Active ingredients: Citalopram
Citalopram 20 mg film-coated tablets
Citalopram package inserts are available for pack sizes:- Citalopram 20 mg film-coated tablets
- Citalopram 40 mg film-coated tablets
- Citalopram 40 mg / ml oral drops, solution
Why is Citalopram used? What is it for?
Citalopram Mylan Generics belongs to a group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs), also known as antidepressants.
Citalopram Mylan Generics is used for the treatment of:
- Depression (major depressive episodes)
- Panic disorders (panic attacks, including those caused by agoraphobia, which is a fear of open spaces).
Contraindications When Citalopram should not be used
Do not take Citalopram Mylan Generics:
- If you are allergic (hypersensitive) to citalopram or any of the other ingredients of this medicine (listed in section 6).
- If you are taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken them in the last two weeks. These medicines are used to treat depression or Parkinson's disease (e.g. selegenine, moclobemide). After you stop taking Citalopram Mylan Generics it is necessary to allow one week to pass before taking any other MAOIs.
- If you are taking an antibiotic called linezolid
- If you are taking pimozide (to treat mental illness)
- If you are taking sumatriptan (5-HT agonist) used to treat migraine, or similar medicines (see section "Other medicines and Citalopram Mylan Generics").
- If you present from birth or have had an episode of abnormal heart rhythm (identified with an ECG; a test conducted to evaluate how the heart works)
- If you take medicines for heart rhythm problems or which can affect the heart's rhythm. Please also refer to the section "Other medicines and Citalopram Mylan Generics".
Precautions for use What you need to know before taking Citalopram
Warnings and Precautions
Talk to your doctor or pharmacist before taking Citalopram Mylan Generics if you:
- you are diabetic, as your doctor may need to adjust the dose of insulin or other medicines used to lower your blood sugar
- have epilepsy, as your doctor will monitor you more carefully. Treatment with Citalopram Mylan Generics should be stopped if you have a seizure or if you have more seizures than usual (see section 4 ")
- is subjected to an electroshock treatment
- if you suffer from manic phases characterized by hyperactive behavior or thoughts. If you are manic, please contact your doctor
- you have suffered from mental illness in the past, as your psychotic symptoms may increase
- you have suffered from bleeding problems in the past or if you are taking medicines that affect blood clotting or increase the risk of bleeding (see section "Other medicines and Citalopram Mylan Generics").
- suffer from liver problems or severe kidney problems as your doctor may need to adjust your dose
- have low levels of sodium in the blood (see section 4)
- have an abnormal heart rhythm or if you have low levels of salts (potassium, magnesium) in your blood.
- have or have suffered from heart problems or have recently had a heart attack
- have a low resting heart rate and / or if you know you have saline deficiencies as a result of severe and prolonged diarrhea or vomiting (having felt sick) or use diuretics (medicines to urinate)
- on standing up, you happen to have a rapid or irregular heart rhythm, faint, collapse or feel dizzy, which could indicate an "abnormal heart rhythm."
Pay attention:
Citalopram can reduce blood sodium levels by making you feel weak and dizzy, with sore muscles. Tell your doctor if you notice these symptoms.
If you start to feel shaking, confused, shaking and sudden twitching of your muscles, you may have a rare condition called serotonin syndrome, tell your doctor right away. Do not stop treatment with Citalopram Mylan Generics abruptly as you may suffer from withdrawal syndrome (see section 3).
Use in children and adolescents under the age of 18
Citalopram Mylan Generics should not normally be taken by children and adolescents under 18 years of age. When taking this class of medicines, patients under 18 years of age have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (mainly aggression, oppositional behavior and anger).
Despite this, your doctor may prescribe Citalopram Mylan Generics to patients under the age of 18 if they consider it strictly necessary. If your doctor has prescribed Citalopram Mylan Generics for a patient under the age of 18 and you would like more information, please contact your doctor again. You should inform your doctor if any of the above symptoms appear or worsen while a patient under the age of 18 is taking Citalopram Mylan.
Furthermore, the long-term safety effects of Citalopram Mylan Generics related to growth, maturation and cognitive and behavioral development have not yet been demonstrated in this age group.
Thoughts of suicide and worsening of depression or anxiety disorders
If you are depressed and / or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These symptoms may increase when you start taking antidepressants, as all these medicines take time to work, usually around two weeks or even longer.
You may be more inclined to such thoughts:
- If you have previously had thoughts of killing or harming yourself.
- If you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under the age of 25 with psychiatric conditions who have been treated with an antidepressant.
If you have thoughts of killing or harming yourself at any time, contact your doctor or go to a hospital immediately. You can find help by telling close family or friends that you are depressed or have anxiety disorders and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in his behavior.
Interactions Which drugs or foods can modify the effect of Citalopram
Other medicines and Citalopram Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
- Sumatriptan and similar medicines used to treat "migraine" (see section "Do not take Citalopram Mylan Generics"), tryptophan and oxitriptan (used for depression) and tramadol (to treat severe pain), as these medicines may increase the risk of side effects.
- Medicines for depression called mono-amino oxidase (I-MAO) inhibitors, eg. selegiline, moclobemide (see section "Do not Take Citalopram Mylan Generics"). If you stop taking Citalopram Mylan Generics you must allow 7 days to elapse before you start taking any MAOI medicine.
