VALUE HEALTH ONE-A-DAY ALLERGY RELIEF

Method of administration For oral use only. The tablets may be taken without regard to mealtime. Adults and children 12 years of age and over: 10mg daily (one tablet once daily).

Children aged 6 to under 12 years with:

Body weight more than 30 kg: 10mg daily (one tablet once daily).

Body weight 30 kg or less:

The 10mg strength tablet is not appropriate in children with a body weight less than 30 kg. Paediatric population Children aged 2-6 years and children aged > 6 years with body weight < 30 kg: Not recommended. The efficacy and safety of loratadine 10mg tablets in children under 2 years of age have not been established.

Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of one tablet every other day is recommended for adults and children weighing more than 30 kg.

No dosage adjustments are required in the elderly or in patients with renal insufficiency.

The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1000), Very rare (<1/10,000) and not known (cannot be estimated from the available data).

3%), and fatigue (1%). In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2 % of patients in excess of those treated with placebo.

1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table. System Order Class Frequency Adverse Event Immune system disorders Very rare Hypersensitivity reactions (including angioedema and anaphylaxis Nervous system disorders Very rare Dizziness, convulsion Cardiac disorders Very rare Tachycardia, palpitation Gastrointestinal disorders Very rare Nausea, dry mouth, gastritis Hepato-biliary disorders Very rare Abnormal hepatic function Skin and subcutaneous tissue disorders Very rare Rash, alopecia General disorders and administration site conditions Very rare Fatigue Investigations Not known Weight increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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2). The administration of Loratadine should be discontinued at least 48 hours before skin tests, as antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

This medicinal product contains lactose:

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Galpharm one-a-day allergy and hayfever relief 10mg tablets are contraindicated in patients who are hypersensitive to loratadine or to any of the excipients in the formulation.