PHARMACOR METFORMIN 500 metformin hydrochloride 500mg tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Metformin hydrochloride

Dostupné z:

Pharmacor Pty Ltd

INN (Medzinárodný Name):

Metformin hydrochloride

Príbalový leták

Version 05 – February 2010
CONSUMER MEDICINE INFORMATION
PHARMACOR METFORMIN 500
PHARMACOR METFORMIN 850
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 tablets 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 against the benefits expected for you.
What is in your medicine?
•
Pharmacor Metformin 500 : Each film coated tablet contains 500 mg of
the active
ingredient metformin hydrochloride.
•
Pharmacor Metformin 850: Each film coated tablet contains 850 mg of
the active
ingredient metformin hydrochloride.
•
Other inactive ingredients: Sodium starch glycollate, maize starch,
povidone, colloidal
anhydrous silica, magnesium stearate, hypromellose, titanium dioxide,
propylene
glycol, macrogol 6000 and purified talc.
What is your medicine for?
Metformin hydrochloride 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

Súhrn charakteristických

Version 05 – February 2010
PRODUCT INFORMATION
PHARMACOR METFORMIN 500 & PHARMACOR METFORMIN 850
Life threatening lactic acidosis can occur due to accumulation of
metformin. Risk
factors include renal impairment. Other risk factors include old age
with reduced
renal function and high doses of metformin above 2g/day.
Name of the medicine: Metformin hydrochloride.
Chemical Name: 1,1-dimethyl biguanide hydrochloride
Molecular formula: C
4
H
11
N
5
,HCl.
MW: 165.6.
CAS: 1115-70-4.
Metformin hydrochloride
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.
Composition. 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 (noninsulin dependent diabetes mellitus) subjects
lowering both basal
and postprandial 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.
Clinical trials. The prospective randomised study UKPDS has
established the long-term
benefit of intensive blood gluco