Full Prescribing Info
Each tablet also contains lactose, sodium starch glycolate, polyvidone 25,000, microcrystalline cellulose and magnesium stearate as excipients.
The 1-mg tablet also contains red ferric oxide (E172) as colouring agent; the 2-mg tablet also contains yellow ferric oxide (E172) and indigo carmine aluminium lake (E132); and the 3-mg tablet also contains yellow ferric oxide (E172).
Glimepiride is a blood sugar-lowering agent belonging to the sulfonylurea group. The decrease in blood sugar is achieved principally by means of the stimulation of insulin release from pancreatic β-cells. This effect is predominantly based on improved responsiveness of these cells to the physiological glucose stimulus. Glimepiride augments the normal action of insulin on peripheral glucose uptake. Moreover, it mimics such action as well as the glucose output of the liver. Good metabolic control over 24 hrs can be achieved with a single dose of Amaryl.
In patients with insufficient response to the maximum dose, combined use with an additional oral antidiabetic containing metformin or with insulin improves metabolic control.
Non-insulin-dependent (type II) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction alone. Amaryl may also be used in combination with an oral antidiabetic containing metformin or with insulin.
Dosage/Direction for Use
In principle, the dosage of Amaryl is governed by the desired blood sugar level. The dosage of glimepiride must be the lowest which is sufficient to achieve the desired metabolic control.
Treatment with Amaryl must be initiated and monitored by a physician. Amaryl must be taken at the times and in the doses prescribed. Mistakes eg, forgetting to take a dose, must never be corrected by subsequently taking a larger dose. Measures for dealing with such mistakes (in particular, forgetting a dose or skipping a meal), or situations where a dose cannot be taken at the prescribed time, must be discussed and agreed between physician and patient beforehand. A physician must be notified immediately if the dose taken is too high, or an extra dose has been taken.
The initial and the maintenance doses are set based on the results of regular checks of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial Dose and Dose Titration: The usual initial dose is 1 mg once daily. If necessary, the daily dose can be increased. Any increase should be based on regular blood sugar monitoring, and should be gradual ie, at intervals of 1-2 weeks, and carried out stepwise, as follows: 1 mg -2 mg -3 mg -4 mg -6 mg, and, in exceptional cases, 8 mg.
Dose Range in Patients with Well-Controlled Diabetes: The usual dose range in patients with well-controlled diabetes is 1-4 mg of Amaryl daily. Only some patients benefit from daily doses of >6 mg.
Distribution of Doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current lifestyle. Normally, a single daily dose of Amaryl is sufficient. This should be taken immediately before a substantial breakfast or, if none is taken, immediately before the 1st main meal. It is very important not to skip meals after taking Amaryl.
Secondary Dosage Adjustment: As the control of diabetes improves, sensitivity to insulin increases; therefore, glimepiride requirements may fall as treatment proceeds. To avoid hypoglycaemia, a timely dose reduction or cessation of Amaryl therapy must be considered.
A dose adjustment must also be considered whenever the patient's weight or lifestyle changes, or other factors arise which cause an increased susceptibility to hypo- or hyperglycaemia (see under Precautions).
Duration of Treatment: Treatment with Amaryl is normally a long-term therapy.
Changeover from Other Oral Antidiabetics to Amaryl: There is no exact dosage relationship between Amaryl and other oral blood sugar-lowering agents. When substituting Amaryl for other such agents, the initial daily dose is 1 mg; this applies even in changeovers from the maximum dose of another oral blood sugar-lowering agent. Any Amaryl dose increase should be in accordance with guidelines given previously in Initial Dose and Dose Titration. Consideration must be given to the potency and duration of action of the previous blood sugar-lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Use in Combination with Metformin: Whenever blood sugar levels cannot be controlled adequately with the minimum daily dose of either Amaryl or a metformin-containing antidiabetic alone, both medicines may be used concomitantly. In such cases, the dose of the established medicine remains unchanged. Treatment with the additional medicine is started at a low dose, which, depending on the desired blood sugar level, may then be increased gradually up to the maximum daily dose. Combined treatment should be initiated under close medical supervision.
