SW METFORMIN TABLET 500MG

Land: Malaysia

Språk: engelska

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

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Bipacksedel Bipacksedel (PIL)
19-07-2021
Produktens egenskaper Produktens egenskaper (SPC)
13-06-2019

Aktiva substanser:

METFORMIN HYDROCHLORIDE

Tillgänglig från:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (International namn):

METFORMIN HYDROCHLORIDE

Enheter i paketet:

1000Tablet Tablets; 45Tablet Tablets; 1000Tablet Tablets; 100Tablet Tablets; 500Tablet Tablets

Tillverkad av:

SUNWARD PHARMACEUTICAL SDN. BHD.

Bipacksedel

                                METFORMIN TABLET
Metformin Hydrochloride (250/500/850mg) 1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What SW Metformin Tablet is used for
2. How SW Metformin Tablet works
3. Before you use SW Metformin Tablet
4. How to use SW Metformin Tablet
5. While you are using it
6. Side effects
7. Storage and Disposal of SW Metformin
Tablet
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT SW METFORMIN TABLET IS USED FOR
It is used as treatment to control high blood
sugar which is not responsive to diet alone or
diet plus treatment with sulphonylurea.
HOW SW METFORMIN TABLET WORKS
The
active
ingredient
in
the
medicine
is
metformin
hydrochloride.
Metformin
HCL
works in lowering the production of glucose
in
liver
by
three
way
mechanisms
which
known
in
reduction
of
hepatic
glucose
production, increasing insulin sensitivity in
muscle and uptake in peripheral tissue and
also delay of intestinal glucose absorption.
Metformin
has
favourable
effects
on
lipid
metabolism. This shown at therapeutic doses
in controlled of medium or long term clinical
studies that metformin reduce the level of
total
cholesterol,
LDL
cholesterol
and
triglycerides.
BEFORE YOU USE SW METFORMIN TABLET
_- When you must not use it _
Do not take SW Metformin Tablet if you:-

have liver problem.

have severely reduced kidney function.

have lactic acidosis [too much lactic acid in
the
blood
(see
“Risk
of
lactic
acidosis”
below)] 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
of
acidosis
may
include
stomach
pain,
abnormal
breathing
and
drowsiness (if severe).

have
heart
problem
or
congestive
heart
failure.

have low blood pressure.

have diabetes mellitus with excesive acid
level in body.

have
infectious
disease
or
tissue
death
problem.

are during surgery.

are hypersensitivity to metformin HCL or
any
ingredients
listed
at
the
end
                                
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Produktens egenskaper

                                Each tablet contains:-
Metformin HCl 500mg
PHARMACOLOGY:
Metformin is a biguanide with antihyperglycaemic 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: Reduction of hepatic glucose
production by inhibiting gluconeogenesis
and glycogenolysis; in muscle by increasing insulin sensitivity,
improving peripheral glucose uptake and
utilisation; and 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.
This has been shown at therapeutic doses
in controlled, medium-term or long-term clinical studies; metformin
reduces total cholesterol, LDL cholesterol
and triglyceride levels.
PHARMACOKINETICS:
After an oral dose of metformin, Tmax is reached in 2.5 hours.
Absolute bioavailability of a 500mg or 850mg
metformin tablet is approximately 50-60% in healthy subjects.
Metformin is excreted unchanged in the urine. No metabolites have been
identified in humans.
INDICATIONS:
It is used in the treatment of maturity on-set diabetes mellitus not
responsive to diet alone or diet plus treatment
with a sulphonylurea.
SIDE EFFECTS / ADVERSE REACTIONS:
Anorexia, nausea, vomiting and diarrhoea, are not uncommon;
occasionally a metallic taste, loss of weight,
weakness, lassitude or skin rashes may occur.
Lactic acidosis possibly heralded by vomiting, abdominal pain,
hyperventilation and diminished consciousness
may occur.
CONTRAINDICATIONS:
Metformin hydrochloride should not be given to patients with impaired
hepatic or renal function, cardiovascular
collapse, congestive heart failure, acute myocardial infarction, or
other conditions leading to hypotension or to
hypoxaemia. It should not be given to patients with diabetes mellitus
comp
                                
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