GLUCOBETE 850 metformin hydrochloride 850 mg tablets Blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
14-05-2018
Summary of Product characteristics
(SPC)
14-05-2018
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
metformin hydrochloride
Available from:
Fair-Med Healthcare Australia Pty Ltd
INN (International Name):
Metformin hydrochloride
Authorization status:
Registered
Patient Information leaflet
GLUCOBETE
CONSUMER MEDICINE INFORMATION
Version 1.2
Page 1 of 6
GLUCOBETE 500, 850 & 1000
Metformin hydrochloride
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
GLUCOBETE.
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
GLUCOBETE 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 GLUCOBETE IS USED FOR
GLUCOBETE
is
used
to
control
blood glucose (the amount of sugar
in the blood) in people with diabetes
mellitus.
GLUCOBETE 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,
GLUCOBETE 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
GLUCOBETE
HAS
BEEN
PRESCRIBED FOR YOU.
Your
doctor
may
have
prescribed
GLUCOBETE for another reason.
GLUCOBETE is available only with
a doctor’s prescription.
There
is
no
evidence
that
GLUCOBETE is addictive.
_HOW GLUCOBETE WORKS _
GLUCOBETE belongs to a group of
medicines
called
biguanides.
GLUCOBETE
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 disease, blindness, kidney
damage, poor blood circulation and
gangrene.
Signs
Read the complete document
Summary of Product characteristics
Product Information:
GLUCOBETE 500, 850 & 1000 (Metformin Tablets 500mg, 850mg & 1000mg)
Ver 1.3
Page 1 of 11
PRODUCT INFORMATION
GLUCOBETE 500 (500MG METFORMIN HYDROCHLORIDE)
GLUCOBETE 850 (850MG METFORMIN HYDROCHLORIDE) GLUCOBETE 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:
GLUCOBETE 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-term or long-term
clinical
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