Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
aliskiren
Novartis Europharm Ltd.
C09XA02
aliskiren
Agents acting on the renin-angiotensin system
Hypertension
Treatment of essential hypertension
Revision: 4
Withdrawn
2007-08-22
B. PACKAGE LEAFLET 38 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER ENVIAGE 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 y ou have any further questions, ask your doctor or pharmacist. - This m edicine 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 Enviage is and what it is used for 2. Before you take Enviage 3. How to take Enviage 4. Possible side effects 5. How to store Enviage 6. Further information 1. WHAT ENVIAGE IS AND WHAT IT IS USED FOR Enviage belongs to a new class of medicines called renin inhibitors. Enviage helps to lower high blood pressure. Renin inhibitors reduce the am ount 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 tim e, 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 ENVIAGE DO NOT TAKE ENVIAGE - if you are allergic (hypersensitive) to aliskiren or any of the other ingredients of Enviage. If you think you may be allergic, ask your doctor for advice. - if you have already experienced angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue) when taking aliskiren. - during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and br Izlasiet visu dokumentu
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Enviage 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 M ETHOD OF ADMINISTRATION The recommended dose of Enviage 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. Enviage may be used alone or in combination with other antihy pertensive agents (see sections 4.4 and 5.1). Enviage 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 Enviage. Renal impairment No adjustment of the initial dose is required for patients with m ild to severe renal impairment (see sections 4.4 and 5.2). Hepatic impairment No adjustment of the initial dose is required for patients with m ild to severe hepatic impairment (see section 5.2). Elderly patients (over 65 years) No adjustment of the initial dose is required for elderly patients. Paediatric patients (below 18 years) Enviage is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2). 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 2 Medicinal product no longer authorised History of angioedema with aliskiren. Second and third trimesters of pregnancy (see section 4.6). The concomitant use of aliskiren with ciclosporin, a highly potent P-gp inhibitor, and other potent P- gp inhibitors (qu Izlasiet visu dokumentu