DIAFORMIN XR 1000 metformin hydrochloride 1000mg extended release tablet blister pack.
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
18-10-2022
Summary of Product characteristics
(SPC)
18-10-2022
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
metformin hydrochloride, Quantity: 1000 mg
Available from:
Alphapharm Pty Ltd
INN (International Name):
Metformin hydrochloride
Pharmaceutical form:
Tablet, modified release
Composition:
Excipient Ingredients: hypromellose; magnesium stearate; carmellose sodium
Administration route:
Oral
Units in package:
60, 100, 30, 10 (Starter Pack), 90, 120
Prescription type:
(S4) Prescription Only Medicine
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. DIAFORMIN XR and DIAFORMIN XR 1000 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.
Product summary:
Visual Identification: White to off-white, capsule-shaped, biconvex tablet, debossed on one side with 1000; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2014-07-28
Patient Information leaflet
DIAFORMIN
® XR AND DIAFORMIN
® XR 1000
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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 DIAFORMIN XR OR DIAFORMIN XR 1000?
DIAFORMIN XR and DIAFORMIN XR 1000 contains the active ingredient
metformin hydrochloride. DIAFORMIN XR and
DIAFORMIN XR 1000 are used to control blood glucose (sugar) in people
with Type 2 diabetes mellitus. For more information, see
Section 1. Why am I using DIAFORMIN XR or DIAFORMIN XR 1000? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DIAFORMIN XR OR DIAFORMIN XR 1000?
Do not use if you have ever had an allergic reaction to DIAFORMIN XR
or DIAFORMIN XR 1000 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
DIAFORMIN XR or DIAFORMIN XR 1000? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DIAFORMIN XR and DIAFORMIN XR 1000
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 DIAFORMIN XR OR DIAFORMIN XR 1000?
•
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 DIAFORMIN XR or DIAFORMIN XR 1000?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DIAFORMIN XR OR DIAFORMIN XR 1000?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DIAFORMIN XR or DIAFORMIN XR
1000.
•
Make sure that you, your friends, family and work colleagues can
recognise the symptoms of
hypoglycaemia and hyperglycaemia and know how to treat them.
THINGS YOU
S
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
DIAFORMIN
®
XR 1000
_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 DIAFORMIN XR 1000 extended release tablet contains 1000 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
DIAFORMIN XR 1000 mg extended release tablets: white to off-white,
capsule-shaped, biconvex tablet,
debossed on one side with 1000.
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.
DIAFORMIN XR 1000 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 DIAFORMIN XR 500 mg
For patients new to metformin, the usual starting dose of DIAFORMIN XR
is one tablet (500 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
every 10-15 days, up to a maximum of 2000 mg once daily with the
evening meal.
Combining DIAFORMIN XR Dosage Strengths
The combined use of different stren
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