Enviage
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
19-05-2011
Charakterystyka produktu
(SPC)
19-05-2011
Sprawozdanie z oceny publicznego
(PAR)
19-05-2011
Składnik aktywny:
aliskiren
Dostępny od:
Novartis Europharm Ltd.
Kod ATC:
C09XA02
INN (International Nazwa):
aliskiren
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Treatment of essential hypertension
Podsumowanie produktu:
Revision: 4
Status autoryzacji:
Withdrawn
Data autoryzacji:
2007-08-22
Ulotka dla pacjenta
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
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Charakterystyka produktu
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
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