MIZART HCT 80/12.5mg telmisartan 80mg and hydrochlorothiazide 12.5mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

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

Dostupné s:

Alphapharm Pty Ltd

INN (Mezinárodní Name):

Hydrochlorothiazide,Telmisartan

Léková forma:

Tablet, multilayer

Složení:

Excipient Ingredients: lactose monohydrate; magnesium stearate; povidone; sodium hydroxide; mannitol; meglumine; sodium stearylfumarate; purified water; iron oxide red

Podání:

Oral

Jednotky v balení:

28

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

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

Přehled produktů:

Visual Identification: Oblong biconvex bilayered uncoated tablets with one white/off white color layer and one pink colour mottled layer debossed with L200. White to off white color layer may contain pink color specks.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizace:

Licence status A

Datum autorizace:

2016-08-19

Informace pro uživatele

MIZART
® HCT
_Telmisartan and Hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MIZART HCT. It
does not contain all available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking MIZART
HCT against the benefits they expect
it will have for you.
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 INFORMATION WITH YOUR
MIZART HCT TABLETS.
You may need to read it again later.
_TO FIND OUT MORE ABOUT_
_MIZART HCT_
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT YOUR
MEDICINE IF YOU HAVE ANY CONCERNS
OR IF YOU HAVE ANY TROUBLE BEFORE,
DURING OR AFTER USING MIZART
HCT.
WHAT MIZART HCT IS
USED FOR
MIZART HCT lowers high blood
pressure, also called 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 when your blood
pressure stays higher than normal,
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. You may
feel fine and have no symptoms, but
if high blood pressure is not treated,
it can lead to serious health problems
(such as stroke, heart disease and
kidney failure).
MIZART HCT helps to lower your
blood pressure but does not cure
hypertension.
MIZART HCT contains telmisartan
and hydrochlorothiazide. Both
medicines reduce blood pressure in
different ways. Telmisartan belongs
to a group of medicines called
angiotensin II receptor anta

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
MIZART
® HCT
_Telmisartan and hydrochlorothiazide tablet _
1
NAME OF THE MEDICINE
Telmisartan and Hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each MIZART HCT 40/12.5 tablet contains Telmisartan 40 mg and
Hydrochlorothiazide 12.5 mg
Each MIZART HCT 80/12.5 tablet contains Telmisartan 80 mg and
Hydrochlorothiazide 12.5 mg
Each MIZART HCT 80/25 tablet contains Telmisartan 80 mg and
Hydrochlorothiazide 25 mg
Excipients with known effect:
MIZART HCT 40/12.5 tablet: lactose and sulfites
MIZART HCT 80/12.5 and 80/25 tablets: sugars as lactose and sulfites
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablet
40/12.5 mg Tablet:
Each tablet is an oblong shaped, biconvex, bilayered, uncoated tablets
with one white to off-white color layer
and one pink color mottled layer debossed with ‘L199’. White to
off white color layer may contain pink color
specks.
80/12.5 mg Tablet:
Each tablet is an oblong shaped, biconvex, bilayered, uncoated tablets
with one white to off-white color layer
and one pink color mottled layer debossed with ‘L200’. White to
off white color layer may contain pink color
specks.
80/25 mg Tablet:
Each tablet is an oblong shaped, biconvex, bilayered, uncoated tablets
with one white to off-white color layer
and one yellow color mottled layer debossed with ‘L201’. White to
off white color layer may contain yellow
color specks.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MIZART HCT 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 MIZART
HCT. Direct change from monotherapy
to the fixed combinations may be considered.
MIZART
®
HCT – PRODUCT INFORMATION
2
MIZART HCT 40/12.5 mg may be administered in patients whose blood
pressure is not adequately controlled
by Telmisartan 40 mg or hydrochlor