- Other antidepressants, eg. amitriptilline, desipramine, fluvoxamine, imipramine, clomipramine, nortriptyline.
- Linezolide (an antibiotic).
- Lithium, tryptophan or pimozide (to treat mental illness)
- Other medicines for the treatment of mental illnesses eg. flupentixol, chlorpromazine, haloperidol, since there is a risk of a possible lowering of the epileptic threshold
- Medicines used for the treatment of gastric ulcers eg. cimetidine, omeprazole, esomeprazole, lansoprazole
- Medicines used to thin the blood (anticoagulants), eg. warfarin, acetylsalicylic acid (aspirin)
- Medicines used to prevent blood clotting eg. ticlopidine, dipyridamole
- Medicines used to treat irregular heart rhythms, eg. flecainide, propafenone
- Any medicine that can reduce the amount of potassium or magnesium in the blood
- Metoprolol, a beta blocker used to lower high blood pressure
- Mefloquine (for malaria), bupropion (to help you quit smoking), or tramadol (a pain reliever) as there is a risk of a possible lowering of the seizure threshold.
- St. John's wort (Hypericum perforatum), a herbal remedy
- Medicines called non-steroidal anti-inflammatory drugs (NSAIDs) eg. ibuprofen.
Do not take Citalopram Mylan Generics if you are taking medicines for heart rhythm problems or which can affect the rhythm of the heart, such as class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (such as sparfloxacin, moxifloxacin, erythromycin IV, pantamidine, antimalarial treatments, especially halofantrine), some antihistamines (astemizole, mizolastine). If you have any further questions, please contact your doctor.
Citalopram Mylan Generics with food, drink and alcohol
You should not drink alcohol while being treated with this medicine.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Citalopram Mylan Generics if you are pregnant or planning to become pregnant unless your doctor considers it absolutely necessary. There are no adequate data from the use of Citalopram Mylan Generics in pregnant women.
You should not abruptly stop taking Citalopram Mylan Generics. If you are taking Citalopram Mylan Generics in the last 3 months of pregnancy, tell your doctor, as your baby may have some symptoms at birth. These symptoms usually begin during the first 24 hours after the baby is born. They include difficulty falling asleep or difficulty feeding, trouble breathing, cyanosis, unstable temperature, feeling sick, constant crying, stiff or limp muscles, lethargy, tremors, agitation or convulsions. If your baby has any of these symptoms at birth, contact your doctor immediately who will be able to advise you.
Make sure your midwife and / or doctor are aware that you are taking citalopram. When taken during pregnancy, especially in the last 3 months of pregnancy, medicines such as Citalopram Mylan Generics may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and it makes it appear purplish. These symptoms usually appear within the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and / or doctor immediately.
Feeding time
Citalopram Mylan Generics passes into breast milk in small amounts. If you are taking citalopram, tell your doctor before you start breastfeeding.
Fertility
Citalopram has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility but, the impact on human fertility has not yet been observed.
Driving and using machines
Do not drive or use any tools or machines if you notice that your abilities are impaired. Medicines for the treatment of mental illness can decrease your ability to perform tasks that require precision and a lot of attention.
Citalopram Mylan Generics contains lactose.
If you have been told by your doctor that you have an "intolerance to some sugars, such as lactose, contact your doctor before starting to take this medicine.
Dose, Method and Time of Administration How to use Citalopram: Posology
Always take Citalopram Mylan Generics exactly as your doctor has told you. If in doubt, you should consult your doctor or pharmacist.
How much to take
Adults
Depression
The recommended dose is 20 mg per day. The dose can be increased by your doctor up to a maximum of 40 mg per day.
Panic Disorder
The starting dose for the first week is 10 mg per day, after which the dose can be increased to 20-30 mg per day. The dose can be increased by your doctor up to a maximum of 40 mg per day.
Elderly patients (over 65 years of age)
The starting dose should be reduced to half the recommended dose, e.g. 10-20 mg per day.
Elderly patients should not normally receive more than 20 mg per day
Patients with particular risk factors
Patients with liver problems should not receive more than 20 mg per day.
Use in children and adolescents under the age of 18 Citalopram Mylan Generics should not be given to children and adolescents under the age of 18 (See section "Warnings and precautions").
Route and method of administration
- For oral use
- Swallow the tablets with a glass of water
- Try to take the tablets at the same time each day, either in the morning or in the evening.
Overdose What to do if you have taken an overdose of Citalopram
If you take more Citalopram Mylan Generics than you should
Contact your doctor or the nearest emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose may include drowsiness, coma, seizures, nausea or vomiting, and changes in heart rhythm.
If you forget to take Citalopram Mylan Generics
If you forget to take a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue as usual with the rest of the tablets. Do not take a double dose to make up for a forgotten dose.
If you stop taking Citalopram Mylan Generics
Do not suddenly stop taking your medicine, as you may experience withdrawal symptoms (See section 4 'Withdrawal symptoms'). If you need to stop taking your medicine, your doctor will reduce your dose slowly over at least 1 to 2 weeks.
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 Citalopram
Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common side effects are more likely to occur in the first two weeks of treatment.
If you experience any of the following symptoms, you should stop taking CITALOPRAM MYLAN GENERICS and contact your doctor immediately:
- A severe allergic reaction which causes swelling of the face and throat, tightness in the chest, difficulty in breathing or swallowing.
