AURO TELMISARTAN 80 (Telmisartan Tablets 80mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TELMISARTAN

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

TELMISARTAN

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit VII)

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AURO TELMISARTAN 40 (TELMISARTAN TABLETS
40MG)
AURO TELMISARTAN 80 (TELMISARTAN TABLETS
80MG)
Telmisartan 40mg & 80mg
1
WHAT IS IN THIS LEAFLET
1.
What AURO TELMISARTAN
is used for
2.
How AURO TELMISARTAN
works
3.
Before you use AURO
TELMISARTAN
4.
How to use AURO
TELMISARTAN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of AURO
TELMISARTAN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS AURO TELMISARTAN
USED FOR
AURO TELMISARTAN is used to
treat high blood pressure. It is also
used to reduce your risk of
cardiovascular events such as a heart
attack, stroke or death from
cardiovascular causes in patients 55
years or older at high risk of
developing major cardiovascular
events who are unable to take a
group of medicines called ACE
inhibitors.
AURO TELMISARTAN can be used
in additional to other needed
treatment such as for blood pressure,
anti-blood clotting or cholesterol
lowering therapy.
HOW AURO TELMISARTAN
WORKS
AURO TELMISARTAN works by
blocking a receptor called
angiotensin II receptor. 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 AURO
TELMISARTAN
_-When you must not use it _
Do not use AURO TELMISARTAN
if you are allergic to Telmisartan or
any other ingredients in this
medication.
If you are more than 3 months
pregnant. It is best to avoid this
medication in early pregnancy.
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 are diabetic or have renal
(kidney) disease and are on a high
blood pressure medication called
Aliskiren.
If you are breastfeeding.
_-Before you start to use it _
Please tell your doctor if you are

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Telmisartan Tablets 40mg
Telmisartan Tablets 80mg
TRADE NAME OF THE PRODUCT
AURO TELMISARTAN 40
AURO TELMISARTAN 80
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AURO TELMISARTAN 40mg Tablets
Each Uncoated Tablet Contains
Telmisartan Ph. Eur. 40mg
AURO TELMISARTAN 80mg Tablets
Each Uncoated Tablet Contains
Telmisartan Ph. Eur. 80mg
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
AURO TELMISARTAN 40
White to off-white, oblong shaped, biconvex uncoated tablets, debossed
with ‘N & 40’ on either side of the
score line on one side and plain on the other side.
AURO TELMISARTAN 80
White to off-white, oblong shaped, biconvex uncoated tablets, debossed
with ‘N & 80’ on either side of the
score line on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
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).
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. 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.
4.2
DOSAGE AND ADMINISTRATION
Adults
TREATMENT OF ESSENTIAL HYPERTENSION
The recommended dose is 40 mg once