DIAXEMET XR 750 metformin hydrochloride 750 mg extended release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 750 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

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

Administration route:

Oral

Units in package:

10's, 120's, 30's, 90's, 100's, 60's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Metformin is indicated in the 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. Metformin HCl Extended Release Tablets 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 tablets with MX debossed on one side and 750 on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-10-16

Patient Information leaflet

DIAXEMET XR
Ver: 01
1
DIAXEMET XR 500
DIAXEMET XR 750
DIAXEMET XR 1000
_metformin hydrochloride _
DIAXEMET XR 500 metformin hydrochloride 500 mg extended release
tablets
DIAXEMET XR 750 metformin hydrochloride 750 mg extended release
tablets
DIAXEMET XR 1000 metformin hydrochloride 1000 mg extended release
tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
DIAXEMET 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
DIAXEMET 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 DIAXEMET XR IS
USED
FOR
DIAXEMET 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.
DIAXEMET 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 DIAXEMET XR _
_WORKS _
DIAXEMET X

Summary of Product characteristics

DIAXEMET XR
Ver: 01
1
AUSTRALIAN PRODUCT INFORMATION
DIAXEMET XR 500,
DIAXEMET XR 750 AND
DIAXEMET XR 1000
(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
DIAXEMET XR 500, DIAXEMET XR 750 or DIAXEMET XR 1000 extended release
tablets
are available in three strengths.
DIAXEMET XR 500 extended release tablets 500 mg
Each extended release tablet contains 500 mg metformin hydrochloride.
DIAXEMET XR 750 extended release tablets 750 mg
Each extended release tablet contains 750 mg metformin hydrochloride.
DIAXEMET XR 1000 extended release tablets 1000 mg
Each extended release tablet contains 1000 mg metformin hydrochloride.
For the full list of excipients, see section 6.1 List of Excipients.
DIAXEMET XR
Ver: 01
2
3. PHARMACEUTICAL FORM
Extended release tablets.
DIAXEMET XR 500 extended release tablets 500 mg
White to off white, oval shaped, biconvex, tablets with ‘MX’
debossed on one side and ‘500’ on
other.
DIAXEMET XR 750 extended release tablets 750 mg
White to off white, capsule shaped tablets with ‘MX’ debossed on
one side and ‘750’ on other
side.
DIAXEMET XR 1000 extended release tablets 1000 mg
White to off white, oval shaped uncoated tablet with 'PR' debossed on
one side and '1000' on
other side.
All three tablet strengths are 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
Metformin is indicated in the 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. DIAXEMET XR 500, DIAXEMET XR 750 or DIAXEMET XR
1000 may
be used as monotherapy or in combination with other oral antidiabetic
ag