MIZART telmisartan 80mg tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

telmisartan, Quantity: 80 mg

Prieinama:

Alphapharm Pty Ltd

INN (Tarptautinis Pavadinimas):

Telmisartan

Vaisto forma:

Tablet

Sudėtis:

Excipient Ingredients: mannitol; meglumine; magnesium stearate; sodium hydroxide; sodium stearylfumarate; povidone

Vartojimo būdas:

Oral

Vienetai pakuotėje:

28

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

MIZART is indicated for: - Treatment of hypertension - Prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage (see CLINICAL TRIALS)

Produkto santrauka:

Visual Identification: White to off-white color, oval shape, biconvex, uncoated tablets debossed with L204 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorizacija statusas:

Licence status A

Leidimo data:

2015-08-13

Pakuotės lapelis

MIZART
®
_Telmisartan_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MIZART.
It does not contain all the 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
against the benefits they expect it
will 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 MIZART IS USED
FOR
MIZART is used to:
•
treat high blood pressure (also
called hypertension)
•
prevent cardiovascular
complications, including death
due to cardiovascular causes, in
patients older than 55 years of
age with coronary artery disease,
peripheral vascular disease,
previous stroke, previous
transient ischaemic attack (TIA)
or high risk diabetes with
evidence of end organ damage.
TREATMENT OF HYPERTENSION
MIZART 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 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. If high
blood pressure is not treated, it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
_HOW MIZART WORKS_
MIZART contains telmisartan.
Telmisartan belongs to a

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION
MIZART
®
_Telmisartan tablet_
_ _
1
NAME OF THE MEDICINE
Telmisartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each MIZART tablet contains 40 mg or 80 mg of telmisartan as the
active ingredient.
Excipients with known effect: sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
40 mg Tablet:
MIZART tablets are white to off-white color, oval-shaped, biconvex
uncoated tablets debossed with
‘L203’ on one side and plain on the other side.
80 mg Tablet:
MIZART tablets are white to off-white color, oval-shaped, biconvex
uncoated tablets debossed with
‘L204’ on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MIZART is indicated for:
•
Treatment of hypertension in adults
•
Prevention of cardiovascular morbidity and mortality in adult 55 years
or older with coronary
artery disease, peripheral artery disease, previous stroke, transient
ischaemic attack or high
risk diabetes with evidence of end organ damage (see Section 5.1
PHARMACODYNAMIC
PROPERTIES, CLINICAL TRIALS)
4.2
DOSE AND METHOD OF ADMINISTRATION
MIZART is available as tablets for oral administration.
TREATMENT OF HYPERTENSION
_Adults:_
The recommended dose is 40 mg once daily. In cases where the target
blood pressure is not
achieved, telmisartan dose can be increased to 80 mg once daily. When
considering raising the dose, it
must be borne in mind that, while reduction in blood pressure is
achieved after the first dose, the
maximum antihypertensive effect is generally attained four to eight
weeks after the start of treatment.
Telmisartan may be used in combination with thiazide-type diuretics
such as hydrochlorothiazide or
calcium-channel blockers such as amlodipine, which have been shown to
have an additive blood
pressure lowering effect with telmisartan.
MIZART
®
– PRODUCT INFORMATION
2
PREVENTION OF CARDIOVASCULAR MORBIDITY AND MORTALITY
The recommended dose is 80 mg once daily. It is not known whether
doses lower than 80 mg of