Active ingredients: Cetirizine (Cetirizine dihydrochloride)
FORMISTIN 10 mg film-coated tablets
Formistin package inserts are available for pack sizes:- FORMISTIN 10 mg film-coated tablets
- FORMISTIN 10 mg / ml oral drops, solution
Why is Formistin used? What is it for?
FORMISTIN contains the active substance cetirizine dihydrochloride and is an anti-allergic medicine belonging to the category of antihistamines.
This medicine is used in adults and children from 6 years of age to treat:
- Nasal and ocular symptoms of allergic rhinitis (inflammatory disease of the nasal mucosa), seasonal and perennial.
- Chronic idiopathic urticaria (chronic itchy and swollen skin disease).
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Formistin should not be used
Do not take FORMISTIN
- If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to hydroxyzine or piperazine derivatives (active ingredients closely related to that present in FORMISTIN).
- If you have severe kidney disease (severe kidney failure with creatinine clearance below 10ml / min).
Precautions for use What you need to know before you take Formistin
Talk to your doctor or pharmacist before taking FORMISTIN.
Take FORMISTIN with particular caution and ask your doctor for advice:
- If you suffer from kidney failure (reduced kidney function); in this case you will need to take a lower dose which will be defined by your doctor based on your kidney function.
- If you suffer from epilepsy (neurological disease characterized by sudden loss of consciousness and convulsive movements of the muscles) or are at risk for convulsions (involuntary movements of the muscles with shaking and spasms of the body).
- If you have urinary retention or conditions that make you prone to urinary retention (e.g. spinal cord injury, prostatic hyperplasia), as cetirizine may increase the risk of developing this condition.
If you need to have skin (skin) tests for allergy, stop taking FORMISTIN within the previous 3 days as these tests may be falsified if you are taking antihistamines (antiallergic drugs including cetirizine).
Children and adolescents
Children under 6 years of age should not take FORMISTIN as this formulation does not allow for appropriate dose adjustment (see "Do not take FORMISTIN").
Interactions Which drugs or foods may change the effect of Formistin
Other medicines and FORMISTIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions with other drugs are expected.
FORMISTIN with alcohol
During or following the simultaneous intake of FORMISTIN (at normal doses) and alcohol (for blood levels of 0.5 g / L, corresponding to a glass of wine), no interactions of potential relevant impact were observed.
However, use caution if you drink alcohol at the same time as, as with all antihistamines, the simultaneous use of alcohol or other sedative substances on the central nervous system can decrease your alertness and your ability to react (see "Driving and use of machinery ").
FORMISTIN with food and drink
Food does not significantly affect the absorption of cetirizine.
Warnings It is important to know that:
Pregnancy and, 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 taking this medicine.
Pregnancy
If you are pregnant, take FORMISTIN only when clearly needed, with great caution and under close medical supervision.
Feeding time
Cetirizine is excreted in breast milk. Therefore, while breastfeeding, take FORMISTIN only if clearly needed, with great caution, and under strict medical supervision.
Driving and using machines
If you intend to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose and you should carefully observe your response to the drug.
If you are a sensitive patient, the simultaneous use of alcohol or other substances with a depressing action (sedative activity) on the central nervous system can further alter your attention and your ability to react (see "FORMISTIN with alcohol").
FORMISTIN 10 mg film-coated tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Formistin: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Take the tablets with a glass of water.
Adults
The recommended dose is 10 mg (1 tablet) to be taken once a day.
Use in children and adolescents
Children with renal insufficiency
In children with renal insufficiency, the dose should be individually adjusted, taking into account the renal elimination, age and body weight of the patient.
Elderly patients: If your renal function is normal, no dose reduction is necessary.
Patients with moderate to severe renal insufficiency
If you suffer from moderate renal insufficiency the recommended dose is 5 mg (half tablet) to be taken once a day.
Patients with moderate to severe hepatic impairment
If you only have hepatic insufficiency, no dosage adjustment will be necessary.
