DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

gliclazide, Quantity: 60 mg

Հասանելի է:

Servier Laboratories (Aust) Pty Ltd

INN (Միջազգային անվանումը):

Gliclazide

Դեղագործական ձեւ:

Tablet, modified release

Կազմը:

Excipient Ingredients: lactose monohydrate; magnesium stearate; maltodextrin; hypromellose; colloidal anhydrous silica

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

60, 20

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

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, a modified release formulation of gliclazide (30 mg-120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.

Ապրանքի ամփոփագիր:

Visual Identification: White oblong tablets. Break bar. DIA 60 on both faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Լիազորման կարգավիճակը:

Licence status A

Հաստատման ամսաթիվը:

2009-11-11

Տեղեկատվական թերթիկ

DIAMICRON
® 60 MG 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 DIAMICRON 60 mg
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 DIAMICRON
60 mg 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 DIAMICRON 60
MG MR IS
The name of your medicine is
DIAMICRON 60 mg MR.
DIAMICRON 60 mg 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 DIAMICRON 60
MG MR IS USED FOR
DIAMICRON 60 mg 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 DIAMICRON 60 MG MR_
_IS USED FOR TYPE II DIABETES_
_MELLITUS_
DIAMICRON 60 mg MR is used
when diet and exercise are not
enough to control your blood
glucose.
DIAMICRON 60 mg 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

Ապրանքի հատկությունները

AUSTRALIAN PRODUCT INFORMATION
DIAMICRON
® 60 MG MR
TABLET, MODIFIED RELEASE
Version: 6
1/14
AUSTRALIAN PRODUCT INFORMATION
DIAMICRON
® 60 MG MR TABLET, MODIFIED RELEASE
1
NAME OF THE MEDICINE
Gliclazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DIAMICRON 60 mg MR tablet contains 60 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.
Excipient with known effect: each tablet contains 71.36 mg of lactose
monohydrate.
For the full list of excipients, see _section 6.1 - List of
excipients_.
3
PHARMACEUTICAL FORM
Tablet, modified release: white, oblong, scored with a break bar on
both sides with an engraving of
"DIA 60" on both faces.
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, a
modified release formulation of
gliclazide (30 mg - 120 mg), 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.
DIAMICRON 60 mg MR tablets have a break bar and may be administered as
whole or as half
tablets (see _section 5.2 – Pharmacokinetic properties_). So that
the modified release properties of
the product can be maintained, tablets should not be chewed or
crushed.
Whole or half tablets of DIAMICRON 60 mg MR should be taken with food
because there is an
increased risk of hypoglycaemia 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.
A single daily dose provides an effective blood glucose control. The
daily dose may vary from half
a tablet to two tablets per day i.e. 30 mg t