METFORMIN GH metformin hydrochloride 1000 mg tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

metformin hydrochloride, Quantity: 1000 mg

Beszerezhető a:

Generic Health Pty Ltd

INN (nemzetközi neve):

Metformin hydrochloride

Gyógyszerészeti forma:

Tablet, film coated

Összetétel:

Excipient Ingredients: maize starch; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; titanium dioxide; propylene glycol; macrogol 6000; purified talc; sodium starch glycollate type A

Az alkalmazás módja:

Oral

db csomag:

30, 90, 20, 100, 60, 28, 10, 14, 56

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

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.

Termék összefoglaló:

Visual Identification: White to off-white, film-coated, oval shaped, biconvex tablets debossed with 10 and 00 on either side of deep notch on one side and breakline on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2017-07-19

Betegtájékoztató

CONSUMER MEDICINE INFORMATION
METFORMIN GH
(METFORMIN HYDROCHLORIDE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
medicine.
It does not contain all 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 this
medicine against the benefits
expected for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR,
PHARMACIST OR DIABETES
EDUCATOR.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to
read it again.
WHAT METFORMIN GH IS
USED FOR
It is used to control blood
glucose (the amount of sugar in
the blood) in people with
diabetes mellitus.
It 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, 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 IT
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another reason.
It is available only with a doctor's
prescription.
There is no evidence it is
addictive.
_HOW IT WORKS _
It belongs to a group of
medicines called biguanides. It
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 of hyperglycaemia may
include:
•
tiredness or lack of energy;
•
headache;
•
thirst;
•
passing large amounts of
urine;

Termékjellemzők

AUSTRALIAN PRODUCT INFORMATION
METFORMIN GH
(METFORMIN HYDROCHLORIDE) TABLET, FILM COATED
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. RISK FACTORS INCLUDE
RENAL IMPAIRMENT, OLD AGE AND THE USE OF HIGH DOSES OF METFORMIN ABOVE
2 G PER DAY.
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Metformin GH 500 mg tablet contains 500 mg of metformin
hydrochloride. Each Metformin GH
850 mg tablet contains 850 mg of metformin hydrochloride. Each
Metformin GH 1000 mg tablet
contains 1000 mg of metformin hydrochloride.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
METFORMIN GH 500 MG:
White, film-coated, round, biconvex tablets debossed with “500” on
one side and plain on the other
side.
METFORMIN GH 850 MG:
White, film-coated, round, biconvex tablets debossed with “850” on
one side and plain on the other
side.
METFORMIN GH 1000 MG:
White to off-white, film-coated, oval shaped, biconvex tablets
debossed with ‘10’ and ‘00’ on either side
of deep notch on one side and breakline on other side.
4
CLINICAL PARTICULARS
4.1 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.
Metformin GH v4.0
Page 2 of 14
(metformin hydrochloride) tablet, film coated
4.2 DOSE AND METHOD OF ADMINISTRATION
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. RISK FACTORS INCLUDE
RENAL IMPAIRMENT, OLD AGE AND THE USE OF HIGH DOSES OF METFORMIN ABOVE
2 G PER DAY.
It is important that the tablets are taken in divided doses with
meals.
Half tablet dos