GLYADE MR gliclazide 30mg tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

gliclazide, Quantity: 30 mg

Dostupno od:

Servier Laboratories (Aust) Pty Ltd

INN (International ime):

Gliclazide

Farmaceutski oblik:

Tablet, modified release

Sastav:

Excipient Ingredients: colloidal anhydrous silica; maltodextrin; magnesium stearate; hypromellose; calcium hydrogen phosphate dihydrate

Administracija rute:

Oral

Jedinice u paketu:

20 tablets, 100tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.

Proizvod sažetak:

Visual Identification: White oblong tablets, presenting a groove on one face.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status autorizacije:

Registered

Datum autorizacije:

2007-09-07

Uputa o lijeku

GLYADE
® MR
_Modified release tablets containing gliclazide (pronounced
gli-cla-zide)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about GLYADE MR.
It does not contain all the available
information
Reading this leaflet does not take the
place of talking to your doctor,
pharmacist, or diabetes educator.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking GLYADE MR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST, OR DIABETES
EDUCATOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT GLYADE MR IS
The name of your medicine is
GLYADE MR.
GLYADE MR contains the active
ingredient 'gliclazide'.
Gliclazide belongs to a group of
medicines called sulphonylureas.
The medicine releases the active
ingredient gliclazide progressively
over 24 hours.
WHAT GLYADE MR IS
USED FOR
GLYADE MR is used to control
blood glucose (sugar) in patients with
Type II diabetes mellitus. This type
of diabetes is also known as non-
insulin-dependent diabetes
(NIDDM), or maturity-onset
diabetes).
_WHY GLYADE MR IS USED FOR_
_TYPE II DIABETES MELLITUS_
GLYADE MR is used when diet and
exercise are not enough to control
your blood glucose.
GLYADE MR can be used alone or
together with insulin or other
medicines for treating diabetes.
_HOW IT WORKS_
Glucose is used by the body as fuel,
and all people have glucose
circulating in their blood. In diabetes,
levels of blood glucose are higher
than is needed, which is also known
as hyperglycaemia. If your blood
glucose is not properly controlled,
you may experience hypoglycaemia
(low blood glucose) or
hyperglycaemia (high blood
glucose). High blood glucose can
lead to serious problems with our
heart, circulation and/or kidneys.
It is very important to control high
blood glucose whether or not you
feel unwell. This really helps to
avoid serious long-term health
problems, which can involve the
heart, eyes, circulat

Svojstava lijeka

AUSTRALIAN PRODUCT INFORMATION
GLYADE
® MR TABLET, MODIFIED RELEASE
Version: 9
1/13
AUSTRALIAN PRODUCT INFORMATION
GLYADE
® MR TABLET, MODIFIED RELEASE
1
NAME OF THE MEDICINE
Gliclazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each GLYADE MR tablet contains 30 mg of gliclazide.
Gliclazide is an oral hypoglycaemic sulphonylurea which differs from
other related compounds by
an N-containing heterocyclic ring with an endocyclic bond.
For the full list of excipients, _see section 6.1 - List of
excipients_.
3
PHARMACEUTICAL FORM
Tablet, modified release: white, oblong, with an engraving of "DIA
"30" on one face and
on the
other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Type II diabetes in association with dietary measures when dietary
measures alone are inadequate
to control blood glucose.
During controlled clinical trials in patients with type II diabetes
GLYADE MR, taken as a single daily
dose, was shown to be effective long term in controlling blood glucose
levels, based on monitoring
of HbA1c.
4.2
D
OSE AND METHOD OF ADMINISTRATION
For adult use only.
GLYADE MR tablets are modified release tablets and therefore should be
neither broken nor
chewed.
GLYADE MR should be taken with food because there is increased risk of
hypoglycemia if a meal
is taken late, if an inadequate amount of food is consumed or if the
food is low in carbohydrate. It is
recommended that the medication be taken at breakfast time. If a dose
is forgotten, the dose taken
on the next day should not be increased.
The daily dose may vary from 30 to 120 mg taken orally, once daily.
The initial recommended dose
is 30 mg daily, even in elderly patients (≥ 65 years). It should not
exceed 120 mg.
As with all hypoglycaemic agents, the dose should be titrated
according to the individual patient's
response. Titration should be carried out in steps of 30 mg, according
to the fasting blood glucose
response. Each step should last for at least two weeks.
AUSTRALIAN PRODUCT INFORMATION
GLYADE
® MR TABLET, MODIFIED RELEASE
Version: 9
2/13
Pr