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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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