FORMET 1000 metformin hydrochloride 1000mg tablet bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

metformin hydrochloride, Quantity: 1000 mg

Disponível em:

Arrotex Pharmaceuticals Pty Ltd

Forma farmacêutica:

Tablet, film coated

Composição:

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

Via de administração:

Oral

Unidades em pacote:

60 tablets, 10 tablets, 100 tablets, 90 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

Visual Identification: Oval, white tablet, embossed with M/O on one side and ">/>" on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Registered

Data de autorização:

2002-10-31

Folheto informativo - Bula

FORMET tablets
1
FORMET TABLETS
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.
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 can occur suddenly.
Signs may

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION – FORMET (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
FORMET tablets come in four strengths:
FORMET 250 contains 250 mg metformin hydrochloride.
FORMET 500 contains 500 mg metformin hydrochloride.
FORMET 850 contains 850 mg metformin hydrochloride.
FORMET 1000 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:
FORMET 250
round, white tablet (approx. 9mm), embossed with MO on one side and
the
Arrow symbol, “
>
” on the other.
FORMET 500
oblong, white film-coated tablet, embossed with M

O on one side and the
Arrow symbol, “>” on the other.
FORMET 850
round, white film-coated tablet (approx. 13 mm), embossed with MO on
one
side and the Arrow symbol, “>” on the other.
FORMET 1000
oval, white tablet, embossed with M

O on one side and “
>

>
” on the other.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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
neces