Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
CANDESARTAN CILEXETIL
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
C09CA06
CANDESARTAN CILEXETIL 16 mg
TABLET
CANDESARTAN CILEXETIL 16 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Licence number in the source country: NOT APPLICAPABLE
Suspended
2020-12-11
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER CANDESARTAN CRESCENT 8 MG TABLETS CANDESARTAN CRESCENT 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. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. WHAT IS IN THIS LEAFLET 1. What Candesartan Tablets are and what they are used for 2. What you need to know before you take Candesartan Tablets 3. How to take Candesartan Tablets 4. Possible side effects 5. How to store Candesartan Tablets 6. Contents of the pack and other information 1. WHAT CANDESARTAN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Candesartan Tablets. 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. Candesartan can be 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 MRA are medicines used to treat heart failure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CANDESARTAN TABLETS DO NOT TAKE CANDESARTAN TABLETS: • if you are allergic to candesartan cilexetil or any of the other ingredients o Belgenin tamamını okuyun
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Candesartan Crescent 8 mg Tablets Candesartan Crescent 16 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg candesartan cilexetil. Each tablet contains 16 mg candesartan cilexetil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Candesartan Crescent 8 mg Tablets are light red, round tablets with a break line on one side and debossed with T/T on the same side. Candesartan Crescent 16 mg Tablets are red, round tablets with a break line on one side and debossed with C/C on the same side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Candesartan cilexetil is indicated for the: • Treatment of primary hypertension in adults. • The treatment of hypertension in children and adolescents aged 6 to < 18 years. • Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction, LVEF ≤ 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 section 4.3, 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 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 el Belgenin tamamını okuyun