TIH-METFORMIN metformin hydrochloride 850 mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

metformin hydrochloride, Quantity: 850 mg

Beschikbaar vanaf:

Arrotex Pharmaceuticals Pty Ltd

farmaceutische vorm:

Tablet, film coated

Samenstelling:

Excipient Ingredients: povidone; magnesium stearate; purified water; hypromellose; macrogol 400

Toedieningsweg:

Oral

Eenheden in pakket:

60 tablets, 10 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Metformin is indicated in the treatment of type 2 diabetes mellitus not satisfactorily controlled by diet, where the risk of lactic acidosis is minimised by excluding predisposing factors, especially impaired renal, hepatic or cardiovascular function. Metformin may be used as initial therapy or in sulfonylurea failure, either alone or in combination with a sulfonylurea or as adjuvant therapy in insulin-dependent diabetes.

Product samenvatting:

Visual Identification: Round, white tablet (approx. 13mm), emobossed with MO on one side and the Arrow symbol ">" on the other.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2020-06-23

Bijsluiter

APX-METFORMIN tablets
1
APX-METFORMIN TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-METFORMIN.
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 risk of you
taking APX-METFORMIN against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY WANT TO READ IT AGAIN.
WHAT APX-METFORMIN IS
USED FOR
The name of your medicine is APX-
METFORMIN. It contains the active
ingredient metformin hydrochloride.
Metformin is used to control blood
glucose (the amount of sugar in the
blood) in patients with diabetes mellitus,
when diet and exercise are not enough
to control blood glucose.
Metformin can be used in patients with
Type II diabetes mellitus in adults and
children over 10 years of age. It is
especially useful in those who are
overweight, when diet and exercise are
not enough to lower blood glucose
levels (hyperglycaemia). For adult
patients, metformin can be used alone,
or in combination with other oral diabetic
medicines or in combination with insulin
in insulin requiring Type II diabetes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY APX-
METFORMIN WAS PRESCRIBED FOR YOU.
Your doctor may have prescribed APX-
METFORMIN tablets for another reason.
APX-METFORMIN is only available with
a doctors prescription.
There is no evidence that APX-
METFORMIN is addictive.
_HOW APX-METFORMIN WORKS _
Metformin belongs to a group of
medicines called biguanides.
Metformin lowers high blood glucose
(hyperglycaemia) by helping your body
make better use of the insulin produced
by your pancreas.
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 your hear

Productkenmerken

1
AUSTRALIAN PRODUCT INFORMATION – APX-METFORMIN
(METFORMIN HYDROCHLORIDE) TABLETS
Life threatening lactic acidosis can occur due to accumulation of
metformin. Risk factors include renal
impairment, old age and the use of high doses of metformin above 2 g
per day.
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-METFORMIN tablets come in three strengths:
APX-METFORMIN 500 mg contains 500 mg metformin hydrochloride.
APX-METFORMIN 850 mg contains 850 mg metformin hydrochloride.
APX-METFORMIN 1000 mg contains 1000 mg metformin hydrochloride.
The tablets are gluten free.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablets:
APX-METFORMIN 500 MG
oblong, white film-coated tablet, embossed with M

O on one side
and the Arrow symbol, “>” on the other.
APX-METFORMIN 850 mg
round, white film-coated tablet (approx. 13 mm), embossed with MO
on one side and the Arrow symbol, “>” on the other.
APX-METFORMIN 1000 MG
oval, white tablet, embossed with M

O on one side and “
>

>
” on the
other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
2
Metformin is indicated in the treatment of type 2 diabetes mellitus
not satisfactorily controlled by
diet, where the risk of lactic acidosis is minimised by excluding
predisposing factors, especially
impaired renal, hepatic or cardiovascular function.
Metformin may be used as initial therapy or in sulphonylurea failure,
either alone or in combination
with a sulphonylurea or as adjuvant therapy in insulin-dependent
diabetes.
4.2
D
OSE AND METHOD OF ADMINISTRATION
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 per day.
It is important that the tablets are taken in divided doses with
meals.
Initially 500 mg should be taken once or twice a day and, if
necessary, increased over a few weeks up
to 1 g three times per day.
The dose should be titrated with g