APO-METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

metformin hydrochloride, Quantity: 500 mg

Διαθέσιμο από:

Arrotex Pharmaceuticals Pty Ltd

INN (Διεθνής Όνομα):

Metformin hydrochloride

Φαρμακοτεχνική μορφή:

Tablet, modified release

Σύνθεση:

Excipient Ingredients: povidone; colloidal anhydrous silica; hypromellose; magnesium stearate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

120 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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 modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Περίληψη προϊόντος:

Visual Identification: White, capsule shaped uncoated tablet with XR 500 on one side and a plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2017-01-04

Φύλλο οδηγιών χρήσης

APO-METFORMIN XR
_Contains the active ingredient metformin hydrochloride_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Metformin XR is used to control
blood glucose (sugar) in people with
Type 2 diabetes mellitus, especially
in those who are overweight. It is
used when diet and exercise are not
enough to control high levels of
blood glucose.
Metformin XR can be used alone, or
in combination with other medicines
for treating diabetes.
Metformin 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 it
normally uses glucose
•
reducing the amount of glucose
your liver makes
•
delaying the amount of glucose
your intestine absorbs.
This medicine is available only with
a doctor's prescription.
_TYPE 2 DIABETES MELLITUS_
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 to 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 hyperglyc

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION
APO-METFORMIN XR (500 & 1000) (METFORMIN
HYDROCHLORIDE) MODIFIED RELEASE TABLETS
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 HYDROCHLORIDE (≥ 2 G PER
DAY).
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-METFORMIN XR 500 modified release tablets contain 500 mg metformin
hydrochloride
(HCl).
APO-METFORMIN XR 1000 modified release tablets contain 1000 mg
metformin hydrochloride
(HCl).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Modified release tablet.
APO-METFORMIN XR 500: White, capsule shaped uncoated tablet with XR
500 on one side and
plain on the other side.
APO-METFORMIN XR 1000: White, capsule shaped uncoated tablet with XR
1000 one side and
plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
may be used as monotherapy or in combination with other oral
hypoglycaemic agents, or with
insulin.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Intended for oral administration.
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 HCL (≥ 2 G PER DAY).
2
MONOTHERAPY AND COMBINATION WITH OTHER ORAL HYPOGLYCAEMIC AGENTS
Initiating Therapy with Metformin XR
For patients new to metformin, the usual starting dose is one
Metformin XR 500 tablet, once
daily, with the evening meal. If the starting dose requires 750 mg
modified release metformin
HCl, then alternative brands will be required, as Metformin XR 500
cannot be divided.
After 10 to 15 days the dos