Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
LTT Pharma Limited
NIFEDIPINE
10 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat Retard 10 mg Prolonged-Release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated, prolonged-release tablet contains 10 mg nifedipine. Excipients: contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated, prolonged-release tablets _Product imported from the UK:_ Grey-pink, circular tablets marked with A10 on one side and a Bayer cross on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the management of chronic stable angina pectoris and the treatment of mild to moderate hypertension. Adalat retard 10 mg is intended primarily for the treatment of milder forms of cardiovascular diseases and, in general, for those patients who, irrespective of the severity of their disease, respond particularly intensely to nifedipine. In addition Adalat retard 10 mg permits a gradual start to treatment and very finely adjusted dosage. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION ORAL USE DOSAGE REGIMEN As far as possible the treatment must be tailored to the needs of the individual according to the severity of the disease and the patient's response. Depending on the clinical picture in each case, the basic dose must be introduced gradually Adalat retard 10 mg is particularly suitable for dose titration. Dose titration is particularly recommended for hypertensives with severe cerebrovascular disease and for patients, who because of low body weight or multiple therapies with other antihypertensive drugs, are likely to have an excessive reaction to nifedipine. In addition, patients in whom side effects in response to the nifedipine treatment make a finer dose adjustment desirable should be individually stabilized with Adalat ret Baca dokumen lengkap