LORATADINE

Posology Adults and children over 12 years of age: 10mg once daily (one film-coated tablet once daily). The film-coated tablet may be taken without regard to mealtime.

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

Body weight more than 30 kg: 10 mg once daily (one film-coated tablet once daily). Bodyweight more than 30kg: 10mg once daily (one tablet once daily).

Bodyweight 30 kg or less:

The 10mg strength tablet is not appropriate in children with a body weight less than 30kg. There are other formulations more suitable for children 2 to 12 years old with body weight 30 kg or less. Safety and efficacy of loratadine 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.

Patients with 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 Loratadine tablets are for oral use.

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.

1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table. Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000).

Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to <1/100) Very Rare (< 1/10,000) Immune system disorders Hypersensitivity reactions (including angioedema and anaphylaxis) Metabolism and nutrition disorders Increased appetite Nervous system disorders Headache, somnolence, nervousness Insomnia Dizziness, convulsions Cardiac disorders Tachycardia, palpitation.

Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders Nausea, , dry mouth and gastritis Hepatobiliary disorders Abnormal hepatic functions Skin and subcutaneous tissue disorders Rash, alopecia General disorders and administration site conditions Fatigue 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). Caution is required with concomitant use of drugs which affect hepatic cytochromes P450 3A4 and 2D6. 5; interaction with other medicinal products and other forms of interaction). The administration of Loratadine should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

Loratadine may cause dry mouth in certain patients. Therefore during long- term treatment, good oral hygiene is important for these patients, because dry mouth may increase the risk of caries. 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.

1.