Use in Combination with Insulin: Whenever blood sugar levels cannot be controlled adequately with the maximum daily dose of Amaryl, insulin may be given concomitantly. In this case, the current dose of Amaryl remains unchanged. Insulin treatment is started at a low dose, which is subsequently increased stepwise according to the desired blood sugar level. Combined treatment should be initiated under close medical supervision.
Administration: Amaryl tablets must be swallowed without chewing and with sufficient amounts of liquid (approximately ½ glass).
Amaryl is not suitable for the treatment of insulin-dependent (type I) diabetes mellitus (eg, for the treatment of diabetics with a history of ketoacidosis), of diabetic ketoacidosis, or of diabetic precoma or coma. Amaryl must not be used in patients hypersensitive to glimepiride, other sulfonylureas, other sulfonamides, or any of the excipients (risk of hypersensitivity reactions).
No experience has been gained concerning the use of Amaryl in patients with severe impairment of liver function and in dialysis patients. In patients with severe impairment of renal or hepatic function, a changeover to insulin is indicated, not least to achieve optimal metabolic control.
Use in Pregnancy & Lactation: To avoid risk of harm to the child, Amaryl must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician and should changeover to insulin. Ingestion of glimepiride with the breastmilk may harm the child. Therefore, Amaryl must not be taken by breastfeeding women. Either a changeover to insulin or a complete discontinuation of breastfeeding is necessary.
Special Precautions
To achieve optimal control of blood sugar, a correct diet, regular and sufficient physical exercise and, if necessary, reduction of body weight are just as important as regular intake of Amaryl. Clinical signs of insufficiently lowered blood sugar (hyperglycaemia) are increased urinary frequency, intense thirst, dryness of the mouth and dry skin.
When starting treatment, the patient must be informed about the effects and risks of Amaryl and about its role in conjunction with dietary measures and physical exercise; the importance of adequate cooperation must also be stressed.
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 cooperate; undernutrition, 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 (eg, in certain disorders of thyroid function and in anterior pituitary or adrenocortical insufficiency); concurrent administration of certain other medicines (see Interactions).
The physician must be informed about such factors and about hypoglycaemic episodes, since these require particularly careful monitoring.
If such risk factors for hypoglycaemia are present, it may be necessary to adjust the dosage of Amaryl or the entire therapy. This also applies whenever illness occurs during therapy or the patient's lifestyle changes.
Those symptoms of hypoglycaemia which reflect the body's adrenergic counter-regulation (see under Adverse Reactions) may be milder or absent in those situations where hypoglycaemia develops gradually, in the elderly, and in patients with autonomic neuropathy or those receiving concurrent treatment with β-blockers, clonidine, reserpine, guanethidine or other sympatholytic drugs.
Hypoglycaemia can almost always be promptly controlled by immediate intake of carbohydrates (glucose or sugar eg, in the form of sugar lumps, sugar-sweetened fruit juice or sugar-sweetened tea). For this purpose, patients must carry a minimum of 20 g 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. It is known from other sulfonylureas that despite initially successful countermeasures, hypoglycaemia may recur. Therefore, continued close observation is necessary. Severe hypoglycaemia requires, in addition, immediate treatment and follow-up by a physician and, in some circumstances, hospitalization.
If treated by different physicians (eg, 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 (eg, trauma, surgery, infections with fever), blood sugar control may deteriorate and a temporary change to insulin may be necessary.
During treatment with Amaryl, glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycated haemoglobin.
Effects on the Ability to Drive or Operate Machinery: Alertness and reactions may be impaired due to hypoglycaemia or hyperglycaemia, especially when beginning or after altering treatment, or when Amaryl is not taken regularly. This may affect the ability to operate a vehicle or machinery.