- High fever, feeling agitated or confused, tremor, sudden muscle spasms. These symptoms can be a sign of a rare condition called serotonin syndrome.
- fast and irregular heartbeat, fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes.
He may need medical attention.
Thoughts of suicide and worsening of your depression or anxiety disorders
Thoughts of suicide or self-harm may occur or escalate in the first few weeks of treating depression, until the antidepressant effect sets in. Tell your doctor immediately if you have any distressing thoughts or experiences. Patients who are predisposed to panic attacks may experience a temporary period of increased anxiety after starting treatment. This usually resolves during the first two weeks (see also section 2 "Thoughts of suicide and worsening of depression or" anxiety disorders ").
Contact your doctor immediately if any of the following occur:
- A seizure (convulsions) or if you are epileptic, if you notice an increase in the number of fits
- If you feel weak and confused with sore muscles. These symptoms may be a sign that citalopram has reduced the amount of sodium in your blood.
Some patients may suffer from a feeling of restlessness and difficulty sitting or still. These effects are most likely during the first few weeks of treatment. Tell your doctor immediately if you notice these symptoms.
Other side effects you may experience are:
Very common side effects (may affect more than 1 in 10 patients):
- Drowsiness or difficulty sleeping
- headache
- blurred vision
- irregular heartbeat, palpitations
- feeling unwell
- dry mouth
- increased sweating
- sense of weakness
Common side effects (may affect up to 1 in 10 patients):
- Weight loss
- Trouble sleeping
- Loss of memory, difficulty concentrating
- Abnormal dreams
- Feeling anxious, feeling confused
- Decreased sexual drive
- Feeling agitated, nervous
- Loss of appetite
- Changes in mood
- Migraine
- Itching or Tingling
- Tremble
- Dizziness
- Difficulty in attention
- Ringing in the ears
- Increase or decrease in blood pressure
- Itchy and runny nose, inflamed and swollen nasal passages
- Indigestion, stomach pain, malaise
- Feeling of being sick
- Flatulence
- Increased salivation
- Constipation or diarrhea
- Irritated skin
- Muscle pain, joint pain
- Disturbances in urination
- Impaired sexual function in men
- Absence of orgasm or abnormal orgasm and in women
- Painful menstruation
- Tiredness, yawn
Uncommon side effects (may affect up to 1 in 100 patients):
- Increased appetite
- Weight gain
- Euphoria
- Increased sex drive
- Aggression
- Depersonalization
- Hallucinations
- Feeling of arousal leading to unusual behavior (mania)
- Fainting
- Dilated pupils
- Slow heartbeat
- Fast heartbeat
- Cough
- Sensitivity of the skin to light
- Urticaria
- Rash
- Hair loss
- Reddish spots on the skin
- Difficulty urinating
- Abundant menstruation
- Feeling of general malaise
- Swelling due to excessive amounts of fluid in the body.
Rare side effects (may affect up to 1 in 1000 patients):
- Changes in taste
- Seizures (seizures)
- Uncontrollable twitching, twitching or twisting of the body and other movement disorders
- Hemorrhage
- Hepatitis
- Fever
- Low levels of sodium in the blood (hyponatraemia) which can cause tiredness and confusion, muscle spasms, fits or coma.
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
- Feeling faint or light-headed when standing up
- Reduction in the number of platelets in the blood which increases the risk of bleeding or bruising
- Allergic reactions
- Overproduction of a hormone causing water retention, leading to weakness, tiredness or confusion
- Low levels of potassium in the blood which can cause muscle weakness, twitching or an abnormal heart rhythm
- Panic attacks
- Feeling restless or having difficulty staying still
- Teeth grinding (while sleeping)
- Movement Disorders
- Serotonin syndrome (high fever, muscle twitching, confusion and anxiety)
- Eyesight problems
- Unusual or very fast heart rate or chest pain
- Nosebleeds
- Gastro-intestinal and rectal haemorrhage
- Abnormal liver function test results
- Bruising
- Serious allergic reaction with which causes swelling of the face or throat
- Persistent painful erection
- Abnormal breast milk secretion in men
- Vaginal bleeding
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Withdrawal symptoms
You may experience withdrawal symptoms when you stop taking Citalopram. This is more likely if you stop treatment suddenly. Some patients experienced the following side effects within the first few days of stopping treatment:
- Dizziness
- Sensory disturbances (e.g. tingling or numbness in the hands and feet, sensation of electric shock)
- Sleep disturbances (e.g. difficulty sleeping or abnormal dreams)
- Agitation or anxiety
- Feeling sick
- Tremor
- Confusion
- Sweating
- Headache
- Diarrhea
- Palpitations
- Emotional instability, irritability
- Visual disturbances
These symptoms are usually mild to moderate and usually resolve within a couple of weeks. However, in some patients they may be more severe or last longer. If you need to stop taking your medicine, your doctor will slowly reduce your dose over a period of at least 1 to 2 weeks. If you experience severe withdrawal symptoms when you stop taking Citalopram, please tell your doctor He / she may ask you to start the treatment again and stop it more slowly.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet
Expiry and Retention
Keep out of the sight and reach of children.
Do not use Citalopram Mylan Generics after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
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.
