Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil
IMED Healthcare Ltd.
C09CA06
Candesartan cilexetil
16 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
candesartan
Authorised
2010-02-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATACAND ® 8 MG TABLETS ATACAND ® 16 MG TABLETS candesartan cilexetil 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 or pharmacist. 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. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Atacand is and what it is used for 2. What you need to know before you take Atacand 3. How to take Atacand 4. Possible side effects 5. How to store Atacand 6. Contents of the pack and other information 1. WHAT ATACAND IS AND WHAT IT IS USED FOR The name of your medicine is Atacand. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and widen. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body. Atacand can be used to: treat high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years. treat adult heart failure patients with reduced heart muscle function, when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or in addition to ACE-inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used (ACE-inhibitors and MRAs are medicines used to treat heart failure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATACAND DO NOT TAKE ATACAND: if you are allergic to candesartan cilexetil 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 Atacand in early pregnancy – see pre Aqra d-dokument sħiħ
Health Products Regulatory Authority 25 July 2022 CRN00D0J9 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand 16 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg candesartan cilexetil. Excipient(s) with known effect: lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets _Product imported from Italy:_ Round, light pink tablets with a score and marked A/CH on one side and 016 on the other side. The tablet can be divided in equal doses. 4 CLINICAL PARTICULARS As per PA2239/010/003 5 PHARMACOLOGICAL PROPERTIES As per PA2239/010/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Carmellose calcium Hydroxypropyl cellulose Iron oxide red (E172) Lactose monohydrate Magnesium stearate Maize starch Macrogol 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister strip and outer package of the product in the country of origin 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. Health Products Regulatory Authority 25 July 2022 CRN00D0J9 Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Over-labelled cardboard carton containing 2 blister strips (14 tablets per strip). Pack size 28 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/031/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 th February 2010 10 DATE OF REVISION OF THE TEXT July 2022 Aqra d-dokument sħiħ