Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
aliskiren
Novartis Europharm Ltd.
C09XA02
aliskiren
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension.
Revision: 5
Withdrawn
2007-08-22
56 B. PACKAGE LEAFLET Medicinal product no longer authorised 57 PACKAGE LEAFLET: INFORMATION FOR THE USER SPRIMEO 150 MG FILM-COATED TABLETS Aliskiren 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 is and what it is used for 2. Before you take Sprimeo 3. How to take Sprimeo 4. Possible side effects 5. How to store Sprimeo 6. Further information 1. WHAT SPRIMEO IS AND WHAT IT IS USED FOR Sprimeo belongs to a new class of medicines called renin inhibitors. Sprimeo helps to lower high blood pressure. 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. BEFORE YOU TAKE SPRIMEO DO NOT TAKE SPRIMEO - if you are allergic (hypersensitive) to aliskiren or any of the other ingredients of Sprimeo. If you think you may be allergic, ask your doctor for advice. - if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue): - angioedema when taking aliskiren. - hereditary angioedema. - angioedema without any known cause. - during Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Sprimeo 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg aliskiren (as hemifumarate). For a 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of Sprimeo 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. Sprimeo 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). Sprimeo 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. 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). Sprimeo is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m 2 ). Concomitant use of Sprimeo 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 (over 65 years) The recommended starting dose of aliskiren in elderly patients is 150 mg. No clinically meaningful a Lestu allt skjalið