CETIRIZINE HYDROCHLORIDE

Elderly Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. Renal Impairment Patients with moderate to severe 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.

85 for women) 72 x serum creatinine (mg / dl) Dosing adjustments for adult patients with impaired renal function Group Creatinine clearance (ml/min) Dosage and frequency Normal ≥80 10 mg once daily Mild 50 – 79 10 mg once daily Moderate 30 – 49 5 mg once daily Severe <30 5 mg once every 2 days End-stage renal disease <10 Contra-indicated In paediatric 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. Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate to severe renal impairment above). Paediatric Population Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily).

The tablet formulation should not be used in children under 6 years of age as it does not allow the necessary dose adjustments. Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet). Method of administration The tablets need to be swallowed with a glass of liquid.

4. CLINICAL PARTICULARS

Clinical studies have shown that cetirizine at the recommended dosage 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 Clinical trials Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 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.

8 % 1. 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 the MedDRA System Organ Class and by estimated frequency based on post- marketing exposure.

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).

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.

Allergy skin tests are inhibited by antihistamines and a washout 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 this medicine.

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. 4. CLINICAL PARTICULARS

1, to hydroxyzine or to any piperazine derivatives. Patients with severe renal impairment at less than 10 ml/min creatinine clearance.