Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NIFEDIPINE
Bayer Limited
C08CA05
NIFEDIPINE
20 mg Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
nifedipine
Not Marketed
1981-04-15
PACKAGE LEAFLET - INFORMATION FOR THE USER ADALAT® RETARD 20MG 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 IS 2 BEFORE YOU TAKE ADALAT RETARD 3 HOW YOU TAKE ADALAT RETARD 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ADALAT RETARD 6 FURTHER INFORMATION 1 WHAT ADALAT RETARD IS Adalat Retard contains nifedipine, which belongs to a group of medicines called _calcium antagonists. _ ADALAT RETARD IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA (_chest pain_). For high blood pressure: Adalat Retard 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 works 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 DO NOT TAKE ADALAT RETARD: • 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 are listed in section 6. • IF YOU ARE TAKING RIFAMPICIN, an antibiotic. • IF YOU HAVE BEEN TOLD THAT YOU HAVE A NARROWING OF THE AORTIC HEART VALVE _(stenosis). _ • IF YOU Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat Retard 20 mg Prolonged-Release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated, prolonged-release tablet contains 20 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 1U 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. 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) 1 Adalat retard 20 MG tablet twice daily (2 x 20 mg/day) If higher dosages are necessary, the dose can be increased in stages up to maximum 60 mg daily. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Read the complete document