ZIRTEK ALLERGY RELIEF FOR CHILDREN

Posology 10 mg once daily (10 mL oral solution (2 full spoons)). Special population Elderly 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. Dosing adjustments for adult patients with impaired renal function Group GFR (mL/min) Dosage and frequency Normal renal function ≥90 10 mg once daily Mildly decreased renal function 60 – < 90 10 mg once daily Moderately decreased renal function 30 – < 60 5 mg once daily Severely decreased renal function 15 - <30 not requiring dialysis treatment 5 mg once every 2 days End-stage renal disease <15 requiring dialysis treatment Contra-indicated Hepatic impairment No dose adjustment is needed in patients with solely hepatic impairment.

In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Renal impairment above). Paediatric Population Children aged from 6 to 12 years: 5 mg twice daily (5 mL oral solution twice daily (a full spoon twice daily)).

Adolescents over 12 years of age: 10 mg once daily (10 mL oral solution (2 full spoons)). In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance, age and body weight of the patient.

Method of administration The solution can be swallowed as such.

Clinical studies • Overview 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. • Listing of ADRs 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.

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, oculogyric crisis Ear and labyrinth disorders: Not known: vertigo Cardiac disorders: Rare: tachycardia Gastro-intestinal 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, myalgia 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 is recommended in epileptic patients and patients at risk of convulsions.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). Patients with rare hereditary problems of fructose intolerance should not take cetirizine 1 mg/ml oral solution. Response to allergy skin tests are 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 Due to the amount of some excipients in the formulation, the use of the product is not recommended in children aged less than 6 years.

1, to hydroxyzine or to any piperazine derivatives. Patients with end-stage renal disease with GFR (Glomerular Filtration Rate) below 15 ml/min.