DIABEX 850 metformin hydrochloride 850mg tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

metformin hydrochloride, Quantity: 850 mg

Commercializzato da:

Alphapharm Pty Ltd

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: hypromellose; magnesium stearate; povidone

Via di somministrazione:

Oral

Confezione:

10 tablets, 60 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Metformin is indicated for the treatment of type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. For adult patients, metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes.

Dettagli prodotto:

Visual Identification: White, circular, convex, film-coated tablet. The tablet has no embossing and no score line.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

1996-10-25

Foglio illustrativo

DIABEX
D
I
A
B
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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 DIABEX?
DIABEX contains the active ingredient metformin hydrochloride. DIABEX
is used to control blood glucose (the amount of sugar in
the blood) in people with diabetes mellitus. For more information, see
Section 1. Why am I using DIABEX? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DIABEX?
Do not use if you have ever had an allergic reaction to DIABEX 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? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DIABEX 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?
•
The dose varies from person to person.
•
The usual starting dose for adults is 500 mg one to two times a day.
Your doctor may increase or decrease the dose, depending
on your blood glucose levels. More instructions can be found in
Section 4. How do I use DIABEX? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DIABEX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DIABEX.
•
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
SHOULD NOT DO
•
Do not take DIABEX to treat any other complaints unless your doctor
tells you to.
•
Do not skip meals while taking DIABEX.
•
Do not stop taking your medicine or change the dosage without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
DIABEX by itself is unlikely to affect how you drive or operate
machinery.
•
L

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION
DIABEX
_Metformin hydrochloride film-coated tablet _
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. RISK FACTORS INCLUDE
RENAL IMPAIRMENT, OLD AGE AND THE USE OF HIGH DOSES OF METFORMIN ABOVE
2 G PER DAY.
1
NAME OF THE MEDICINE
Metformin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The tablets contain metformin hydrochloride as the active ingredient
and are available in three strengths 500 mg,
850 mg and 1000 mg.
Excipients with known effect: sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
DIABEX
:
Metformin hydrochloride 500 mg tablet: white, oblong, convex,
film-coated,
tablet. The tablet is embossed with "DIABEX" on one side and is scored
on the
other.
DIABEX 850
:
Metformin hydrochloride 850 mg tablet: white, circular, convex,
film-coated
tablet. The tablet has no embossing and no score line.
DIABEX 1000
:
Metformin hydrochloride 1000 mg tablet: white, oval, biconvex,
film-coated
tablet, with a line on both sides and “1000” engraved on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metformin is indicated in the treatment of type 2 diabetes mellitus in
adults, children from 10 years of age and
adolescents, particularly in overweight patients, when dietary
management and exercise alone does not result in
adequate glycaemic control.
For adult patients, metformin may be used as initial treatment or in
sulfonylurea failures either alone or in
combination with a sulfonylurea and other oral agents or as adjuvant
therapy in insulin requiring type 2 diabetes.
4.2
DOSE AND METHOD OF ADMINISTRATION
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. RISK FACTORS INCLUDE
RENAL IMPAIRMENT, OLD AGE AND THE USE OF HIGH DOSES OF METFORMIN ABOVE
2 G PER DAY.
DIABEX – AUSTRALIAN PRODUCT
INFORMATION
2
It is important that the tablets are taken in divided doses with
meals.
Half tablet doses of the 1000 mg tablet may be administered, if care
is taken not to cru