Each tablet contains 10 mg of loratadine.

Tablet White, oval tablets, scored on one side and plain on the other side, debossed “L” and “10” on each side of the scoreline

Galpharm Non-Drowsy Allergy Relief tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

Adults and children 12 years of age and over:

10 mg daily (one tablet once daily).

The tablets may be taken without regard to mealtime.

Children aged 2 to under 12 years with

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

Efficacy and safety of Galpharm Non-Drowsy Allergy Relief 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.

Galpharm Non-Drowsy Allergy Relief tablets are contraindicated in patients who are hypersensitive to loratadine or to any of the excipients in the formulation.

Loratadine should be used with caution in the treatment of patients with severe liver impairment. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. The administration of Galpharm Non-Drowsy Allergy Relief tablets should be discontinued at least 48 hours before skin tests, as antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
 

When administered concomitantly with alcohol, Galpharm Non-Drowsy Allergy Relief tablets have no potentiating effects as measured by psychomotor performance studies.

Due to the wide therapeutic index of loratadine no clinically relevant interactions are expected and none were observed in the conducted clinical trials.

In clinical trials in a paediatric population children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), 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. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table.

BOOTS COMPANY PLC

P - Pharmacy

05 March 2010