APO-METFORMIN 850

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

metformin hydrochloride

Commercializzato da:

Cipla Australia Pty Ltd

INN (Nome Internazionale):

Metformin hydrochloride

Stato dell'autorizzazione:

Registered

Foglio illustrativo

APO-METFORMIN
500/850/1000
_Contains the active ingredient metformin (met-FOR-min) hydrochloride_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about metformin It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist or diabetes educator.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Metformin 500, 850 or 1000 tablets.
It contains the active ingredient
metformin (as metformin
hydrochloride).
It is used to treat type 2 diabetes (also
called non-insulin dependent diabetes
mellitus or maturity onset diabetes)
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 high
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 2 diabetes.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's

Scheda tecnica

Product Information – Australia
APO-Metformin 500/850/1000 Tablets
Page 1
APO-METFORMIN 500 TABLETS
APO-METFORMIN 850 TABLETS
APO-METFORMIN 1000 TABLETS
NAME OF THE MEDICINE
Metformin hydrochloride.
Chemical Name:
1,1-dimethylbiguanide hydrochloride
Structural Formula:
N
H
2
N
H
N
CH
3
CH
3
NH
NH
, HCl
Molecular Formula:
C
4
H
11
N
5
.HCl
Molecular Weight:
165.6
CAS Registry No:
1115-70-4
DESCRIPTION
Metformin hydrochloride is a white, crystalline powder which is almost
odourless and hygroscopic. It is
freely soluble in water, slightly soluble in ethanol (96%) and
practically insoluble in chloroform and in
ether.
PHARMACOLOGY
Metformin is an oral biguanide hypoglycaemic agent. It causes an
increased peripheral uptake of
glucose by increasing the biological efficiency of available exogenous
or endogenous insulin.
The mode of action of metformin may be linked to an increase of
insulin sensitivity. It does not
stimulate insulin release but does require the presence of insulin to
exert its anti-hyperglycaemic
effect. Possible mechanisms of action include inhibition of
gluconeogenesis in the liver, delay in
glucose absorption from the gastrointestinal tract and an increase in
peripheral uptake of glucose.
Metformin has an antiketogenic activity which is comparable, though
somewhat inferior, to insulin
itself. Metformin lowers both basal and post-prandial blood glucose in
diabetic patients but does not
cause hypoglycaemia in either diabetics or normal individuals.
PHARMACOKINETICS
Absorption
After
oral
administration,
metformin
hydrochloride
is
absorbed
along
the
entire
gastrointestinal
mucosa. Studies using single oral doses of metformin tablets indicate
that there is a lack of dose
proportionality with increasing doses, which is due to decreased
absorption of meformin rather than an
increase in elimination. After oral administration, metformin
absorption is saturable and incomplete. It
is assumed that the pharmacokinetics of metformin absorption are
non-linear.
At usual clinical doses and dosing schedules of metfor