Glanil Glibenclamide Caplets

Glanil® Caplets for oral administration

Active ingredients, Composition, Indication, Contraindications, Precautions, Pregnancy and lactation effects, Adverse reactions, Interactions, Dosage and administration: initial dose and dose titration, dose range in patients with well controlled diabetes-maximum doses, distribution of doses, secondary dosage adjustment, duration of treatment, changeover from other oral antidiabetics to Glanil, administration, Expiry date, Presentation and Manufacturer of Glanil Caplet Medicine for Diabetes.

 

ACTIVE INGREDIENT

Glibenclamide.

 

COMPOSITION

Each caplet of Glanil contains as active ingredient 5mg glibenclamide as well as the excipients.

 

INDICATION

Non-insulin dependent (type2) diabetes mellitus, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction alone.

 

CONTRAINDICATIONS

Glanil must not be used for

– Patient with insulin-dependent (type 1) 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 one of the excipients,

– Pregnant women,

– Breast-feeding women.

 

PRECAUTIONS

To achieve the goal of treatment with Glanil 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 Glanil.

Clinical signs of hyperglycaemia are: increased urinary frequency, intense thirst, dryness of the mouth, and dry skin.

During treatment with Glanil 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 Glanil 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-glucose-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 missed 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 Glanil,

– 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 of particularly careful monitoring.
If necessary, the dosage of Glanil 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 (excess reduction in blood sugar) which reflect the body’s adrenergic counterregulation (see under “Advserse 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 of sugar, e.g in the form of sugar lumps, sugar sweetened fruit juice of 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. Patient 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 treatment by different doctors (e.g hospital stay, after an accident, illness while or 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 maybe necessary to maintain good metabolic control.

Persons allergic to sulphonamide derivatives may develop an allergic reaction to glibenclamide as well.

 

PREGNANCY AND LACTATION

Glanil 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, Glanil must not be taken by breast-feeding women. If necessary the patient must change over to insulin, or must stop breast-feeding.

 

ADVERSE REACTIONS

Hypoglycaemia

Hypoglycaemia (excessive reduction in blood sugar) (sometimes prolonged and even life-threatening) may occur as a result of the blood sugar-lowering action of Glanil.

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, paresses, sensory disturbances, dizziness, helplessness, loss of self-control, delirius, 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, angiana pectoris, and cardia arrhythmias.

The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke.

The symptoms nearly always subside when hypoglycaemia is corrected.

 

Eye

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 Glanil.

In isolaled cases there may be elevation of liver enzyme levels and even impairment of liver function – e.g with impaired excretation bile pigment (cholestasis) and jaundice and hepatitis which can regress after withdrawal of glibenclamide, although they may lead to life threatening liver failure.

 

Blood

Potentially life threatening changes in the blood picture may occur: they may include – rarely- mild to severe thrombocytopenia (e.g presenting as purpura) and in isolated case-haemolytic anaemia, erythrocytope, leucopenia, granulocytopenia, granulocytopenia, granulocytopenia, agranulocytosis, and (e.g. due to myelosupression) pancytopenia. In principle, these reactions are reversible once Glanil has been withdrawn.

 

Other adverse reactions

Occasionally, allergic or pseudo-allergic reactions may occur, e.g in the form of itching or rashes. In isolated cases, mild reactions in the forms 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 one 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 rare 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.
Alertness and reactions may be impaired by hypoglycaemic or hyperglycaemic episodes, especially when beginning or after altering treatment or when Glanil is not taken regularly. This may, for example affect the ability to drive a vehicle or cross the road safely, or to operate machinery.

 

INTERACTIONS

Patients who take or discontinue taking certain other medicines while undergoing treatment with Glanil may experience changes in blood sugar control.

Potentiation of blood-sugar lowering effect and, thus, some instances hypoglycaemia (excessive reduction In blood sugar) may occur when taking other drugs, including: insulin and other (oral) antidiabetics, ACE inhibitors, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, coumarin derivatives, cylophosphamide, disopyramide fenfluramine, fenyramidol, fibrates, fluoxetine, infosfamide MAO inhibitors, miconazole, oxyphenbutazone, paraaminosalicylic acid, penfoxifylline (high dose parenteral), phenylbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulphonamides, sympatholytic agents (such as beta blockers and guanethidine), tetracyclines, tritoqualine, trofosfamide.

