البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
Takeda UK Limited
C09CA06
CANDESARTAN CILEXETIL
32 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain
Authorised
2009-01-16
ARTWORK ISSUE DATE 28-07-2016 OPERATOR RI006M DRAFT 02 SEPARATIONS: BLACK P334 PRODUCT CODE: 6127363.02 PRODUCT NAME: I-BLOPRESS 2-4-8-16-32 MG COUNTRY: IRL Laetus code I X I I I I I (159) MEASURES (mm): 160X600 (2X300) FONT TYPE: HELVETICA NEUE LT Size: 9PT PREVIOUS CODE: 6127363.01 SOVRASTAMPA ATTIVA SOVRASTAMPA NON ATTIVA PREMEDIA@EURPACK.IT TAKEDA Realized by : PACKA GING DE PDF 1.5 VE LOPMENT CENTER PAGE 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BLOPRESS 2 MG, 4 MG, 8 MG, 16 MG AND 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. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Blopress is and what it is used for 2. What you need to know before you take Blopress 3. How to take Blopress 4. Possible side effects 5. How to store Blopress 6. Contents of the pack and other information 1. What BlopRess is and What it is used foR The name of your medicine is Blopress. 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 under 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 sympt اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Blopress 32 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 32 mg candesartan cilexetil. Each tablet contains 162.7 mg lactose monohydrate. For a full list excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Blopress 32 mg Tablets are round light pink tablets with convex faces, debossed 32 on one face and scored on the other face. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Blopress is indicated for the: • Treatment of essential 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 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 Blopress 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. Blopress 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 Blopress. _Older people_ 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 section 4.4). _ اقرأ الوثيقة كاملة