ULTARIN

Posology Adults 10 mg once daily (one tablet once daily). Paediatric population Children 6 years of age and older with a body weight greater than 30 kg: 10 mg once daily (one tablet once daily). For appropriate dosing in children younger than 6 years or with body weight of 30 kg or less, there are other formulations more suitable.

Children under 2 years of age:

Safety and efficacy of Ultarin 10 mg Tablets have 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 patients with renal insufficiency. Elderly No dosage adjustments are required in the elderly.

Method of administration Oral use. The tablet 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%). 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. 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). The administration of Ultarin 10 mg Tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index. These tablets contain lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. There are no significant interactions between loratadine and food.

Information on sodium content:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1.