País: Israel
Língua: inglês
Origem: Ministry of Health
NIFEDIPINE
BAYER ISRAEL LTD
C08CA05
TABLETS PROLONGED RELEASE
NIFEDIPINE 20 MG
PER OS
Required
BAYER PHARMA AG, GERMANY
NIFEDIPINE
NIFEDIPINE
Chronic stable angina, hypertension.
2012-03-31
1/14 THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED BY IT ON DECEMBER 2016. 1. NAME OF THE MEDICINAL PRODUCT Osmo-Adalat 20 mg Osmo-Adalat 30 mg Osmo-Adalat 60 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Osmo-Adalat 20 Each prolonged-release tablet contains 20 mg nifedipine. Osmo-Adalat 30 mg Each prolonged-release tablet contains 30 mg nifedipine. Osmo-Adalat 60 mg Each prolonged-release tablet contains 60 mg nifedipine. Each tablet contains a 10% overage of nifedipine to deliver the label claim For excipients see Section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. Osmo-Adalat 20 mg Pink, round, convex prolonged-release tablet with a laser hole on one side and marked with Adalat 20. Osmo-Adalat 30 mg Pink, round, convex prolonged-release tablet, with a laser hole on one side and marked with Adalat 30. Osmo-Adalat 60 mg Pink round, convex prolonged-release tablet, with a laser hole on one side and marked with Adalat 60. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of chronic stable angina, and hypertension. 2/14 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION _ _Dosage regimen _ 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: For CHRONIC STABLE ANGINA PECTORIS (angina of effort): 1 Osmo-Adalat 20 mg tablet once daily (1 x 20 mg/day) 1 Osmo-Adalat 30 mg tablet once daily (1 x 30 mg/day) 1 Osmo-Adalat 60 mg tablet once daily (1 x 60 mg/day) For hypertension: 1 Osmo-Adalat 20 mg tablet once daily (1 x 20 mg/day) 1 Osmo-Adalat 30 mg tablet once daily (1 x 30 mg/day) 1 Osmo-Adalat 60 mg tablet once daily (1 x 60 mg/day) In general, for both indications, therapy should be initiated with 30 mg once daily. Where registered a starting dose of 20 mg once daily may be considered when medically Leia o documento completo