Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
PHOLCODINE
Mercury Pharmaceuticals (Ireland) Ltd
5 MG/5ml
Unknown
1978-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pholcolin 5 mg/5 ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of solution contains Pholcodine 5 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Oral solution Amber coloured, sweet tasting oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of non-productive cough. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pholcolin is for oral administration. Adults: 10mg up to three times daily. Children: 1 - 2 years: 2.5 mg up to three times daily. Over 2 years: 5.0 mg up to three times daily. 4.3 CONTRAINDICATIONS Use in patients with hypersensitivity or idiosyncratic response to pholcodine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should only be used for suppression of non-productive cough. Pholcolin is not for use in infants less than 1 year without consulting a doctor. If symptoms persist of worsen, the doctor should be consulted. The product should not be taken for persistent or chronic cough such as occurs with smoking, asthma or emphysema or if the cough is accompanied by excessive mucus (phlegm), unless directed by a doctor. This medicinal product contains Nipasept sodium, a preservative which contains hydroxybenzoates that may sometimes cause allergic reactions (possibly delayed). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/01/2007_ _CRN 2032334_ _page number: 1_ This medicinal product contains less than 1 mmol sodium per dose, i.e. essentially ‘sodium free’. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Concomitant administration of alcohol or other CNS depressants may lead to greater drowsiness and sedation. 4. Przeczytaj cały dokument