Composition and pharmaceutical form
What Citalopram Mylan Generics contains
- The active ingredient is citalopram. Each tablet contains 20 mg of citalopram (as citalopram hydrobromide)
- The other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, povidone, crospovidone, magnesium stearate. The coating also includes titanium dioxide (E171), macrogol 4000 and hypromellose (E464).
What Citalopram Mylan Generics looks like and contents of the pack
Your medicine comes as a white coated tablet.
The 20 mg tablets are white, oval film-coated tablets marked "CM" score line "20" on one side and "G" on the other. The tablets can be divided into equal halves. Citalopram Mylan Generics 20 mg film-coated tablets are available in blisters of 10, 12, 14, 20, 28, 30, 49, 50, 56, 60, 98, 100 and 500 tablets or in plastic bottles of 12, 14, 20, 28, 50 , 100 and 250 tablets 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
CITALOPRAM MYLAN GENERICS 20 mg TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains citalopram hydrobromide equivalent to 20 mg of citalopram.
Excipients: 53.28 mg lactose monohydrate
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
White, oval, film-coated tablets, imprinted with "CM + rhyme 20" on one side and "G" on the other. The tablet can be divided into equal halves.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of major depressive episodes.
Panic crisis treatment with or without agoraphobia.
04.2 Posology and method of administration
Citalopram should be administered as a single oral dose in the morning or in the evening. The tablets can be taken with or without food but with liquid.
Adults
Treatment of major depressive episodes
The usual dose is 20 mg of citalopram once daily, with a maximum recommended dose of 60 mg / day. The dose will depend on the individual patient response. After initiation of treatment an antidepressant effect should not be expected for at least two weeks. Treatment should continue as long as the patient remains asymptomatic for at least 4-6 months to provide adequate protection against possible relapses.
Panic crisis treatment
A single daily dose of 10 mg is recommended for the first week. Subsequently the dose can be increased to 20 mg / day. The dose may continue to be increased up to 60 mg / day, depending on the individual patient response. Maximum effectiveness is reached after 3 months. Treatment may need to be continued for several months.
Senior citizens
Treatment of major depressive episodes
The recommended daily dose is 10 mg once a day. The dose can be increased up to a maximum of 30 mg / day depending on the individual response.
Panic crisis treatment
The recommended daily dose is 10 mg once a day. The dose can be increased up to a maximum of 40 mg / day depending on the individual response.
For use by children and adolescents under the age of 18
Citalopram should not be used for the treatment of children and adolescents under 18 years of age. (see section 4.4 Special warnings and precautions for use)
Reduced liver function:
Patients with hepatic impairment should receive a starting dose of 10 mg / day. In these patients the dose should not exceed 30 mg. These patients need to be clinically monitored.
Reduced kidney function:
A dose adjustment is not necessary in patients with mild or moderate renal dysfunction. No information is available for cases of severe renal impairment (creatinine clearance
CYP2C19 slow metabolisers
For known CYP2C19 poor metabolisers, a starting dose of 10 mg / day is recommended for the first two weeks of therapy. Depending on the result of the therapy, the dose may then be increased to 20 mg (see section 5.2).
Withdrawal symptoms observed following discontinuation of treatment
Abrupt discontinuation of administration should be avoided. When deciding to discontinue citalopram therapy, the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 Special warnings and precautions for use and 4.8 Undesirable effects). . If unsustainable symptoms occur following a decrease in dose or discontinuation of therapy, resuming the previously prescribed dose may be considered. Thereafter, your doctor may continue to decrease the dose, but more gradually.
04.3 Contraindications
Hypersensitivity to citalopram or to any of the excipients.
Monoamine oxidase inhibitors
Citalopram should not be used in combination with MAO inhibitors. Citalopram should not be administered within 14 days of stopping treatment with an irreversible MAO inhibitor or for the period specified in the relevant RIMA prescribing instructions after stopping a reversible MAO inhibitor (RIMA). At least 7 days must elapse between the interruption of treatment with citalopram and the initiation of therapy with both irreversible and reversible MAO inhibitors (see also section 4.5 Interactions with other medicinal products and other forms of interaction).
5-HT agonists
The serotonergic effects of sumatriptan are believed to be enhanced by SSRIs. Until further evidence becomes available it is recommended not to use citalopram in combination with 5-HT-agonists such as sumatriptan.
04.4 Special warnings and appropriate precautions for use
For use by children and adolescents under the age of 18
Citalopram should not be used for the treatment of children and adolescents under 18 years of age. Suicidal behaviors (suicide attempts and suicidal ideation) and hostility (essentially aggression, oppositional behavior and anger) were observed more frequently in clinical trials in children and adolescents treated with antidepressants than in those treated with placebo. If, based on medical need, a decision to treat is made, the patient should be closely monitored for the appearance of suicidal symptoms. Furthermore, long-term safety data for children and adolescents are not available with regard to growth, maturation and cognitive and behavioral development.
Diabetes
In diabetic patients, SSRI treatment can impair glycemic control. The dosage of insulin or oral hypoglycaemics may need to be adjusted.
Seizures
Seizures are a potential risk with the use of antidepressant drugs. The drug should be discontinued if a seizure occurs in the patient. Citalopram should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be closely monitored. Citalopram should be carefully monitored. be discontinued if there is an increase in the frequency of seizures.
