NUMARK ALLERGY & HAYFEVER

Posology Adults, including the elderly, and children 12 years of age and over:

One 10mg tablet once daily Children 2 to 12 years of age with: Body weight more than 30kg: 10mg once daily (one tablet) Body weight 30kg or less: 5ml (5mg) of the syrup once daily. The 10mg strength tablet is not appropriate in children with a body weight less than 30kg.

Efficacy and safety of RelonChem Hayfever and Allergy 10mg tablets in children under 2 years of age has not been established in this age group.

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 10mg every other day is recommended for adults and children weighing more than 30kg Patients with renal impairment: No dosage adjustments are required in the elderly or in patients with renal insufficiency.

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 urticarial (CIU), at the recommended dose of 10mg 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. 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) and 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

2). 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. The administration of RelonChem Hayfever and Allergy 10mg tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

1.