Sprimeo HCT
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
28-08-2012
Karatteristiċi tal-prodott
(SPC)
28-08-2012
Rapport ta 'Valutazzjoni Pubblika
(PAR)
28-08-2012
Ingredjent attiv:
aliskiren, hydrochlorothiazide
Disponibbli minn:
Novartis Europharm Ltd.
Kodiċi ATC:
C09XA52
INN (Isem Internazzjonali):
aliskiren, hydrochlorothiazide
Grupp terapewtiku:
Agents acting on the renin-angiotensin system
Żona terapewtika:
Hypertension
Indikazzjonijiet terapewtiċi:
Treatment of essential hypertension in adults.Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.Sprimeo 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.
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2011-06-23
Fuljett ta 'informazzjoni
135
B. PACKAGE LEAFLET
Medicinal product no longer authorised
136
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPRIMEO HCT 150 MG/12.5 MG FILM-COATED TABLETS
SPRIMEO HCT 150 MG/25 MG FILM-COATED TABLETS
SPRIMEO HCT 300 MG/12.5 MG FILM-COATED TABLETS
SPRIMEO 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 Sprimeo HCT is and what it is used for
2.
Before you take Sprimeo HCT
3.
How to take Sprimeo HCT
4.
Possible side effects
5.
How to store Sprimeo HCT
6.
Further information
1.
WHAT SPRIMEO HCT IS AND WHAT IT IS USED FOR
Sprimeo 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.
Spr
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Sprimeo 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.
Sprimeo HCT is indicated in patients whose blood pressure is not
adequately controlled on aliskiren or
hydrochlorothiazide used alone.
Sprimeo 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 Sprimeo HCT is one tablet per day. Sprimeo 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 Sprimeo 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.
Sprimeo 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 Sprimeo HCT 300 mg/25 mg daily. Dosing should b
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