Weakening of the blood-sugar-lowering effect and, thus raised blood sugar levels may occur when taking other drugs. including: acetazoplamide, barbiturates, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetic agents, glucagon, corticosteroids, laxatives (after protracted use), nicotinic acid (in high doses), oestrogens and progestogens, phenothiazines, phenytoine, thyroid hormones, rifampicin.

H2 antagonists, clonidine and reserpin may lead to either potentiation or weakening of the blood sugar lowering effect: Under the influence of sympathotholytic drugs such as beta blockers clonidine, guanethidine and reserpine, the signs 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 glibenclamide in an unpredictable fashion.

Glibenclamide may either potentiate or weaken the effects of coumarin derivatives.

 

DOSAGE AND ADMINISTRATION

In principle, the dosage of Glanil is governed by the desired blood sugar level. The dosage of Glanil must be the lowest which is effective.

Treatment with Glanil must be initiated and monitored by doctor. The patient must take Glanil at the times and in the doses prescribed by the doctor.

Mistakes, e.g 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 in the event a dose cannot be taken at the prescribed time must be discussed and agreed between doctor and patient beforehand.

If it is discovered that too high a dose or an extra dose of Glanil had been taken, a doctor must be notified immediately.

 

Initial dose and dose titration

The usual initial dosage is 1/2 to 1 caplet Glanil once daily.

It is recommended that treatment be started with the smallest possible dose. This applies in particular to patients who are prone hypoglycaemia (excessive reduction in blood pressure) or who weigh less than 50kg.

If necessary the daily dose can be raised. It is recommended that the dose be increased gradually, i.e in increments of not more than ½ (1) caplet and at intervals of one to two weeks, and that the increase by guided by regular blood sugar monitoring.

 

Dose range in patients with well controlled diabetes; maximum doses

The usual single dose is 1/2 to 2 caplets Glanil. A single dose of 2 caplets Glanil must not be exceeded. Larger daily doses must be divided into at least two separate single doses.
The usual daily dose is 1 to 2 caplets Glanil. Exceeding a total daily dose of 3 caplets Glanil is not recommended because higher daily doses of up to 4caplets are more effective only in exceptional cases.

 

Distribution of doses

Timing and distribution of doses are to be decided by the doctor, taking into consideration the patient’s current life-style. Normally a single daily dose of Glanil is sufficient.

It is recommended that daily doses up to 2 caplets be taken before a substantial breakfast or before the first main meal, and any remaining portions of the total daily dose before the evening meal.

lt is very important not to skip meals after the caplets have been taken.

 

Secondary dosage adjustment

Glibenclamide requirements may fall as treatment proceeds. To avoid hypoglycaema timely dose reduction or cessation of Glanil therapy must therefore be considered.
Correction of dosage must also be considered, whenever

– The patient’s weight changes or

– The patient’s life-style changes or

Other factors arise which cause an increase susceptibility to hypoglycaemia or hyperglycaemia (see under precaution).

 

Duration of treatment

Treatment with Glanil is normally a long-term therapy.

 

Changeover from other oral antidiabetics to Glanil

There is no exact dosage relationship between Glanil and other oral antidiabetics. When substituting Glanil for other oral antidiabetics (drugs to lower blood sugar), it is recommended that the procedure be the same as for initial dosage starting with daily dose of 1/2 to 1 caplets Glanil. This applies even in cases where the patient is being switched from the maximum dose of another oral antidiabetic. Consideration must be given to the potency and duration of action of the previous antidiabetic agent. A break from medication may be required to avoid any summation of effects entailing a risk of hypoglycaemia.

 

Administration

Glanil caplets must be swallowed whole with sufficient amounts of liquid, e.g with roughly half to one glass of water.

 

EXPIRY DATE

Do not use than the date of expiry

Keep medicine out of the reach of children

 

Presentation

30 and 100 caplets of 5mg.

 

Manufactured by

Nigerian-German Chemicals Plc

Km 38, Abeokuta Expressway, Otta,

Ogun State, Nigeria.