Metformin

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Metformin hydrochloride 850mg;  ;  ; Metformin hydrochloride 850mg

Διαθέσιμο από:

Ipca Pharma (NZ) Pty Limited

INN (Διεθνής Όνομα):

Metformin hydrochloride 850 mg

Δοσολογία:

850 mg

Φαρμακοτεχνική μορφή:

Film coated tablet

Σύνθεση:

Active: Metformin hydrochloride 850mg     Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000 Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Sodium starch glycolate Titanium dioxide Active: Metformin hydrochloride 850mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000 Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Sodium starch glycolate Titanium dioxide

Μονάδες σε πακέτο:

Blister pack, PVC/PVdC/Al, 14 tablets

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Ipca Laboratories Limited

Θεραπευτικές ενδείξεις:

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. Metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 14 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 84 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 250 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Ημερομηνία της άδειας:

2005-03-03

Αρχείο Π.Χ.Π.

NEW ZEALAND DATA SHEET
METFORMIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet Page 1
1
METFORMIN (500MG, 850MG AND 1000MG TABLETS)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metformin hydrochloride 500mg
Metformin hydrochloride 850mg
Metformin hydrochloride 1000mg
EXCIPIENT OF KNOWN EFFECT
PROPYLENE GLYCOL
This excipient may cause skin irritation.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Metformin 500 mg: White coloured, film coated, round, biconvex tablets
embossed on one face with
‘500’
Metformin 850 mg: White coloured, film coated, round, biconvex tablets
embossed on one face with
‘850’
Metformin 1000mg: White to off white, oval shaped, biconvex, film
coated tablets debossed with '10'
and '00' on either side of deep notch on one side and breakline on
other side.
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.

Metformin may be used as initial treatment or in sulfonylurea failures
either alone or in
combination with a sulfonylurea and other oral agents.

Adjuvant therapy in insulin dependent diabetes especially if
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 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
It is important that the tablets are taken in divided doses with
meals.
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS IN
ADULTS WITH NORMAL RENAL
FUNCTION
Initially 500 mg should be taken once or twice a day and, if
necessary, increased over a few weeks
up to a maximum of 1 g three times per day. The dose should be
titrated with gradual dose
increments until the desired effect is obtained. 500 mg three times a
day is often sufficient to obtain
diabetic control. Cont