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CETIRIZINA MY * 7CPR RIV 10MG

  • MYLAN SpA
  • 037713043
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CETIRIZINA MY * 7CPR RIV 10MG

Therapeutic indications

Cetirizine is indicated in adults and children from 6 years of age: - For the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - For the symptomatic treatment of chronic idiopathic urticaria.

Dosage and method of use

Dosage. 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 (one tablet). Senior citizens: The data do not suggest the need for dose reduction in elderly people with normal renal function. Pediatric population: The use of the film-coated tablet formulation is not recommended in children under 6 years of age as this formulation does not allow for adequate dose adjustment. Patients with moderate to severe renal impairment: Dosing intervals should be individualized based on 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: 71260_1.PNG Dosage adjustment for adults with impaired renal function.

Group Creatinine clearance (ml / min) Dosage and frequency
Normal ≥80 10 mg once a day
Mild 50-79 10 mg once a day
Moderate 30-49 5 mg once a day
Serious 5 mg once every 2 days
End-stage renal disease - Patients on dialysis Contraindicated

In pediatric patients with renal impairment, the dose will need to be adjusted individually, taking into account the patient's renal clearance, age and body weight. Impaired liver function: No dose adjustment is required in patients with hepatic impairment only. Impaired liver and kidney function: dosage adjustment is recommended (see above “Patients with moderate to severe renal impairment”). Method of administration: The tablets should be taken with a glass of liquid.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to hydroxyzine or to any derivative of piperazine. Patients with severe renal impairment with creatinine clearance less than 10 ml / min.

Side 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 observed. Although cetirizine is a selective inhibitor of peripheral H1 receptors and is relatively free of anticholinergic activity, there have been rare reports of difficulty in micturition, disturbances in accommodation of the eye and dryness. of the 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. a) Clinical trials: In double-blind controlled clinical trials or clinical pharmacology studies comparing the effects of cetirizine versus placebo or other antihistamines at the recommended dosage (10 mg per day for cetirizine) for which data are available safe quantities, more than 3200 subjects were treated with cetirizine. Based on these data, the following adverse events were reported in placebo-controlled trials with an incidence of 1.0 or greater% with cetirizine 10 mg:

Adverse Events (WHO-ART) Cetirizine 10 mg (n = 3260) Placebo (n = 3061)
Organism as a whole - general pathologies
Fatigue 1.63% 0.95%
Pathologies of the central and peripheral nervous system
Dizziness 1.10% 0.98%
Headache 7.42% 8.07%
Disorders of the gastrointestinal system
Abdominal pain 0.98% 1.08%
Dry mouth 2.09% 0.82%
Nausea 1.07% 1.14%
Psychiatric disorders
Drowsiness 9.63% 5.00%
Respiratory system disorders
Pharyngitis 1.29% 1.34%

Although statistically the incidence of somnolence was more common with cetirizine than with placebo, it was mild to moderate in the majority of cases. Further studies in which objective tests have been carried out have shown that usual daily activities are not compromised at the recommended daily dose in young healthy volunteers. Adverse reactions with an incidence equal to or greater than 1% in children aged 6 months to 12 years, in placebo-controlled clinical trials or clinical pharmacology studies, are:

Adverse reactions (WHO-ART) Cetirizine (n = 1656) Placebo (n = 1294)
Diseases of the gastrointestinal system
Diarrhea 1.0% 0.6%
Psychiatric disorders
Drowsiness 1.8% 1.4%
Respiratory system disorders
Rhinitis 1.4% 1.1%
Organism as a whole - general pathologies
Fatigue 1.0% 0.3%
b) Post-marketing experience

: Isolated cases of the following adverse reactions reported in post-marketing experience should be added to the adverse events reported in clinical trials listed in the previous section. Undesirable effects are described according to MedDRA system organ class and frequency estimated based on post-marketing experience. Frequencies are defined as follows: very common (≥1 / 10), common (≥1 / 100a) Blood and lymphatic system disorders. 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: tick; Not known: suicidal thoughts. Nervous system disorders. Uncommon: paraesthesia; Rare: convulsions; Very rare: dysgeusia, dyskinesia, dystonia, syncope, tremor; 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 (elevation of transaminases, alkaline phosphatase, γ- GT and bilirubin). Skin and subcutaneous tissue disorders. Uncommon: itching, rash; Rare: hives; 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 adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

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. Caution should be exercised in patients with predisposing factors for urinary retention (such as 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. Allergic skin tests are inhibited by antihistamines therefore a wash-out period (of 3 days) is required before performing them. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take cetirizine film-coated tablets.

Pregnancy and breastfeeding

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 0.25-0.90 compared to those measured in plasma, depending on the sampling time after administration. Therefore, caution should be used when prescribing Cetirizine Mylan Generics to breastfeeding women.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Due to the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, no interactions are expected with this antihistamine. Indeed, neither pharmacodynamic nor significant pharmacokinetic interactions were reported in drug-drug interaction studies, 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.

Overdose

a) 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. b) 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.

Active principles

Each film-coated tablet contains 10 mg cetirizine dihydrochloride. Excipient with known effects Each film-coated tablet contains 74.3 mg of lactose monohydrate. For the full list of excipients, see section 6.1.

Excipients

Core of the tablet: Lactose monohydrate, Pregelatinised maize starch, Povidone K29 / 32, Magnesium stearate. Tablet coating: Talc, Titanium dioxide (E171), Hypromellose 5cP (E464), Macrogol 400.

MYLAN SpA
037713043
12 Items