BROWN & BURK ONCE-A-DAY HAYFEVER & ALLERGY

Posology Adults and children over 12 years of age: 10 mg once daily (one tablet once daily). .

Paediatric population Children 2 to 12 years of age are dosed by weight :

Body weight more than 30 kg: 10 mg once daily (one tablet once daily) Body weight 30 kg or less: The 10 mg strength tablet is not appropriate in children with a body weight less than 30 kg. There are other formulations more suitable for children 2 to 12 years old with body weight 30 kg or less.

Efficacy and safety of this medicine in children under 2 years of age has not been established. No data are available. Hepatic impairment Patient with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine.

An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg, Renal impairment No dosage adjustments are required in patients with renal insufficiency. Elderly No dosage adjustments are required in the elderly.

Method of administration Oral use. The tablet may be taken without regard to mealtime.

Summary of the safety profile In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticarial (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%). Tabulated list of adverse reactions The following adverse reactions reported during the post-marketing period are listed in the following table by System Organ Class. Frequencies are defined as 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) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. System Organ Class Frequency Adverse Experience Term Immune system disorders Very rare Hypersensitivity reactions (including angioedema and anaphylaxis).

3%), and fatigue (1%). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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2) This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The administration of this medicine should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

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