VASTANLUPI FILM COATED TABLETS 80 MG

Country: Malaysia

Language: English

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

Active ingredient:

VALSARTAN

Available from:

Generic Health Sdn. Bhd.

INN (International Name):

VALSARTAN

Units in package:

28tablet Tablets

Manufactured by:

Jubilant Generics Limited

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
VASTANLUPI FILM COATED TABLETS
valsartan (80mg and 160mg)
1
WHAT IS IN THIS LEAFLET
1.
What Vastanlupi is used for
2.
How Vastanlupi works
3.
Before you use Vastanlupi
4.
How to use Vastanlupi
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Vastanlupi
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1. WHAT VASTANLUPI IS USED FOR
Vastanlupi can be used to treat
high blood pressure. High blood
pressure increases the workload
on the heart and arteries. If not
treated it can damage the blood
vessels of the brain, heart, and
kidneys, and may result in a
stroke, heart failure, or kidney
failure.
High blood pressure increases
the risk of heart attacks.
Lowering your blood pressure to
normal reduces the risk of
developing these disorders.
Vastanlupi is used to treat adult
heart failure patients. Heart
failure is associated with
shortness of breath, and swelling
of the feet and legs due to fluid
build-up. Heart failure means
that the heart muscle cannot
pump blood strongly enough to
supply all the blood needed
throughout the body.
Vastanlupi can also be used to
treat adults after a heart attack
(myocardial infarction) to
improve survival and reduce
further heart problems.
2. HOW VASTANLUPI WORKS
Vastanlupi belongs to a class of
medicines known as angiotensin
II receptor antagonist, which
help to control high blood
pressure. Angiotensin II is a
substance in the body that
causes vessels to tighten, thus
causing your blood pressure to
increase.
Vastanlupi works by blocking
the effect of angiotensin II. As a
result, blood vessels relax and
blood pressure is lowered
3. BEFORE YOU USE VASTANLUPI
_ _
_WHEN YOU MUST NOT USE IT _
•
if you are ALLERGIC
(hypersensitive) to valsartan
or any of the other ingredients
of Vastanlupi.
•
if you are pregnant or
planning to be pregnant.
_ _
_BEFORE YOU USE IT _
Follow all instructions given to
you by your doctor carefully,
even if they differ from the
information contained

Summary of Product characteristics

For the use of a registered medical practitioner or a hospital or a
laboratory only
VASTANLUPI FILM COATED TABLETS
80 MG & 160 MG
PRODUCT NAME:
Vastanlupi Film Coated Tablets 80 mg
Vastanlupi Film Coated Tablets 160 mg
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Each film-coated tablet contains:
Valsartan Ph. Eur…..80 mg
Valsartan Ph. Eur…..160 mg
PRODUCT DESCRIPTION:
VASTANLUPI FILM COATED TABLETS 80 MG
Peach coloured, round, biconvex, film coated tablets, scored on one
side and debossed with ‘80’ on
scored side and ‘J’ on the other.
VASTANLUPI FILM COATED TABLETS 160 MG
Yellow coloured, oval shaped, biconvex, film coated tablets, scored on
one side and debossed with
‘160’ on scored side and ‘J’ on the other.
PHARMACODYNAMICS / PHARMACOKINETICS:
Angiotensin II antagonist.
The active hormone of the renin-angiotensin-aldosterone system (RAAS)
is angiotensin II, which is
formed from angiotensin I through ACE. Angiotensin II binds to
specific receptors located in the cell
membranes of various tissues. It has a wide variety of physiological
effects, including in particular
both direct and indirect involvement in the regulation of blood
pressure. As a potent vasoconstrictor,
angiotensin II exerts a direct pressor response. In addition, it
promotes sodium retention and
stimulation of aldosterone secretion.
Valsartan is an orally active, potent and specific angiotensin II (Ang
II) receptor antagonist. It acts
selectively on the AT1 receptor subtype, which is responsible for the
known actions of angiotensin
II. The increased plasma levels of Ang II following AT1 receptor
blockade with valsartan may
stimulate the unblocked AT2 receptor, which appears to counterbalance
the effect of the AT1
receptor. Valsartan does not exhibit any partial agonist activity at
the AT1 receptor and has much
(about 20,000 fold) greater affinity for the AT1 receptor than for the
AT2 receptor.
Valsartan does not inhibit ACE, also known as kininase II, which
converts Ang I to Ang II and
degrades bradykinin. Since there is no effec