Imprida
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
11-05-2017
Charakterystyka produktu
(SPC)
11-05-2017
Sprawozdanie z oceny publicznego
(PAR)
11-05-2017
Składnik aktywny:
valsartan, amlodipine (as amlodipine besilate)
Dostępny od:
Novartis Europharm Ltd
Kod ATC:
C09DB01
INN (International Nazwa):
amlodipine, valsartan
Grupa terapeutyczna:
Agents acting on the renin-angiotensin system
Dziedzina terapeutyczna:
Hypertension
Wskazania:
Treatment of essential hypertension.Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Podsumowanie produktu:
Revision: 20
Status autoryzacji:
Withdrawn
Data autoryzacji:
2007-01-17
Ulotka dla pacjenta
83
B. PACKAGE LEAFLET
Medicinal product no longer authorised
84
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMPRIDA 5 MG/80 MG FILM-COATED TABLETS
amlodipine/valsartan
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 Imprida is and what it is used for
2.
What you need to know before you take Imprida
3.
How to take Imprida
4.
Possible side effects
5.
How to store Imprida
6.
Contents of the pack and other information
1.
WHAT IMPRIDA IS AND WHAT IT IS USED FOR
Imprida tablets contain two substances called amlodipine and
valsartan. Both of these substances help
to control high blood pressure.
Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine
stops calcium from moving into the blood vessel wall which stops the
blood vessels from
tightening.
Valsartan belongs to a group of substances called “angiotensin-II
receptor antagonists”.
Angiotensin II is produced by the body and makes the blood vessels
tighten, thus increasing the
blood pressure. Valsartan works by blocking the effect of angiotensin
II.
This means that both of these substances help to stop the blood
vessels tightening. As a result, the
blood vessels relax and blood pressure is lowered.
Imprida is used to treat high blood pressure in adults whose blood
pressure is not controlled enough
with either amlodipine or valsartan on its own.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMPRIDA
DO NOT TAKE IMPRIDA
if you are allergic to amlodipine or to any other calcium channel
blockers. This may involve
itching, r
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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
Imprida 5 mg/80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 80 mg of valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Dark yellow, round film-coated tablet with bevelled edges, imprinted
with “NVR” on one side and
“NV” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Imprida is indicated in adults whose blood pressure is not adequately
controlled on amlodipine or
valsartan monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Imprida is one tablet per day.
Imprida 5 mg/80 mg may be administered in patients whose blood
pressure is not adequately
controlled with amlodipine 5 mg or valsartan 80 mg alone.
Imprida can be used with or without food.
Individual dose titration with the components (i.e. amlodipine and
valsartan) is recommended before
changing to the fixed dose combination. When clinically appropriate,
direct change from monotherapy
to the fixed-dose combination may be considered.
For convenience, patients receiving valsartan and amlodipine from
separate tablets/capsules may be
switched to Imprida containing the same component doses.
_ _
_Renal impairment _
There are no available clinical data in severely renally impaired
patients. No dosage adjustment is
required for patients with mild to moderate renal impairment.
Monitoring of potassium levels and
creatinine is advised in moderate renal impairment.
_Hepatic impairment _
Imprida is contraindicated in patients with severe hepatic impairment
(see section 4.3).
Medicinal product no longer authorised
3
Caution should be exercised when administering Imprida to patients
with hepatic impairment or
biliary obstructive disorders (see section 4.4). In patients with mild
to moderate hepatic impa
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