Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
Teva Pharma B.V.
CANDESARTAN CILEXETIL
32 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2014-06-26
PRODUCT : AMENDS: APPROVAL: SENIOR ARTWORK CO-ORDINATO R • SUBJECT TO REG. AGENCY APPROVAL • APPROVED BY REG. DEPT. FOR PRINT DESIGN DEPARTMENT Harlow Signed Signed 27226 CANDESARTAN T EVA PHARMA 4/8/16/32MG T ABS ALL TEI (BLU) V2 27-2-13 148x600mm 5 12-03-14 TB KA Leafl et CUTTER GUIDE PMS PROCESS BLACK PMS GREEN INDESIGN CS6 Last amend: X SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered. The only exceptions to this are: bleeds, chokes, spreads or other adjustments required for print reproduction purposes only . If you have any diffi culties please contact the T eva Artwork T eam. W e must receive a copy of the 3rd Party V endors Proof before fi nal approval can be made. Body: Univers 55 Roman/ 65 Bold/ 55 Oblique 10pts Subhead: Univers 65 Bld 11pts Header: Univers 65 Bld 14pts CANDESARTAN TEVA PHARMA 4 MG, 8 MG, 16 MG & 32 MG TABLETS CANDESARTAN CILEXETIL PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. 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 leafl et. WHAT IS IN THIS LEAFLET: 1. WHAT CANDESARTAN TEVA PHARMA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CANDESARTAN TEVA PHARMA 3. HOW TO TAKE CANDESARTAN TEVA PHARMA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CANDESARTAN TEVA PHARMA 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT CANDESARTAN TEVA PHARMA IS AND WHAT IT IS USED FOR The name of your medicine is Candesartan Teva Pharma. The active ingredie Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan Teva Pharma 32 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 32 mg candesartan cilexetil. Excipient with known effect: 363.5 mg lactose monohydrate/tablet. For the full list of excipient, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Candesartan Teva Pharma 32 mg tablets are light red, elliptic biconvex tablets, marked CC and 32 on the same face and are scored on both faces. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Candesartan Teva Pharma is indicated for the: Treatment of essential hypertension in adults. Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction 40%) as add-on therapy to Angiotensin Converting Enzyme (ACE) inhibitors or when ACE inhibitors are not tolerated (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in Hypertension The recommended initial dose and usual maintenance dose of Candesartan Teva Pharma is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily. Therapy should be adjusted according to blood pressure response. Candesartan Teva Pharma may also be administered with other antihypertensive agents. Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Candesartan Teva Pharma. _Elderly population_ No initial dose adjustment is necessary in elderly patients. _Patients with intravascular volume depletion_ An initial dose of 4 mg may be considered in patients at risk for Baca dokumen lengkap