Riprazo HCT
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
20-09-2012
Vara einkenni
(SPC)
20-09-2012
Opinber matsskýrsla
(PAR)
20-09-2012
Virkt innihaldsefni:
aliskiren, hydrochlorothiazide
Fáanlegur frá:
Novartis Europharm Ltd.
ATC númer:
C09XA52
INN (Alþjóðlegt nafn):
aliskiren, hydrochlorothiazide
Meðferðarhópur:
Agents acting on the renin-angiotensin system
Lækningarsvæði:
Hypertension
Ábendingar:
Treatment of essential hypertension in adults.Riprazo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.Rirpozo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.
Leyfisstaða:
Withdrawn
Leyfisdagur:
2011-04-13
Upplýsingar fylgiseðill
134
B. PACKAGE LEAFLET
Medicinal product no longer authorised
135
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIPRAZO HCT 150 MG/12.5 MG FILM-COATED TABLETS
RIPRAZO HCT 150 MG/25 MG FILM-COATED TABLETS
RIPRAZO HCT 300 MG/12.5 MG FILM-COATED TABLETS
RIPRAZO HCT 300 MG/25 MG FILM-COATED TABLETS
Aliskiren/hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. 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 Riprazo HCT is and what it is used for
2.
Before you take Riprazo HCT
3.
How to take Riprazo HCT
4.
Possible side effects
5.
How to store Riprazo HCT
6.
Further information
1.
WHAT RIPRAZO HCT IS AND WHAT IT IS USED FOR
Riprazo HCT tablets contain two active substances, called aliskiren
and hydrochlorothiazide. Both of
these substances help to control high blood pressure (hypertension).
Aliskiren is a substance that belongs to a new group of medicines
called renin inhibitors. These reduce
the amount of angiotensin II the body can make. Angiotensin II causes
blood vessels to tighten, which
makes blood pressure higher. Lowering the amount of angiotensin II
allows the blood vessels to relax;
this lowers blood pressure.
Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics. Hydrochlorothiazide
increases urine output, which also 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.
Rip
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Riprazo HCT 150 mg/12.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate)
and 12.5 mg hydrochlorothiazide.
Excipients: Each tablet contains 25 mg lactose monohydrate and 24.5 mg
wheat starch.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, biconvex, ovaloid film-coated tablet imprinted with “LCI”
on one side and “NVR” on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Riprazo HCT is indicated in patients whose blood pressure is not
adequately controlled on aliskiren or
hydrochlorothiazide used alone.
Riprazo HCT is indicated as substitution therapy in patients
adequately controlled with aliskiren and
hydrochlorothiazide, given concurrently, at the same dose level as in
the combination.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of Riprazo HCT is one tablet per day. Riprazo HCT
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 Riprazo HCT.
The antihypertensive effect is largely manifested within 1 week and
the maximum effect is generally
seen within 4 weeks.
Posology in patients not adequately controlled with aliskiren or
hydrochlorothiazide monotherapy
Individual dose titration with each of the two components may be
recommended before changing to
the fixed combination. When clinically appropriate, direct change from
monotherapy to the fixed
combination may be considered.
Riprazo HCT 150 mg /12.5 mg may be administered in patients whose
blood pressure is not
adequately controlled with aliskiren 150 mg or hydrochlorothiazide
12.5 mg alone.
If blood pressure remains uncontrolled after 2-4 weeks of therapy, the
dose may be titrated up to a
maximum of Riprazo HCT 300 mg/25 mg daily. Dosing should b
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