Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: 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Withdrawn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
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Tekturna 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 Tekturna 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. Tekturna may be used alone or in combination with other antihy pertensive agents (see sections 4.4 and 5.1). Tekturna should be taken with a light meal once a day, preferably at the same time each day. Grapefruit juice should not be ta ken together with Tekturna. 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) Tekturna 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 inhibi Aqra d-dokument sħiħ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Tekturna 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 Tekturna 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. Tekturna may be used alone or in combination with other antihy pertensive agents (see sections 4.4 and 5.1). Tekturna should be taken with a light meal once a day, preferably at the same time each day. Grapefruit juice should not be ta ken together with Tekturna. 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) Tekturna 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 inhibi Aqra d-dokument sħiħ