Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil
Imbat Limited
C09CA; C09CA06
Candesartan cilexetil
4 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; candesartan
Authorised
2012-10-12
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATACAND ® 4MG TABLETS (candesartan cilexetil) Your medicine is available using the name Atacand 4mg tablets but will be referred to as Atacand throughout this leaflet. 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). Preberite celoten dokument
Health Products Regulatory Authority 23 July 2019 CRN00968R Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand 4 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg candesartan cilexetil. Excipient: Each 4 mg tablet contains 93.4 mg lactose monohydrate For the full list of excipients, see section 6.1_._ 3 PHARMACEUTICAL FORM Tablets. _Product imported from UK_ Round, white tablets with a scoreline on each side. 4 CLINICAL PARTICULARS As per PA1019/004/001. 5 PHARMACOLOGICAL PROPERTIES As per PA1019/004/001. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Carmellose calcium Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Maize starch Macrogol 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer carton containing blister strips. Pack size 28 tablets. Health Products Regulatory Authority 23 July 2019 CRN00968R Page 2 of 2 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Imbat Limited Unit L2 North Ring Business Park Santry Dublin 9 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1151/109/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12th October 2012 10 DATE OF REVISION OF THE TEXT July 2019 Preberite celoten dokument