If you also suffer from renal insufficiency, your doctor will adopt an appropriate dosage.
If you have the feeling that the effect of FORMISTIN is too weak or too strong, please tell your doctor.
The duration of treatment depends on the type, duration and course of your ailments and is determined by your doctor.
Overdose What to do if you have taken too much Formistin
If you take more FORMISTIN than you should
If you think you have taken too much FORMISTIN please inform your doctor who will decide what measures to take.
Confusion, diarrhea, dizziness, tiredness, headache, malaise, mydriasis (dilation of the pupil), itching, restlessness, sedation, drowsiness, stupor, tachycardia (increased heart rate heart), tremor and urinary retention (inability to pass urine).
A specific antidote to cetirizine (ie a substance capable of neutralizing the action of cetirizine) is not known.
If you take too much medicine, symptomatic or supportive treatment is recommended. Following recent ingestion, gastric lavage (emptying of the stomach) is recommended.
If you forget to take FORMISTIN
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of FORMISTIN, ask your doctor or pharmacist.
Side Effects What are the side effects of Formistin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the first symptoms of hypersensitivity (allergy), contact your doctor, who will determine the severity and decide on any measures to be taken if necessary (discontinuation of treatment).
The effects that may occur following the use of this medicine are:
Common side effects (may affect up to 1 in 10 people)
- Fatigue
- Dry mouth (mouth and throat).
- Nausea.
- Dizziness, headache
- Drowsiness.
- Pharyngitis (inflammation of the mucous membrane between the oral cavity and the esophagus), rhinitis (inflammation of the nasal mucosa).
Uncommon side effects (may affect up to 1 in 100 people)
- Asthenia (lack of strength), malaise.
- Paresthesia (altered perception of the sensitivity of the limbs or other parts of the body).
- Agitation.
- Abdominal pain.
- Itching, rash (rash with red skin).
- Diarrhea
Rare side effects (may affect up to 1 in 1,000 people)
- Tachycardia (rapid heartbeat).
- Edema (accumulation of fluids).
- Hypersensitivity (allergy).
- Impaired hepatic (liver) function, with an increase in liver enzymes and bilirubin (a pigmented substance present in the bile resulting from the breakdown of hemoglobin).
- Weight gain.
- Convulsions, movement disorders.
- Aggression, confusion, depression, hallucinations, insomnia.
- Urticaria (allergic skin disease).
Very rare side effects (may affect up to 1 in 10,000 patients) -
- Thrombocytopenia (low level of platelets in the blood).
- Accommodation disorder (eye focusing mechanism), blurred vision, oculogyration (uncontrolled circular eye movements).
- Anaphylactic shock (very severe allergic reaction).
- Syncope, tremor, dysgeusia (altered taste), dyskinesia and dystonia (involuntary movements of the muscles with contractions).
- Tic.
- Dysuria (pain when passing urine) and enuresis (uncontrolled passing of urine).
- Angioneurotic edema (allergic syndrome with rapid swelling of the skin, mucosa and submucosal tissues), fixed drug eruption.
Undesirable effects with frequency not known (frequency cannot be estimated from the available data)
- Amnesia, memory impairment.
- Increased appetite.
- Suicidal ideation.
- Urinary retention (inability to pass urine).
- Dizziness.
If you notice any of the side effects described above, please tell your doctor.
Additional side effects in children and adolescents
Common side effects (may affect up to 1 in 10 people)
- Diarrhea.
- Drowsiness.
- Rhinitis (inflammation of the nasal mucosa).
- Fatigue.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 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 carton. The expiry date refers to the last day of that month and to the unopened, correctly stored product. No special storage precautions are required.
Do not use this medicine if you notice visible signs of deterioration.
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 FORMISTIN
1 film-coated tablet contains:
Active ingredient: cetirizine dihydrochloride 10 mg.
Other components: microcrystalline cellulose, lactose, macrogol 400, magnesium stearate, hypromellose, anhydrous colloidal silica, titanium dioxide (E 171).
