DIABEX XR 500 metformin hydrochloride 500mg extended release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 500 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; magnesium stearate; microcrystalline cellulose; carmellose sodium

Administration route:

Oral

Units in package:

90 Tablets, 10 Tablets (Starter Pack), 30 Tablets, 100 Tablets, 60 Tablets, 120 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. DIABEX XR 500 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Product summary:

Visual Identification: White to off-white, capsule shaped, biconvex tablet, debossed with "500" on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2005-02-24

Patient Information leaflet

DIABEX
® XR
_metformin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Diabex XR.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or diabetes educator.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Diabex XR
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR, PHARMACIST OR DIABETES
EDUCATOR.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DIABEX XR IS
USED FOR
Diabex XR is used to control blood
glucose (sugar) in people with Type
2 diabetes mellitus, especially in
those who are overweight. It is used
when diet and exercise are not
enough to control high levels of
blood glucose.
Diabex XR can be used alone, or in
combination with other medicines for
treating diabetes.
TYPE 2 DIABETES MELLITUS
Type 2 diabetes mellitus is also
called non-insulin dependent diabetes
mellitus (NIDDM) or maturity onset
diabetes.
Insulin is a hormone that enables
body tissues to take up glucose from
the blood and to use it for energy or
fat storage for future use.
People with Type 2 diabetes are
unable to make enough insulin or
their body does not respond properly
to the insulin it does make. This
causes a build-up of glucose in the
blood (hyperglycaemia), which can
lead to serious medical problems.
Long-term hyperglycaemia can lead
to heart disease, blindness, kidney
damage, poor blood circulation and
gangrene.
Signs of hyperglycaemia may
include:
•
tiredness or lack of energy
•
headache
•
thirst
•
passing large amounts of urine
•
blurred vision
_HOW DIABEX XR WORKS_
Diabex XR belongs to a group of
medicines called biguanides. It
lowers high blood glucose levels by:
•
improving your body's sensitivity
to insulin and restoring the way it
normally uses glucose
•
reducing the amount of glucose
your liver makes
•
delaying the amount of glucose
your intestine abso

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
DIABEX
®
XR 500
_Metformin hydrochloride extended release tablets _
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. THE MAIN RISK FACTOR IS
RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUDE OLD AGE ASSOCIATED WITH
REDUCED RENAL FUNCTION.
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Diabex XR 500 extended release tablet contains 500 mg of
metformin hydrochloride.
Diabex XR 500 also contains trace amounts of sulfites. For the full
list of excipients, see Section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
Metformin hydrochloride 500 mg extended release tablets: white to
off-white, capsule-shaped, biconvex tablet,
debossed “500” on one side.
DIABEX 500 is gluten free.
The tablet shells may be present in the faeces. Patients should be
advised that this is normal.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary management
and exercise alone does not result in adequate glycaemic control.
Diabex XR 500 may be used as monotherapy
or in combination with other oral antidiabetic agents, or with
insulin.
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. THE MAIN RISK FACTOR IS
RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUDE OLD AGE ASSOCIATED WITH
REDUCED RENAL FUNCTION.
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS
INITIATING THERAPY WITH DIABEX XR
For patients new to metformin, the usual starting dose of Diabex XR is
one tablet of Diabex XR 500 or Diabex
XR 750 once daily taken with the evening meal.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A slow increase
of dose may improve gastro-intestinal tolerability. Dosage increases
should be made in increments of 500 mg
or 750 mg every 10-15 days.
DIABEX
®
XR 500 – AUSTRALIAN PRODUCT INFORMATION
2
COMBINING DIABEX XR DOSAGE STRENGTHS
The