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GLIBENCLAMIDE 2.5 MG TABLETS

Active substance(s): GLIBENCLAMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Glibenclamide 2.5mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Glibenclamide 2.5mg
For excipients, see 6.1

3

PHARMACEUTICAL FORM
Tablet for oral use
Glibenclamide 2.5mg Tablets are white, circular tablets marked ‘GL 2.5’ on one face
and plain on the reverse.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Glibenclamide is a hypoglycaemic agent indicated in the treatment of noninsulin
dependent diabetes in patients who respond inadequately to dietary measures alone.

4.2

Posology and method of administration
Treatment of previously untreated diabetes:
Stabilisation can be started with one 5mg tablet daily with or immediately after
breakfast or the first main meal. If control is satisfactory one tablet is
continued as the maintenance dose. If control is unsatisfactory, the dose can be
adjusted by increments of 2.5 or 5mg at weekly intervals. The total daily
dosage rarely exceeds 15mg and increasing the daily dosage above this does
not generally produce any additional effect.
The total daily requirement should normally be given as a single dose at
breakfast, or with the first main meal. The patient’s diet and activity should be
taken into account.
Children: Glibenclamide is not recommenced for use in children.

Elderly: In debilitated patients or aged patients who may be more liable to
hypoglycaemia, treatment should be initiated with one 2.5mg tablet daily.
Changeover from other sulphonylureas:
The changeover to glibenclamide from other drugs with similar mode of action
can be carried out without any break in therapy.
Treatment is commenced with the equivalent dose of glibenclamide without
exceeding an initial dose of 10mg. If response is inadequate, the dose can be
raised in a stepwise fashion to 15mg daily. One 5mg tablet of glibenclamide is
approximately equivalent to 1g tolbutamine or glymidine, 250mg
chlorpropamide or tolazamide, 500mg acetohexamide, 25mg glibornuride or
5mg glipizide.
Changeover from biguanides: The biguanide should be withdrawn and
glibenclamide treatment started with one 2.5mg tablet. The dosage should then
be adjusted by increments of 2.5mg to achieve control.
Combination with biguanides: If adequate control is not possible with diet and
15mg of glibenclamide, control may be established by combined
administration of glibenclamide and a biguanide derivative.
Changeover from insulin:
While it is appreciated that most patients who are on insulin therapy will continue to
need it, there may be a few patients, particularly those on low daily doses, who will
remain stabilised if transferred from insulin to glibenclamide.

4.3

Contraindications
i) Those patients who have or have ever had diabetic ketoacidosis.
ii) Insulin dependent diabetes mellitus.
iii) Severe impairment of renal, hepatic, thyroid or adrenocortical function.
iv) Circumstances of unusual stress such as surgery, severe infection and trauma.
v) Hypersensitivity to glibenclamide.

4.4

Special warnings and precautions for use
Care is necessary in elderly, debilitated or malnourished patients who are particularly
susceptible to the hypoglycaemic effects of sulphonylureas, and during excessive
exercise as hypoglycaemia may be provoked.

4.5

Interaction with other medicinal products and other forms of interaction
The hypoglycaemic effect of glibenclamide may be increased by: antiinfective
agents (eg: chloramphenicol, fluconazole, miconazole, sulphonamides
including co-trimoxazole), anti-inflammatory/analgesic agents (e.g.:
phenylbutazone, salicylates), dicoumarin anticoagulants and heparin, lipid
regulating agents (e.g. clofibrate), some antidepressants (monoamine oxidase
inhibitors, doxepin, nortriptyline), ACE-inhibitors captopril, enalapril, H2blockers, cimetidine, ranitidine, fenfluramine, methyldopa and
sulphinpyrazone, necessitating dosage reduction.
The hypoglycaemic effect of glibenclamide may be diminished by rifampicin,
thiazide diuretics and beta-blockers, necessitating dosage increase. Betablockers may
mask some of the symptoms of hypoglycaemia. Alcohol may interact with the
sulphonylureas, provoking facial flushing, and has a variable effect on blood sugar
levels.

4.6

Fertility, Pregnancy and lactation
There is no specific information on glibenclamide in pregnancy – insulin
therapy is usually substituted. Glibenclamide may be secreted in breast milk and
caution should be exercised when prescribing for nursing mothers, as there is a
possibility of causing hypoglycaemia in the infant.

4.7

Effects on ability to drive and use machines
None (unless there is a risk of hypoglycaemia).

4.8

Undesirable effects
Hypoglycaemia occurs with all hypoglycaemic agents. Gastrointestinal disturbances
(e.g.: nausea, vomiting, heartburn, anorexia, diarrhoea, metallic taste) are usually
mild and dose dependant. Increased appetite and weight gain may occur, also rashes
(usually hypersensitivity reactions), pruritus and photosensitivity. Severe
manifestations of hypersensitivity include cholestatic jaundice, leucopenia,
thrombocytopenia, aplastic anaemia, agranulocytosis, haemolytic anaemia, erythema
multiforme, Stevens-Johnson syndrome, exfoliative dermatitis and erythema
nodosum. Infrequently a syndrome of inappropriate secretion of antidiuretic hormone
may be induced.

4.9

Overdose
In acute poisoning the stomach should be emptied by emesis or lavage.

Hypoglycaemia should be treated urgently in the conscious patient with oral glucose.
If the patient is comatose glucose should be administered as an intravenous infusion.
Alternatively glucagon, administered in a dose of 1mg subcutaneously or
intramuscularly may be used. The patient should be observed over several days in
case hypoglycaemia recurs.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Glibenclamide is an orally active hypoglycaemic agent, which acts by
stimulating insulin secretion.
ATC Code: A10BB01

5.2

Pharmacokinetic properties
Glibenclamide is rapidly absorbed and is extensively bound to plasma proteins, but is
not readily displaced by acidic drugs. It is excreted as metabolites in the urine and
bile.

5.3

Preclinical safety data
There are no pre-clinical data of any relevance to the prescriber, which are additional
to those already included in other sections.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose monohydrate
Maize Starch
Povidone K30
Magnesium stearate

6.2

Incompatibilities
None.

6.3

Shelf life
36 months

6.4

Special precautions for storage
Polyethylene/polypropylene and glass containers: Do not store above 25° C.
Store in the original container. Keep the container tightly closed.
Blister strips: Do not store above 25° C. Store in the original container. Keep in the
outer carton.

6.5

Nature and contents of container
Polypropylene or polyethylene tablet container with polypropylene or
polyethylene tamper evident closure containing 100, 500 or 1000 tablets
Glass container with plastic tamper evident closure containing 100, 500 or
1000 tablets.
White opaque blister (250μm UPVC 40gsm UPVDC) sealed with 20μm tempered
aluminium foil. Tablets are packed in multiples of strips of 10, 14 or 28 tablets.

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0148

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/02/2012

10

DATE OF REVISION OF THE TEXT
24/09/2015

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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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