THE PREPARATION DESCRIPTION IS NOT INTENDED FOR MEDICATION WITHOUT PARTICIPATION OF THE DOCTOR!

What is it used for?

Non-insulin-dependent (type II) diabetes mellitus, whenever blood glucose levels cannot be controlled adequately by diet, physical exercise and weight reduction alone. Amaryl may also be used in combination with metformin (another oral antidiabetic) or insulin if your diabetes is not sufficiently controlled with Amaryl alone.

Contraindications and cautions:
AMARYL must not be used
- in patients hypersensitive to glimepiride, other suphonylureas, other sulfonamides, or any of the excipients (risk of hypersensitivity reactions).
- in pregnant or breast-feeding women (see under “Pregnancy and lactation”).
- in insulin dependent diadetes, diabetic coma, ketoacidosis.
- in severe renal or hepatic function disorders. In this case a change over to insulin is indicated, not least to achieve optimal metbolic control.
To achieve the goal of treatment with AMARYL - optimal control of blood glucose - adherence to correct diet, regular and sufficient physical exercise and, if necessary, reduction of body weight are just as necessary as regular ingestion of AMARYL.
Clinical signs of a still insufficiently lowered blood glucose (hyperglycaemia) are, e.g., increased urinary frequency, intense thirst, dryness of the mouth, and dry skin.
In the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates especially careful monitoring.
Factors favouring hypoglycaemia include
- unwillingness or (more commonly in older patients) incapacity of the patient to co-operate.
- undernourishment, irregular mealtimes or skipped meals.
- imbalance between physical exertion and carbohydrate intake.
- alterations of diet.
- consumption of alcohol, especially in combination with skipped meals.
- impaired renal function.
- severe impairment of liver function.
- overdosage with AMARYL.
- certain 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 corticoadrenal insufficiency).
- concurrent administration of certain other medicines (see “Interactions”).
The patient must inform the physician about such factors and about hypoglycaemic episodes since they may indicate the need for particularly careful monitoring.

Side effects:
Hypoglycaemia (sometimes life-threatening) may occur as a result of the blood-glucose-lowering action of AMARYL. This happens when there is imbalance between AMARYL dosage, carbohydrate intake (diet), physical exercise and other factors influencing metabolism.
Based on what is known of other sulfonylureas, drugs of this class may also cause prolonged hypoglycaemia.
Possible symptoms of hypoglycaemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, impaired alertness and reactions, depression, confusion, speech disorders, aphasia, 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 bradycardia.
In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris, and cardiac arrhythmias.
Especially at the start of treatment, there may be temporary visual impairment due to the change in blood glucose levels. The cause is a temporary alteration in the turgidity and hence the refractive index of the lens, this being dependent on blood glucose level.
Occasionally, gastrointestinal symptoms such as nausea, vomiting, sensations of pressure or fullness in the epigastrium, abdominal pain and diarrhoea may occur.
Rarely, elevation of liver enzymes may occur. In isolated cases, impairment of liver function (e.g. with cholestasis and jaundice) may develop, as well as hepatitis which may progress to liver failure.
Potentially life-threatening changes in the blood picture may occur: rarely, thrombocytopenia and, in isolated cases, leucopenia may develop. Based on what is known of other sulfonylureas, drugs of this class may - in isolated instances -cause in addition to the above haemolytic anaemia or, e.g., erythrocytopenia, granulocytopenia, agranulocytosis and (e.g. due to myelosuppression) pancytopenia.

Interactions:
Patients who take or discontinue taking certain other medicines while undergoing treatment with AMARYL may experience changes in blood glucose control.
Based on experience with AMARYL and on what is known of other sulfonylureas, the following interactions must be considered:
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following drugs is taken, for example:
- insulin and other, oral antidiabetics,
- ACE inhibitors,
- anabolic steroids and male sex hormones,
- chloramphenicol,
- coumarin derivatives,
- cyclophosphamide,
- disopyramide,
- fenfluramine,
- fenyramidol,
- fibrates,
- fluoxetine,
- guanethidine,
- ifosfamide,
- others
Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur when one of the following drugs is taken, for example:
- acetazolamide,
- barbiturates
- corticosteroids,
- diazoxide,
- diuretics,
- epinephrine (adrenaline) and other sympathomimetic agents,
- glucagon,
- laxatives (after protracted use),
- nicotinic acid (in high doses),
- others
H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect. Under the influence of sympatholytic drugs such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent. Both acute and chronic alcohol intake may potentiate or weaken the blood-glucose-lowering action of AMARYL in an unpredictable fashion.