Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Amlodipine besylate
LTT Pharma Limited
C09BB; C09BB04
Perindopril arginine; Amlodipine besylate
5/5 mg/mg
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers; perindopril and amlodipine
Authorised
2011-11-11
ACERYCAL 5MG/5MG TABLETS ACERYCAL 5MG/10MG TABLETS ACERYCAL 10MG/5MG TABLETS ACERYCAL 10MG/10MG TABLETS (perindopril arginine / amlodipine) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. * Keep this leaflet. You may need to read it again. * If you have any further questions, ask your doctor, pharmacist or nurse. * This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. * If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: What Acerycal is and what it is used for What you need to know before you take Acerycal How to take Acerycal Possible side effects How to store Acerycal Content of the pack and other information WHAT ACERYCAL IS AND WHAT IT IS USED FOR Acerycal is prescribed for treatment of high blood pressure (hypertension) and/or treatment of stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked). Patients already taking perindopril and amlodipine from separate tablets may instead receive one tablet of Acerycal which contains both ingredients. Acerycal is a combination of two active ingredients, perindopril and amlodipine. Perindopril is an ACE (angiotensin converting enzyme) inhibitor. Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines). Together they work to widen and relax the blood vessels so that blood passes through them more easily and makes it easier for your heart to maintain a good blood flow. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACERYCAL DO NOT TAKE ACERYCAL * if you are allergic to perindopril or any other ACE inhibitor, or to amlodipine or any other calcium antagonists, or any of the other ingredients of this medicine (listed in Section 6), * if you are more than 3 months pregnant. (It is also better to avoid A Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acerycal 5mg/5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine and 6.935 mg amlodipine besilate equivalent to 5 mg amlodipine. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet _Product imported from Hungary:_ White rod shaped tablet engraved with 5/5 on one face and on the other face. 4 CLINICAL PARTICULARS As per PA0568/018/001 5 PHARMACOLOGICAL PROPERTIES As per PA0568/018/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Cellulose, microcrystalline (E460) Silica, colloidal anhydrous (E551) Magnesium stearate (E470B) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Keep the container tightly closed in order to protect from moisture. Store in the original package. 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_ _7_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _8_ _5_ _9_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER 30 tablets in polypropylene container equipped with a low density polyethylene flow reducer and a low density polyethylene stopper containing a desicca Lugege kogu dokumenti