Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Nifedipine
IMED Healthcare Ltd.
C08CA; C08CA05
Nifedipine
20 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; nifedipine
Authorised
2012-04-05
PACKAGE LEAFLET - INFORMATION FOR THE USER ADALAT® LA 20 MG 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 LA IS 2 BEFORE YOU TAKE ADALAT LA 3 HOW YOU TAKE ADALAT LA 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ADALAT LA 6 FURTHER INFORMATION 1 WHAT ADALAT LA IS Adalat LA contains nifedipine, which belongs to a group of medicines called _calcium antagonists. _ ADALAT LA IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA _(chest _ _pain). _ For high blood pressure: Adalat LA works 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 LA 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 LA DO NOT TAKE ADALAT LA: • IF YOU HAVE HAD A HEART ATTACK within the last month. • IF YOU GET A SUDDEN ANGINA ATTACK. Adalat LA 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 LA are listed in section 6. • IF YOU ARE TAKING RIFAMPICIN, an antibiotic. • IF YOU HAVE A LIVER DISEASE that prevents your liver from working properly. • IF YOU HAVE INFLAMMATION OF THE BOWEL OR INTESTINES, such as Crohn’s Les hele dokumentet
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. Each tablet contains 8.3mg sodium For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet. _Product imported from the UK:_ Pink, round tablets with a laser hole on one side and marked ‘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 apply 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) 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _4_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _2_ _8_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ In general therapy should be initiated with 30 mg once daily. Where registered a starting dose of 20 mg once daily may be conside Les hele dokumentet