Electroconvulsive Therapy (ECT)
Clinical experience with the concomitant administration of ECT and citalopram is limited, therefore caution is recommended.
Mania
Citalopram should be used with caution in patients with a history of mania / hypomania. Citalopram should be discontinued if the patient enters a manic phase.
Suicide / suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is clinical experience in general that the risk of suicide may increase in the early early stages of improvement.
Other psychiatric conditions for which citalopram is prescribed may also be associated with an increased risk of suicide - related events. Furthermore, there may be co-morbidities of such pathologies with major depression. The same precautions observed in the treatment of patients with major depression must therefore be observed in the treatment of patients with other psychiatric pathologies.
Patients with a history of suicide-related events or those who experience a significant degree of suicidal ideation prior to initiation of therapy are at increased risk for suicidal thoughts or suicide attempts, and should be closely monitored during therapy. A meta-analysis of clinical trials conducted with antidepressant drugs in comparison with placebo in the therapy of psychiatric disorders, showed an increased risk of suicidal behavior in the age group below 25 years of patients treated with antidepressants compared to placebo.
Pharmacological therapy with antidepressants, especially in the initial stages of treatment and following dose changes, should always be associated with close surveillance of patients, especially those at high risk. Patients (and their caregivers) should be advised of the need to monitor for any clinical worsening, the onset of suicidal behavior and / or thoughts and unusual changes in behavior and to seek immediate medical attention if such symptoms occur. present.
Psychosis
Treatment of psychotic patients with depressive episodes can increase psychotic symptoms.
Hemorrhages
Coagulation abnormalities such as ecchymosis, purpura, gynecological haemorrhages, gastrointestinal bleeding and other cutaneous or mucosal bleeding have been reported with SSRIs. Caution is advised in patients taking citalopram particularly in case of concomitant use of oral anticoagulants, substances that can affect platelet function or other substances that can increase the risk of bleeding (e.g. atypical antipsychotics and phenothiazines, most of the tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs), ticlopidine and dipyridamole) as well as in patients with a history of bleeding disorders.
Serotonin syndrome
In rare cases, a serotonin syndrome has been reported in patients treated with SSRIs. An association of symptoms such as agitation, tremor, myoclonus and hyperthermia may indicate the development of this condition. Treatment with citalopram should be discontinued immediately and symptomatic therapy initiated.
Citalopram should not be used in combination with medicinal products with a serotonergic effect such as tramadol, tryptophan, oxytryptan, sumatriptan or other triptans.
Hyponatremia
Hyponatremia and the syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported rarely, mainly in the elderly and are generally reversible after discontinuation of therapy.
St. John's wort
Undesirable effects may be more common during concomitant use of citalopram and herbal preparations containing St John's wort (Hypericum perforatum). Therefore citalopram and preparations containing St. John's wort should not be taken at the same time (see section 4.5 "Interactions with other medicinal products and other forms of interaction").
Akathisia / psychomotor agitation
The use of SSRIs / SNRIs has been associated with the development of akathisia, characterized by subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. These symptoms are more likely to present within the first few weeks of treatment. In patients who develop such symptoms, increasing the dosage can be harmful.
Withdrawal symptoms observed following discontinuation of treatment
Withdrawal symptoms are common upon discontinuation of treatment, particularly if discontinuation is sudden (see section 4.8 Undesirable effects).
The risk of withdrawal symptoms may be dependent on various factors, including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances. Generally these symptoms are mild to moderate; however, in some patients they can be severe in intensity. They usually appear within the first few days of stopping treatment; however, very rare cases of withdrawal symptoms have been reported in patients who inadvertently missed a dose. In general, these symptoms are self-limiting and usually resolve within 2 weeks, although in some patients they may be prolonged (2-3 months or more). Therefore, it is recommended to gradually reduce the dosage of citalopram over a period of several weeks or months, according to the patient's needs, should treatment be discontinued (see "Withdrawal symptoms observed following discontinuation of treatment", section 4.2 Posology and method of administration).
Factors that may affect the disposition of a secondary metabolite of citalopram (didemethylcitalopram) should be considered, as increased levels of this metabolite can theoretically prolong QTc intervals in susceptible individuals. However, no clinically significant changes were observed in ECG monitoring of 2500 patients in clinical trials, including 277 with pre-existing heart disease.
The use of citalopram in patients with severe renal impairment (creatinine clearance less than 20 ml / min) is not recommended as no information is available on its use in these patients (see section 4.2 "Posology and method of administration"). .
In case of hepatic impairment, a dose reduction is recommended (see section 4.2 "Posology and method of administration") and hepatic function should be carefully monitored.
The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp Lactase deficiency or glucose-galactose malabsorption should not take this drug.
Some patients with panic attacks have an initial anxiogenic effect when starting pharmacotherapy. A reduced starting dose (see section 4.2 "Posology and method of administration") reduces the risk of this effect.
04.5 Interactions with other medicinal products and other forms of interaction
Monoamine oxidase inhibitors (MAOIs): Cases of severe and sometimes fatal reactions have been reported in patients receiving selective serotonin reuptake inhibitors (SSRIs) in combination with monoamine oxidase inhibitors (MAOIs), including selegiline selective irreversible MAOI and selective reversible MAOI moclobemide (RIMA) .
