Indoco Metformin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metformin hydrochloride 500mg

Available from:

Miro Healthcare Limited

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:

Blister pack, PVC/PVdC/aluminium, 100 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: Blister pack, PVC/PVdC/aluminium - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, 750 cc HDPE containers, induction sealed and wadded 53 mm screw caps - 1000 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2009-05-13

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
METFORMIN GENERIC
HEALTH
_metformin hydrochloride _
500 mg and 850 mg tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start
using Metformin Generic Health.
This leaflet answers some common questions
about Metformin Generic Health. It does not
contain all the available information. It does not
take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor
has weighed the risks of you taking Metformin
Generic Health against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine. You may
need to read it again.
WHAT METFORMIN GENERIC HEALTH
IS USED FOR
Metformin Generic Health is used to control high
blood glucose level (the amount of sugar in the
blood) in people with type 2 diabetes mellitus.
This type of diabetes is also called non-insulin-
dependent diabetes mellitus (NIDDM) or maturity
onset diabetes.
Metformin Generic Health is used when diet and
exercise have not been enough to control your
blood glucose.
It can be used alone, or together with other
medicines for treating diabetes.
Metformin Generic Health contains the active
ingredient metformin hydrochloride which
belongs to a group of medicines called
biguanides.
It works by reducing liver glucose (sugar)
production, improving insulin sensitivity in the
muscles and slowing down the absorption of
glucose from the intestinal tract.
Your doctor may have prescribed Metformin
Generic Health for another reason.
Ask your doctor if you have any questions about
why Metformin Generic Health has been
prescribed for you.
This medicine is available only with a doctor's
prescription.
Metformin Generic Health is not recommended
for use in children.
BEFORE YOU TAKE METFORMIN
GENERIC HEALTH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE METFORMIN GENERIC HEALTH IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing metformin
hydrochloride or a class of medicines
calle

Summary of Product characteristics

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Indoco Metformin 500mg Film Coated Tablet
Indoco Metformin 850mg Film Coated Tablet
Film Coated Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Indoco Metformin 500mg Film Coated Tablet contains 500mg metformin
hydrochloride.
Indoco Metformin 850mg Film Coated Tablet contains 850mg metformin
hydrochloride.
For a full list of excipients, see _Section 6.1_.
3.
PHARMACEUTICAL FORM
Indoco Metformin500mg Film Coated Tablet: white to off white,
circular, biconvex film
coated tablet with beveled edges.
Indoco Metformin 850mg Film Coated Tablet: white to off white,
circular, biconvex film
coated tablet with beveled edges.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
To control hyperglycemia 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 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
This product may not be interchangeable with other products containing
this ingredient in
the New Zealand market.
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 SECTION _
_4.4)._
2 | P a g e
DOSE
_ADULTS_
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 o