POLLENSHIELD HAYFEVER RELIEF, CETIRIZINE HYDROCHLORIDE

Posology 10mg once daily (1 tablet).

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 individualised 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 10mg once daily Mildly decreased renal function 60 – 90 10mg once daily Moderately decreased renal function 30 – 60 5mg once daily Severely decreased renal function 15 - <30 not requiring dialysis treatment 5mg 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 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 6 to 12 years: 5mg twice daily (a half tablet twice daily).

Adolescents above 12 years: 10 mg once daily (1 tablet). In paediatric 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 For oral use. The tablets need to be swallowed with a glass of liquid.

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 (10mg 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 effects 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). Uncommon Rare Very rare Not known Blood and lymphatic disorders: thrombocytopenia Immune system disorders: hypersensitivity anaphylactic shock Metabolism and nutrition disorders: increased appetite Psychiatric disorders: agitation aggression, confusion, depression, hallucination, insomnia tic suicidal ideation, nightmares Nervous system disorders: paraesthesia convulsions dysgeusia, syncope, tremor, dystonia, dyskinesia amnesia, memory impairment Eye disorders: accommodation disorder, blurred vision, oculogyric crisis Ear and labyrinth disorders: vertigo Cardiac disorders: tachycardia Gastro- intestinal disorders: diarrhoea Hepatobiliary disorders: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ- hepatitis GT and bilirubin) Skin and subcutaneous tissue disorders: pruritus, rash urticaria angioneurotic oedema, fixed drug eruption Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorder Arthralgia, myalgia Renal and urinary disorders: dysuria, enuresis urinary retention General disorders and administration site conditions: asthenia, malaise oedema Investigations: weight increased Description of selected adverse reactions After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.

5g/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.

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 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 paediatric formulation of cetirizine. This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.

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