorder
The efficacy of risperidone in the short-term treatment of disruptive behavior disorders was demonstrated in two double-blind, placebo-controlled clinical trials in approximately 240 patients aged 5 to 12 years with a diagnosis of disruptive behavior (DBD) according to DSM-IV criteria and borderline intellectual functioning or, mild or moderate mental retardation / learning disorder. In the two studies, risperidone 0.02 0.06 mg / kg / day was significantly superior to placebo all "endpoint primary specified above, i.e., the change from baseline in the N-CBRF, subscale for the Problem of Conduct of Nisonger-Child Behavior Rating Form, at Week 6.
05.2 Pharmacokinetic properties
Risperdal orodispersible tablets and oral solution are bioequivalent to Risperdal film-coated tablets.
Risperidone is metabolised to 9-hydroxy-risperidone with pharmacological activity similar to that of risperidone (see Biotransformation and elimination).
Absorption
Following oral administration, risperidone is completely absorbed, reaching maximum plasma concentrations within 1 to 2 hours. The absolute oral bioavailability of risperidone is 70% (CV = 25%). The relative oral bioavailability of risperidone from one tablet is 94% (CV = 10%) compared to that of a solution. Absorption is not affected by food, therefore risperidone can be given without regard to meals. In most patients, steady state of risperidone is achieved within 1 day. Steady state of 9-hydroxy-risperidone is achieved within 4- 5 days from the dose.
Distribution
Risperidone is distributed rapidly. The volume of distribution is 1-2 l / kg. Risperidone binds to albumin and alpha1-acid glycoprotein in plasma. The plasma protein binding of risperidone is 90%, while that of 9-hydroxy-risperidone is 77%.
Biotransformation and elimination
Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, with pharmacological activity similar to that of risperidone. Risperidone and 9-hydroxy-risperidone form the active antipsychotic fraction. CYP2D6 is subject to genetic polymorphism. Rapid metabolisers of CYP 2D6 convert risperidone rapidly to 9-hydroxy-risperidone, while poor metabolisers convert it much more slowly. Although extensive metabolisers have lower risperidone and higher 9-hydroxy-risperidone concentrations than poor metabolisers, the pharmacokinetics of risperidone and 9-hydroxy-risperidone combined (i.e. the active antipsychotic fraction), after single and repeated doses, they are similar in rapid and slow poor metabolisers of CYP 2D6.
Another metabolic pathway of risperidone is N-dealkylation. In vitro studies in human liver microsomes have shown that risperidone, at a clinically relevant concentration, does not substantially inhibit the metabolism of drugs metabolised by cytochrome P450 isoenzymes, including CYP 1A2, CYP 2A6, CYP 2C8 / 9/10, CYP 2D6, CYP 2E1, CYP 3A4 and CYP 3A5. One week after administration of oral risperidone, 70% of the dose is excreted in the urine and 14% in the faeces. In urine, risperidone plus 9-hydroxy-risperidone account for 35-45% of the dose. The remainder is represented by inactive metabolites.
After oral administration to psychotic patients, risperidone is eliminated with a "half-life of approximately 3 hours." The elimination half-life of 9-hydroxy-risperidone and the active antipsychotic fraction is 24 hours.
Linearity / Non-linearity
Risperidone plasma concentrations are dose proportional over the therapeutic dose range.
Elderly patients, hepatic insufficiency and renal insufficiency
A single dose study showed on average 43% higher plasma concentrations of the active antipsychotic fraction, a 38% longer half-life and a 30% lower clearance of the active antipsychotic fraction in the elderly. In patients with renal insufficiency they were Higher plasma concentrations of the active antipsychotic fraction and reduced clearance of the antipsychotic fraction on average by 60% were observed. Risperidone plasma concentrations were normal in patients with hepatic impairment, although the mean free fraction of risperidone in plasma was increased by approximately 35%.
Pediatric patients
The pharmacokinetics of risperidone, 9-hydroxy-risperidone and the active antipsychotic fraction in children were similar to that of adults.
Sex, race and smoking
A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking on the pharmacokinetic profile of risperidone or the active antipsychotic fraction.