Some cases present with features similar to those of a serotonin syndrome. Symptoms of an interaction with MAOIs include: hyperthermia, rigidity, myoclonus, instability of the autonomic nervous system, with possible rapid fluctuations in vital parameters, changes in mental status including confusion, irritability and extreme agitation which can lead to delirium and coma.
Therefore, Citalopram should not be used in combination with MAO inhibitors or should not be administered within 14 days following discontinuation of treatment with an irreversible MAO inhibitor or for the period specified in the relevant prescribing instructions (RIMA) after discontinuation of a reversible MAO-inhibitor. At least 7 days must elapse between stopping citalopram treatment and initiating therapy with both irreversible and reversible MAO inhibitors (see section 4.3).
Linezolid, an antibiotic with properties similar to those of a reversible and non-selective MAO-inhibitor, should not be given at the same time as Citalopram. When the use of linezolid is still urgent and when the one-week withdrawal period from treatment with citalopram has not been respected, linezolid therapy can be started under careful medical supervision of cardiac function and other symptoms related to serotonin syndrome.
The metabolism of citalopram is only partially dependent on the hepatic cytochrome P450 isoenzyme CYP2D6 and unlike some other SSRIs, citalopram is only a weak inhibitor of this important enzyme system which involves the metabolism of many drugs (including: antiarrhythmics, neuroleptics, beta- blockers, TCAs and some SSRIs) Protein binding is relatively low (
Alcohol: the association between alcohol and citalopram is not recommended. However, clinical studies have not shown negative pharmacodynamic interactions between citalopram and alcohol.
Serotonergic drugs: the association with serotonergics (eg: tramadol, tryptophan, oxitriptan, sumatriptan and other triptans) can lead to a serotonin syndrome.In combination with triptans there is a potential risk of coronary vasoconstriction and also of hypertension. Therefore, the simultaneous use of citalopram and these active substances is not recommended (see 4.4 "Special warnings and precautions for use").
Lithium: there are no pharmacokinetic interactions between lithium and citalopram. However, cases of serotonin syndrome have been reported when SSRIs are administered in combination with lithium and therefore their concomitant use should be undertaken with caution; a more careful and assiduous clinical control is required.
The combination of citalopram and metoprolol (CYP2D6 substrate) results in a doubling of the plasma levels of metoprolol. No clinically significant effects on blood pressure or heart rate have been observed.
In a pharmacokinetic study no effects on the levels of citalopram or imipramine were shown, although the level of desipramine, the primary metabolite of imipramine, was increased. When desipramine is combined with citalopram, an increase in plasma concentrations of desipramine has been observed. A dose reduction of desipramine may be required.
Cimetidine, a known enzyme inhibitor, caused a slight increase in mean steady state levels of citalopram. Therefore, caution is recommended when administering high doses of citalopram in combination with high doses of cimetidine.
Citalopram and the herbal preparations of St. John's wort (Hypericum perforatum) can give interactions, with a consequent increase in undesirable effects.
No pharmacodynamic interactions were observed in clinical trials in which citalopram was administered in combination with benzodiazepines, neuroleptics, analgesics, lithium, alcohol, antihistamines, antihypertensive drugs, beta-blockers and other cardiovascular drugs.
Caution is warranted in patients treated concomitantly with anticoagulants, active substances known to affect platelet function, or other medicinal products that may increase the risk of bleeding (e.g. NSAIDs, acetylsalicylic acid, dipyridamole, ticlopidine, atypical antipsychotics, phenothiazines, most tricyclic antidepressants) (see section 4.4 "Special warnings and special precautions for use").
Experience with citalopram did not reveal clinically relevant interactions with neuroleptics. However, as with other SSRIs, the possibility of pharmacodynamic interactions cannot be ruled out.
The absorption and other pharmacokinetic properties of citalopram were not affected by food.
QT interval lengthening: Caution is required in the concomitant use of other drugs that lengthen the QT interval or drugs that induce hypokalaemia / hypomagnesaemia since they too, like citalopram, lengthen the QT interval.
Convulsions: SSRIs can lower the seizure threshold. Caution is required in the simultaneous use of other drugs capable of lowering the seizure threshold [eg antidepressants (tricyclics, SSRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine, bupropion and tramadol.
Escitalopram: the metabolism of escitalopram is mediated primarily by CYP2C19. CYP3A4 and CYP2D6 may also contribute, albeit to a lesser extent. The metabolism of the major metabolite S-DCT (demethylated escitalopram) appears to be partially catalysed by CYP2D6.
Co-administration of escitalopram and omeprazole (a CYP2C19 inhibitor) 30 mg once daily caused a moderate increase (approximately 50%) in the plasma concentrations of escitalopram.
Therefore caution should be exercised in concomitant use with CYP2C19 inhibitors (eg omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. dose of citalopram.
04.6 Pregnancy and lactation
Pregnancy
There are limited data on the use of citalopram in pregnancy. Studies in rats have shown teratogenic effects at high doses resulting in maternal toxicity (see section 5.3 "Preclinical safety data"). The potential risk for humans is unknown. Citalopram should only be used in pregnancy if considered clearly necessary.
If maternal use of citalopram is continued during later stages of pregnancy, and particularly in the third trimester, neonates should be observed. Abrupt discontinuation of administration should be avoided during pregnancy.
