METFORMIN MYLAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

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:

metformin

Authorization status:

Not Marketed

Authorization date:

2010-04-23

Patient Information leaflet

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METFORMIN MYLAN 500 MG FILM-COATED TABLETS
METFORMIN MYLAN 850 MG FILM-COATED TABLETS
METFORMIN MYLAN 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 Mylan is and what it is used for.
2.
What you need to know before you take Metformin Mylan.
3.
How to take Metformin Mylan.
4.
Possible side effects.
5.
How to store Metformin Mylan.
6.
Contents of the pack and other information.
1. WHAT METFORMIN MYLAN IS AND WHAT IT IS USED FOR
WHAT METFORMIN MYLAN IS
Metformin Mylan contains the active substance metformin hydrochloride,
a medicine to treat diabetes. It
belongs to a group of medicines called biguanides._ _
Insulin is a hormone produced by the pancreas that 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 Mylan helps to lower
your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metformin Mylan over a long
period of time also helps to lower the
risk of complications associated with diabetes.
Metformin Mylan is associated with either a stable body weight or
modest weight loss.
WHAT METFORMIN MYLAN IS USED FOR
Metformin Mylan is used to treat patients with type 2 diabetes (also

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metformin Mylan 1000 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000 mg film-coated tablet contains 1000 mg metformin
hydrochloride equivalent to metformin base 780 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, film coated tablet, debossed “MF” and “3” on
either side of the breakline on one side and “G” on the other
side. The tablet can be divided into equal halves.
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 glycaemic control.
• In adults, Metformin Mylan 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 Mylan
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 as first-line therapy after diet failure (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS WITH NORMAL RENAL FUNCTION (GFR
90 ML/MIN):
_Monotherapy and combination with other oral antidiabetic agents:_
• The usual starting dose is one tablet of 500 mg or 850 mg
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.
In patients receiving a high metformin dose (2 to 3 grams per day), it
is possible to replace two Metformin Mylan 500
mg film-coated tablets with one Metformin Mylan 1000 mg film-coated
tablet.
The maximum recommended dose of metformin hydrochloride is 3 g daily,
taken as 3 divided doses.
If transfer from another oral antidiabetic agent is intende