Rasilamlo
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-03-2017
Charakterystyka produktu
(SPC)
21-03-2017
Sprawozdanie z oceny publicznego
(PAR)
28-03-2017
Składnik aktywny:
aliskiren, amlodipine
Dostępny od:
Novartis Europharm Ltd
Kod ATC:
C09XA53
INN (International Nazwa):
aliskiren hemifumarate, amlodipine besilate
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2011-04-14
Ulotka dla pacjenta
Medicinal product no longer authorised
134
B. PACKAGE LEAFLET
Medicinal product no longer authorised
135
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASILAMLO 150 MG/5 MG FILM-COATED TABLETS
RASILAMLO 150 MG/10 MG FILM-COATED TABLETS
RASILAMLO 300 MG/5 MG FILM-COATED TABLETS
RASILAMLO 300 MG/10 MG FILM-COATED TABLETS
Aliskiren/amlodipine
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rasilamlo is and what it is used for
2.
What you need to know before you take Rasilamlo
3.
How to take Rasilamlo
4.
Possible side effects
5.
How to store Rasilamlo
6.
Contents of the pack and other information
1.
WHAT RASILAMLO IS AND WHAT IT IS USED FOR
WHAT RASILAMLO IS
Rasilamlo contains two active substances, called aliskiren and
amlodipine. Both of these substances
help to control high blood pressure (hypertension).
Aliskiren is a renin inhibitor. It reduces the amount of angiotensin
II the body can make.
Angiotensin II causes blood vessels to tighten, which raises blood
pressure. Lowering the amount of
angiotensin II allows the blood vessels to relax; this lowers blood
pressure.
Amlodipine belongs to a group of medicines known as calcium channel
blockers, which help to
control high blood pressure. Amlodipine causes blood vessels to dilate
and relax, thus blood pressure
is lowered.
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 kidne
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Charakterystyka produktu
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Rasilamlo 150 mg/5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg aliskiren (as hemifumarate)
and 5 mg amlodipine (as
besylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow, convex, ovaloid tablet with a bevelled edge, with
“T2” debossed on one side and
“NVR” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasilamlo is indicated for the treatment of essential hypertension in
adult patients whose blood
pressure is not adequately controlled with aliskiren or amlodipine
used alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Rasilamlo is one tablet per day.
The antihypertensive effect is manifested within 1 week and the effect
is near maximal at around
4 weeks. If blood pressure remains uncontrolled after 4 to 6 weeks of
therapy, the dose may be
titrated up to a maximum of 300 mg aliskiren/10 mg amlodipine. Dose
should be individualised and
adjusted according to the patient’s clinical response.
Rasilamlo may be administered with other antihypertensive medicinal
products 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).
_Posology in patients not adequately controlled with aliskiren or
amlodipine monotherapy _
Rasilamlo 150 mg/5 mg may be administered in patients whose blood
pressure is not adequately
controlled with aliskiren 150 mg or amlodipine 5 mg alone.
A patient who experiences dose limiting adverse reactions on either
component alone may be
switched to Rasilamlo containing a lower dose of that component to
achieve similar blood pressure
reductions.
Ind
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