Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Amlodipine besylate
Primecrown 2010 Limited
C09BB; C09BB04
Perindopril arginine; Amlodipine besylate
10/10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers; perindopril and amlodipine
Authorised
2015-01-30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACERYCAL 5MG / 5MG TABLETS ACERYCAL 10MG / 5MG TABLETS ACERYCAL 5MG / 10MG TABLETS ACERYCAL 10MG / 10MG TABLETS perindopril arginine / amlodipine 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 medicine (listed in Section 6), - if you are more than 3 months pregnant (It is also better to avoid Acerycal in early pregnancy - see pregnancy section), - if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE Inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema), - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren, Läs hela dokumentet
Health Products Regulatory Authority 05 October 2018 CRN008K9F Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ACERYCAL 10mg/10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine and 13.870 mg amlodipine besilate equivalent to 10 mg amlodipine Excipient: lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Poland:_ White, round tablet engraved with 10/10 on one face and on the other face. 4 CLINICAL PARTICULARS As per PA0568/018/004 5 PHARMACOLOGICAL PROPERTIES As per PA0568/018/004 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 Health Products Regulatory Authority 05 October 2018 CRN008K9F Page 2 of 2 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 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 an overlabelled polypropylene container equipped with a low density polyethylene flow reducer and a low density polyethylene stopper containing a desiccant gel repackaged in an outer cardboard carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Primecrown 2010 Limited 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS, United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1633/035/004 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 th January 2015. 10 DATE OF REVISION OF THE TEXT October 2018 Läs hela dokumentet