Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil
PCO Manufacturing Ltd.
C09CA; C09CA06
Candesartan cilexetil
8 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; candesartan
Authorised
2004-02-06
_ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATACAND ® 4 MG TABLETS 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 a Прочетете целия документ
Health Products Regulatory Authority 21 September 2022 CRN00D5MJ Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand 8 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg candesartan cilexetil. Excipient(s) with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Italy, Portugal and Poland:_ Light, pink, round tablets with a score and marked 'A/CG' on one side and '008' on the other side. _Product imported from Italy:_ Pale pink, round tablets with a single score line on both sides. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS As per PA2239/010/002 5 PHARMACOLOGICAL PROPERTIES As per PA2239/010/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS The product imported from Italy contains: Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate Maize starch Macrogol Iron oxide red (E172) The product imported from Portugal and Poland contains: Carmellose calcium Hydroxypropyl cellulose Lactose monohydrate Magnesium stearate Maize starch Macrogol Iron oxide (E172) Health Products Regulatory Authority 21 September 2022 CRN00D5MJ Page 2 of 2 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is 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 Do not store above 30 °C. 6.5 NATURE AND CONTENTS OF CONTAINER Blister pack containing 28 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING 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 PPA0465/116/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 6 th February 2004 Date of last renewal: 6 th February 2009 10 DATE OF REVISION OF THE TEXT September 2022 Прочетете целия документ