Riprazo
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-09-2012
Charakterystyka produktu
(SPC)
20-09-2012
Sprawozdanie z oceny publicznego
(PAR)
20-09-2012
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: 8
Status autoryzacji:
Withdrawn
Data autoryzacji:
2007-08-22
Ulotka dla pacjenta
60
B. PACKAGE LEAFLET
Medicinal product no longer authorised
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIPRAZO 150 MG FILM-COATED TABLETS
Aliskiren
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Riprazo is and what it is used for
2.
What you need to know before you take Riprazo
3.
How to take Riprazo
4.
Possible side effects
5.
How to store Riprazo
6.
Contents of the pack and other information
1.
WHAT RIPRAZO IS AND WHAT IT IS USED FOR
Riprazo tablets contain an active substance called aliskiren.
Aliskiren belongs to a class of medicines
called renin inhibitors. Riprazo helps to lower high blood pressure in
adult patients. 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIPRAZO
DO NOT TAKE RIPRAZO
-
if you are allergic to aliskiren or any of the other ingredients of
this medicine (listed in section
6). If you think you may be allergic, ask your doctor for advice.
-
if you have experienced the following forms of angioedema
(d
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Riprazo 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
For the 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 in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Riprazo 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.
Riprazo 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).
Special populations
_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). Riprazo is not recommended in patients with
severe renal impairment (GFR
< 30 ml/min/1.73 m
2
). Concomitant use of Riprazo 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 aged 65 years and over_
The recommended starting dose of aliskiren in elderly patients is 150
mg. No clinically meaningful
additional blood pressure reduction is observed by increasing the dose
to 300 mg in the majority
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