Tekturna

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

aliskiren

זמין מ:

Novartis Europharm Ltd.

קוד ATC:

C09XA02

INN (שם בינלאומי):

aliskiren

קבוצה תרפויטית:

Agents acting on the renin-angiotensin system

איזור תרפויטי:

Hypertension

סממני תרפויטית:

Treatment of essential hypertension

leaflet_short:

Revision: 4

מצב אישור:

Withdrawn

תאריך אישור:

2007-08-22

עלון מידע

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

מאפייני מוצר

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