Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Candesartan cilexetil
KRKA, d.d., Novo mesto
C09CA; C09CA06
Candesartan cilexetil
4 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; candesartan
Marketed
2012-03-09
PACKAGE LEAFLET: INFORMATION FOR THE USER CANDESARTAN KRKA 4 MG TABLETS CANDESARTAN KRKA 8 MG TABLETS CANDESARTAN KRKA 16 MG TABLETS CANDESARTAN KRKA 32 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 Krka is and what it is used for 2. What you need to know before you take Candesartan Krka 3. How to take Candesartan Krka 4. Possible side effects 5. How to store Candesartan Krka 6. Contents of the pack and other information 1. WHAT CANDESARTAN KRKA IS AND WHAT IT IS USED FOR The name of your medicine is Candesartan Krka. 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 is medicine is used for - treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to under 18 years. - Candesartan Krka can be used to 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 CANDESARTAN KRKA DO NOT TAKE CANDESARTAN KRKA - if you are allergic to can Prečítajte si celý dokument
Health Products Regulatory Authority 11 July 2023 CRN00DJ4H Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan Krka 4 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg candesartan cilexetil. Excipient with known effect: 4 mg tablets Lactose monohydrate 94.050 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, white, biconvex tablets, scored on one side, engraved with mark 4. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of primary hypertension in adults. Treatment of hypertension in children and adolescents aged 6 to <18 years. Treatment of adult patients with heart failure and impaired left ventricle 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in hypertension The recommended initial dose and usual maintenance dose of Candesartan Krka 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 Krka 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 Krka. _Older people_ No initial dosage adjustment is necessary in older people. _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 Prečítajte si celý dokument