Exforge HCT 10mg/160mg/25mg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

Available from:

Novartis Pharma Stein AG

ATC code:

C09DX01

INN (International Name):

amlodipine (amlodipine besilate), valsartan, hydrochlorothiazide

Dosage:

10mg+ 160mg+ 25mg

Pharmaceutical form:

tablets film-coated

Units in package:

(14/1x14), in blister, (28/2x14/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-06-06

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXFORGE HCT 5 MG/160 MG/12.5 MG FILM-COATED TABLETS
EXFORGE HCT 5 MG/160 MG/25 MG FILM-COATED TABLETS
EXFORGE HCT 10 MG/160 MG/12.5 MG FILM-COATED TABLETS
EXFORGE HCT 10 MG/160 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 Exforge HCT is and what it is used for
2.
What you need to know before you take Exforge HCT
3.
How to take Exforge HCT
4.
Possible side effects
5.
How to store Exforge HCT
6.
Contents of the pack and other information
1.
WHAT EXFORGE HCT IS AND WHAT IT IS USED FOR
Exforge 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 relax and blood
pressure is lowered.
Exforge HCT is used to treat h

Summary of Product characteristics

68
1.
NAME OF THE MEDICINAL PRODUCT
Exforge HCT 10 mg/160 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besylate), 160 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)
Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and
“VHL” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Exforge HCT is one tablet per day, to be taken
preferably in the morning.
Before switching to Exforge HCT patients should be controlled on
stable doses of the
monocomponents taken at the same time. The dose of Exforge HCT should
be based on the doses of
the individual components of the combination at the time of switching.
The maximum recommended dose of Exforge HCT is 10 mg/320 mg/25 mg.
_Special populations _
_Renal impairment _
Due to the hydrochlorothiazide component, Exforge HCT is
contraindicated for use in patients with
anuria (see section 4.3) and in patients with severe renal impairment
(glomerular filtration rate (GFR)
<30 ml/min/1.73 m
2
) (see sections 4.3, 4.4 and 5.2).
No adjustment of the initial dose is required for patients with mild
to moderate renal impairment (see
sections 4.4 and 5.2).
_Hepatic impairment _
Due to the valsartan component, Exforge HCT is contraindicated in
patients with severe hepatic
impairment (see section 4.3). In patients with mild to moderate
hepatic impairment without
cholestasis, the maximum recommended dose is 80 mg valsartan and
therefore Exforge HCT is not
s