Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Nifedipine
Imbat Limited
C08CA; C08CA05
Nifedipine
30 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Dihydropyridine derivatives; nifedipine
Authorised
2009-06-19
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ADALAT ® LA 30MG PROLONGED-RELEASE TABLET (nifedipine) Your medicine is available using the name Adalat LA 30mg Prolonged-Release Tablet but will be referred to as Adalat LA throughout this 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 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. Contents of the pack and other 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 d_ihydropyridines) _or to any of the other ingredients. The ingredients of Adalat LA are listed in section 6. Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adalat LA 30mg Prolonged-Release Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 30 mg nifedipine. Excipient with known effect: Sodium For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet. _Product imported from the UK, Romania and Spain:_ Pink, circular, convex tablets with 'Adalat 30' marked on one side and plain on the reverse. 4 CLINICAL PARTICULARS As per PA1410/025/006 5 PHARMACOLOGICAL PROPERTIES As per PA1410/025/006 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from the UK and Romania:_ Polyethylene oxide Hypromellose Magnesium stearate Sodium chloride Cellulose acetate Macrogol Hydroxypropylcellulose Propylene glycol Titanium dioxide (E171) Iron oxide (E172) Shellac* (* in product sourced from the UK only). _Product imported from Spain:_ Polyethylene oxide Hypromellose Magnesium stearate Sodium chloride Red iron oxide (E172) 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_ _ _ _2_ _6_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _8_ _6_ _8_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Cellulose acetate Macrogol Hydroxypropylcellulose Propylene glycol Titanium dioxide (E171) Black iron oxide (E172) 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed in the cou Lue koko asiakirja