MICARDIS PLUS 4012.5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

HYDROCHLOROTHIAZIDE; TELMISARTAN

Boleh didapati daripada:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

HYDROCHLOROTHIAZIDE; TELMISARTAN

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Boehringer Ingelheim Hellas Single Member S.A

Risalah maklumat

MICARDIS
® PLUS
Telmisartan/Hydrochlorothiazide (40/12.5mg, 80/12.5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What MICARDIS PLUS is used for
2.
How MICARDIS PLUS works
3.
Before you use MICARDIS PLUS
_ _
4.
How to use MICARDIS PLUS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of MICARDIS
PLUS
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
1. WHAT MICARDIS PLUS 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.
2. HOW MICARDIS PLUS WORKS
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 blockers. 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
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.
3. BEFORE YOU USE MICARDIS PLUS
-
_When you must not use it _
•
if you are allergic (hypersensitive)
to telmisartan or any other
ingredients of this medicine (listed
in section 8).
•
if you are allergic (hypersensitive)
to hydrochlorothiazide or to any
other sulfonamide-derived
medicines.
•
if y

Ciri produk

1 | P a g e
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
Tablet for oral use.
40/12.5mg: Oblong, white-red, biconvex two-layer tablets, possibly
with red specks in the white layer.
The white face is marked with “H4” and the Boehringer Ingelheim
company symbol.
80/12.5mg: Oblong, white-red, biconvex two-layer tablets, possibly
with red specks in the white layer.
The white face is marked with “H8” and the Boehringer Ingelheim
company symbol.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
As fixed dose combination MICARDIS PLUS is indicated in patients whose
blood pressure is not
adequately controlled on telmisartan alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
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 to 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 eff