Description of what FORMISTIN looks like and contents of the pack
Film-coated tablets.FORMISTIN is presented as oblong white film-coated tablets with a score line, contained in colorless and clear blisters. Blister containing 7 film-coated tablets.
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
FORMISTIN 10 MG TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
Excipients: one film-coated tablet contains 66.40 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
White, oblong film-coated tablet with score line
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Adults and pediatric patients from 6 years of age:
- Cetirizine is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- Cetirizine is indicated for the symptomatic treatment of chronic idiopathic urticaria.
04.2 Posology and method of administration
Children between the ages of 6 and 12: 5 mg twice a day (half tablet twice a day).
Adults and children over 12 years of age: 10 mg once daily (1 tablet). The tablets should be taken with a glass of liquid.
Elderly patients: based on available data, no dose reduction is required in elderly subjects with normal renal function.
Patients with moderate to severe renal insufficiency: no data are available documenting the efficacy / safety ratio in patients with renal insufficiency. Since cetirizine is predominantly excreted via the kidney (see section 5.2), in cases where alternative treatments cannot be used, the dose intervals should be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml / min is required. CLcr (ml / min) can be obtained from the serum creatinine value (mg / dl) using the following formula:
Dosage adjustment for adults with impaired renal function
In pediatric patients with renal insufficiency, the dose will have to be individually adjusted taking into account the renal clearance, age and body weight of the patient.
Patients with hepatic insufficiency: Patients with hepatic insufficiency only do not require any dosage adjustment.
Patients with hepatic and renal insufficiency: dosage adjustment is recommended (see Patients with moderate to severe renal impairment above).
04.3 Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to hydroxyzine or to any derivative of piperazine.
Patients with severe renal insufficiency with creatinine clearance less than 10 ml / min.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take cetirizine film-coated tablets.
04.4 Special warnings and appropriate precautions for use
At therapeutic doses, there was no evidence of clinically significant interactions with alcohol (for blood alcohol levels of 0.5 g / l). However, caution is recommended in case of concomitant alcohol intake.
This medicinal product should be used with caution in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia), as cetirizine may increase the risk of urinary retention.
Caution is advised in epileptic patients and in patients at risk for seizures.
Allergy skin tests are inhibited by antihistamines and a wash-out period (3 days) is required before performing them.
Pediatric population
The use of the film-coated tablets is not recommended in children under 6 years of age as this formulation does not allow for dosage adjustment.
04.5 Interactions with other medicinal products and other forms of interaction
Due to the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, no interactions are expected with this antihistamine. In drug-drug interaction studies, in fact, neither pharmacodynamic nor significant pharmacokinetic interactions were reported, in particular with pseudoephedrine or theophylline (400 mg / day).
The extent of absorption of cetirizine is not reduced by food, although the rate of absorption is decreased.
04.6 Pregnancy and lactation
Pregnancy
Very few clinical data on exposed pregnancies are available for cetirizine. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Prescribing to pregnant women should be done with caution.
Feeding time
Cetirizine is excreted in breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the sampling time after administration. Therefore, prescribing to breastfeeding women should be done with caution.
04.7 Effects on ability to drive and use machines
Objective measurements of ability to drive, sleep latency and assembly line performance did not demonstrate any clinically relevant effect at the recommended dose of 10 mg.
Patients intending to drive vehicles, engage in potentially hazardous activities or operate machinery should not exceed the recommended dose and take into account the individual response to the drug. In sensitive patients, the concomitant intake of cetirizine with alcohol or other CNS depressant substances may cause a further decrease in alertness and impaired performance.
04.8 Undesirable effects
Clinical studies have shown that cetirizine at the recommended dosage has minor CNS undesirable effects, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.
Although cetirizine is a selective antagonist of peripheral H1 receptors and is relatively devoid of anticholinergic activity, there have been rare reports of difficulty in micturition, eye accommodation disturbances and dry mouth.
