METFORMIN AUROBINDO 1000 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

Aurobindo Pharma Limited

ATC code:

A10BA02

INN (International Name):

METFORMIN HYDROCHLORIDE

Dosage:

1000 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Biguanides

Authorization status:

Authorised

Authorization date:

2009-04-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN AUROBINDO 500 MG/ 850 MG/ 1000 MG FILM-COATED TABLETS
metformin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Metformin Aurobindo is and what it is used for
2.
What you need to know before you take Metformin Aurobindo
3.
How to take Metformin Aurobindo
4.
Possible side effects
5.
How to store Metformin Aurobindo
6.
Contents of the pack and other information
1.
WHAT METFORMIN AUROBINDO IS AND WHAT IT IS USED FOR
WHAT METFORMIN AUROBINDO IS
Metformin Aurobindo contains metformin, a medicine to treat diabetes.
It belongs to a group of
medicines called biguanides.
Insulin is a hormone produced by the pancreasthat makes your body take
in glucose (sugar) from the
blood. Your body uses glucose to produce energy or stores it for
future use.
If you have diabetes, your pancreas does not make enough insulin or
your body is not able to use
properly the insulin it produces. This leads to a high level of
glucose in your blood. Metformin
Aurobindo helps to lower your blood glucose to as normal a level as
possible.
If you are an overweight adult, taking Metformin Aurobindo over a long
period of time also helps to
lower the risk of complications associated with diabetes. Metformin
Aurobindo is associated with
either a stable body weight or modest weight loss.
WHAT METFORMIN AUROBINDO IS USED FOR
Metformin Aurobindo is used to treat patients with type 2 diabetes
(also called 'non-insulin dependent
diabetes') when diet and exercise alone have no

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metformin Aurobindo 1000 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1000 mg metformin hydrochloride
corresponding to 780 mg metformin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, biconvex, capsule shaped film coated tablets with break line on
both sides. The size is 20.5 mm X 8.6 mm. The
tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus, particularly in overweight
patients, when dietary management and exercise alone
does not result in adequate glycemic control.
In adults, Metformin Aurobindo film-coated tablets may be used as
monotherapy or in combination with other
oral anti-diabetic agents or with insulin.
In children from 10 years of age and adolescents, Metformin Aurobindo
film-coated tablets may be used as
monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight
type 2 diabetic adult patients treated with
metformin hydrochloride as first-line therapy after diet failure (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS:
_ADULTS WITH NORMAL RENAL FUNCTION (GFR 90 ML/MIN)_
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS:
-
The usual starting dose is 500mg or 850mg metformin hydrochloride 2 or
3 times daily given during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A slow increase of dose
may improve gastrointestinal tolerability.
The maximum recommended dose of metformin hydrochloride is 3 g daily,
taken as 3 divided doses.
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and initiate metformin
hydrochloride at the dose indicated above.
COMBINATION WITH INSULIN:
Metformin hydrochloride and insulin may be used in combination therapy
to achieve better blood glucose