AURO-METFORMIN 850 metformin hydrochloride 850 mg tablets Bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 850 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Metformin hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; povidone; hypromellose; macrogol 6000; macrogol 400

Administration route:

Oral

Units in package:

100, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Metformin is indicated in the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.,For adult patients, metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes.

Product summary:

Visual Identification: White, biconvex, circular shaped, film coated tablets with 'A' debossed on one side and '61' debossed on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2011-11-24

Patient Information leaflet

AURO-METFORMIN
CONSUMER MEDICINE INFORMATION
Version 1.2
Page 1 of 6
AURO-METFORMIN 500, 850 & 1000
Metformin hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
AURO-
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.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
taking
AURO-
METFORMIN 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 AURO-METFORMIN IS
USED FOR
AURO-METFORMIN
is
used
to
control blood glucose (the amount of
sugar in the blood) in people with
diabetes mellitus.
AURO-METFORMIN 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
(hyperglycaemia).
For
adult
patients,
AURO-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
AURO-
METFORMIN
HAS
BEEN
PRESCRIBED FOR YOU.
Your
doctor
may
have
prescribed
AURO-METFORMIN
for
another
reason.
AURO-METFORMIN
is
available
only with a doctor’s prescription.
There is no evidence that AURO-
METFORMIN is addictive.
_HOW AURO-METFORMIN WORKS _
AURO-METFORMIN belongs to a
group
of
medicines
called
biguanides.
AURO-METFORMIN
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

Summary of Product characteristics

Product Information:
AURO-METFORMIN 500, 850 & 1000 (Metformin Tablets 500mg, 850mg &
1000mg)
Ver 1.3
Page 1 of 11
PRODUCT INFORMATION
AURO-METFORMIN 500 (500MG METFORMIN HYDROCHLORIDE)
AURO-METFORMIN 850 (850MG METFORMIN HYDROCHLORIDE) AURO-METFORMIN 1000 (1000MG METFORMIN HYDROCHLORIDE)
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 MEDICINE
The name of the medicine is metformin hydrochloride
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.
INACTIVE:
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
utilisation
3)
Delay of intestinal glucose absorption.
Metformin stimulates intracellular glycogen synthesis by acting on
glycogen synthase.
H
2
N
N
N
CH
3
NH
NH
CH
3
H
, HCl
Product Information:
AURO-METFORMIN 500, 850 & 1000 (Metformin Tablets 500mg, 850mg &
1000mg)
Ver 1.3
Page 2 of 11
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
metabolism. This has been shown at therapeutic doses in controlled,
medium-te