METFORMIN GENERICHEALTH 1000 metformin hydrochloride 1000 mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

metformin hydrochloride

Disponível em:

Generic Health Pty Ltd

DCI (Denominação Comum Internacional):

Metformin hydrochloride

Status de autorização:

Registered

Folheto informativo - Bula

Metformin generichealth 1000 CMI
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CONSUMER MEDICINE INFORMATION
METFORMIN GENERICHEALTH 1000
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully before you start to
take these tablets. Keep it until all the prescribed
course of Metformin generichealth 1000 has been
finished, as you may want to read it again. This leaflet
may not contain all the information about this
medicine that you would like to know. It does not take
the place of talking to your doctor, pharmacist or
diabetes educator.
If you have any concerns about taking this medicine,
please talk to your doctor or pharmacist or diabetes
educator. All medicines have risks and benefits. Your
doctor has weighed the risks of you taking Metformin
generichealth 1000 against the benefits expected for
you.
WHAT IS IN YOUR MEDICINE?

Metformin generichealth 1000: Each film coated
tablet contains 1000 mg of the active ingredient
metformin hydrochloride.

Other inactive ingredients. Sodium starch
glycollate, maize starch, povidone, colloidal
anhydrous silica, magnesium stearate,
hypromellose, titanium dioxide (E171), propylene
glycol, macrogol 6000 and purified talc.
WHAT IS YOUR MEDICINE FOR?
Metformin generichealth 1000 is one of the groups of
medicines called oral hypoglycaemics, which work by
reducing the level of sugar in the blood in people with
diabetes mellitus.
Diabetes mellitus is a condition in which the blood
glucose levels are not adequately controlled.
There are two types of diabetes:

Type 1 which is called insulin dependent diabetes
or juvenile onset diabetes, when insulin alone is
not enough to control blood glucose levels.

Type 2 which is called Non insulin Dependent
Diabetes Mellitus (NIDDM) or maturity onset
diabetes.
People with type 2 diabetes are not able to make
enough insulin or respond normally to the insulin their
bodies make. When this happens, sugar (glucose)
builds up in the blood. This can lead to serious
medical problems including kidney damage,
amputation and blindness.
Diabetes is also closely linked t

Características técnicas

Metformin generichealth 1000 PI v3
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PRODUCT INFORMATION
METFORMIN GENERICHEALTH 1000
LIFE-THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. RISK FACTORS
INCLUDE RENAL IMPAIRMENT. OTHER RISK FACTORS INCLUDE OLD AGE
ASSOCIATED WITH REDUCED RENAL
FUNCTION AND HIGH DOSES OF METFORMIN ABOVE 2GL
DAY.
NAME OF THE MEDICINE
Metformin Hydrochloride.
Chemical name: 1, l-dimethylbiguanide hydrochloride.
Molecular formula: C
4
H
11
N
5
.HCl
MW: 165.6
CAS number. 1115-70-4
DESCRIPTION
Metformin hydrochloride is a white crystalline powder which is
odourless or almost odourless and
hygroscopic. It is freely soluble in water, slightly soluble in
ethanol (96%), and practically insoluble
in chloroform and in ether.
Active: Metformin hydrochloride. Inactive: Sodium starch glycollate,
maize starch, povidone,
colloidal anhydrous silica, magnesium stearate, hypromellose, titanium
dioxide, propylene glycol,
Macrogol 6000 and purified talc.
PHARMACOLOGY
Metformin is an antihyperglycaemic agent which improves glucose
tolerance in NIDDM subjects
lowering both basal and post-prandial plasma glucose. Metformin 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 increased
insulin sensitivity; it does not
stimulate insulin release but does require the presence of insulin to
exert its antihyperglycaemic
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 has a modest favourable effect on serum lipids,
which are often abnormal in
NIDDM patients.
Metformin generichealth 1000 PI v3
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PHARMACOKINETICS
Absorption: A randomised, open, balanced, crossover bioequivalence
study using Formin tablets 500
mg film-coated table