Tobumide Tablet

Country: Malasía

Tungumál: enska

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

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
03-09-2020

Virkt innihaldsefni:

TOLBUTAMIDE

Fáanlegur frá:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Alþjóðlegt nafn):

TOLBUTAMIDE

Einingar í pakka:

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

Framleitt af:

SUNWARD PHARMACEUTICAL SDN. BHD.

Upplýsingar fylgiseðill

                                1
TOBUMIDE TABLET
®
Tolbutamide (500mg)
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.What Tobumide Tablet is used for
2. How Tobumide Tablet works
3. Before you use Tobumide Tablet
4. How to use Tobumide Tablet
5. While you are using Tobumide Tablet
6. Side Effects
7. Storage and Disposable of Tobumide Tablet
8. Product Description
9. Manufacturer and Product Registration
Holder
10.Date of Revision
WHAT TOBUMIDE TABLET IS USED FOR
Tobumide Tablet is used for the treatment for
non insulin dependent diabetes mellitus.
HOW TOBUMIDE TABLET WORKS
The
active
ingredient
in
the
medicine
is
Tolbutamide.
This
belongs
to
a
group
of
medicine called sulphonylurea. It stimulates
secretion of insulin by functioning beta islet
cells, restoring the early phase insule secrition,
resulting in a physiological release of insule.
BEFORE YOU USE TOBUMIDE TABLET
_- When you must not use it _

If you are allergic to Tolbutamide or any
other ingredients in the product_ _

If you have insulin-dependent diabetes
mellitus_ _

If you have diabetic ketoacidosis (A serious
diabetes complication where the body pro-
duces excess blood acids , ketones)_ _

If you have coma and precoma diabetes

If you are pregnancy or lactating
_ _
_- Before you start to use it _
You should check with your doctor:-

If you are or think you may be pregnant

If you are planning to become pregnant

If you are breastfeeding

If you plan to undergo surgery

If you have kidney and or liver disease

If
you
experience
severe
trauma
or
infections
_- Taking Other Medicines _
There are a few medicines which may not mix
with Tobumide Tablet. It is important to tell
your doctor or pharmacist about all the
medicines that you are taking, including those
obtained without doctor’s prescription.
You should talk to you doctor or pharmacist
if you are on the following:-

Beta blocker

Antibiotics

Thiazide and other diuretics

Minor Tranquilizers

Corticosteroids

Estrogens/oral contraceptives

P
                                
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Vara einkenni

                                Each tablet contains:
Tolbutamide 500mg
PHARMACODYNAMICS:
Tolbutamide is a sulphonylurea hypoglycaemic agent with actions and
uses similar to those of
chlorpropamide which is also a sulphonylurea.
Tolbutamide is a sulfonamide but not a sulfanilamide derivative. It is
devoid of chemotherapeutic
effect and it has no anti-bacterial activity.
The potency of chlorpropamide is approximately six times that of
tolbutamide. However, similar
to chlorpropamide, tolbutamide appears to lower blood glucose acutely
by stimulating the
release of insulin from the pancreas, an effect dependent upon
functioning beta cells in the
pancreatic islets. The mechanism by which tolbutamide lowers blood
glucose during long term
administration has not been clearly established. Extra-pancreatic
effects may play a part in the
mechanism of action of oral sulfonylurea hypoglycaemic drugs.
Tolbutamide is readily absorbed from the gastrointestinal tract and is
extensively bound to
plasma proteins. The duration of action is about 10 hours. The
half-life is generally within the
range of 4 to 8 hours but may be considerably longer. Tolbutamide is
metabolised in the liver and
excreted in the urine chiefly as metabolites with little hypoglycaemic
activity.
INDICATIONS:
The principal clinical indication for tolbutamide is diabetes mellitus
of the stable type without
acute complications such as acidosis or ketosis. This form of diabetes
has been variously
described as relatively mild adult, maturity-onset or non-ketotic
type. In certain patients with
labile diabetes, its use as a supplement to insulin therapy may effect
stabilization of the diabetic
condition and reduce insulin requirement.
ADVERSE REACTIONS:
Adverse
effects
include
nausea,
vomiting,
epigastric
pain,
dizziness,
weakness
and
paraesthesia. Sensitivity reactions with fever, eosinophilia,
jaundice, skin rashes and blood
disorders, including leucopenia, thrombocytopenia, aplastic anaemia
and agranulocytosis have
occurred. Intolerance to alcohol, characterised by facial flushing may
also occur
                                
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