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TOLBUTAMIDE TABLETS 500MG

Active substance(s): TOLBUTAMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Glyconon
Tolbutamide Tablets 500mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolbutamide BP 500.00 mg

3

PHARMACEUTICAL FORM
Tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
As an oral hypoglycaemic agent in the treatment of diabetes mellitus of the
maturity-onset type, where control cannot be achieved by diet alone.
Glyconon is especially suitable for elderly patients.
The hypoglycaemic effect of Tolbutamide only occurs when the beta cells of
the islet tissue in the pancreas are intact and retain some functional capacity.
Glyconon has no place in the treatment of the severe diabetic but finds its
chief use in the treatment of maturity-onset diabetes, responding inadequately
to dietary treatment alone. In some of these patients it can replace low doses
of insulin or reduce the requirement for high doses.

4.2

Posology and method of administration
Adults:
Glyconon should be given with or just before meals for optimum control of
blood sugar.

1st day:
2nd day:
3rd day:

6 tablets
3 tablets
2-4 tablets

Maintenance: 2-3 tablets daily taken either as a single dose or divided into 2 or
3 doses. The correct dose is that which is sufficient to correct glycosuria and
hyperglycaemia without producing hypoglycaemia. The full effect of therapy
may take up to a week to develop. Patients who do not respond to 4 tablets
daily will generally not respond to higher doses. Where a patient is already
taking insulin, the change to Tolbutamide may be effected immediately where
the dose of insulin is 20 units or less per day. Where insulin is being given in
greater amounts, the number of units should be decreased over several days
and glycosuria should be monitored.
Elderly:
Glyconon is particularly suitable for elderly patients. However, since this patient
group may be more liable to sulphonylurea- induced hypoglycaemia, treatment
should be initiated at a lower dose.
Children:
As non-insulin dependent diabetes is not usually a disease of childhood,
Glyconon is not recommended for use in children.
Route of Administration: Oral.

4.3

Contraindications
Diabetes complicated by fever, trauma or gangrene and diabetic ketoacidosis.
Impaired renal, hepatic or thyroid function.

4.4

Special warnings and precautions for use
The possibility of thrombocytopenia and blood dyscrasias should be borne in
mind and a platelet count performed if indicated.
Cases which initially respond to Tolbutamide may relapse and this should be
considered as a possibility should glycosuria or hyperglycaemia appear during
treatment.
If fever or sore throat occurs, a white cell count should be performed and
should be repeated after five days as blood abnormalities may develop slowly.

4.5

Interaction with other medicinal products and other forms of interaction
Hypoglcaemia has occurred with the concomitant administration of alcohol,
azapropazone, beta-adrenergic blocking agents, cimetidine, chloramphenicol,
coumarins, fluconazole, miconazole, monoamine oxidase inhibitors,
phenylbutazone, phenytoin, sulfinpyrazone and sulphonamides. A
diminishing effect occurs with corticosteroids, loop and thiazide diuretics, oral
contraceptives and rifamycins.

4.6

Pregnancy and lactation
Use in Pregnancy: Do not use during pregnancy, particularly during the first and
last trimester unless clinically imperative. Safety in pregnancy has not been
proven.
Nursing mothers: Tolbutamide has been detected in small quantities in breast
milk.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
Gastric irritation may occur and be reduced by dividing the doses. Skin
sensitisation, weakness, paraesthesias, tinnitus, headache, intolerance to
alcohol and jaundice have been reported. Reversible blood dyscrasias have
also been observed. A small proportion of patients have difficulty in
metabolising Tolbutamide and as a result develop hypoglycaemia even with
low doses.

4.9

Overdose
Hypoglycaemia may be treated with oral dextrose or lump sugar (3-4 lumps)
and repeated if necessary. In the comatose patient glucose may be given by
sub-cutaneous or intra- muscular injection of 1 mg to produce consciousness.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Tolbutamide is a sulphonylurea and an orally active hypoglycaemic agent
which reduces blood-sugar concentration.
It is thought to act by stimulating insulin secretion and is only effective in the
presence of functioning islet tissue.
After a single dose the maximum effect on blood-sugar concentration occurs
in about 5 hours and lasts for 8-10 hours.

5.2

Pharmacokinetic properties
Tolbutamide is readily absorbed from the gastro-intestinal tract and is
extensively bound to plasma proteins.
Tolbutamide is metabolised in the liver and the metabolites are excreted in the
urine, with up to 75% of a dose being recovered in 24 hours.

5.3

Preclinical safety data
Not applicable

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Maize Starch
Methylcellulose
Purified water
Pregelatinised Starch
Sodium Starch Glycollate
Magnesium Stearate
Stearic Acid

6.2

Incompatibilities
There are no major incompatibilities.

6.3

Shelf life
36 months all pack sizes

6.4

Special precautions for storage
Protect from light.

6.5

Nature and contents of container
Polypropylene or high density polystyrene with polythene closures and
polyurethane wads or polythene inserts.
Pack sizes: 100, 500

6.6

Special precautions for disposal
No special instructions

7

MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0114

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/07/1987 / 28/10/2002

10

DATE OF REVISION OF THE TEXT
26/02/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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