Ország: Európai Unió
Nyelv: angol
Forrás: EMA (European Medicines Agency)
aliskiren, hydrochlorothiazide
Noden Pharma DAC
C09XA52
aliskiren, hydrochlorothiazide
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension in adults.Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.Rasilez 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.
Revision: 17
Withdrawn
2009-01-16
92 B. PACKAGE LEAFLET Medicinal Product no longer authorised 93 PACKAGE LEAFLET: INFORMATION FOR THE USER RASILEZ HCT 150 MG/12.5 MG FILM-COATED TABLETS RASILEZ HCT 150 MG/25 MG FILM-COATED TABLETS RASILEZ HCT 300 MG/12.5 MG FILM-COATED TABLETS RASILEZ HCT 300 MG/25 MG FILM-COATED TABLETS Aliskiren/hydrochlorothiazide 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 Rasilez HCT is and what it is used for 2. What you need to know before you take Rasilez HCT 3. How to take Rasilez HCT 4. Possible side effects 5. How to store Rasilez HCT 6. Contents of the pack and other information 1. WHAT RASILEZ HCT IS AND WHAT IS IT USED FOR WHAT RASILEZ HCT IS This medicine contains two active substances, called aliskiren and hydrochlorothiazide. Both of these active substances help to control high blood pressure (hypertension). Aliskiren is a renin inhibitor. It reduces 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. This helps to lower high blood pressure in adult patients. 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 Olvassa el a teljes dokumentumot
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Rasilez HCT 150 mg/12.5 mg film-coated tablets Rasilez HCT 150 mg/25 mg film-coated tablets Rasilez HCT 300 mg/12.5 mg film-coated tablets Rasilez HCT 300 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rasilez HCT 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide. _Excipients with known effect: _ Each tablet contains 25 mg lactose (as monohydrate) and 24.5 mg wheat starch. Rasilez HCT 150 mg/25 mg film-coated tablets Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide. _Excipients with known effect: _ Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat starch. Rasilez HCT 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 12.5 mg hydrochlorothiazide. _Excipients with known effect: _ Each tablet contains 25 mg lactose (as monohydrate) and 24.5 mg wheat starch. Rasilez HCT 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 25 mg hydrochlorothiazide. _Excipients with known effect: _ Each tablet contains 50 mg lactose (as monohydrate) and 49 mg wheat starch. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Rasilez HCT 150 mg/12.5 mg film-coated tablets White, biconvex, ovaloid film-coated tablet imprinted with “LCI” on one side and “NVR” on the other. Rasilez HCT 150 mg/25 mg film-coated tablets Pale yellow, biconvex, ovaloid film-coated tablet imprinted with “CLL” on one side and “NVR” on the other. Rasilez HCT 300 mg/12.5 mg film-coated tablets Violet white, biconvex, ovaloid film-coated tablet imprinted with “CVI” on one side and “NVR” on the other. Rasilez HCT 300 mg/25 mg film-coated tablets Light yellow, biconvex, ovaloid film-coated tablet imprinted Olvassa el a teljes dokumentumot