After maternal use of SSRIs / SNRIs in the later stages of pregnancy in the newborn the following symptoms may occur: respiratory distress, cyanosis, apnea, convulsions, body temperature instability, difficulty in breastfeeding, vomiting, hypoglycemia, hypertonus, hypotonus, hyperflexia , tremors, nervousness, irritability, lethargy, constant crying, drowsiness and sleep difficulties. These symptoms may be due to both serotonergic effects and withdrawal symptoms. In most cases, complications begin immediately or shortly after (delivery.
Epidemiological data indicate that the use of SSRIs during pregnancy, particularly late pregnancy, may increase the risk of persistent lung hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population, 1 to 2 cases of PPHN occur per 1000 pregnancies.
Feeding time
Citalopram is excreted in small amounts in milk. The benefits of breastfeeding must outweigh the potential side effects for the baby.
04.7 Effects on ability to drive and use machines
Patients who are prescribed psychotropic drugs may have some alteration in concentration due to the disease, the drugs, or both. Patients should be warned about their ability to drive and operate machinery. Citalopram by itself does not cause alterations in intellectual functions or psychomotor performance.
04.8 Undesirable effects
Adverse effects seen with citalopram are usually mild and transient. They are more frequent during the first or first two weeks of treatment and usually subside as depressive state improves.
Epidemiological studies conducted mainly in patients 50 years of age and older show an increased risk of bone fractures in patients taking SSRIs and TCAs. The mechanism behind this risk is unknown.
Withdrawal symptoms observed following discontinuation of treatment
Withdrawal of SSRI / SNRI (particularly when it is sudden) commonly causes withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and vivid dreams) have been reported , agitation or anxiety, nausea and / or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances. Generally these events are mild to moderate and are self-limiting; however, in some patients they may be severe and / or prolonged. If therapy with citalopram is no longer necessary, it is therefore recommended to discontinue it gradually by gradually reducing the dosage (see sections 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use).
04.9 Overdose
Citalopram is given to patients with potential suicide risk and some suicide attempts have been reported. Details about the precise dose or association with other drugs and / or alcohol are often missing.
Symptoms
Somnolence, coma, numbness, convulsions, changes in ECG (eg lengthening of the QT interval), atrioventricular arrhythmia, nausea, vomiting, perspiration, cyanosis, hyperventilation. It is possible the appearance of some features of the serotonin syndrome, especially in the case of simultaneous intake of other substances.
Treatment
There is no known specific antidote to citalopram. Treatment should be symptomatic and supportive. Activated charcoal, osmotic laxatives (such as sodium sulfate) and gastric lavage should be considered. In the presence of impaired consciousness, the patient should be intubated. ECG and vital signs should be monitored.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: selective serotonin reuptake inhibitors (SSRIs)
ATC code: N 06A B04.
Citalopram has been shown to be a potent serotonin (5-HT) reuptake inhibitor. Long-term treatment does not induce tolerance to inhibition of 5-HT uptake.
Citalopram is the most potent Selective Serotonin Reuptake Inhibitor (SSRI) described so far, with minimal effects on the uptake of noradreanaline (NA), dopamine (DA) and gamma-aminobutyric acid (GABA). Citalopram has no or minimal affinity on it. a series of receptors including: 5-HT1A, 5-HT2, dopamine D1 and D2 receptors, alpha1-, alpha2- and beta-adrenoceptors, histamine H1, cholinergic muscarine, benzodiazepines, opioid receptors. This in contrast to many tricyclic antidepressants and some of the other SSRIs.The lack of affinity for the receptors was confirmed using a series of functional tests in vitro on isolated organs and also with tests in vivo. This absence of receptor effects may explain why citalopram produces fewer traditional side effects such as dry mouth, bladder and bowel disorders, blurred vision, sedation, cardiotoxicity and orthostatic hypotension.
Like tricyclic antidepressants, other SSRIs and MAO inhibitors, citalopram suppresses REM sleep and increases deep slow wave sleep. REM sleep suppression is considered predictive of antidepressant activity. Although citalopram does not bind to opioid receptors, it potentiates the anti-nociceptive effect of commonly used opioid analgesics. An enhancement of d-amphetamine-induced hyperactivity was observed following administration of citalopram.
The major metabolites of citalopram are all SSRIs although their potency and selectivity ratios are lower than those of citalopram. However, the selectivity ratios of citalopram metabolites are superior to those of many other SSRIs. The metabolites do not contribute to the overall antidepressant effect.
05.2 Pharmacokinetic properties
Absorption
Absorption is almost complete and independent of food intake (mean Tmax 3.8 hours). Oral bioavailability is approximately 80%.
Distribution
The apparent volume of distribution (Vd) β is approximately 12.3 L / kg. Plasma protein binding is less than 80% for citalopram and its major metabolites.
Biotransformation
Citalopram is metabolised to demethylcitalopram, didemethylcitalopram, citalopram-N-oxide and an inactive derivative of deaminated propionic acid. All active metabolites are SSRIs themselves, although weaker than the parent compound. Unchanged citalopram is the predominant compound in the The main metabolizing enzyme is CYP2C19, and contributions from CYP3A4 and CYP2D6 are also possible.
