CETIRIZINE HYDROCHLORIDE

Posology Adults and adolescents over 12 years of age 10 mg once daily (1 tablet) Paediatric population The tablet formulation should not be used in children under 6 years of age as it does not allow the necessary dose adjustments. Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily) Elderly patients Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.

Renal impairment There are no data to document the efficacy/safety ratio in patients with renal impairment. 2), in cases no alternative treatment can be used, the dosing intervals must 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 needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: CLcr = [140 - age(years)] x weight (kg) 72 x serum creatinine (mg/dl) Dosing adjustments for adult patients with impaired renal function Group Creatinine clearance (ml/min) Dose and frequency Normal Mild Moderate Severe End-stage renal disease- Patients undergoing dialysis ≥ 80 50-79 30-49 <30 <10 10 mg once daily 10 mg once daily 5 mg once daily 5 mg once every 2 days Contra-indicated In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age and his body weight.

Hepatic impairment No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic and renal impairment, adjustment of the dose is recommended (see Renal impairment above). Method of administration The tablets need to be swallowed with a glass of liquid.

Clinical studies Overview Clinical studies have shown that cetirizine at the recommended dose has minor undesirable effects on the CNS, 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 free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported. Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported.

Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride. Listing of ADRs Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dose (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3,200 subjects exposed to cetirizine.

34 % Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases. Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.

3 % Post-marketing experience In addition to the adverse reactions reported during clinical studies and listed above, the following undesirable effects have been reported in post-marketing experience. Undesirable effects are described according to MedDRA System Organ Class and by estimated frequency based on post-marketing experience.

Frequencies are defined as follows:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data) Blood and lymphatic disorders Very rare: thrombocytopenia Immune system disorders Rare: hypersensitivity Very rare: anaphylactic shock Metabolism and nutrition disorders Not known: increased appetite Psychiatric disorders Uncommon: agitation Rare: aggression, confusion, depression, hallucination, insomnia Very rare: tics Not known: suicidal ideation, nightmare Nervous system disorders Uncommon: paraesthesia Rare: convulsions 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: vertigo Cardiac disorders Rare: tachycardia Gastrointestinal disorders Uncommon: diarrhoea Hepatobiliary disorders Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin) Not known: hepatitis Skin and subcutaneous tissue disorders Uncommon: pruritus, rash Rare: urticaria Very rare: angioneurotic oedema, fixed drug eruption Not known: acute generalized exanthematous pustulosis Musculoskeletal and connective tissue disorders Not known: arthralgia Renal and urinary disorders Very rare: dysuria, enuresis Not known: urinary retention General disorders and administration site conditions Uncommon: asthenia, malaise Rare: oedema Investigations Rare: weight increased Description of selected adverse reactions After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.

5 g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly. g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention. Caution in epileptic patients and patients at risk of convulsions is recommended.

Response to allergy skin tests is inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation.

In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted. 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.

It is recommended to use a pediatric formulation of cetirizine. Excipients This medicine contains 77,7 mg lactose per tablet. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Patients with severe renal impairment at less than 10 ml/min creatinine clearance. 85 for women)