Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil
Rowex Ltd
C09CA; C09CA06
Candesartan cilexetil
4 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; candesartan
Marketed
2009-09-04
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CATASART 4 MG TABLETS CATASART 8 MG TABLETS CATASART 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 Catasart is and what it is used for 2. What you need to know before you take Catasart 3. How to take Catasart 4. Possible side effects 5. How to store Catasart 6. Contents of the pack and other information 1. WHAT CATASART IS AND WHAT IT IS USED FOR_ _ The name of your medicine is Catasart. The active substance 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 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 CATASART_ _ DO NOT TAKE CATASART if you are allergic to candesartan cilexetil or to any of the ingredients of this medicine listed in section 6 if you are more than 3 months pregnant (it is also be Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Catasart 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of candesartan cilexetil. Excipients with known effect Each tablet contains 70.24 mg lactose (as monohydrate) and up to 0.003 mg (0.0001 mmol) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round biconvex tablet, debossed with 4 on one side and scored on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Catasart is indicated for the: Treatment of essential hypertension in adults Treatment of hypertension in children and adolescents aged 6 to < 18 years. The 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in hypertension The recommended initial dose and usual maintenance dose of Catasart 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. Catasart 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 Catasart. _Elderly_ 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 d Прочитајте комплетан документ