TSART 80 (TELMISARTAN TABLETS USP 80MG)

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

TELMISARTAN

Disponible depuis:

Ascend Laboratories Sdn Bhd

DCI (Dénomination commune internationale):

TELMISARTAN

Unités en paquet:

6 x 10 Tablets; 3 x 10 Tablets

Fabriqué par:

ALKEM LABORATORIES LTD

Notice patient

_Consumer Medication Information Leaflet (RiMUP) _
TSART 40/80
TELMISARTAN TABLETS USP 40MG/80MG
Page 1 of 2
WHAT IS IN THIS LEAFLET?
1.
What Telmisartan Tablets is used
for
2.
How Telmisartan Tablets works
3.
Before you use Telmisartan Tablets
4.
How to use Telmisartan Tablets
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Telmisartan Tablets
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial number
1.
WHAT TELMISARTAN TABLETS IS USED
FOR
Telmisartan is used to treat essential
hypertension (high blood pressure) in
adults. ‘Essential’ means that the high
blood pressure is not caused by any
other condition.
Also
used
to
reduce
cardiovascular
events (i.e. heart attack or stroke) in
adults
who
are
at
risk
because
they
have a reduced or blocked blood supply
to the heart or legs or have had a stroke
or have high risk diabetes. Your doctor
can tell you if you are at high risk for
such events.
2.
HOW TELMISARTAN TABLETS WORKS
Telmisartan belongs to a class of
medicines known as angiotensin II
receptor antagonists. Angiotensin II is a
substance produced in your body which
causes your blood vessels to narrow,
thus increasing your blood pressure.
Telmisartan
blocks
the
effect
of
angiotensin II so that the blood vessels
relax, and your blood pressure is
lowered.
3.
BEFORE
YOU
USE
TELMISARTAN
TABLETS
_-When you must not use it_
Do not take Telmisartan
•
if you are allergic to telmisartan or
any other ingredients of this medicine
•
if you are more than 3 months
pregnant.
•
if you have severe liver problems
such
as
cholestasis
or
biliary
obstruction (problems with drainage of
the bile from the liver and gall bladder)
or any other severe liver disease.
•
if
you
have
diabetes
or
impaired
kidney
function
and
you
are
treated
with
a
blood
pressure
lowering
medicine containing aliskiren.
If any of the above applies to you, tell
your doctor or pharmacist before taking
Telmisartan.
_-Before you start to use it_
Talk
to
your
doctor
before
taking
Telmi

Résumé des caractéristiques du produit

COMPOSITION:
Each uncoated tablet of TSART 40 contains
Telmisartan Ph. Eur ….. 40mg
Each uncoated tablet of TSART 80 contains
Telmisartan Ph. Eur ….. 80mg
PRODUCT DESCRIPTION :
TSART 40 : White to off white oblong shaped biconvex, uncoated tablets
debossed with
TELon one side and 40 on other side
TSART 80 : White to off white oblong shaped biconvex,
uncoated tablets debossed with TEL on one side and 80 on other side.
PHARMACODYNAMICS
Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC
code: C09CA07.
Mechanism of action
Telmisartan is an orally active and specific angiotensin II receptor
(type AT1)
antagonist.
Telmisartan displaces angiotensin II with very high affinity from its
binding site at the
AT1 receptor subtype, which is responsible for the known actions of
angiotensin II.
Telmisartan does not exhibit any partial agonist activity at the
AT1receptor. Telmisartan
selectively binds the AT1 receptor. The binding is long-lasting.
Telmisartan does not
show affinity for other receptors, including AT2 and other less
characterised AT
receptors. The functional role of these receptors is not known, nor is
the effect of their
possible overstimulation by angiotensin II, whose levels are increased
by telmisartan.
Plasma aldosterone levels are decreased by telmisartan. Telmisartan
does not inhibit
human plasma renin or block ion channels. Telmisartan does not inhibit
angiotensin
converting
enzyme
(kininase
II),
the
enzyme
which
also
degrades
bradykinin.
Therefore it is not expected to potentiate bradykinin-mediated adverse
effects.
In human, an 80 mg dose of telmisartan almost completely inhibits the
angiotensin II
evoked blood pressure increase. The inhibitory effect is maintained
over 24 hours and
still measurable up to 48 hours.
PHARMACOKINETICS:
Absorption
Absorption of telmisartan is rapid although the amount absorbed
varies. The mean
absolute bioavailability for telmisartan is about 50%.
When telmisartan is taken with food, the reduction in the area under
the plasma
concentration-time curve (AUC
)