METFORMIN ARW 850 metformin hydrochloride 850 mg tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

metformin hydrochloride

Pieejams no:

Arrow Pharma Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Metformin hydrochloride

Autorizācija statuss:

Registered

Lietošanas instrukcija

FORMET 500 & 850 tablets
1
FORMET 500 & 850
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FORMET.
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 FORMET 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 FORMET IS USED FOR
The name of your medicine is FORMET
500 or FORMET 850. 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 FORMET WAS
PRESCRIBED FOR YOU.
Your doctor may have prescribed
FORMET tablets for another reason.
FORMET is only available with a doctors
prescription.
There is no evidence that FORMET is
addictive.
_HOW FORMET 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 heart, eyes,
circulation or kidneys.
Low blood glucose

Produkta apraksts

1
AUSTRALIAN PRODUCT INFORMATION – FORMET 500 AND 850
(METFORMIN HYDROCHLORIDE) TABLET (BLISTER PACKS)
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
FORMET 500 contains 500 mg metformin hydrochloride.
FORMET 850 contains 850 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:
FORMET 500:
white
to
off-white
circular,
biconvex,
bevel-edged,
film-coated
tablets
debossed with '500' on one side.
FORMET 850:
white
to
off-white
circular,
biconvex,
bevel-edged,
film-coated
tablets
debossed with '850' on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FORMET 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.
FORMET 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.
2
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 the use of 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 gradual
dose increments until the desired
effect is obtained. 500 mg three times a day is often sufficient to
obtain diabetic control. If necessary,
the dose can be increased to 1 g three times daily, which is the
maximum recommended daily dose.
Control may b