Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
Bayer Limited
C08CA05
NIFEDIPINE
10 mg Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
nifedipine
Not Marketed
1987-11-06
PACKAGE LEAFLET - INFORMATION FOR THE USER ADALAT® RETARD 10MG prolonged-release tablets NIFEDIPINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have more questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1 WHAT ADALAT RETARD 10 MG IS 2 BEFORE YOU TAKE ADALAT RETARD 10 MG 3 HOW YOU TAKE ADALAT RETARD 10 MG 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ADALAT RETARD 10 MG 6 FURTHER INFORMATION 1 WHAT ADALAT RETARD 10 MG IS Adalat Retard 10 mg contains nifedipine, which belongs to a group of medicines called _calcium antagonists. _ ADALAT RETARD 10 MG IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA (_chest pain_). For high blood pressure: Adalat Retard 10 mg work by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart. For angina: Adalat Retard 10 mg work by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart. 2 BEFORE YOU TAKE ADALAT RETARD 10 MG DO NOT TAKE ADALAT RETARD 10 MG: • IF YOU HAVE HAD A HEART ATTACK within the last month. • IF YOU GET A SUDDEN ANGINA ATTACK. Adalat Retard will not help relieve symptoms of angina quickly. • IF YOU HAVE UNSTABLE ANGINA. • IF YOU ARE ALLERGIC to the active ingredient (nifedipine), to any other similar medicines (known as _dihydropyridines) _or to any of the other ingredients. The ingredients of Adalat Retard 10 mg are listed in section 6. • IF YOU ARE TAKING RIFAMPICIN, an antibiotic. • IF YOU HAVE BEEN TOLD THAT Y Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat Retard 10 mg Prolonged-Release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated, prolonged-release tablet contains 10 mg nifedipine. Excipients: Lactose monohydrate 10.00 mg per tablet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated, prolonged-release tablets. 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 retard 10 mg. Unless otherwise prescribed, the following dosage guidelines apply for adults: IN CORONARY HEART DISEASE: CHRONIC STABLE ANGINA PECTORIS 1 Adalat retard 10 MG tablet twice daily (angina of effort) (2 x 10 mg/day) H E A L T H P R O D U C Read the complete document