Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
McDermott Laboratories Ltd t/a Gerard Laboratories
C09CA06
CANDESARTAN CILEXETIL
16 Milligram
Tablets
Product subject to prescription which may be renewed (B)
candesartan
Not Marketed
2011-08-26
PAGE 1 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CANDESARTAN MYLAN 4 MG TABLETS CANDESARTAN MYLAN 8 MG TABLETS CANDESARTAN MYLAN 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 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 Mylan is and what it is used for 2. What you need to know before you take Candesartan Mylan 3. How to take Candesartan Mylan 4. Possible side effects 5. How to store Candesartan Mylan 6. Contents of the pack and other information 1. WHAT CANDESARTAN MYLAN IS AND WHAT IT IS USED FOR Candesartan Mylan contains the active substance candesartan which belongs to a group of medicines known as angiotensin II receptor antagonists that lower blood pressure. It works by making your blood vessels relax and widen (which helps to lower your blood pressure). It also makes it easier for your heart to pump blood to all parts of your body. Candesartan Mylan 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 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 CANDESARTAN MYLAN DO NOT TAKE CANDESARTAN MYLAN: if you are allergic to candesartan cilexetil or any of the Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan Mylan 16mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg candesartan cilexetil. Excipient with known effect Each tablet contains 74.0 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off white, round, biconvex tablet debossed with “M over C6” on one side and plain with a break line on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction 40%) when Angiotensin Converting Enzyme (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 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 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 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. _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 hypotension, such as patients with possible volume depletion (see Baca dokumen lengkapnya