There have been reports of abnormal liver function with liver enzyme elevations accompanied by elevated bilirubin, most of which resolved following discontinuation of cetirizine dihydrochloride.
Clinical trials
In the context of double-blind controlled clinical trials or clinical pharmacology studies, in which cetirizine was compared with placebo or other antihistamines at the recommended dosage (10 mg per day for cetirizine), for which quantitative safety data are available , more than 3200 subjects were exposed to cetirizine treatment.
Based on these data, the following adverse events with an incidence of 1.0% or greater with cetirizine 10 mg were reported in placebo-controlled trials:
Although statistically the incidence of somnolence was more common with cetirizine than with placebo, it was mild to moderate in the majority of cases. are impaired at the recommended daily dose in young healthy volunteers.
Adverse reactions with an incidence of 1.0% or greater in children aged 6 months to 12 years in placebo-controlled clinical trials or clinical pharmacology studies are:
Post-marketing experience
The following undesirable effects reported in post-marketing experience should be added to the adverse reactions encountered in clinical trials, listed in the previous section.
Undesirable effects are described according to the MedDRA system organ class and according to the frequency estimated based on post-marketing experience.
Frequencies are defined as follows: very common (≥1 / 10); common (≥1 / 100,
Disorders of the blood and lymphatic system:
Very rare: thrombocytopenia
Disorders of the immune system:
Rare: hypersensitivity
Very rare: anaphylactic shock
Metabolism and nutrition disorders:
Not known: increased appetite
Psychiatric disorders:
Uncommon: agitation
Rare: aggression, confusion, depression, hallucinations, insomnia
Very rare: tics
Not known: suicidal ideation
Nervous system disorders:
Uncommon: paraesthesia
Rare: convulsions, movement disorders
Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Not known: amnesia, memory impairment
Eye disorders:
Very rare: accommodation disorder, blurred vision, oculogyration
Ear and labyrinth disorders
Not known: dizziness
Cardiac pathologies:
Rare: tachycardia
Gastrointestinal disorders:
Uncommon: diarrhea
Hepatobiliary disorders:
Rare: impaired liver function (elevations in transaminases, alkaline phosphatase, γ-GT and bilirubin)
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angioneurotic edema, fixed drug eruption
Renal and urinary disorders:
Very rare: dysuria, enuresis
Not known: urinary retention
General disorders and administration site conditions:
Uncommon: asthenia, malaise
Rare: edema
Diagnostic tests:
Rare: weight gain
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. "Italian Medicines Agency Website: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Symptoms
Symptoms observed following an overdose of cetirizine are mainly associated with central nervous system effects or with effects that may suggest "anticholinergic activity."
Following a dose of at least 5 times the recommended daily dose, the following adverse events have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor and urinary retention.
Treatment
A specific antidote to cetirizine is not known.
In the event of an overdose, symptomatic or supportive treatment is recommended. Following recent ingestion, gastric lavage is recommended. Cetirizine is not effectively removed by dialysis.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: piperazine derivatives.
ATC code R06A E07.
Cetirizine, a metabolite of hydroxyzine in humans, is a potent and selective antagonist at peripheral H1 receptors. Receptor binding studies in vitro they showed no measurable affinity for other receptors other than H1.
In addition to the anti-H1 effect, cetirizine has antiallergic activity: at a dose of 10 mg once or twice a day, it inhibits the late recruitment phase of eosinophils, in the skin and conjunctiva of atopic subjects exposed to allergens.
Studies in healthy volunteers show that cetirizine, at doses of 5 and 10 mg, markedly inhibits the wheal and erythematous reactions induced by very high concentrations of histamine in the skin, but the correlation with efficacy is not established.
In a 35-day study in children aged 5 to 12 years, there was no evidence of tolerance to the antihistamine effect (suppression of wheals and erythema) of cetirizine. After discontinuation of repeated dose treatment with cetirizine, the skin recovers its normal reactivity to histamine within 3 days.
