DIAFORMIN XR metformin hydrochloride 500mg extended release tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

metformin hydrochloride, Quantity: 500 mg

Tersedia dari:

Alphapharm Pty Ltd

INN (Nama Internasional):

Metformin hydrochloride

Bentuk farmasi:

Tablet, modified release

Komposisi:

Excipient Ingredients: hypromellose; microcrystalline cellulose; magnesium stearate; carmellose sodium

Rute administrasi :

Oral

Unit dalam paket:

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

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

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

Ringkasan produk:

Visual Identification: White to off-white, capsule shaped, 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

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2005-10-18

Selebaran informasi

DIAFORMIN
® XR AND DIAFORMIN
® XR 1000
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1
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0
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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

Karakteristik produk

AUSTRALIAN PRODUCT INFORMATION
DIAFORMIN
®
XR
_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 extended release tablet contains 500 mg of metformin
hydrochloride.
Diaformin XR also contains trace amounts of sulfites, for the full
list of excipients, see Section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
Metformin hydrochloride 500 mg extended release tablets: white to
off-white, capsule-shaped, biconvex tablet,
debossed “500” on one side.
Diaformin XR is gluten free.
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 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.
DIAFORMIN XR– AUSTRALIAN PRODUCT INFORMATION
2
COMBINING