LORATADINE

Posology Adults and children and adolescents over 12 years of age 10 ml (10 mg) of the syrup once daily. Paediatric population (under 12 years of age) Children 2 to 12 years of age are dosed by weight: Body weight more than 30 kg: 10 ml (10 mg) of the syrup once daily.

Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily. The safety and efficacy of loratadine syrup 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 10 mg every other day is recommended for adults and children weighing more than 30 kg and for children weighing 30 kg or less, 5 ml (5 mg) 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 For oral use. The syrup 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 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%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table by System Organ Class. Tabulated of list of adverse reactions 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 <1,000); very rare (< 1/10,000); 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). Loratadine syrup contains 600 mg of sucrose per ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The administration of loratadine syrup should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

1.