TELMIDIP 80 mg Tablets

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

TELMISARTAN

Διαθέσιμο από:

GENPHARMA SDN. BHD

INN (Διεθνής Όνομα):

TELMISARTAN

Μονάδες σε πακέτο:

3 x 10s Tablets; 10 x 10s Tablets

Κατασκευάζεται από:

Alembic Pharmaceuticals Limited (Formulation Division)

Φύλλο οδηγιών χρήσης

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TELMIDIP TABLETS
Telmisartan (40 mg and 80 mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_TELMIDIP_
is used for
2.
How
_TELMIDIP_
works
3.
Before you use
_TELMIDIP_
4.
How to use
_TELMIDIP_
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
_TELMIDIP_
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _TELMIDIP_ 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 _TELMIDIP _WORKS
_TELMIDIP_
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.
_TELMIDIP_
blocks the effect
of
angiotensin
II
so
that
the
blood
vessels relax, and your blood pressure
is lowered.
BEFORE YOU USE _TELMIDIP _
-
_When you must not take it _
Do not take
_TELMIDIP_
if:
▪
you are allergic (hypersensitive)
to telmisartan or any other
ingredients included in the tablets
(see section
_Product description _
for a list of other ingredients)
▪
you are pregnant (when
pregnancy is detected,
_TELMIDIP_
should be
discontinued as soon as possible)
▪
you are breastfeeding
▪
you have biliary obstructive
disorders (problem with the
damage of the bile from the liver
and gall bladder)
▪
you have severe liver problems
If any of the above applies to you, tell
your doctor or pharmacist before
taking
_TELMIDIP_
.
-
_Before you start to take it _
Please tell your doctor if you are
suffering or have ever suffered from
any of the following conditions or
illnesses:
▪
Kidney disease or kidney
transplant
▪
Renal artery st

Αρχείο Π.Χ.Π.

1
1.
NAME OF THE MEDICINAL PRODUCT
TELMIDIP 40 mg Tablets
TELMIDIP 80 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TELMIDIP 40 mg Tablets
Each tablet contains 40 mg telmisartan.
TELMIDIP 80 mg Tablets
Each tablet contains 80 mg telmisartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
TELMIDIP 40 mg Tablets
White to off-white color, oval shape, biconvex, uncoated tablets
debossed with 'L203' on one side and
plain on other side.
Dimension: Thickness 3.90 mm to 4.70 mm
Length 11.80 mm to 12.20 mm
Width 5.70 mm to 6.10 mm
TELMIDIP 80 mg Tablets
White to off-white color, oval shape, biconvex, uncoated tablets
debossed with 'L204' on one side and
plain on other side.
Dimension: Thickness 4.80 mm to 5.60 mm
Length 16.00 mm to 16.40 mm
Width 7.70 mm to 8.10 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults.
Cardiovascular risk reduction
Telmisartan is indicated for reduction of the risk of myocardial
infarction, stroke, or death from
cardiovascular causes in patients 55 years of age or older at high
risk of developing major
cardiovascular events who are unable to take ACE inhibitors.
High risk of cardiovascular events can be evidenced by history of
coronary artery disease, peripheral
arterial disease, stroke, transient ischemic attack, or high-risk
diabetes (insulin-dependent or non-
insulin dependent) with evidence of end-organ damage. Telmisartan can
be used in additional to
other needed treatment (such as antihypertensive, antiplatelet or
lipid-lowering therapy).
Consider using the ACE inhibitor first, and, if it is stopped for
cough only, consider re-trying the
ACE inhibitor after the cough resolves.
2
Use of telmisartan with an ACE inhibitor is not recommended.
Studies of Telmisartan in this setting do not exclude that it may not
preserve a meaningful fraction of the
effect of the ACE inhibitor to which it was compared.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_Treatment of essential hype