Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
aliskiren, hydrochlorothiazide
Novartis Europharm Ltd.
C09XA52
aliskiren, hydrochlorothiazide
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension in adults.Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.Sprimeo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Withdrawn
2011-06-23
135 B. PACKAGE LEAFLET Medicinal product no longer authorised 136 PACKAGE LEAFLET: INFORMATION FOR THE USER SPRIMEO HCT 150 MG/12.5 MG FILM-COATED TABLETS SPRIMEO HCT 150 MG/25 MG FILM-COATED TABLETS SPRIMEO HCT 300 MG/12.5 MG FILM-COATED TABLETS SPRIMEO HCT 300 MG/25 MG FILM-COATED TABLETS Aliskiren/hydrochlorothiazide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Sprimeo HCT is and what it is used for 2. Before you take Sprimeo HCT 3. How to take Sprimeo HCT 4. Possible side effects 5. How to store Sprimeo HCT 6. Further information 1. WHAT SPRIMEO HCT IS AND WHAT IT IS USED FOR Sprimeo HCT tablets contain two active substances, called aliskiren and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension). Aliskiren is a substance that belongs to a new group of medicines called renin inhibitors. These reduce the amount of angiotensin II the body can make. Angiotensin II causes blood vessels to tighten, which makes blood pressure higher. Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure. Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases urine output, which also lowers blood pressure. High blood pressure increases the workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart failure, heart attack or kidney failure. Lowering the blood pressure to a normal level reduces the risk of developing these disorders. Spr Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Sprimeo HCT 150 mg/12.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide. Excipients: Each tablet contains 25 mg lactose monohydrate and 24.5 mg wheat starch. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, biconvex, ovaloid film-coated tablet imprinted with “LCI” on one side and “NVR” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone. Sprimeo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of Sprimeo HCT is one tablet per day. Sprimeo HCT should be taken with a light meal once a day, preferably at the same time each day. Grapefruit juice should not be taken together with Sprimeo HCT. The antihypertensive effect is largely manifested within 1 week and the maximum effect is generally seen within 4 weeks. Posology in patients not adequately controlled with aliskiren or hydrochlorothiazide monotherapy Individual dose titration with each of the two components may be recommended before changing to the fixed combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered. Sprimeo HCT 150 mg /12.5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or hydrochlorothiazide 12.5 mg alone. If blood pressure remains uncontrolled after 2-4 weeks of therapy, the dose may be titrated up to a maximum of Sprimeo HCT 300 mg/25 mg daily. Dosing should b Đọc toàn bộ tài liệu