05.3 Preclinical safety data
In some (sub) chronic toxicity studies, in which dosing was initiated in sexually immature rats and dogs, dose-dependent effects on the female and male genital tract and mammary gland were observed. attributable to an increase in serum prolactin levels, resulting from the antagonist activity for the dopaminergic D2 receptors of risperidone. Furthermore, tissue culture studies suggest that cell growth in human breast cancers could be stimulated by prolactin. Risperidone was not teratogenic in rats and rabbits. In rat reproduction studies with risperidone, adverse effects on parental mating and offspring birth weight and survival were observed. In a toxicity study in juvenile rats treated with oral risperidone, an increase was observed. mortality in puppies and a delay in physical development. In a 40-week study of juvenile dogs treated with oral risperidone, sexual maturation was delayed. Based on AUC, long bone growth was not affected in dogs for equal exposures. 3.6 times the maximum human oral exposure in adolescents (1.5 mg / day), while effects on long bone and sexual maturation were observed at 15 times the maximum human oral exposure in adolescents.
Intrauterine exposure to risperidone has been associated with adult cognitive deficits in rats. Other dopamine antagonists, when administered to pregnant animals, caused adverse effects on learning and motor development in the offspring. In a battery of tests, risperidone was not shown to be genotoxic. In clinical studies on the carcinogenicity of the offspring. risperidone in rats and mice, increases in pituitary adenomas (mouse), endocrine adenomas of the pancreas (rat) and mammary adenomas (both species) were observed. These tumors have been related to prolonged dopaminergic D2 receptor antagonist activity and hyperprolattemia. The importance of these findings of tumors in rodents in terms of human risk is not known.
Both in vitro and in vivo, animal models show that risperidone may cause prolongation of the QT interval at high doses, which has been associated with an increased theoretical risk of torsades de pointes in patients.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Risperdal film-coated tablets
Risperdal 1 mg film-coated tablets:
Nucleus
Lactose monohydrate
Cornstarch
Microcrystalline cellulose (E460)
Hypromellose (E464)
Magnesium stearate
Anhydrous colloidal silica
Sodium lauryl sulfate
Coating
Hypromellose (E464)
Propylene glycol (E490)
Risperdal 2 mg film-coated tablets:
Nucleus
Lactose monohydrate
Cornstarch
Microcrystalline cellulose (E460)
Hypromellose (E464)
Magnesium stearate
Anhydrous colloidal silica
Sodium lauryl sulfate
Coating
Hypromellose (E464)
Propylene glycol (E490)
Titanium dioxide (E171)
Talc (E553B)
Sunset yellow-aluminum lake (E110)
Risperdal 3 mg film-coated tablets:
Nucleus
Lactose monohydrate
Cornstarch
Microcrystalline cellulose (E460)
Hypromellose (E464)
Magnesium stearate
Anhydrous colloidal silica
Sodium lauryl sulfate
Coating
Hypromellose (E464)
Propylene glycol (E490)
Titanium dioxide (E171)
Talc (E553B)
Quinoline yellow (E104)
Risperdal 4 mg film-coated tablets:
Nucleus
Lactose monohydrate
Cornstarch
Microcrystalline cellulose (E460)
Hypromellose (E464)
Magnesium stearate
Anhydrous colloidal silica
Sodium lauryl sulfate
Coating
Hypromellose (E464)
Propylene glycol (E490)
Titanium dioxide (E171)
Talc (E553B)
Quinoline yellow
Indigotindisulfonate-aluminum lake (E132)
Risperdal orodispersible tablets
Risperdal 1 mg, square orodispersible tablets
Polacrilex resin
Gelatin (E485)
Mannitol (E421)
Glycine (E640)
Simethicone
Carbomer
Sodium hydroxide
Aspartame (E951)
Red iron oxide (E172)
Peppermint oil
Risperdal 2 mg square orodispersible tablets
Polacrilex resin
Gelatin (E485)
Mannitol (E421)
Glycine (E640)
Simethicone
Carbomer
Sodium hydroxide
Aspartame (E951)
Red iron oxide (E172)
Peppermint oil
Xanthan gum
Risperdal 1 mg / ml oral drops, solution:
Tartaric acid (E334)
Benzoic acid (E210)
Sodium hydroxide
Purified water
06.2 Incompatibility
Film-coated tablets: Not applicable.
