Amval 5mg160mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

AMLODIPINE BESYLATE; VALSARTAN

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

AMLODIPINE BESYLATE; VALSARTAN

Unit dalam pakej:

10 Tablets; 100 Tablets; 30 Tablets; 500 Tablets; 1000 Tablets; 14 Tablets; 28 Tablets; 56 Tablets; 84 Tablets; 112 Tablets; 168 Tablets

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
AMVAL FILM COATED TABLETS
Amlodipine/Valsartan 5mg/80mg, 5mg/160mg, 10mg/160mg
1
WHAT IS IN THIS LEAFLET
1.
What Amval is used for
2.
How Amval works
3.
Before you use Amval
4.
How to use Amval
5.
While you are using Amval
6.
Side effects
7.
Storage and Disposal of Amval
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT AMVAL IS USED FOR
Amval
contains
amlodipine,
a
medicine that belongs to the class
of
calcium
antagonists
and
valsartan,
which
belongs
to
angiotensin-II receptor antagonists.
They
both
help
to
control
high
blood pressure.
Amval
is
indicated
to
treat
high
blood
pressure
which
is
not
adequately controlled by a single
drug.
HOW AMVAL WORKS
Amlodipine
blocks
calcium
channels
at
the
blood
vessels.
Angiotensin
II
is
a
natural
substance
produced
by
the
body
that causes blood vessels to tighten,
thus increasing the blood pressure.
Valsartan
works
by
blocking
the
effect of angiotensin II. As a result
of both mechanisms, blood vessels
relax and blood pressure is lowered.
If
you
have
any
questions
about
how
Amval
works
or
why
this
medicine has been prescribed for
you, ask your doctor.
BEFORE YOU USE AMVAL
Follow
your
doctor’s
instructions
carefully. They may differ from the
general instructions in this leaflet.
−
_When you must not use it _
•
If you have ever had an unusual
or allergic reaction to amlodipine
besylate or valsartan or to any
other ingredients of this product
listed at the end of this leaflet. If
you think you may be allergic,
ask your doctor for advice.
•
If you are pregnant or planning to
become pregnant.
•
If you have high level of sugar in
the blood and you are suffering
from type 2 diabetes (also called
non-insulin
dependent
diabetes
mellitus) while you are taking a
blood pressure lowering medicine
called aliskiren
•
If
you
have
severe
liver
impairment;
biliary
cirrhosis
(blocking
of
bile
ducts
in
the
liver) and cholestasis (bile cannot
flow from liver to intestine

Ciri produk

AMVAL 5MG/80MG
AMVAL 5MG/160MG
AMVAL 10MG/160MG
FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Amval 5mg/80mg Film Coated Tablets
Amval 5mg/160mg Film Coated Tablets
Amval 10mg/160mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMVAL 5MG/80MG FILM COATED TABLETS:
Each tablet contains 6.934mg of Amlodipine
besylate equivalent to Amlodipine 5mg and Valsartan 80mg.
AMVAL 5MG/160MG FILM COATED TABLETS:
Each tablet contains 6.934mg of Amlodipine
besylate equivalent to Amlodipine 5mg and Valsartan 160mg.
AMVAL 10MG/160MG FILM COATED TABLETS:
Each tablet contains 13.868mg of Amlodipine
besylate equivalent to Amlodipine 10mg and Valsartan 160mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
AMVAL 5MG/80MG FILM COATED TABLETS:
Light yellow, round shaped film-coated tablets,
debossed with “N” on one side and “7” on the other side.
AMVAL 5MG/160MG FILM COATED TABLETS:
Light yellow, capsule shaped film-coated tablets,
debossed with “N 5” on one side and plain on the other side.
AMVAL
10MG/160MG
FILM
COATED
TABLETS:
Light
yellow,
capsule
shaped
film-coated
tablets, debossed with “N 4” on one side and plain on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Amval
is
indicated
in
patients
whose
blood
pressure
is
not
adequately
controlled
by
monotherapy.
Amval is indicated for the initial treatment of hypertension. The
choice of Amval for initial
treatment should be based on an assessment of the potential benefits
and risks.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL TARGET POPULATION
A patient whose blood pressure is not
adequately controlled on monotherapy may be
switched to combination therapy with Amval. The recommended dose is
one tablet per day.
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 may be
switched to Amval containing the s