Tolura 40 mg tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TELMISARTAN

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

TELMISARTAN

Unit dalam pakej:

30tablet Tablets; 28 Tablets

Dikeluarkan oleh:

KRKA, d.d., Novo mesto

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET_
_(RIMUP)_
1
TOLURA TABLETS
Telmisartan (40 mg, 80 mg)
WHAT IS IN THIS
LEAFLET
1.
What Tolura is used for
2.
How Tolura
works
3.
Before you use Tolura
4.
How to use Tolura
5.
While you are using
it
6.
Side
effects
7.
Storage and Disposal
of
Tolura
8.
Product
Description
9.
Manufacturer
and Product
Registration
Holder
10.
Date of
revision
WHAT TOLURA IS USED FOR
TOLURA 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.
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.
TOLURA IS ALSO USED TO reduce
cardiovascular events (i.e. heart attack
or stroke) in adults 55 years of age or
older 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 TOLURA WORKS
Tolura 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.
Tolura blocks the effect of angiotensin
II so that the blood vessels relax, and
your blood pressure is lowered.
BEFORE YOU USE TOLURA
-
_When you must not use_
_it_

if you are allergic to telmisartan or
any other ingredients of this
medicine.

if you are more than 3 months
pregnant. (It is also better to avoid
Tolura in early pregnancy – see
pregnancy section.)

if you have severe liver problems
such as cholestasis or biliary
obstruction (problems with the
drainage of the bile from the liver
and gall bladder) or any other
severe liver disease.
If any o

Ciri produk

1.3.1
Telmisartan
SPC, Labeling and Package Leaflet
MY
SmPCPIL115956_2
20.07.2018 – Updated: 17.09.2019
Page 1 of 12
TOLURA
_Telmisartan_
NAME OF THE MEDICINAL PRODUCT
Tolura 40 mg tablets
Tolura 80 mg tablets
COMPOSITION
Each tablet contains 40 mg telmisartan.
Each tablet contains 80 mg telmisartan.
PRODUCT DESCRIPTION
Tolura 40 mg tablets are presented as white to almost white, biconvex,
oval tablets, thickness 4.0 mm
– 5.2 mm.
Tolura 80 mg tablets are presented as white to almost white, biconvex,
capsule shaped tablets,
thickness 4.8 mm – 6.2 mm.
THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension.
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.
Use of telmisartan with an ACE inhibitor is not recommended.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Treatment of essential hypertension:
The recommended dose is 40 mg once daily. In cases where the target
blood pressure is not achieved,
telmisartan dose can be increased to a maximum of 80 mg once daily.
Alternatively, telmisartan may
be used in combination with thiazide-type diuretics such as
hydrochlorothiazide, which has been
1.3.1
Telmisartan
SPC, Labeling and Package Leaflet
MY
SmPCPIL115956_2
20.07.2018 – Updated: 17.09.2019
Page 2 of 12
shown to have an additive blood pressure l