Dafiro
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
11-11-2022
Produktets egenskaber
(SPC)
11-11-2022
Offentlige vurderingsrapport
(PAR)
10-07-2015
Aktiv bestanddel:
amlodipine, valsartan
Tilgængelig fra:
Novartis Europharm Limited
ATC-kode:
C09DB01
INN (International Name):
amlodipine, valsartan
Terapeutisk gruppe:
Agents acting on the renin-angiotensin system
Terapeutisk område:
Hypertension
Terapeutiske indikationer:
Treatment of essential hypertension. Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.,
Produkt oversigt:
Revision: 30
Autorisation status:
Authorised
Autorisation dato:
2007-01-15
Indlægsseddel
51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE USER
DAFIRO 5 MG/80 MG FILM-COATED TABLETS
DAFIRO 5 MG/160 MG FILM-COATED TABLETS
DAFIRO 10 MG/160 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. See section 4.
-
WHAT IS IN THIS LEAFLET
1.
What Dafiro is and what it is used for
2.
What you need to know before you take Dafiro
3.
How to take Dafiro
4.
Possible side effects
5.
How to store Dafiro
6.
Contents of the pack and other information
1.
WHAT DAFIRO IS AND WHAT IT IS USED FOR
Dafiro 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.
Dafiro is used to treat high blood pressure in adults whose blood
pressure is not controlled enough
with either amlodipine or valsartan on its own.
53
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAFIRO
DO NOT TAKE DAFIRO
−
if you are allergic to amlodipine or to any other cal
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dafiro 5 mg/80 mg film-coated tablets
Dafiro 5 mg/160 mg film-coated tablets
Dafiro 10 mg/160 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dafiro 5 mg/80 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 80 mg of valsartan.
Dafiro 5 mg/160 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 160 mg of valsartan.
Dafiro 10 mg/160 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate) and 160 mg of
valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Dafiro 5 mg/80 mg film-coated tablets
Dark yellow, round film-coated tablet with bevelled edges, imprinted
with “NVR” on one side and
“NV” on the other side. Approximate size: diameter 8.20 mm.
Dafiro 5 mg/160 mg film-coated tablets
Dark yellow, oval film-coated tablet, imprinted with “NVR” on one
side and “ECE” on the other side.
Approximate size: 14.2 mm (length) x 5.7 mm (width).
Dafiro 10 mg/160 mg film-coated tablets
Light yellow, oval film-coated tablet, imprinted with “NVR” on one
side and “UIC” on the other side.
Approximate size: 14.2 mm (length) x 5.7 mm (width).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Dafiro is indicated in adults whose blood pressure is not adequately
controlled on amlodipine or
valsartan monotherapy.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Dafiro is one tablet per day.
Dafiro 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.
Dafiro 5 mg/160 mg may be administered in patients whose blood
pressure is not adequately
controlled with amlodipine 5 mg or valsartan 160 mg alone.
Dafiro 10 mg/160 mg may be administered in patients whose blood
pressure is
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