Orodispersible tablets: Not applicable.
Oral drops, solution: incompatible with different types of tea, including black tea.
06.3 Period of validity
Film-coated tablets: 3 years (1/2/3/4 mg) and 2 years (0.5 / 6 mg)
Orodispersible tablets: 2 years.
Oral drops, solution: 3 years
After first opening the bottle: 3 months.
06.4 Special precautions for storage
Risperdal film-coated tablets: Do not store above 30 ° C.
Blister pack: Store in the original package in order to protect from light.
Risperdal orodispersible tablets: do not store above 30 ° C. Store in the original packaging.
Risperdal oral drops, solution: do not store above 30 ° C. Do not freeze. Store in the original package to protect from light and moisture.
06.5 Nature of the immediate packaging and contents of the package
Risperdal film-coated tablets
The tablets are packaged in opaque PVC / LDPE / PVDC / aluminum blisters and HDPE bottles with a PP screw cap. The tablets are available in the following pack sizes:
• 0.5 mg: in blisters containing 20 or 50 tablets and bottles containing 500 tablets
• 1 mg: in blisters containing 6, 20, 50, 60, or 100 tablets and bottles containing 500 tablets
• 2 mg: in blisters containing 10, 20, 50, 60, or 100 tablets and bottles containing 500 tablets
• 3 mg: in blisters containing 20, 50, 60, or 100 tablets
• 4 mg: in blisters containing 10, 20, 30, 50, 60, or 100 tablets
• 6 mg: in blisters containing 28, 30 or 60 tablets
Not all pack sizes may be marketed.
Risperdal orodispersible tablets
The orodispersible tablets are packed in aluminum blisters.
Risperdal oral drops, solution
The drops are packaged in amber glass bottles of 30ml and 100ml, with childproof tamper-evident plastic (polypropylene) cap.
The pipette supplied with the bottle is graduated in milligrams and milliliters with a minimum volume of 0.25 ml and a maximum volume of 3 ml. 0.25 ml graduation marks (corresponding to 0.25 mg of solution) are printed on the pipette in increments of up to 3 ml (corresponding to 3 mg of solution)
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
Film-coated tablets: no special disposal instructions
Orodispersible tablets (see section 4.2).
Oral solution: no special disposal instructions
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Janssen-Cilag SpA
Via M.Buonarroti, 23
20093 Cologno Monzese (MI)
08.0 MARKETING AUTHORIZATION NUMBER
Risperdal 1 mg film-coated tablets - 20 tablets AIC 028752018
Risperdal 1 mg film-coated tablets - 60 tablets AIC 028752057
Risperdal 2 mg film-coated tablets - 20 tablets AIC 028752020
Risperdal 2 mg film-coated tablets - 60 tablets AIC 028752069
Risperdal 3 mg film-coated tablets - 20 tablets AIC 028752032
Risperdal 3 mg film-coated tablets - 60 tablets AIC 028752071
Risperdal 4 mg film-coated tablets - 20 tablets AIC 028752044
Risperdal 4 mg film-coated tablets - 60 tablets AIC 028752083
Risperdal 1 mg / ml oral drops, solution - 1 bottle of 100 ml AIC 028752095
Risperdal 1 mg / ml oral drops, solution - 1 bottle of 30 ml AIC 028752145
Risperdal 1 mg orodispersible tablets - 28 tablets AIC 028752222
Risperdal 1 mg orodispersible tablets - 56 tablets AIC 028752234
Risperdal 2 mg orodispersible tablets - 28 tablets AIC 028752246
Risperdal 2 mg orodispersible tablets - 56 tablets AIC 028752259
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Film-coated tablets: 15/07/1995 - 27/06/2010
Oral drops, solution - bottle 100 ml: 21/12/1999 - 27/06/2010
Oral drops, solution - bottle 30 ml: 22/12/2000 - 27/06/2010
Orodispersible tablets: 02/14/2008 - 06/27/2010.
10.0 DATE OF REVISION OF THE TEXT
April 2015
