Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
aliskiren
Novartis Europharm Ltd.
C09XA02
aliskiren
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension.
Revision: 8
Withdrawn
2007-08-22
60 B. PACKAGE LEAFLET Medicinal product no longer authorised 61 PACKAGE LEAFLET: INFORMATION FOR THE USER RIPRAZO 150 MG FILM-COATED TABLETS Aliskiren 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. WHAT IS IN THIS LEAFLET 1. What Riprazo is and what it is used for 2. What you need to know before you take Riprazo 3. How to take Riprazo 4. Possible side effects 5. How to store Riprazo 6. Contents of the pack and other information 1. WHAT RIPRAZO IS AND WHAT IT IS USED FOR Riprazo tablets contain an active substance called aliskiren. Aliskiren belongs to a class of medicines called renin inhibitors. Riprazo helps to lower high blood pressure in adult patients. Renin inhibitors reduce the amount of angiotensin II the body can produce. Angiotensin II causes blood vessels to tighten, which increases the blood pressure. Reducing the amount of angiotensin II allows the blood vessels to relax, which 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIPRAZO DO NOT TAKE RIPRAZO - if you are allergic to aliskiren or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice. - if you have experienced the following forms of angioedema (d Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Riprazo 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg aliskiren (as hemifumarate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Riprazo is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the dose may be increased to 300 mg once daily. The antihypertensive effect is substantially present within two weeks (85-90%) after initiating therapy with 150 mg once daily. Riprazo may be used alone or in combination with other antihypertensive agents 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). Special populations _Renal impairment _ No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2). Riprazo is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m 2 ). Concomitant use of Riprazo with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m 2 ) (see section 4.3). _Hepatic impairment _ No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2). _Elderly patients aged 65 years and over_ The recommended starting dose of aliskiren in elderly patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority Les hele dokumentet