Metformin Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Metformin hydrochloride 500mg;  ;  ; Metformin hydrochloride 500mg

Available from:

Viatris Limited

INN (International Name):

Metformin hydrochloride 500 mg

Dosage:

500 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Metformin hydrochloride 500mg     Excipient: Dri-Klear Magnesium stearate Povidone Active: Metformin hydrochloride 500mg Excipient: Magnesium stearate Opadry clear 20C59060 Povidone

Prescription type:

Prescription

Manufactured by:

Exemed Pharmaceuticals

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.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, , HDPE with Polyproplyene screw caps - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, , HDPE with Polyproplyene screw caps - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, , HDPE with Polyproplyene screw caps - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, , HDPE with Polyproplyene screw caps - 1000 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2013-06-10

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
METFORMIN VIATRIS
_METFORMIN HYDROCHLORIDE, FILM COATED TABLETS, 500 & 850 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Metformin Viatris.
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
Viatris 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
VIATRIS IS USED FOR
Metformin Viatris is used to control
blood glucose (the amount of sugar
in the blood) in people with type 2
diabetes mellitus.
This type of diabetes is also known
as non-insulin-dependent diabetes
mellitus (NIDDM) or maturity onset
diabetes.
Metformin Viatris is used when diet
and exercise are not enough to
control your blood glucose.
It can be used alone, or together
with other medicines for treating
diabetes.
Metformin Viatris contains the active
ingredient metformin hydrochloride.
It belongs to a group of medicines
called biguanides.
It works by reducing liver glucose
(sugar) production, increasing
insulin sensitivity in the muscles and
delaying the absorption of glucose
from the intestinal tract.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
This medicine does not cause
hypoglycaemia (low blood sugar)
and is not expected to affect your
ability to drive a car or operate
machinery. However there is a risk
of hypoglycaemia when Metformin
Viatris is used in combination with
other antidiabetic medicines (see
Taking other medicines).
Metformin Viatris is not
recommended for use in children.
BEFORE YOU TAKE
METFORMIN VIATRIS
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE METFOR

Summary of Product characteristics

Page 1 of 12
NEW ZEALAND DATA SHEET
METFORMIN VIATRIS
1. PRODUCT NAME
Metformin Viatris, 500 mg, 850 mg & 1000 mg, film coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 500 mg, 850 mg or 1000 mg of
metformin hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Metformin Viatris 500 mg: White, round, normal convex, film coated
tablet, plain on both sides.
Metformin Viatris 850 mg: White, round, normal convex, film coated
tablet, plain on both sides.
Metformin Viatris 1000 mg: White, oval, film coated tablet, debossed
“MF” and “3” on either side of
the break line on one side and “G” on the other side.
Do not halve the 500 mg and 850 mg tablets. Dose equivalence when the
tablet is divided has not
been established.
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 SECTION 4.4).
DOSE
_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. Control may be attained within a few days but
occasionally requires up to two weeks.
Once control has been obtained, the dosage