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Daonil
Glibenclamide
Product description
White, biplane oblong tablets with a score-line
on both sides. LDI is engraved each side of score-line and inverted. The other face is plain.
Composition
Each tablet contains, as active ingredient,
5mg glibenclamide. Excipients: Lactose monohydrate, maize starch, starch pregelatinised,
talc, colloidal anhydrous silica, magnesium stearate.
Mode of action
Glibenclamide can exert its effect only in
the presence of functionally competent beta-cells of the pancreas. It produces its hypoglycaemic
effect by releasing endogenous insulin. The intensity of its effect is enhanced by giving
glucose at the same time. Glibenclamide lowers the critical threshold at which insulin secretion begins.
Indication
Non-insulin-dependent (type II) diabetes mellitus,
whenever blood sugar levels cannot be controlled adequately by diet, physical exercise, or weight reduction alone.
Contraindications
Daonil must not be used for
- patients with insulin-dependent
(type I) diabetes mellitus,
- treatment of diabetic ketoacidosis,
- treatment of diabetic precoma or
coma,
- patients with serious renal dysfunction,
- patients with serious hepatic dysfunction,
- patients hypersensitive to glibenclamide
or to any of the excipients (see under "Composition"),
- pregnant women,
- breast-feeding women.
Precautions
To achieve the goal of treatment with Daonil
- optimal control of blood sugar
- adherence to correct diet, regular
and sufficient physical exercise
and, if necessary, reduction of
body weight are just as necessary
as regular intake of Daonil.
Clinical signs of hyperglycaemia
are: increased urinary frequency,
intense thirst, dryness of the
mouth, and dry skin.
During treatment with Daonil, glucose levels in
blood and urine must be measured regularly. In addition, it is recommended that regular
determinations of the proportion of glycated haemoglobin be carried out. When starting treatment,
the patient must be informed about the effects and risks of Daonil and about its interaction with dietary measures
and physical exercise; the
importance of adequate cooperation must also be stressed. As is necessary during treatment
with any blood-sugar-lowering drug, the patient and the doctor must be aware of the risk of
hypoglycaemia (excessive reduction in blood sugar).
Factors favouring hypoglycaemia include:
- unwillingness or (more commonly in older patients) incapacity of the patient to cooperate,
- undernutrition, irregular mealtimes, or skipped meals,
- alterations of diet or unaccustomed physical exertion,
- consumption of alcohol, especially in combination with skipped meals,
- impaired renal function,
- serious liver dysfunction,
- overdosage with Daonil
- uncompensated disorders of the endocrine system
affecting carbohydrate metabolism or counter-regulation of hypoglycaemia (as for example in
certain disorders of thyroid function and in anterior pituitary or adrenocortical insufficiency),
- concurrent administration of certain other medicines (see under "Interactions').
The patient must inform the doctor about
such factors and about hypoglycaemic episodes, since they may indicate the need for
particularly careful monitoring. If necessary, the dosage of Daonil or the entire therapy
must be modified. This also applies whenever illness occurs during therapy or the patient's life-style changes.
Those symptoms of hypoglycaemia (excessive reduction in blood sugar) which reflect the
body's adrenergic counterregulation (see under "Adverse Reactions") may be milder or absent
where hypoglycaemia develops gradually, where there is autonomic neuropathy
(disorder of part of the nervous system) or where the patient is receiving concurrent treatment
with beta-blockers, clonidine, reserpine, guanethidine, or other sympatholytic drugs. Hypoglycaemia can, almost always,
be promptly controlled by immediate intake of carbohydrates (glucose or sugar, e.g., in the
form of sugar lumps, sugar sweetened fruit juice or tea). For this purpose, patients must
carry a minimum of 20 grams of glucose with them at all times. They may require the assistance
of other persons to avoid complications. Artificial sweeteners are ineffective
in controlling hypoglycaemia. Despite initially successful countermeasures, hypoglycaemia
(excessive reduction in blood sugar) may recur. Patients must, therefore, remain under close observation.
