AURO METFORMIN 850 (Metformin Tablets BP 850 mg)

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

METFORMIN HYDROCHLORIDE

Διαθέσιμο από:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Διεθνής Όνομα):

METFORMIN HYDROCHLORIDE

Μονάδες σε πακέτο:

28tablet Tablets; 28tablet Tablets

Κατασκευάζεται από:

Aurobindo Pharma Limited Unit - III

Φύλλο οδηγιών χρήσης

AURO METFORMIN
_Consumer Medication Information Leaflet (RiMUP)_
Metformin Hydrochloride (500mg, 850mg, 1000mg)
1
WHAT IS IN THIS LEAFLET
1.
What AURO METFORMIN is
used for
2.
How AURO METFORMIN
works
3.
Before you use AURO
METFORMIN
4.
How to use AURO
METFORMIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of AURO
METFORMIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS AURO METFORMIN
USED FOR
Treatment of Type 2 Diabetes
Mellitus, particularly in overweight
patients, when dietary management
and exercise alone does not result in
adequate glucose level (glycaemia)
control.
In adults, AURO METFORMIN may
be used as alone or in combination
with other oral anti-diabetic agents or
with insulin.
In children from 10 years of age and
adolescents, AURO METFORMIN
may be used as alone or in
combination with insulin.
A reduction of diabetic
complications has been shown in
overweight Type 2 diabetic adult
patients treated with AURO
METFORMIN as first-line therapy
after diet failure.
HOW AURO METFORMIN WORKS
AURO METFORMIN belongs to a
group of medicines called biguanides
which act by lowering blood plasma
glucose (i.e. anti-hyperglycaemic
effect) during both i.e before & after
taking food (basal and postprandial).
It does not stimulate insulin secretion
and therefore does not decrease the
blood glucose level (hypoglycaemia).
BEFORE YOU USE AURO
METFORMIN
-
_When you must not use it _
Do not take AURO METFORMIN:
•
If you have allergic
(hypersensitivity) to metformin
hydrochloride or to any of the
excipients
•
If you have shortage of insulin
(diabetic ketoacidosis), diabetes
related to decreased glucose
level (diabetic pre-coma)
•
If you have severely reduced
kidney function
•
If you have lactic acidosis [too
much lactic acid in the blood
(see "Risk of lactic acidosis")] or
ketoacidosis. Ketoacidosis is a
condition in which substances
called 'ketone bodies'
accumulate in the blood and
which can lead to diabetic pre-
coma. Symptoms

Αρχείο Π.Χ.Π.

NAME OF DRUG PRODUCT:
Metformin Tablets BP 500 mg
Metformin Tablets BP 850 mg
Metformin Tablets BP 1000 mg
(TRADE) NAME OF PRODUCT:
AURO METFORMIN 500
AURO METFORMIN 850
AURO METFORMIN 1000
STRENGTH: 500 mg, 850 mg and 000 mg.
PHARMACEUTICAL DOSAGE FORM: Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Metformin Tablets BP 500 mg_
Each film-coated tablet contains:
Metformin Hydrochloride Ph. Eur..................500 mg
_Metformin Tablets BP 850 mg_
Each film-coated tablet contains:
Metformin Hydrochloride Ph. Eur.................. 850 mg
_Metformin Tablets BP1000 mg_
Each film-coated tablet contains:
Metformin Hydrochloride Ph. Eur…………..1000 mg
PHARMACEUTICAL FORM:
_Metformin Tablets BP 500 mg: _ White, biconvex, circular
shaped film coated tablets with 'A' debossed on one side and
'60' debossed on the other side.
_Metformin Tablets BP 850 mg:_ White, biconvex, circular
shaped film coated tablets with 'A' debossed on one side and
'61' debossed on the other side.
_Metformin Tablets BP 1000 mg: _White, biconvex, oval shaped
film coated tablets with a score line in between '6' and '2' on
one side and 'A' debossed on the other side.
CLINICAL PARTICULARS:
PHARMACODYNAMICS/PHARMACOKINETICS
PHARMACODYNAMIC PROPERTIES
Metformin is a biguanide with anti hyperglycaemic effects,
lowering both basal and postprandial plasma glucose. It does
not stimulate insulin secretion and therefore does not produce
hypoglycaemia.
Metformin may act via 3 mechanisms:
(1)
Reduction of hepatic glucose production by inhibiting
gluconeogenesis and glycogenolysis.
(2)
In muscle, by increasing insulin sensitivity, improving
peripheral glucose uptake and utilization.
(3)
Delay of intestinal glucose absorption.
Metformin
stimulates
intracellular
glycogen
synthesis
by
acting on glycogen synthase.
Metformin increases the transport capacity of all types of
membrane glucose transporters (GLUT).
In
humans,
independently
of
its
action
on
glycaemia,
Metformin
has
favourable
effects
on
lipid
metabolism.
Metformin reduces total cholesterol, LDL ch