METFORMIN DOC GENERICS 750mg, prolonged release tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Saadav alates:

Doc Generici srl Via Turati, 40-20121, Milano, Italy

ATC kood:

A10BA02

INN (Rahvusvaheline Nimetus):

METFORMIN HYDROCHLORIDE 750 mg

Ravimvorm:

PROLONGED-RELEASE TABLET

Koostis:

METFORMIN HYDROCHLORIDE 750 mg

Retsepti tüüp:

POM

Terapeutiline ala:

DRUGS USED IN DIABETES

Toote kokkuvõte:

Licence number in the source country: NOT APPLICAPABLE

Volitamisolek:

Authorised

Loa andmise kuupäev:

2022-11-07

Infovoldik

Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN DOC GENERICS 500 MG, PROLONGED-RELEASE TABLETS
METFORMIN DOC GENERICS 750 MG, PROLONGED-RELEASE TABLETS
METFORMIN DOC GENERICS 1000 MG, PROLONGED-RELEASE TABLETS
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 DOC GENERICS is and what it is used for
2.
What you need to know before you take
METFORMIN DOC GENERICS
3.
How to take METFORMIN DOC GENERICS
4.
Possible side effects
5.
How to store METFORMIN DOC GENERICS
6.
Contents of the pack and other information
1.
WHAT METFORMIN DOC GENERICS IS AND WHAT IT IS USED FOR
METFORMIN DOC GENERICS contains metformin, a drug used to treat
diabetes. It belongs to a
group of drugs called biguanides.
Insulin is a hormone produced by the pancreas, which allows the body
to take glucose (sugar) from the
blood. The body uses glucose to generate energy or stores it for later
use.
In diabetic patients, the pancreas does not produce enough insulin, or
the body is unable to make
proper use of the insulin produced. This leads to an excessive
increase in blood glucose levels.
METFORMIN DOC GENERICS
helps to reduce blood glucose levels to values as close to normal as
possible.
In overweight adults, long-term use of METFORMIN DOC GENERICS
also reduces the risk of
diabetic complications.
METFORMIN DOC GENERICS
is used in the treatment of patients with type 2 diabetes (also
known as "insulin-dependent" diabetes) when dietary management and
exercise alone does not result
in adequate glycaemic control.

Toote omadused

Page
1
of
11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
METFORMIN DOC GENERICS 500 mg, prolonged-release tablets
METFORMIN DOC GENERICS 750 mg, prolonged-release tablets
METFORMIN DOC GENERICS 1000 mg, prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
METFORMIN DOC GENERICS 500 mg, prolonged-release tablets.
One prolonged-release tablet contains 500 mg of metformin
hydrochloride, which corresponds to 390
mg of metformin.
METFORMIN DOC GENERICS 750 mg, prolonged-release tablets.
One prolonged-release tablet contains 750 mg of metformin
hydrochloride, which corresponds to 585
mg of metformin.
METFORMIN DOC GENERICS 1000 mg, prolonged-release tablets.
One prolonged-release tablet contains 1000 mg of metformin
hydrochloride, which corresponds to
780 mg of metformin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablets.
METFORMIN DOC GENERICS 500 mg, prolonged-release tablets
White to off-white, round (12.10mm - 12.50mm), debossed tablet with
“16” and “C”.
METFORMIN DOC GENERICS 750 mg, prolonged-release tablets
White, to off-white and capsule shaped (18.80mm X 9.30mm - 19.20mm X
9.70mm), debossed tablet
with “15” and “C”.
METFORMIN DOC GENERICS 1000 mg, prolonged-release tablets
White, to off-white and capsule shaped ,(22.30mm X 10.30 mm –
22.70mm X 10.70 mm) , debossed
tablet with “14” and “C”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
Treatment of type 2 diabetes in adults, especially in overweight
patients when dietary management and
exercise alone does not result in adequate glycaemic control.
METFORMIN DOC GENERICS can be
used in monotherapy or in combination with other oral antidiabetics or
insulin.
In adult patients with type 2 diabetes and overweight treated with
metformin, used as a first-line drug
in case of dietary failure, a reduction in the number of complications
of diabetes has been
demonstrated (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
Page
2
of
11
Posology
_