In a 6-week placebo-controlled study in 186 patients with allergic rhinitis and concomitant mild to moderate asthma, cetirizine at a dose of 10 mg once daily improved symptoms of rhinitis without affecting lung function. . This study supports the safety of cetirizine administration in allergic patients with mild or moderate asthma.
In a placebo-controlled study, cetirizine, given at the high daily dose of 60 mg for seven days, did not cause a statistically significant prolongation of the QT interval.
Cetirizine, at the recommended dosage, has been shown to improve the quality of life of patients with seasonal and perennial allergic rhinitis.
05.2 Pharmacokinetic properties
The steady-state plasma concentration is approximately 300 ng / mL and is reached within 1.0 0.5 hours. No accumulation was observed following doses
daily of 10 mg of cetirizine for 10 days. The pharmacokinetic distribution parameters, such as peak plasma (Cmax) and area under the curve (AUC), are unimodal in healthy volunteers.
The extent of absorption of cetirizine is not reduced by food, although the rate of absorption is decreased. The degree of bioavailability of cetirizine is similar when taken as a solution, capsule or tablet.
The apparent volume of distribution is 0.50 l / kg. The plasma protein binding of cetirizine is 93 0.3%. Cetirizine does not alter the binding of warfarin to plasma proteins.
Cetirizine does not undergo extensive first pass metabolism. About two thirds of the dose is excreted unchanged in the urine. The terminal half-life was approximately 10 hours.
Cetirizine exhibits linear kinetics between 5 mg and 60 mg.
Special populations
Senior citizens: In 16 elderly subjects following a single oral dose of 10 mg, the half-life increased by approximately 50% and the clearance decreased by 40% compared to normal subjects. The reduction of cetirizine clearance in these volunteers elderly appears to be related to decreased renal function.
Children: The half-life of cetirizine was approximately 6 hours in children aged 6 to 12 years, 5 hours in children aged 2 to 6 years and reduced to 3.1 hours in children aged 6 to 24 months.
Patients with renal insufficiency: the pharmacokinetics of the drug in patients with mild renal insufficiency (creatinine clearance greater than 40 ml / min) were similar to that of healthy volunteers. Patients with moderate renal impairment had a 3-fold higher half-life and a 70% reduction in clearance compared to healthy volunteers.
Patients on hemodialysis (creatinine clearance less than 7 ml / min), given a single oral dose of 10 mg of cetirizine, had a three-fold increase in half-life and a 70% decrease in clearance. clearance of normal subjects. Cetirizine is eliminated in low quantities by hemodialysis. Dosage adjustment is necessary in patients with moderate to severe renal impairment (see section 4.2).
Patients with hepatic insufficiency: Patients with chronic liver disease (hepatocellular, cholestatic and biliary cirrhosis) who received a single dose of 10 or 20 mg of cetirizine had a 50% increase in half-life along with a 40% decrease in clearance compared to subjects healthy.
Dosage adjustment is necessary in patients with hepatic insufficiency only if associated with renal insufficiency.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
- Microcrystalline cellulose
- Lactose
- Colloidal anhydrous silica
- Magnesium stearate
- Opadry Y-1-7000
- Hydroxypropylmethylcellulose (E 464)
- Titanium dioxide (E 171)
- Macrogol 400
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Blister in thermoformed PVC, transparent, colorless, physiologically inert heat-sealed with aluminum foil covered with suitable lacquer in a cardboard box.
Packs of 7 and 20 tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
LUSOFARMACO
ISTITUTO LUSO FARMACO D "ITALIA S.p.A.
Milanofiori - Street 6 - Building L - 20089 Rozzano (MI)
08.0 MARKETING AUTHORIZATION NUMBER
7 tablets A.I.C. n. 027329034
20 tablets A.I.C. n. 027329010
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
7 tablets
25.03.2004/01.06.2010
20 tablets 01.04.1989 / 01.06.2010
