Cetirizine Hydrochloride 10mg Tablets

Each tablet contains Cetirizine hydrochloride 10mg.Pharmaceutical form Film-coated tablet.White circular biconvex film-coated tablets, embossed 'C' on one side and a deep score on the other.Therapeutic indications In adults and paediatric patients 6 years and above: - Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice daily). Adults and adolescents over 12 years of age: 10mg once daily (1 tablet) The tablets need to be swallowed with a glass of liquid. Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.Hypersensitivity to cetirizine hydrochloride, to any of the excipients listed in section 6.1, to hydroxyzine or to any piperazine derivatives. Patients with severe renal impairment at less than 10 ml/min creatinine clearance. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly. Caution should be taken in patients with predisposition factors or urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention. Caution in epileptic patients and patients who are at risk of convulsions is recommended. Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. Paediatric population The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.Due to pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day). The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

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