MICARDIS TABLET 80 mg

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

TELMISARTAN

Saadav alates:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC kood:

C09CA07

Annus:

80 mg

Ravimvorm:

TABLET

Koostis:

TELMISARTAN 80 mg

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

BOEHRINGER INGELHEIM PHARMA GMBH & CO KG

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

1999-08-16

Infovoldik

1
Abcd
PACKAGE LEAFLET: INFORMATION FOR THE USER
MICARDIS 40MG TABLETS
MICARDIS 80MG TABLETS
Telmisartan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MICARDIS is and what it is used for
2.
What you need to know before you take MICARDIS
3.
How to take MICARDIS
4.
Possible side effects
5.
How to store MICARDIS
6.
Contents of the pack and other information
7.
Marketing Authorization Holder and Manufacturer
8.
Product registration number
9.
Date of revision
1. WHAT MICARDIS IS AND WHAT IT IS USED FOR
MICARDIS
is used to treat essential hypertension (high blood pressure) in
adults.
MICARDIS
contains telmisartan belongs to a class of medicines called
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. Telmisartan blocks the effect of angiotensin II
so that the blood vessels relax, and your
blood pressure is lowered.
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 adults 55 years 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

Toote omadused

1
MICARDIS
®
Abcd
1.
NAME OF THE MEDICINAL PRODUCT
Micardis 40 mg tablets
Micardis 80 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Micardis 40 mg tablets
Each tablet contains 40 mg telmisartan
Micardis 80 mg tablets
Each tablet contains 80 mg telmisartan
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Micardis 40 mg tablets
40mg: White or off white, oblong tablets; one face marked with 51H,
the other face with the Boehringer
Ingelheim company symbol
Micardis 80mg tablets
80mg: White or off white, oblong tablets; one face marked with
“52H”, the other face with the Boehringer
Ingelheim company symbol
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Reduction of the risk of non-fatal stroke or non-fatal myocardial
infarction in adults 55 years or older at high
risk of developing major cardiovascular events who cannot tolerate an
angiotensin coverting enzyme
inhibitor (ACEI).
High risk of cardiovascular events includes evidence of coronary
artery disease, peripheral arterial disease,
stroke, transient ischemic attack, or diabetes mellitus with evidence
of end-organ damage.
4.2
POSOLOGY AND METHOD OF
ADMINISTRATION
POSOLOGY
TREATMENT OF ESSENTIAL HYPERTENSION
The recommended dose is 40 mg once daily.
Some patients may already benefit at a daily dose of 20 mg. In
cases where the target blood pressure is not achieved, telmisartan
dose can be increased to a maximum of
80 mg once daily. When considering raising the dose, it must be borne
in mind that the maximum
antihypertensive effect is generally attained four to eight weeks
after the start of treatment. Alternatively,
telmisartan may be used in combination with thiazide-type diuretics
such as hydrochlorothiazide
or calcium-
channel-blockers such as amlodipine, which have been shown to have an
additive blood pressure lowering
effect with telmisartan.
In patients with severe hypertension treatment with telmisartan at
doses up to 160 mg alone and in
combination with hydrochloro