LORATADINE

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

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

Body weight more than 30kg: 10ml (10mg) of the Oral Solution once daily. Body weight 30kg or less: 5ml (5mg) of the Oral Solution once daily. The safety and efficacy of Loratadine Oral Solution in children under 2 years of age has not been established.

No data are available. Patients with hepatic 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 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 Oral Solution may be taken without regard to meal time.

Summary of the safety profile In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (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. 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. uk/yellowcard.

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

1.