LORATADINE

Posology Adults and children over 12 years of age: 10ml (10mg) of the syrup once daily.

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

Body weight more than 30kg: 10ml (10mg) of the syrup once daily; Body weight 30kg or less: 5ml (5mg) of the syrup once daily. Efficacy and safety of Loratadine 5mg/5ml Syrup in children under 2 years of age has not been established.

Patients with severe liver impairment Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg, and for children weighing 30kg or less, 5ml (5mg) every other day is recommended.

Patients with severe renal impairment No dosage adjustments are required in the elderly or in patients with renal insufficiency. Elderly No dosage adjustments are required in the elderly. Method of administration For oral administration.

a.

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Font color: Auto Formatted: Font color: Auto Formatted: Font color: Auto Formatted: Font color: Auto Formatted: Bullets and Numbering In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with the placebo.

1%). b. 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 Reaction 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 c.

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 sucrose; patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine. The administration of Loratadine 5mg/5ml Syrup 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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1).