MICARDIS PLUS TABLET 8012.5 mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

HYDROCHLOROTHIAZIDE; TELMISARTAN

Διαθέσιμο από:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

C09DA07

Δοσολογία:

12.5 mg

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

HYDROCHLOROTHIAZIDE 12.5 mg; TELMISARTAN 80 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2003-08-20

Φύλλο οδηγιών χρήσης

1
Abcd
PACKAGE LEAFLET: INFORMATION FOR THE USER
MICARDIS PLUS 40/12.5 MG TABLETS
MICARDIS PLUS 80/12.5 MG TABLETS
Telmisartan/hydrochlorothiazide
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 PLUS is and what it is used for
2.
What you need to know before you take MICARDIS PLUS
3.
How to take MICARDIS PLUS
4.
Possible side effects
5.
How to store MICARDIS PLUS
6.
Contents of the pack and other information
1. WHAT MICARDIS PLUS IS AND WHAT IT IS USED FOR
MICARDIS PLUS is used to treat high blood pressure (essential
hypertension) in patients whose
blood pressure is not controlled enough when either telmisartan or
hydrochlorothiazide is used alone.
MICARDIS PLUS is a combination of two active substances, telmisartan
and hydrochlorothiazide in
one tablet. Both of these substances help to control high blood
pressure.
•
Telmisartan belongs to a group of medicines called angiotensin II
receptor blocker. 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.
•
Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics, which cause your
urine output to increase, leading to a lowering of your blood
pressure.
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
blindne

Αρχείο Π.Χ.Π.

Page 1 of 15
MICARDIS
® PLUS
abcd
1. NAME OF THE MEDICINAL PRODUCT
MICARDIS PLUS 40/12.5 mg
MICARDIS PLUS 80/12.5 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
[1,1’-biphenyl]-2-carboxylic acid,
4’-[(1,4’dimethyl-2’-propyl[2,6-bi-1H-benzimidazole]-1’-yl)methyl]
(= telmisartan) 40 or 80 mg and hydrochlorothiazide 12.5 mg
3. PHARMACEUTICAL FORM
40/12.5mg: Oblong, white-red, Biconvex two-layer tablets. The white
face is marked with “H4” and
the Boehringer Ingelheim company symbol
80/12.5mg: Oblong, white-red, Biconvex two-layer tablets. The white
face is marked with “H8” and
the Boehringer Ingelheim company symbol
4. CLINICAL PARTICULARS
4.1 INDICATIONS
Treatment of essential hypertension.
As fixed dose combination MICARDIS PLUS is indicated in patients whose
blood pressure is not
adequately controlled on telmisartan or hydrochlorothiazide alone.
4.2 DOSAGE AND ADMINISTRATION
Adults
MICARDIS PLUS should be taken once daily. The dose of telmisartan
could be up-titrated before
switching to MICARDIS PLUS. Direct change from monotherapy to the
fixed combinations may be
considered.
•
MICARDIS PLUS 40/12.5 mg may be administered in patients whose blood
pressure is not
adequately controlled by MICARDIS 40 mg or hydrochlorothiazide.
•
MICARDIS PLUS 80/12.5 mg may be administered in patients whose blood
pressure is not
adequately controlled by MICARDIS 80 mg or by MICARDIS PLUS 40/12.5
mg.
Sodium or volume depletion should be corrected before treatment
commencement with MICARDIS
PLUS.
The maximum antihypertensive effect is generally attained with
MICARDIS PLUS 4 – 8 weeks after
the start of treatment.
When necessary, MICARDIS PLUS may be administered with another
antihypertensive drug.
In patients with severe hypertension treatment with telmisartan at
doses up to 160 mg alone and in
combination with hydrochlorothiazide 12.5 - 25 mg daily was well
tolerated and effective.
_Special populations: _
Geriatric patients
No dose adjustment is necessary for geriatric patients.
Paediatric p