MICARDIS PLUS 80/12.5 telmisartan 80 mg and hydrochlorothiazide 12.5 mg tablet blister pack

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

hydrochlorothiazide, Quantity: 12.5 mg; telmisartan, Quantity: 80 mg

Fáanlegur frá:

Boehringer Ingelheim Pty Ltd

Lyfjaform:

Tablet, multilayer

Samsetning:

Excipient Ingredients: magnesium stearate; meglumine; sodium hydroxide; sorbitol; microcrystalline cellulose; iron oxide red; maize starch; lactose monohydrate; povidone; sodium starch glycollate

Stjórnsýsluleið:

Oral

Einingar í pakka:

98 Tablets, 28 Tablets, 7 Tablets, 56 Tablets, 14 Tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

MICARDIS PLUS is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.

Vörulýsing:

Visual Identification: 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.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2002-09-12

Upplýsingar fylgiseðill

MICARDIS
® PLUS
_TABLETS_
_telmisartan and hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Micardis Plus.
It does not contain all available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking this medicine
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MICARDIS PLUS IS
USED FOR
Micardis Plus is used to lower high
blood pressure (hypertension).
Everyone has blood pressure. This
pressure helps your blood move
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension (high blood pressure)
when your blood pressure stays
higher than is needed, even when you
are calm or relaxed.
There are usually no signs of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated, it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
_HOW MICARDIS PLUS WORKS_
Micardis Plus contains telmisartan
and hydrochlorothiazide in one single
tablet. These two active ingredients
help to reduce blood pressure in
different ways:
•
Telmisartan belongs to a group of
medicines called angiotensin II
receptor blockers. Angiotensin II
is a substance in the body which
causes blood vessels to narrow,
thus increasing blood pressure.
Telmisartan works by bloc

Vara einkenni

MICARDIS PLUS PI0126-14
1
AUSTRALIAN PRODUCT INFORMATION – MICARDIS
® PLUS TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLETS
1 NAME OF THE MEDICINE
telmisartan and hydrochlorothiazide.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MICARDIS PLUS is available in three tablet strengths:
•
MICARDIS PLUS 40/12.5 mg containing telmisartan 40
mg/hydrochlorothiazide 12.5 mg,
•
MICARDIS PLUS 80/12.5 mg containing telmisartan 80
mg/hydrochlorothiazide 12.5 mg, and
•
MICARDIS PLUS 80/25 mg containing telmisartan 80
mg/hydrochlorothiazide 25 mg.
Excipients with known effect:
Each 40/12.5 mg tablet and 80/12.5 mg tablet contains 112 mg of
lactose monohydrate.
Each 80/25 mg tablet contains 99 mg of lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
MICARDIS PLUS 40/12.5 mg tablets are 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.
MICARDIS PLUS 80/12.5 mg tablets are 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.
MICARDIS PLUS 80/25 mg tablets are oblong, white-yellow, biconvex,
two-layer tablets, possibly
with yellow specks in the white layer. The white face is marked with
H9 and the Boehringer Ingelheim
company symbol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MICARDIS PLUS is indicated for the treatment of hypertension.
Treatment should not be initiated
with these combinations.
4.2 DOSE AND METHOD OF ADMINISTRATION
_Adults_: The recommended dose is one tablet once daily.
The dose of telmisartan can be increased 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 i