Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Perindopril arginine
PCO Manufacturing Ltd.
C09AA; C09AA04
Perindopril arginine
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; perindopril
Authorised
2007-08-31
_ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COVERSYL ® ARGININE 5 MG FILM-COATED TABLETS perindopril arginine 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Coversyl arginine is and what it is used for 2. What you need to know before you take Coversyl arginine 3. How to take Coversyl arginine 4. Possible side effects 5. How to store Coversyl arginine 6. Content of the pack and other information 1. WHAT COVERSYL ARGININE IS AND WHAT IT IS USED FOR Coversyl arginine is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Coversyl arginine is used: to treat _HIGH BLOOD PRESSURE_ (hypertension), to treat _HEART FAILURE_ (a condition where the heart is unable to pump enough blood to meet the body’s needs), to reduce the risk of cardiac events, such as heart attack, in patients with _STABLE CORONARY _ _ARTERY DISEASE_ (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVERSYL ARGININE DO NOT TAKE COVERSYL ARGININE if you are allergic to perindopril or any of the other ingredients of this medicine (listed in Section 6), or to any other ACE inhibitor, if you have experienced symptoms such as wheezing, swelling of the face, tongue or th Baca dokumen lengkap
Health Products Regulatory Authority 14 January 2020 CRN009FPG Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril arginine. One film-coated tablet contains 3.395mg perindopril corresponding to 5mg perindopril arginine. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Greece, Poland, Hungary and the UK:_ Light-green, rod-shaped film-coated tablet engraved with the Servier logo on one face and scored on both edges. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS As per PA0568/002/005 5 PHARMACOLOGICAL PROPERTIES As per PA0568/002/005 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Core:_ Lactose monohydrate Magnesium stearate Maltodextrin Hydrophobic colloidal silica Sodium starch glycolate (type A) _Film-coating: _ Glycerol (E422a) Hypromellose (E464) Copper chlorophyllin (E141 ii) Macrogol Magnesium stearate Titanium dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable Health Products Regulatory Authority 14 January 2020 CRN009FPG Page 2 of 2 6.3 SHELF LIFE The shelf-life expiry date of 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 Store in the original package. Keep the container tightly closed in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER _Product imported from Greece, UK & Poland:_ 30 tablets in a white polypropylene tablet container equipped with a polyethylene flow reducer and a green opaque stopper containing a dessicant gel. _Product imported from Hungary:_ 30 tablets in a white polypropylene tablet container equipped with a polyethylene flow reducer and a white opaque stopper containing a dessicant gel. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Baca dokumen lengkap