Use In Pregnancy & Lactation
To avoid risk of harm to the child, Amaryl must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician and should changeover to insulin. Ingestion of glimepiride with the breastmilk may harm the child. Therefore, Amaryl must not be taken by breastfeeding women. Either a changeover to insulin or a complete discontinuation of breastfeeding is necessary.
Adverse Reactions
Based on experience with Amaryl and on what is known of other sulfonylureas, the following adverse effects must be considered:
Hypoglycaemia: As a result of the blood sugar-lowering action of Amaryl, hypoglycaemia may occur and may also be prolonged.
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, paresis, 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 eg, sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmias. The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke. Once hypoglycaemia has been corrected, all of the previously mentioned symptoms almost always subside.
Eyes: Especially at the start of treatment, temporary visual impairment may occur due to the change in blood sugar levels.
Digestive Tract: Occasionally, gastrointestinal symptoms such as the following may occur: Nausea, vomiting, sensations of pressure or fullness in the epigastrium, abdominal pain and diarrhoea.
In isolated cases, liver enzyme levels may increase and impairment of liver function (eg, with cholestasis and jaundice) and hepatitis may develop, possibly resulting in liver failure.
Blood: Severe changes in the blood picture may occur: Rarely, thrombopenia and, in isolated cases, leucopenia, haemolytic anaemia, or eg, erythrocytopenia, granulocytopenia, agranulocytosis and pancytopenia (eg, due to myelosuppression) may develop.
Others: Occasionally, allergic or pseudoallergic reactions may occur eg, in the form of itching, urticaria or rashes. Such reactions are mild but may become more serious and accompanied by dyspnoea and a fall in blood pressure, sometimes progressing to shock. If urticaria occurs, a physician must be notified immediately.
In isolated cases, the following may occur: Allergic vasculitis, hypersensitivity of the skin to light and a decrease in serum sodium.
Consult a physician if any of these adverse effects or any other undesired effects or unexpected changes are noticed.
Since some adverse effects eg, severe hypoglycaemia, certain changes in blood picture, severe allergic or pseudoallergic reactions, or liver failure, may under certain circumstances, become life-threatening, it is essential, if sudden or severe reactions do occur, to inform a physician at once, and on no account continue taking the drug without a physician's express guidance.
Drug Interactions
Patients who take or discontinue taking certain other medicines while undergoing treatment with Amaryl may experience changes in blood sugar control.
Based on experience with Amaryl and on what is known of other sulfonylureas, the following interactions must be considered:
Potentiation of the blood sugar-lowering effect and, thus, in some instances, hypoglycaemia may occur when one of the following medicines is taken eg, insulin and other oral antidiabetics, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAO inhibitors, miconazole, para-aminosalicylic acid, pentoxifylline (high-dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides, tetracyclines, tritoqualine, trofosfamide.
Weakening of the blood sugar-lowering effect and, thus, raised blood sugar levels may occur when one of the following medicines is taken eg, acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetic agents, glucagon, laxatives (after protracted use), nicotinic acid (in high doses), oestrogens and progestogens, phenothiazines, phenytoin, rifampicin and thyroid hormones.
H2-Receptor antagonists, clonidine and reserpine may lead to either potentiation or weakening of the blood sugar-lowering effect.
Beta-blockers decrease glucose tolerance. In patients with diabetes mellitus, this may lead to deterioration of metabolic control. In addition, β-blockers may increase the tendency to hypoglycaemia (due to impaired counter-regulation). Under the influence of sympatholytic drugs eg, β-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 sugar-lowering action of Amaryl unpredictably.
The effect of coumarin derivatives may be potentiated or weakened.
Store below +25°C.
MIMS Class
ATC Classification
A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Tab 1 mg x 120's. 2 mg x 120's. 3 mg x 120's. 4 mg x 30's.
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