Elimination
The elimination half-life (T½ β) is approximately 1.5 days and the systemic plasma clearance of citalopram (CIs) is approximately 0.33 L / min, and the oral plasma clearance (CIoral) is approximately 0.41 L / min.
Citalopram is mainly excreted by the liver (85%) and the remainder (15%) by the kidney. About 12 - 23% of the daily dose is excreted in the urine as unchanged citalopram. Hepatic (residual) clearance is approximately 0.35 L / min while renal clearance is approximately 0.068 L / min.
The kinetics are linear. Steady state of plasma levels is achieved in 1-2 weeks. Average concentrations of 250 nmol / L (100-500 nmol / L) are achieved at a daily dose of 40 mg. There is no clear relationship between plasma levels of citalopram and therapeutic effect or side effects.
Elderly patients (≥ 65 years old)
A longer half-life and decreased clearance values due to reduced metabolic activity have been observed in elderly patients.
Reduced liver function
Citalopram is eliminated more slowly in patients with impaired liver function. The half-life of citalopram is approximately twice as long and steady state concentrations of a given dose will be approximately twice as high as in patients with normal liver function.
Reduced kidney function
Citalopram is eliminated more slowly in patients with mild to moderate decreased renal function, with no major impact on the pharmacokinetics of citalopram. No information is currently available for the treatment of patients with severely reduced renal function (creatinine clearance
05.3 Preclinical safety data
No evidence of a particular hazard to humans was found in laboratory animals based on conventional studies of safety pharmacology, repeated dose toxicity, genetic toxicity and carcinogenic potential. Phospholipidosis was observed in several organs in repeat dose studies. in the rat. This reversible effect is known for several lipophilic amines and was not associated with functional and morphological effects. The clinical relevance is unclear. Embryotoxicity studies in the rat showed skeletal abnormalities at maternally toxic doses. Effects may be correlated with pharmacological activity or may be an indirect effect due to maternal toxicity. Peri- and postnatal studies have revealed a reduction in the survival of the offspring during the lactation period. The potential risk for humans is unknown.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Core of the tablet
Lactose monohydrate
Cornstarch
Microcrystalline cellulose
Povidone
Crospovidone
Magnesium stearate
Coating of tablets
Titanium dioxide (E171)
Lactose monohydrate
Macrogol 4000
Hypromellose (E464)
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
The product does not require any particular storage precautions.
06.5 Nature of the immediate packaging and contents of the package
PVC / PVdC blisters sealed with aluminum foil (including single-dose packs).
Packs containing: 10, 12, 14, 20, 28, 30, 49, 50, 56, 60, 98, 100 or 500 tablets.
PVC / PVdC blisters sealed with aluminum foil.
"Calendar" pack of 28 tablets.
High-density polyethylene (HDPE) tablet bottles with polypropylene cap. Packs containing: 12, 14, 20, 28, 50, 100 or 250 tablets.
Polypropylene tablet bottles with polyethylene cap.
Packs containing: 12, 14, 20, 28, 50, 100 or 250 tablets.
Not all pack sizes will be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Mylan S.p.A.
Via Vittor Pisani 20 - 20124 Milan, Italy
08.0 MARKETING AUTHORIZATION NUMBER
AIC 036046011 / M - 12 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046023 / M - 14 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046035 / M - 20 film-coated tablets in pvc / pvdc blisters of 20 mg
AIC 036046047 / M - 28 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046050 / M - 30 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046062 / M - 49 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046074 / M - 50 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046086 / M - 56 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046098 / M - 60 film-coated tablets in pvc / pvdc blisters of 20 mg
AIC 036046100 / M - 98 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046112 / M - 100 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046124 / M - 500 film-coated tablets in pvc / pvdc blister of 20 mg
AIC 036046136 / M - 12 film-coated tablets in hdpe bottle with pp cap of 20 mg
AIC 036046148 / M - 14 film-coated tablets in hdpe bottle with pp cap of 20 mg
AIC 036046151 / M - 20 film-coated tablets in hdpe bottle with pp cap of 20 mg
AIC 036046163 / M - 28 film-coated tablets in hdpe bottle with pp cap of 20 mg
AIC 036046175 / M - 50 film-coated tablets in hdpe bottle with pp cap of 20 mg
AIC 036046187 / M - 100 film-coated tablets in hdpe bottle with pp cap of 20 mg
AIC 036046199 / M - 250 film-coated tablets in hdpe bottle with pp cap of 20 mg
AIC 036046201 / M - 12 film-coated tablets in pp bottle with pe cap of 20 mg
AIC 036046213 / M - 14 film-coated tablets in pp bottle with pe cap of 20 mg
AIC 036046225 / M - 20 film-coated tablets in pp bottle with pe cap of 20 mg
AIC 036046237 / M - 28 film-coated tablets in pp bottle with pe cap of 20 mg
AIC 036046249 / M - 50 film-coated tablets in pp bottle with pe cap of 20 mg
AIC 036046252 / M - 100 film-coated tablets in pp bottle with pe cap of 20 mg
AIC 036046264 / M -250 film-coated tablets in pp bottle with pe cap of 20 mg
AIC 036046276 / M - 28 film-coated tablets in pvc / pvdc blister calendar pack size of 20 mg
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: February 2005
Date of last renewal: July 2008
10.0 DATE OF REVISION OF THE TEXT
October 2010
