MICARDIS TABLET 40MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TELMISARTAN

Boleh didapati daripada:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TELMISARTAN

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Boehringer Ingelheim Ellas A.E

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
TABLET MICARDIS 20 MG (MAL 20014487A)
TABLET MICARDIS 40 MG (MAL 19992673A)
TABLET MICARDIS 80 MG (MAL 19992674A)
TELMISARTAN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1. What Micardis is and what it is used for
2. Before you take Micardis
3. How to take Micardis
4. Possible side effects
5. How to store Micardis
6. Further information
1. WHAT MICARDIS IS AND WHAT IT IS USED FOR
Micardis 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. Micardis blocks the effect of angiotensin II so that the
blood vessels relax, and your blood
pressure is lowered.
MICARDIS 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.
MICARDIS 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.
2. BEFORE YOU TAKE MICARDIS
DO

Ciri produk

Package Insert – C lean 1
Micardis ® Abcd
1. NAME OF THE MEDICINAL PRODUCT
MICARDIS 40 mg
MICARDIS 80 mg
2. QUALIT AT IVE AND QUAN TITATYVE COMPOSITION
1 tablet contains 40 or 80 mg
[1,1’ -biphenyl] -2 -carboxylic acid, 4’ -[(1, 4’dimethyl -2’ -propyl[2,6- bi-1H -benzimidazole] -1’ -yl)m ethyl] (=
telmisartan)
3 . PHARMACEUTICAL FORM
Tablet for oral use.
40mg: W hite or off -white, oblong tablets; one face marked with 51 H, the other with the Boehringer
Company symbol .
80mg: W hite or off -white, oblong tablets ; one face impressed with “5 2 H ”; the other face impressed with the
Company symbol .
4. CLINICAL PARTICULARS
4.1 Indications
Hypertension
Treatment of essential hypertension.
Cardiovascular risk r eduction
MICARDIS 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. MICARDIS 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 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 t