Severe hypoglycaemia, or a protracted episode, which can only be temporarily controlled by usual
amounts of sugar, further requires immediate treatment and follow-up by a doctor and, in some circumstances,
in-patient hospital care. If treated by different doctors (e.g. hospital stay, after an accident,
illness while on holiday), the patients must inform them of their diabetic condition and previous treatment.
In exceptional stress situations (e.g. trauma, surgery, febrile infections), blood glucose regulation may deteriorate,
and a temporary change to insulin may be necessary to maintain good metabolic control.
Persons allergic to other sulfonamide derivatives may develop an allergic reaction to glibenclamide as well.
Pregnancy and lactation
Daonil must not be taken during pregnancy.
The patient must change over to insulin during pregnancy. Patients planning a pregnancy must
inform their doctor. Such patients should change over to insulin. To prevent possible ingestion with the breast milk,
Daonil must not be taken by breastfeeding women. If necessary, the patient must change over to insulin, or must stop breastfeeding.
Adverse reactions
Hypoglycaemia: Hypoglycaemia
(excessive reduction in blood sugar), sometimes prolonged and even lifethreatening,
may occur as a result of the blood-sugar-lowering action of Daonil. Possible symptoms of
hypoglycaemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness,
disordered sleep, restlessness, aggressiveness, impaired concentration, alertness and reactions,
depression, confusion, difficulty in speaking and even speech loss, visual disorders, tremor, pareses, sensory
disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral convulsions,
somnolence and loss of consciousness up to and including coma, shallow respiration and slow
heart rate (bradycardia). In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin,
anxiety, rapid heart rate
(tachycardia), hypertension, palpitations, angina pectoris, and cardiac arrhythmias.
The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke.
The symptoms nearly always subside when hypoglycaemia is corrected.
Eyes: Especially at the start of treatment,
there may be temporary visual impairment due to the change in blood sugar levels.
Digestive tract: Occasionally,
gastrointestinal symptoms such as nausea, vomiting, sensations of pressure or fullness in the epigastrium,
abdominal pain and diarrhoea may occur. However, despite continued treatment, these often subside
and usually do not necessitate discontinuing Daonil. In isolated cases, there may be elevation of
liver enzyme levels and even impairment of liver function - e.g. with impaired excretion of
bile pigment (cholestasis) and jaundice - and hepatitis which can regress
after withdrawal of Daonil, although they may lead to lifethreatening liver failure.
Blood: Potentially life-threatening changes
in the blood picture may occur. They may include rarely - mild to severe thrombopenia
(e.g. presenting as purpura) and - in isolated cases - haemolytic
anaemia, erythrocytopenia,
leucopenia, granulocytopenia, agranulocytosis, and (e.g. due to myelosuppression) pancytopenia.
In principle, these reactions are reversible once Daonil has been withdrawn.
Other adverse reactions:
Occasionally, allergic or pseudoallergic reactions may occur, e.g. in the form of itching or rashes.
In isolated cases, mild reactions in the form of urticaria may develop
into serious and even life
threatening reactions with dyspnoea and fall in blood pressure, sometimes progressing to shock.
In the event of urticaria, a doctor must therefore be notified immediately.
A hypersensitivity reaction may be directed
against glibenclamide itself, but may alternatively be triggered by any of the excipients. Allergy to sulphonamide derivatives
may also be responsible for an allergic reaction to glibenclamide.
In isolated cases, allergic vasculitis
(inflammation of blood vessels) may
arise and, in some circumstances,
may be life-threatening. In isolated
cases, hypersensitivity of the skin to
light may occur, and sodium
concentration in the serum may decrease.
If you notice any adverse reactions, please consult a doctor.
Effects on ability to drive and use machines:
Alertness and reactions may be impaired by hypoglycaemic or hyperglycaemic episodes, especially
when beginning or after altering treatment, or when Daonil is not taken regularly. This may, for
example, affect the ability to drive or operate machinery.
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