Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
IPS Healthcare Limited
20 Milligram
Tablet Prolonged Release
2011-09-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 20 mg Prolonged Release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 20 mg nifedipine. Excipients: Each 20 mg tablet also contains 8.3 mg sodium. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. _Product imported from the UK:_ Pink, round, convex prolonged-release tablet with a laser hole on one side and marked with Adalat 20 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of mild to moderate hypertension. For the management of chronic stable angina pectoris either as monotherapy or in combination with a beta-blocker. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION ORAL USE As far as possible the treatment must be tailored to the needs of the individual. Depending on the clinical picture in each case, the basic dose must be introduced gradually. Unless otherwise prescribed, the following dosage guidelines are recommended for adults: o For CORONARY HEART DISEASE: CHRONIC STABLE ANGINA PECTORIS (angina of effort) 1 Adalat LA 20 mg tablet once daily (1 x 20 mg/day) o For HYPERTENSION: 1 Adalat LA 20 mg tablet once daily (1 x 20 mg/day) In general therapy should be initiated with 30 mg once daily. Where registered a starting dose of 20 mg once daily may be considered when medically indicated. Interim doses i.e. 40 mg, 50 mg etc. can be applied by combinations of i.e. 20 mg + 20 mg or 20 mg + 30 mg tablets. Depending on the severity of the disease and the patient's response the dose can be increased in stages up to 90 mg once daily. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/09/201 Les hele dokumentet