Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LORATADINE
PCO Manufacturing
10 Milligram
Tablets
1998-06-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarityn 10 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Clarityn tablet contains 10 mg of loratadine. Excipients: Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Product sourced from the UK: White, ovaloid tablets, plain on one side, with a breakline on the other side, with a logo above the breakline and ‘10’ below the breakline. Product sourced from Greece: White, circular flat beveled edged tablets, plain on one side, with a breakline on the other side, with ‘10’ above the breakline and a log below the breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarityn tablets are indicated for the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching and ocular itching and burning. Nasal and ocular signs and symptoms are relieved rapidly after oral administration. Clarityn tablets are also indicated for relief of symptoms and signs of chronic urticaria and other dermatologic disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Clarityn is for oral administration. The tablets should be taken on an empty stomach. _ADULTS AND CHILDREN 12 YEARS AND ABOVE_: one tablet (10 mg)daily _PATIENTS WITH SEVER LIVER IMPAIRMENT: _one tablet (10 mg) every other day _CHILDREN UNDER 12: _not recommended 4.3 CONTRAINDICATIONS Clarityn tablets are contra-indicated in patients who have shown hypersensitivity or idiosyncrasy to loratadine or any other component. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE SPECIAL PRECAUTIONS: o During clinical studies the incidence of anticholinergic activity associated with 10 mg Clarityn tablets was comparable to that associated with placebo.However, caution should be observed in patients w Read the complete document