METFORMIN ARW 500 metformin hydrochloride 500 mg film-coated tablet bottle

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

metformin hydrochloride

Предлага се от:

Arrow Pharma Pty Ltd

INN (Международно Name):

Metformin hydrochloride

Статус Оторизация:

Registered

Листовка

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

Данни за продукта

1
AUSTRALIAN PRODUCT INFORMATION – FORMET 500 (METFORMIN
HYDROCHLORIDE) TABLETS (BOTTLE)
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
Each FORMET 500 tablet contains 500 mg of metformin hydrochloride.
The tablet is 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.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FORMET 500 is indicated in the treatment of type 2 diabetes mellitus
not satisfactorily controlled by
diet, where the risk of lactic acidosis is minimized by excluding
predisposing factors, especially
impaired renal, hepatic or cardiovascular function.
FORMET 500 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. The main risk factor
is renal impairment, other risk factors include old age associated
with reduced renal function and
high doses of metformin above 2 g per day.
2
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
be attained within a few days but occasionally requires up to two
weeks. Once control has been
obtained