Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
Teva Pharma B.V.
C09CA06
CANDESARTAN CILEXETIL
8 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain
Authorised
2012-01-06
Teva Pharmaceuticals Europe MODULE 1.3.1 PATIENT INFORMATION LEAFLET TEXT PACKAGE LEAFLET: INFORMATION FOR THE USER CANDESARTAN TEVA 8 MG TABLETS CANDESARTAN TEVA 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Candesartan Teva is and what it is used for 2. What you need to know before you take Candesartan Teva 3. How to take Candesartan Teva 4. Possible side effects 5. How to store Candesartan Teva 6. Contents of the pack and other information 1. WHAT CANDESARTAN TEVA IS AND WHAT IT IS USED FOR The name of your medicine is Candesartan Teva. 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. This medicine is used for: Treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years. Treating adult heart failure patients with reduced heart muscle function when An Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan Teva 8 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg candesartan cilexetil. Excipients with known effects: Lactose: 43.725 mg lactose monohydrate / 8 mg tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pink, capsule shaped tablet, 7.7 mm in length and 3.5 mm in width, scored on both sides. One side of the tablet is debossed with " C | 8 " and the other side is debossed with " 8 | C ". The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Candesartan cilexetil Teva is indicated for the: Treatment of essential hypertension in adults. The treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction 40%) when ACE-inhibitors are not tolerated or as add-on therapy to ACE-inhibitors in patients with symptomatic heart failure, despite optimal therapy, when mineralocorticoid receptor antagonists are not tolerated (see sections 4.2, 4.4, 4.5 and 5.1). Treatment of essential hypertension in children and adolescents aged 6 to <18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in Hypertension The recommended initial dose and usual maintenance dose of Candesartan cilexetil Teva 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 cilexetil Teva may also be administered with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Candesartan cilexetil Teva. _Older people_ No initial dose adjustment is necessary in older people. _Patients with intravascular volume depletion_ An initi Прочитайте повний документ