LORATADINE

Posology Adults and children over 12 years of age 10 mg once daily (one orodispersible tablet once daily). Paediatric population Children 2 to 12 years of age with body weight more than 30 kg: 10 mg once daily (one orodispersible tablet once daily).

The 10 mg strength orodispersible tablet is not appropriate in children with a body weight less than 30 kg. Efficacy and safety of loratadine in children under 2 years of age has not been established. Hepatic impairment Patients with severe hepatic 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. Renal impairment No dose adjustments are required in patients with renal insufficiency. Elderly No dosage adjustments are required in the elderly.

Method of administration Loratadine 10 mg orodispersible tablets should be handled with caution and with dry hands only. Loratadine 10 mg orodispersible tablets are intended for oral use. The tablet shall be put on the tongue and wait until it is thoroughly disintegrated.

Water or other liquid is not needed to swallow the dose. The orodispersible tablet may be taken without regard to mealtime.

Summary of the safety profile In clinical studies 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%). 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) 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.

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2). Loratadine 10 mg orodispersible tablets contain lactose, sorbitol, aspartame, sodium and sulphites This medicinal product contains lactose and sorbitol. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

This medicinal product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria. This medicinal product contains less than 1 mmol (23 mg) sodium per orodispersible tablet, that is to say essentially ‘sodium-free’.

This medicinal product contains sulphites. May rarely cause severe hypersensitivity reactions and bronchospasm. 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.

1.