Metchek 500 mg

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metformin hydrochloride 500mg;  ;  

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

INN (International Name):

Metformin hydrochloride 500 mg

Dosage:

500 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Metformin hydrochloride 500mg     Excipient: Colloidal silicon dioxide Hypromellose E-15 Macrogol 6000 Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Purified water Sodium starch glycolate Titanium dioxide

Units in package:

Jar, plastic, HDPE, 500 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Wanbury Limited

Therapeutic indications:

To control hyperglycaemia in metformin responsive, stable, mild, non-ketosis prone maturity onset type of diabetes (Type II) which cannot be controlled by proper dietary management, exercise and weight reduction or when insulin therapy is not appropriate. It may be used alone or in combination with sulphonylurea therapy. Metformin can be of value for the treatment of obese diabetics. It may also be used as adjuvant therapy in insulin-dependent diabetics especially if they are overweight.

Product summary:

Package - Contents - Shelf Life: Jar, plastic, HDPE - 500 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture. Protect from heat. Keep container tightly closed. - Jar, plastic, HDPE - 1000 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture. Protect from heat. Keep container tightly closed.

Authorization date:

2006-07-31

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 12
1.
PRODUCT NAME (strength pharmaceutical form)
Metchek 500 mg, film-coated tablet, 500mg
Metchek 850 mg, film-coated tablet, 850mg
This product may not be interchangeable with other products containing
Metformin
hydrochloride in the New Zealand Market.
Not all tablet strengths maybe marketed.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Metformin hydrochloride 500 mg
Metformin hydrochloride 850 mg
Excipient(s) with known effect

3.
PHARMACEUTICAL FORM
Oral. Film-coated tablets
Presentations:
Metchek 500 mg: White to off-white, round bevelled edged biconvex film
coated
tablets with ‘500’ debossed on one side and plain on the other
side.
Thickness 6.2 ± 0.2 mm, diameter 11.0 ± 0.2 mm.
Metchek 850 mg: White to off-white, circular, bevelled edged biconvex
film coated
tablets.
Thickness 7.2 ± 0.2 mm, diameter 13.5 ± 0.2 mm.
Do not halve tablets. Dose equivalence when the tablets are divided
has not
been established.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
To control hyperglycaemia in metformin responsive, stable, mild,
non-ketosis prone,
maturity onset type of diabetes (Type II) which cannot be controlled
by proper dietary
management, exercise and weight reduction or when insulin therapy is
not
appropriate.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 12
It may be used alone or in combination with sulphonyl urea therapy.
Metformin can be of value for the treatment of obese diabetics.
It may also be used as adjuvant therapy in insulin-dependent diabetics
especially if they
are overweight.
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 doses of metformin above
2 g per day
(see warnings and precautions).
It is important that the tablets are taken in divided doses with
meals.
Monotherapy and combination with other oral antidia