PIRITEZE ALLERGY

Children aged from 6 to 12 years: 5mg twice daily (a half tablet twice daily). Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet once daily). Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.

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 individualised according to renal function.

Refer to the following table and adjust the dose as indicated. To use this dosing table, anestimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. 85 for woman) 72x 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 - Patients undergoing dialysis < 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, their age and body weight.

Patients with 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).

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 hydrochloride. Clinical trials Double blind controlled clinical or pharmacoclinical 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.

3% Post-marketing experience The adverse effects listed below are classified by system organ class and frequency according to the following convention: 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) or very rare (<1/10,000).

MEDRA SOC Adverse reaction Frequency Blood and lymphatic disorders Thrombocytopenia Very rare Metabolism and nutrition disorders: Increased appetite Not known Agitation Uncommon: Aggression, confusion, depression, hallucinations, insomnia Rare Tic Very rare: Psychiatric disorders: Suicidal ideation, nightmare Not known: Paraesthesia Uncommon Convulsions, movement disorders Rare Dysgeusia, syncope, tremor, dystonia, dyskinesia Very rare Nervous system disorders: Amnesia, memory impairment Unknown Eye disorders Accommodation disorder, blurred vision, oculogyration Very rare Ear and labyrinth disorders Vertigo Not known Cardiac disorders Tachycardia Rare Gastro-intestinal disorders Diarrhoea Uncommon Hepatic function abnormal (increased transaminases, alkaline phosphates, γ-GT and bilirubin) RareHepatobiliary disorders: Hepatitis Unknown Pruritus, rash Uncommon Urticaria Rare Angioneurotic oedema, fixed drug eruption Very rare Skin and subcutaneous tissue disorders Acute generalized exanthematous pustulosis (AGEP) Unknown Musculoskeletal and connective tissue disorder Arthralgia Not known Dysuria, enuresis Very rareRenal and urinary disorders Urinary retention (see section Warnings and Precautions) Not known Asthenia, malaise Uncommon:General disorders and administration site conditions Oedema Rare Investigations Weight increased Rare Hypersensitivity RareImmune system disorders Anaphylactic shock Very rare Skin reactions occuring after discontinuation of cetirizine After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported (see Section Warnings and Precautions).

4. 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 (see Section Adverse Reactions). Caution in epileptic patients and patients at risk of convulsions is recommended.

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. Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation (see Section Adverse Reactions).

In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted. Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency of glucose-galactose malabsorption should not take cetirizine film-coated tablets.

Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any piperazine derivatives. Patients with severe renal impairment at less than 10 ml/min creatinine clearance.