Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Amlodipine besylate
PCO Manufacturing Ltd.
C09BB; C09BB04
Perindopril arginine; Amlodipine besylate
5mg/5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers; perindopril and amlodipine
Authorised
2012-04-20
_ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACERYCAL ® 5 MG/5 MG TABLETS ACERYCAL ® 5 MG/10 MG TABLETS ACERYCAL ® 10 MG/10 MG TABLETS ACERYCAL ® 10 MG/5 MG 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: 1. What Acerycal is and what it is used for 2. What you need to know before you take Acerycal 3. How to take Acerycal 4. Possible side effects 5. How to store Acerycal 6. Content of the pack and other information 1. 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. 2. 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 med Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 18 November 2021 CRN00CN12 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acerycal 5 mg/5 mg 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 : lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. _Product imported from Hungary and Poland:_ White, rod-shaped tablet engraved with 5/5 on one face and the Servier Company Logo 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. 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 desiccant gel. Box of 1 container of 30 tablets. Health Products Regulatory Authority 18 November 2021 CRN00CN12 Page 2 of 2 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/283/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20th April 2012 10 DATE OF REVISION OF THE TEXT November 2021 Lesen Sie das vollständige Dokument