METFORMIN ARW XR metformin hydrochloride 500 mg extended release tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

metformin hydrochloride, Quantity: 500 mg

Saadav alates:

Arrotex Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

Metformin hydrochloride

Ravimvorm:

Tablet, modified release

Koostis:

Excipient Ingredients: carmellose sodium; ethanol; magnesium stearate; microcrystalline cellulose; hypromellose; colloidal anhydrous silica

Manustamisviis:

Oral

Ühikuid pakis:

120 tablets, 90 tablets per pack.

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Treatment of Type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. METFORMIN ARW XR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Toote kokkuvõte:

Visual Identification: White, capsule shaped tablet, debossed with XR5 on one side and 'Arrow' logo on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2008-09-12

Infovoldik

METEX XR- Consumer Medicine Information
Page 1 of 5
Metex XR
metformin hydrochloride
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about METEX XR.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor, pharmacist or diabetes
educator.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking METEX XR
against the benefits they expect it
will have for you.
TALK TO YOUR DOCTOR, PHARMACIST
OR DIABETES EDUCATOR IF YOU
HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT METEX XR IS
USED FOR
The medicine is used to control
blood glucose in patients with Type
2 diabetes mellitus, especially in
those who are overweight. It is
used when diet and exercise are not
enough to control your blood
glucose levels.
It can be used alone, or in
combination with other medicines
for treating diabetes.
Type 2 diabetes mellitus is also
called non-insulin dependent
diabetes mellitus (NIDDM) or
maturity onset diabetes.
Insulin is a hormone that enables
body tissues to take up glucose
from the blood and use it for energy
or fat storage for future use.
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 (hyperglycaemia), which
can lead to serious medical
problems.
Long term hyperglycaemia can lead
to heart disease, blindness, kidney
damage, poor blood circulation and
gangrene.
Signs of hyperglycaemia include:
•
tiredness or lack of energy
•
headache
•
thirst
•
passing large amounts of urine
•
blurred vision.
METEX XR is available only with a
doctor's prescription.
There is no evidence that the
medicine is addictive.
How METEX XR w orks
METEX XR belongs to a group of
medicines called biguanides. It
lowers high blood glucose levels by:
•
improving your body’s sensitivity
to insulin and restoring the way

Toote omadused

METAX XR- Product Information
Page 1 of 10
Metex XR
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.
NAME OF THE MEDICINE
Metformin hydrochloride. The chemical name for metformin hydrochloride
is 1,1 dimethyl biguanide
hydrochloride. Its structural formula is:
C
4
H
11
N
5
.HCl
Molecular weight: 165.6
Cas No.: 1115-70-4
DESCRIPTION
Metformin hydrochloride is a white, crystalline powder which is freely
soluble in water, sparingly
soluble in alcohol, practically insoluble in acetone and methylene
chloride. Metformin is a strong
base with a pKa greater than 12. At pH < 12, which is always the case
in the body, metformin is
very hydrophilic: the octanol/water partition coefficient is 0.05. The
melting point of metformin
hydrochloride is 224°C. Metformin hydrochloride is a very stable
molecule.
Metex XR are extended release tablets that contain 500 mg of metformin
hydrochloride. The
tablets also contain the following excipients: carmellose sodium,
hypromellose, colloidal anhydrous
silica, microcrystalline cellulose and magnesium stearate. The tablets
are gluten free.
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 three 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.
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 th