TELSAR 20 (Telmisartan tablets 20mg)

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
26-11-2021
Ciri produk Ciri produk (SPC)
06-05-2021

Bahan aktif:

TELMISARTAN

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

TELMISARTAN

Unit dalam pakej:

10 x 10's tablet Tablets; 3 x 10 Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

                                TELSAR 20/40/80
_Consumer Medication Information Leaflet (RiMUP) _
Telmisartan (20mg,40mg,80mg)
WHAT IS IN THIS LEAFLET
1.
What TELSAR is used for
2.
How TELSAR works
3.
Before you use TELSAR
4.
How to use TELSAR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TELSAR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TELSAR IS USED FOR
_Telmisartan _
belongs
to
a
group
of
medicines used:
•
To treat essential hypertension
(high
blood
pressure).
‘Essential’ means that the high
blood pressure is not caused by
any other condition.
•
to reduce cardiovascular events
(i.e.heart
attack
or
stroke)
in
patients who are at risk because
they have a reduced or blocked
blood
supply
to
the
heart
or
legs, or have a stroke or have
high risk of diabetes.
HOW TELSAR 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.
BEFORE YOU USE
TELSAR
_When you must _
_not use it _DO NOT TAKE
_TELMISARTAN_:
•
if
you
are
allergic
(hypersensitive)
to
the
active
substance
of
this
medicine
(telmisartan)
or
to
any
of
the
other
ingredients
of
this
medicine
•
If you are more than 3 months
pregnant. (It is better to avoid
Telmisartan in early pregnancy-
see pregnancy section.)
•
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 liver disease.
PREGNANCY AND LACTATION
PREGNANCY
Ask your doctor or pharmacist for advice
before taking any medicine.
You must tell your doctor if you think
you are (or might become) pregnant.
Your doctor will normally advise you to
stop
taking
_Telmisartan _
before
you
become pregnant or as soon as you know
you are pregnant and will advise you to
ta
                                
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Ciri produk

                                PACKAGE INSERT
TELSAR 20/40/80
1. PRODUCT NAME
TELSAR 20/40/80 (Telmisartan tablets 20mg/40mg/80mg)
2. NAME AND STRENGTH OF ACTIVE INGREDIENT (S)
Telmisartan tablets 20mg/40mg/80mg
3. PRODUCT DESCRIPTION
TELSAR 20 (TELMISARTAN TABLETS 20MG)
White to off white, round, flat bevel edged tablets, debossed with
‘H’ on one side
and
‘162’ on other side. The thickness of the tablet is 2.60 ±0.40
mm.
TELSAR 40 (TELMISARTAN TABLETS 40MG)
White to off white, oval shaped, biconvex tablets, debossed with
‘H’ on one side and
‘163’on other side. The thickness of the tablet is 3.80 ±0.40 mm.
TELSAR 80 (TELMISARTAN TABLETS 80MG)
White to off white, oval shaped, biconvex tablets debossed with
‘H’ on one side and
‘164’on other side. The thickness of the tablet is 5.00 ±0.40 mm.
4. PHARMACODYNAMICS / PHARMACOKINETICS
PHARMACODYNAMICS
Telmisartan is an orally effective and specific angiotensin-II
receptor (type AT
1
) antagonist.
It displaces angiotensin II with very high affinity from its binding
site at the AT
1
receptor
subtype, which is responsible for the unknown actions of angiotensin
II. Telmisartan does not exhibit any partial agonist activity at the
AT
1
receptor. Telmisartan
selectively binds the AT
1
receptor. The binding long lasting. Telmisartan does not show
affinity for other receptors, including AT
2
and other less characterized 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 man, 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 
                                
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