COMPOSITION One tablet contains: Active ingredient: cetirizine dihydrochloride 10 mg. Excipients: Core: monohydrated lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Coating: Opadry Y-1-7000 comprising: Hypromellose, macrogol 400, titanium dioxide. PHARMACEUTICAL FORM Film-coated tablets containing 10 mg of cetirizine. Box of 7, 10 or 20 tablets. PHARMACOTHERAPEUTIC CATEGORY Antihistamine. THERAPEUTIC INDICATIONS Symptomatic treatment of seasonal rhinitis and conjunctivitis, chronic allergic rhinitis and urticaria of allergic origin. CONTRAINDICATIONS Established individual hypersensitivity to the drug. PRECAUTIONS FOR USE Although animal studies have not shown any harmful effect on the foetus, as a precaution, Zirtek should not be administered to women who are known or suspected to be pregnant unless, in the judgement of the doctor, the available benefits outweigh the potential risks. For the same reasons, use of Zirtek should be avoided during lactation. It is recommended that the consumption of alcoholic drink be reduced to a minimum during treatment. INTERACTIONS No interactions have appeared between cetirizine and other drugs or with food. SPECIAL WARNINGS The recommended daily doses should not be exceeded if the patient is to drive or operate machinery. DOSE, METHOD AND TIME OF ADMINISTRATION The dosage should be determined by the doctor. For children over 12 years of age and for adults, the dosage should generally be one tablet daily in a single dose. The tablet should be swallowed whole with a little water. The dosage should be reduced in patients with hepatic or renal insufficiency. OVERDOSE Drowsiness may be a symptom of overdose (generally more than 5 tablets). At present there is no specific antidote. UNDESIRABLE EFFECTS At the start of treatment, some patients have sometimes reported mild sedation which can be avoided by dividing the dosage into two individual doses. Tell your doctor or pharmacist of any undesirable effect not described in the leaflet. EXPIRY DATE IMPORTANT: do not use the medicine after the expiry date printed on the pack. STORAGE At ambient temperature. | The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician. |
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