METEX XR metformin hydrochloride 1000 mg modified release tablet blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

metformin hydrochloride, Quantity: 1000 mg

متاح من:

Arrotex Pharmaceuticals Pty Ltd

INN (الاسم الدولي):

Metformin hydrochloride

الشكل الصيدلاني:

Tablet, modified release

تركيب:

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

طريقة التعاطي:

Oral

الوحدات في الحزمة:

30 tablets, 120 tablets, 60 tablets, 90 tablets, 100 tablets

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

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.

ملخص المنتج:

Visual Identification: White, capsule shaped uncoated tablet with XR 1000 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

الوضع إذن:

Licence status A

تاريخ الترخيص:

2015-09-10

نشرة المعلومات

METEX XR CMI
1
METEX XR
_contains the active ingredient 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 or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking METEX XR
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 METEX XR IS USED FOR
METEX XR is used to control blood
glucose (sugar) 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 high levels of
blood glucose.
METEX XR can be used alone, or in
combination with other medicines
for treating diabetes.
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 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
_HOW METEX XR WORKS _
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 it
normally uses glucose
•
reducing the amount of glucose
your liver makes
•
delaying the amount of glu

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION – METEX XR (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.
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Metex XR, (500 mg) modified release tablet contains 500 mg of
metformin hydrochloride.
Each Metex XR, (750 mg) modified release tablet contains 750 mg of
metformin hydrochloride.
Each Metex XR, (1000 mg) modified release tablet contains 1000 mg of
metformin hydrochloride.
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
_METEX XR_
Metformin hydrochloride 500 mg modified release tablet; White,
capsule shaped uncoated tablet with ‘XR 500’ on one side and a
plain
on the other side.
_METEX XR_
Metformin hydrochloride 750 mg modified release tablet; White,
capsule shaped uncoated tablet with ‘XR 750’ on one side and a
plain
on the other side.
_METEX XR_
Metformin hydrochloride 1000 mg modified release tablet; White,
capsule shaped uncoated tablet with ‘XR 1000’ on one side and a
plain
on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 modified
release tablets may be used as monotherapy or in combination with
other oral antidiabetic agents, or
with insulin.
2
4.2
D
OSE AND METHOD OF 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.
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS
INITIATING THERAPY WITH METFORMIN HYDROCHLORIDE MODIFIED RELEASE
TABLETS
For patients new to metformin, the usual starting dose is one tablet