METFORMIN SANDOZ metformin hydrochloride 1000 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 1000 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; purified talc; macrogol 6000; titanium dioxide; povidone; magnesium stearate; maize starch; propylene glycol; sodium starch glycollate; hypromellose

Administration route:

Oral

Units in package:

10 tablets, 30 tablets, 90 tablets, 60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of type 2 diabetes mellitus in adults, particularly in over weight patients, when dietary management and exercise alone, does not result in adequate glycaemic control. Metformin may be used as initial treatment, or in sulphonylurea failures, either alone or in combination with a sulphonylurea and other oral agents or as adjuvant therapy in insulin dependent diabetes.

Product summary:

Visual Identification: White capsule-shaped, biconvex film-coated tablet with a central breakline on one side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-02-15

Patient Information leaflet

METFORMIN SANDOZ
®
1
METFORMIN SANDOZ
®
_metformin hydrochloride tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Metformin Sandoz.
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 risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
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 METFORMIN
SANDOZ IS USED
FOR
This medicine is used to control
blood sugar (glucose) in patients with
diabetes mellitus.
Metformin Sandoz is used to treat
Type 2 diabetes when it cannot be
properly controlled by diet and
exercise. It can also be used in
patients with Type 1 diabetes
mellitus where insulin alone is not
enough to control your blood glucose
levels. Metformin Sandoz can be
used alone, or in combination with
other medicines for treating diabetes.
_HOW METFORMIN SANDOZ _
_WORKS _
It contains the active ingredient
metformin hydrochloride.
Metformin belongs to a group of
medicines called oral
hypoglycaemics.
It works to reduce high levels of
blood glucose by helping your body
to make better use of the insulin
produced by your pancreas.
Diabetes mellitus is a condition in
which the blood glucose levels are
not adequately controlled.
People with type 2 diabetes are not
able to make enough insulin or do
not respond normally to the insulin
their bodies make. When this
happens, sugar (glucose) builds up in
the blood. This can lead to serious
medical problems including heart
disease, kidney damage, poor blood
circulation, gangrene, amputation
and blindness.
If your blood glucose is not properly
controlled, you may experience
hypoglycaemia (low blood glucose)
or hyperglycaemia (high blood
glucose).
_HYPOGLYCAEMIA: _
Hypoglycaemia (low blood glucose)
can occ

Summary of Product characteristics

210421-Metformin Sandoz-pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
METFORMIN SANDOZ
® (METFORMIN HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Metformin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 500 mg film coated tablet contains 500 mg of metformin
hydrochloride.
Each 850 mg film coated tablet contains 850 mg of metformin
hydrochloride.
Each 1000 mg film coated tablet contains 1000 mg of metformin
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Metformin Sandoz film coated tablets 500 mg: white, film coated,
biconvex capsule shaped
tablet with central breakline on one side and 500 embossed on the
other side.
Metformin Sandoz film coated tablets 850 mg: white, film coated,
round, biconvex tablet plain
on one side and ‘850’ embossed on the other side.
Metformin Sandoz film coated tablets 1000 mg: white, film coated,
capsule-shaped, biconvex
tablet plain on one side and central breakline on the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC 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.
Metformin may be used as initial treatment, or in sulphonylurea
failures, either alone or in
combination with a sulphonylurea and other oral agents or as adjuvant
therapy in insulin
dependent type 2 diabetes.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Life-threatening lactic acidosis can occur due to accumulation of
metformin. Risk factors
include renal impairment, old age and high doses of metformin above 2
g/day.
Initially 500 mg should be taken once or twice a day with breakfast
and evening meal. If
necessary the dose may be increased over a few weeks up to 1 g three
times per day. The dose
should be titrated with gradual dose increments until the desired
effect is obtained.
500 mg three times a day is often sufficient to obtain a diabetic
control. If necessary, the dose
can be increased to 1 g thre