Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
aliskiren, amlodipine
Novartis Europharm Ltd
C09XA53
aliskiren hemifumarate, amlodipine besilate
Agents acting on the renin-angiotensin system
Hypertension
Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
Revision: 7
Withdrawn
2011-04-14
Medicinal product no longer authorised 134 B. PACKAGE LEAFLET Medicinal product no longer authorised 135 PACKAGE LEAFLET: INFORMATION FOR THE USER RASILAMLO 150 MG/5 MG FILM-COATED TABLETS RASILAMLO 150 MG/10 MG FILM-COATED TABLETS RASILAMLO 300 MG/5 MG FILM-COATED TABLETS RASILAMLO 300 MG/10 MG FILM-COATED TABLETS Aliskiren/amlodipine 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 Rasilamlo is and what it is used for 2. What you need to know before you take Rasilamlo 3. How to take Rasilamlo 4. Possible side effects 5. How to store Rasilamlo 6. Contents of the pack and other information 1. WHAT RASILAMLO IS AND WHAT IT IS USED FOR WHAT RASILAMLO IS Rasilamlo contains two active substances, called aliskiren and amlodipine. Both of these 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 raises blood pressure. Lowering the amount of angiotensin II allows the blood vessels to relax; this lowers blood pressure. Amlodipine belongs to a group of medicines known as calcium channel blockers, which help to control high blood pressure. Amlodipine causes blood vessels to dilate and relax, thus blood pressure is lowered. 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 kidne Прочитајте комплетан документ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Rasilamlo 150 mg/5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light yellow, convex, ovaloid tablet with a bevelled edge, with “T2” debossed on one side and “NVR” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Rasilamlo is one tablet per day. The antihypertensive effect is manifested within 1 week and the effect is near maximal at around 4 weeks. If blood pressure remains uncontrolled after 4 to 6 weeks of therapy, the dose may be titrated up to a maximum of 300 mg aliskiren/10 mg amlodipine. Dose should be individualised and adjusted according to the patient’s clinical response. Rasilamlo may be administered with other antihypertensive medicinal products with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m 2 ) (see sections 4.3, 4.4 and 5.1). _Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy _ Rasilamlo 150 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 150 mg or amlodipine 5 mg alone. A patient who experiences dose limiting adverse reactions on either component alone may be switched to Rasilamlo containing a lower dose of that component to achieve similar blood pressure reductions. Ind Прочитајте комплетан документ