Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Nifedipine
LTT Pharma Limited
C08CA; C08CA05
Nifedipine
30 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; nifedipine
Authorised
2010-11-26
ADALAT LA 30MG PROLONGED-RELEASE TABLETS (nifedipine) PATIENT INFORMATION LEAFLET 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: What Adalat LA is Before you take Adalat LA How you take Adalat LA Possible side effects How to store Adalat LA Further information 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. 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 disease. * IF YOU HAVE AN OBSTRUCTION Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 30 mg Prolonged-Release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 30 mg nifedipine. Each tablet contains sodium. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet. _Product imported from Spain:_ Pink, circular convex tablets with Adalat 30 marked on one side and a laser hole on the other side. 4 CLINICAL PARTICULARS As per PA1410/025/006 5 PHARMACOLOGICAL PROPERTIES As per PA1410/025/006 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Propylene glycol Cellulose acetate Hypromellose Hydroxypropylcellulose Polyethylene oxide Macrogol Magnesium stearate Titanium dioxide (E171) Ferric oxide red (E172) Iron oxide black (E172) Sodium chloride (salt) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 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_ _ _ _1_ _3_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _4_ _4_ _5_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. Protect from strong light and moisture. Store in the original container. 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips of 2 x 14 tablets. Blister packs composed of PP backed with aluminium foil. Pack size: 28 tablets. 6.6 Belgenin tamamını okuyun