DIABEX XR 500 metformin hydrochloride 500 mg extended release tablet blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

metformin hydrochloride, Quantity: 500 mg

Disponibbli minn:

Alphapharm Pty Ltd

Għamla farmaċewtika:

Tablet, modified release

Kompożizzjoni:

Excipient Ingredients: hypromellose; magnesium stearate; carmellose sodium

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

100 Tablets, 60 Tablets, 90 Tablets, 120 Tablets, 10 Tablets (Starter Pack), 30 Tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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. DIABEX XR 500 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Sommarju tal-prodott:

Visual Identification: White to off-white, round, biconvex tablet, debossed with 500 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2019-08-08

Fuljett ta 'informazzjoni

DIABEX XR
D
I
A
B
E
X
X
R
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING DIABEX XR?
DIABEX XR contains the active ingredient metformin hydrochloride.
DIABEX XR is used to control blood glucose (sugar) in people
with Type 2 diabetes mellitus. For more information, see Section 1.
Why am I using DIABEX XR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DIABEX XR?
Do not use if you have ever had an allergic reaction to DIABEX XR or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use DIABEX XR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DIABEX XR and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE DIABEX XR?
•
The usual starting dose is 500 mg once daily with the evening meal.
Your doctor may increase the dose slowly, depending on
your blood glucose levels. More instructions can be found in Section
4. How do I use DIABEX XR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DIABEX XR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DIABEX XR.
•
Make sure that you, your friends, family and work colleagues can
recognise the symptoms of
hypoglycaemia and hyperglycaemia and know how to treat them.
•
If you become pregnant while taking DIABEX XR, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not skip meals while taking DIABEX XR.
•
Do not stop taking your medicine or change the dose without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
DIABEX XR by itself is unlikely to affect how you drive or operate
machinery.
•
Low blood glucose levels may

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION
DIABEX XR 500
_Metformin hydrochloride extended 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 DIABEX XR 500 extended release tablet contains 500 mg of
metformin hydrochloride.
Excipients with known effect: Trace quantities of sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DIABEX XR 500 mg extended release tablets: white to off-white, round,
biconvex tablet, debossed with “500”
on one side.
The tablet shells may be present in the faeces. Patients should be
advised that this is normal.
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.
DIABEX XR 500 may be used as
monotherapy or in combination with other oral antidiabetic agents, or
with insulin.
4.2
DOSE
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 DIABEX XR
For patients new to metformin, the usual starting dose of DIABEX XR is
one tablet of DIABEX XR 500 or
DIABEX XR 750 (750 mg) once daily taken with the evening meal.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A slow increase
of dose may improve gastro-intestinal tolerability. Dosage increases
should be made in increments of 500 mg
or 750 mg every 10-15 days.
Combining DIABEX XR Dosage Strengths
The combined use of different strengths of DIABEX XR 500, DIABEX XR
750 or DIABEX XR 1000 is