Cresar 80 (Telmisartan Tablets 80mg)

País: Malàisia

Idioma: anglès

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

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
10-10-2019

ingredients actius:

TELMISARTAN

Disponible des:

CIPLA MALAYSIA SDN BHD

Designació comuna internacional (DCI):

TELMISARTAN

Unidades en paquete:

3 x 10 Tablets

Fabricat per:

Jubilant Generics Limited

Informació per a l'usuari

                                CRESAR
TELMISARTAN TABLETS (40MG, 80MG)
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
___________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Cresar is used for
2.
How Cresar works
3.
Before you use Cresar
4.
How to use Cresar
5.
While you are using Cresar
6.
Side effects
7.
Storage and Disposal of Cresar
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT CRESAR IS USED FOR
CRESAR
IS
USED
TO
treat
essential
hypertension
(high
blood
pressure).
‘Essential’ means that the high blood
pressure is not caused by any other
condition.
High blood pressure, if not treated, can
damage blood vessels in several organs,
which could lead sometimes to heart
attack, heart or kidney failure, stroke, or
blindness.
There
are
usually
no
symptoms of high blood pressure before
damage occurs. Thus it is important to
regularly
measure
blood
pressure
to
verify if it is within the normal range.
CRESAR
IS
ALSO
USED
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 had a stroke or have high risk
diabetes. Your doctor can tell you if you
are at high risk for such events.
HOW CRESAR WORKS
CRESAR
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.
Cresar blocks the effect of angiotensin
II so that the blood vessels relax, and
your blood pressure is lowered.
BEFORE YOU TAKE CRESAR
_WHEN YOU MUST NOT TAKE IT _
•
if you are allergic (hypersensitive)
to
telmisartan
or
any
other
ingredients included in Cresar (see
_Product Description_
for a list of
other ingredients).
•
if
you
are
more
than
3
months
pregnant. (It is also better to avoid
Cresar
in
early
pregnancy
–
see
_Pregnancy and breast-feeding_
)
•
if you have severe liver problems
such
as
cholestasis
                                
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Fitxa tècnica

                                _For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for _
_Specialist Use only _
GENERIC NAME
Telmisartan tablets 80 mg
BRAND NAME
Cresar 80
COMPOSITION
Each tablet contains:
Telmisartan Ph Eur……………………………80mg
DOSAGE FORM
Uncoated Tablet
PRODUCT DESCRIPTION
White to off white, oval shaped tablets debossed with “D” on one
side and plain on other side
PHARMACOLOGY
_PHARMACODYNAMICS _
ATC Classification
C09CA07 - telmisartan; Belongs to the class of angiotensin II
antagonists. Used in the
treatment of cardiovascular disease.
_Mechanism of Action _
_Pharmacology: _
Telmisartan is an orally effective 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 AT1
receptor. 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 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
still
measurable up to 48 hours.
_Treatment of Essential Hypertension: _
After the first dose of telmisartan, the antihypertensive
activity gradually becomes evident within 3 hours. The maximum
reduction in blood pressu
                                
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