Dafiro HCT

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

valsartan, hydrochlorothiazide, Amlodipine besilate

Beschikbaar vanaf:

Novartis Europharm Limited

ATC-code:

C09DX01

INN (Algemene Internationale Benaming):

amlodipine besilate, valsartan, hydrochlorothiazide

Therapeutische categorie:

Agents acting on the renin-angiotensin system

Therapeutisch gebied:

Hypertension

therapeutische indicaties:

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.

Product samenvatting:

Revision: 26

Autorisatie-status:

Authorised

Autorisatie datum:

2009-11-03

Bijsluiter

74
B. PACKAGE LEAFLET
75
PACKAGE LEAFLET: INFORMATION FOR THE USER
DAFIRO HCT 5 MG/160 MG/12.5 MG FILM-COATED TABLETS
DAFIRO HCT 10 MG/160 MG/12.5 MG FILM-COATED TABLETS
DAFIRO HCT 5 MG/160 MG/25 MG FILM-COATED TABLETS
DAFIRO HCT 10 MG/160 MG/25 MG FILM-COATED TABLETS
DAFIRO HCT 10 MG/320 MG/25 MG FILM-COATED TABLETS
amlodipine/valsartan/hydrochlorothiazide
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 HCT is and what it is used for
2.
What you need to know before you take Dafiro HCT
3.
How to take Dafiro HCT
4.
Possible side effects
5.
How to store Dafiro HCT
6.
Contents of the pack and other information
1.
WHAT DAFIRO HCT IS AND WHAT IT IS USED FOR
Dafiro HCT tablets contain three substances called amlodipine,
valsartan and hydrochlorothiazide. All
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.
−
Hydrochlorothiazide belongs to a group of substances called
“thiazide diuretics”.
Hydrochlorothiazide increases urine output, which also lowers blood
pressure.
As a result of all three mechanisms, the blood vessels rela

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 12.5 mg of hydrochlorothiazide.
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 12.5 mg of hydrochlorothiazide.
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 25 mg of hydrochlorothiazide.
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 25 mg of hydrochlorothiazide.
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 320 mg of valsartan
and 25 mg of hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets
White, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and “VCL” on the
other side. Approximate size: 15 mm (length) x 5.9 mm (width).
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
Pale yellow, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and “VDL”
on the other side. Approximate size: 15 mm (length) x 5.9 mm (width).
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets
Yellow, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and “VEL” on the
other side. Approximate size: 15 mm (length) x 5