Dyna Metformin Tablet 500mg

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

METFORMIN HYDROCHLORIDE

Commercializzato da:

DYNAPHARM (M) SDN BHD

INN (Nome Internazionale):

METFORMIN HYDROCHLORIDE

Confezione:

1000 Tablet Tablets; 100 Tablet Tablets

Prodotto da:

DYNAPHARM (M) SDN BHD

Foglio illustrativo

Consumer Medication Information Leaflet (RiMUP)
DYNA METFORMIN TABLET 500MG
Metformin Hydrochloride (500mg)
Page 1 of 3
What is in this leaflet
1.
What Metformin is used for
2.
How Metformin works
3.
Before you take Metformin
4.
How to take Metformin
5.
While you are using Metformin
6.
Side Effects
7.
Storage and disposal of Metformin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What METFORMIN is used for
Metformin belongs to a group of
medicines called biguanides (a type of
oral hypoglycaemic). Metformin is used
for the sort of diabetes called Type 2
diabetes or non-insulin-dependent
diabetes mellitus.
This medicine is given when diet and
exercise alone has not been able to
control your blood sugar levels.
Metformin can be given on its own.
However, sometimes it is given with
other medicines for diabetes or with
insulin.
How METFORMIN works
In type 2 diabetes, there is too much
sugar (glucose) in your blood. This is
because your body does not make
enough insulin or because it makes
insulin that does not work properly.
Insulin is a hormone that allows your
body tissue to take glucose from the
blood and use it for energy or for storage
for future use.
Metformin works by improving the
sensitivity of your body to insulin. It
helps your body to use glucose in the
normal way again.
Before you use METFORMIN
When you must not take it
Do not take Metformin if:
-
You are allergic (hypersensitive) to
Metformin or any of the other
ingredients in this tablet (see section
on Product description (ingredients).
An allergic reaction can include a rash,
itching or shortness of breath.
-
You have recently had a heart attack or
any other heart problems
-
You have severe circulation problems
or difficulty in breathing
-
You have liver or kidney problems
-
You have had serious problems with
your diabetes in the past called
diabetic ketoacidosis. When you have
this you lose weight quickly, feel sick
(nausea) or are sick (vomiting). See
also the section on ‘side effects’.
-
You have re

Scheda tecnica

DYNA METFORMIN TABLET 500MG
MAL19961876AZ
DESCRIPTION:
TABLET
Shape
: Round/Flat/Scored
Colour
: White
Marking : “M”
Oral Hypoglycaemic
EACH TABLET CONTAINS:
Metformin HCl .................................................. 500
mg
PHARMACODYNAMICS:
Metformin's mode of action is not clear. It does not stimulate Insulin
releases but does require some Insulin be present
for it to exert a hypoglycaemic effect. Possible mechanisms of action
include delay in the absorption of Glucose from the
gastrointestinal tract, an increase in Insulin sensitivity, and
inhibition of hepatic gluconeogenesis.
PHARMACOKINETICS:
Metformin Hydrochloride is absorbed from the gastrointestinal tract
and is excreted, unchanged, in the urine. It has a
plasma half-life of about 3 hours and it is not bound to plasma
proteins.
INDICATION:
Control of hyperglycaemic of maturity onset diabetes mellitus. It is
used in non Insulin-dependant diabetes mellitus when
diet control fails. It is sometimes given to patients no longer
responding to the sulphonylureas.
RECOMMENDED DOSE:
Initial dose of 500 mg three times daily or 850 mg twice daily with
meals, gradually increased if necessary to a maximum
of 3 g daily.
Renal impairment:
A glomerular filtration rate (GFR) should be assessed before
initiation of treatment with Metformin containing products
and at lease annually thereafter. In patients at an increased risk of
further progression of renal impairment and in the
elderly, renal function should be assessed more frequently, e.g. every
3-6 months.
GFR mL/min
Total maximum daily dose
(to be divided into 2-3 daily doses)
Additional considerations
60-89
3000 mg
Dose reduction may be considered in relation to declining
renal function.
45-59
2000 mg
Factors that may increase the risk of lactic acidosis should
be reviewed before considering initiation of Metformin. The
starting dose is at most half of the maximum dose.
30-44
1000 mg
<30
-
Metformin is contraindicated
ROUTE OF ADMINISTRATION:
FOR ORAL USE ONLY
CONTRAINDICATIONS:
Metformin should not be used