Exforge tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amlodipine (amlodipine besilate), valsartan

Available from:

Novartis Farmaceutica S.A.

ATC code:

C09DB01

INN (International Name):

amlodipine (amlodipine besilate), valsartan

Dosage:

10mg+ 160mg

Pharmaceutical form:

tablets film-coated

Units in package:

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

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-05-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXFORGE 5 MG/80 MG FILM-COATED TABLETS
EXFORGE 5 MG/160 MG FILM-COATED TABLETS
EXFORGE 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.
WHAT IS IN THIS LEAFLET
1.
What Exforge is and what it is used for
2.
What you need to know before you take Exforge
3.
How to take Exforge
4.
Possible side effects
5.
How to store Exforge
6.
Contents of the pack and other information
1.
WHAT EXFORGE IS AND WHAT IT IS USED FOR
Exforge 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.
Exforge 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 EXFORGE DO NOT TAKE EXFORGE
−
if you are allergic to amlodipine or to any other calcium channel
blockers. This may

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Exforge 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.
Exforge 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 Exforge is one tablet per day.
Exforge 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.
Exforge 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 Exforge 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 _
Exforge is contraindicated in patients with severe hepatic impairment
(see section 4.3).
3
Caution should be exercised when administering Exforge to patients
with hepatic impairment or
biliary obstructive disorders (see section 4.4). In patients with mild
to moderate hepatic impairment
without cholestasis, the maximum recommended dose is 80 mg valsartan.
A