METFORMIN AN metformin hydrochloride 1000 mg tablets Blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Metformin hydrochloride

Authorization status:

Registered

Patient Information leaflet

_Metformin AN tablets– Consumer Medicine Information _
_ _
_Doc ID: 74.AN.CMI.1.0 _
_ _
_Page 1 _
METFORMIN AN TABLETS
_metformin (as hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
METFORMIN
AN.
It
does
not
contain
all
the
available
information.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist or diabetes educator.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
METFORMIN
AN
against
the
benefits it is expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR
OR
PHARMACIST
OR
DIABETES EDUCATOR.
KEEP
THIS
LEAFLET
WITH
YOUR
MEDICINE.
You may need to read it again.
WHAT METFORMIN
AN IS USED FOR
METFORMIN
AN
is
used
to
control
blood
glucose
(the
amount of sugar in the blood) in
people with diabetes mellitus.
METFORMIN AN can be used in
type
2
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
(hyperglycemia).
For
adult
patients, METFORMIN AN 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
METFORMIN
AN
HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
METFORMIN
AN
for
another
reason.
METFORMIN
AN
is
available
only with a doctor’s prescription.
There
is
no
evidence
that
METFORMIN AN is addictive.
_HOW METFORMIN AN WORKS _
METFORMIN
AN
belongs
to
a
group
of
medicines
called
biguanides.
METFORMIN
AN
lowers
high
blood
glucose
(hyperglycaemia) by helping your
body
make
better
use
of
the
insulin
produced
by
your
pancreas.
People with type 2 diabetes are
unable to make enough insulin or
their
body
does
not
respond
properly
to
the
insulin
it
does
make. This causes a build up of
glucose in the blood, which can
lead to serious medical problems.
Long-term
hyperglycaemia
can
lead to heart di

Summary of Product characteristics

_Metformin AN tablets Product Information _
_ _
_ _
_ _
_ Amneal Pharma Australia Pty Ltd_
Metformin AN PI v2.0
Page 1 of 11
METFORMIN AN
_(METFORMIN HYDROCHLORIDE TABLETS) _
PRODUCT INFORMATION
_ _
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.
NAME OF THE MEDICINE
The name of the medicine is metformin hydrochloride
NH
NH
H
2
N
NH
N CH
3,
, HCl
CH
3
CHEMICAL NAME: _1,1-dimethyldiguanide hydrochloride._
MOLECULAR FORMULA: C
4
H
11
N
5
• HCl
MOLECULAR WEIGHT: 165.6
CAS REGISTRY NUMBER: _[1115–70–4]_
DESCRIPTION
Metformin hydrochloride is a white, crystalline powder. It is freely
soluble in water, slightly
soluble in ethanol and practically insoluble in acetone and in
methylene chloride.
Metformin AN is available as tablets containing 500 mg, 850 mg and
1000 mg metformin
hydrochloride.
METFORMIN AN ALSO CONTAINS THE FOLLOWING INACTIVE INGREDIENTS:
Povidone, magnesium
stearate and Opadry complete film coating system YS-1R-7006 Clear
(PI-ARTG No. 13068).
PHARMACOLOGY
Metformin is a biguanide with antihyperglycaemic effects, lowering
both basal and postprandial
plasma
glucose.
It
does
not
stimulate
insulin
secretion
and
therefore
does
not
produce
hypoglycaemia.
Metformin may act via 3 mechanisms:
1)
Reduction of hepatic glucose production by inhibiting gluconeogenesis
and
glycogenolysis
2)
In muscle, by increasing insulin sensitivity, improving peripheral
glucose uptake and
_Metformin AN tablets Product Information _
_ _
_ _
_ _
_ Amneal Pharma Australia Pty Ltd_
Metformin AN PI v2.0
Page 2 of 11
utilisation
3)
Delay of intestinal glucose absorption.
Metformin stimulates intracellular glycogen synthesis by acting on
glycogen synthase.
Metformin increases the transport capacity of all types of membrane
glucose transporters (GLUT).
In humans, independently of its action on glycaemia, metformin has
favourable effects on lipid