Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil; Hydrochlorothiazide
PCO Manufacturing Ltd.
C09DA06
Candesartan cilexetil; Hydrochlorothiazide
16 mg/12.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
candesartan and diuretics
Authorised
2004-01-26
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER ATACAND PLUS ® 16 MG/12.5 MG TABLETS candesartan cilexetil/hydrochlorothiazide 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Atacand Plus is and what it is used for 2. What you need to know before you take Atacand Plus 3. How to take Atacand Plus 4. Possible side effects 5. How to store Atacand Plus 6. Contents of the pack and other information 1. WHAT ATACAND PLUS IS AND WHAT IT IS USED FOR The name of your medicine is Atacand Plus. It is used for treating high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to lower your blood pressure. Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes your blood vessels relax and widen. This helps to lower your blood pressure. Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine. This helps to lower your blood pressure. Your doctor may prescribe Atacand Plus if your blood pressure has not been properly controlled by candesartan cilexetil or hydrochlorothiazide alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATACAND PLUS DO NOT TAKE ATACAND PLUS: if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6). if you are allergic to sulphonamide m Прочитајте комплетан документ
Health Products Regulatory Authority 11 April 2022 CRN00CVK8 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand Plus 16 mg/12.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One Atacand Plus 16 mg/12.5 mg tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Excipient(s) with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the Netherlands:_ Peach, oval, biconvex tablets marked ‘A/CS’ on one side and scored on both sides. _Product imported from Italy:_ Peach, oval, biconvex tablets marked A/CS on one side and scored on both sides or Pink, oval tablets marked 16/C and scored on both sides. 4 CLINICAL PARTICULARS As per PA2239/011/002 5 PHARMACOLOGICAL PROPERTIES As per PA2239/011/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Carmellose calcium Hyprolose Lactose monohydrate Magnesium stearate Maize starch Macrogol Iron Oxide (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister and outer carton of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 °C. Health Products Regulatory Authority 11 April 2022 CRN00CVK8 Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Product imported from Italy presented as 28 tablets in a blister pack contained in an outer cardboard carton. Product imported from The Netherlands presented as 30 tablets in a blister pack contained in an overlabelled outer carton. Not all pack sizes may be marketed. 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 PPA0465/117/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 th January 2004 Date of last renewal: Прочитајте комплетан документ