MIZART HCT 80/25mg telmisartan 80mg and hydrochlorothiazide 25mg tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

hydrochlorothiazide, Quantity: 25 mg; telmisartan, Quantity: 80 mg

Disponible depuis:

Alphapharm Pty Ltd

DCI (Dénomination commune internationale):

Hydrochlorothiazide,Telmisartan

forme pharmaceutique:

Tablet, multilayer

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

28

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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

Descriptif du produit:

Visual Identification: Oblong shaped, biconvex, bilayered, uncoated tablets with one white/off white color layer and one yellow colour mottled layer debossed with L201. White to off white color layer may contain yellow 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

Statut de autorisation:

Licence status A

Date de l'autorisation:

2016-08-19

Notice patient

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.
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 antagonists. It works by
widening the blood vessels of the
body, and therefore helping to lower
your blood pressure.
Hydrochlorothiazide belongs to the
group of

Résumé des caractéristiques du produit

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
Excipient with known effect: contains sugars (as lactose monohydrate)
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 a pink mottled and white to off-white biconvex, oval
shaped, two layer tablet. The white to off-
white layer may contain pink specks. The pink mottled face of tablet
is marked with L199.
80/12.5 mg Tablet:
Each tablet is a pink mottled and white to off-white biconvex, oval
shaped, two layer tablet. The white to off-
white layer may contain pink specks. The pink mottled face of tablet
is marked with L200.
80/25 mg Tablet:
Each tablet is a yellow mottled and white to off-white biconvex, oval
shaped, two layer tablet. The white to
off-white layer may contain yellow specks. The white face of tablet is
marked with L201.
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 40/12.5 mg may be administered in patients whose blood
pressure is not adequately controlled
by Telmisartan 40 mg or hydrochlorothiazide.
MIZART HCT 80/12.5 mg may be administered in patients whose blood
pressure is not adequately controlled
by Telmisartan 80 mg or by MIZART HCT 40/12.5 mg.
MIZART HCT 80/25 mg may be administered in patien