Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Nifedipine
PCO Manufacturing Ltd.
C08CA; C08CA05
Nifedipine
60 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; nifedipine
Authorised
2001-12-14
_ _ PACKAGE LEAFLET – INFORMATION FOR THE USER ADALAT ® LA 60MG PROLONGED RELEASE TABLET 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, suc Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 60 mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 60 mg of nifedipine. Excipients: Sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet _Product imported from The Netherlands, Greece and Spain;_ Pink, lacquered tablets printed ‘Adalat 60’ in black on one side, plain on the other side. 4 CLINICAL PARTICULARS As per PA 1410/025/007 5 PHARMACOLOGICAL PROPERTIES As per PA 1410/025/007 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Excipients present in the product imported from The Netherlands: Polyethylene oxide Hypromellose Magnesium stearate Sodium chloride Iron oxide red (E172) Cellulose acetate Macrogol Hyprolose Propylene glycol Titanium dioxide (E171) Printing ink (shellac, iron oxide black (E172)) Excipients present in the product imported from Greece: Polyethylene oxide Hypromellose Magnesium stearate Sodium chloride Iron oxide red (E172) Cellulose acetate 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_ _9_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _5_ _8_ _3_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Macrogol 4000 Propylene glycol Titanium dioxide (E171) Excipients present in the product imported from Spain: Polyethylene oxide Hypromellose Magnesium stearate Sodium chloride Iron oxide red (E172) Cellulose acetate Macrogol Hyprolose Propylene glycol Lees het volledige document