Daonil, Semi-Daonil

Daonil^®
Semi-Daonil^® 
Glibenclamide
sanofi aventis

Composition
Each tablet Daonil contains as active ingredient 5.0 mg glibenclamide.

Each tablet Semi Daonil contains as active ingredient 2.5 mg glibenclamide
Excipient: Lactose, maize starch,talc, colloidal anhydrous silica, magnesium stearate.

Properties
Glibenclamide appear to lower the blood glucose acutely by stimulating the release of insulin from the pancreas and effect dependent upon functioning beta cells in the pancreating islets

Indication
Non-insulin-dependent (type-2) diabetes mellitus, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction alone.

Contraindications
Daonil/Semi Daonil must not be used for:

• patients with insulin-dependent (type 1) diabetes mellitus,
• treatment of diabetic ketoacidosis,
• treatment of diabetic precoma or coma,
• patient with serious renal dysfunction,
• patient with serious hepatic or adrenocortical dysfunction,
• patients hypersensitive to glibenclamide or to one of the excipients (see under "Composition")
• pregnant women
• breast-feeding women.

Precautions
To achieve the goal of treatment with Daonil/Semi 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/ SemiDaonil. Clinical signs of hyperglycaemia are: increased urinary frequency, intense thirst, dryness of the mouth and dry skin.
During treatment with Daonil/SemiDaonil 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/SemiDaonil 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 flavouring hypoglycaemia include.

• unwillingness or (more commonly in order patients) incapacity of the patient to cooperate.
• under nutrition,irregular mealtimes or missed meals,
• alternations of diet or unaccustomed physical exertion,
• consumption of alcohol, especially in combination with skipped meals, 
• impaired renal function,
• serious liver dysfunction,
• overdosage with Daonil/Semi Daonil
• uncompensated disorders of the endocrine system affecting carbohydrate metabolism or counter regulation of hypoglycaemia (as for thyroid function and in anterior pituitary or adrenocortical insufficiency),
• concurrent administration of certain other medicines (see under "interaction").

The patient must inform the doctor about such factors and about hypoglycaemia episodes since they may indicate the need or particularly careful monitoring if necessary, the dosage of Daonil/Semi-Daonil or the entire therapy must be modified. This also applies, whenever illness occurs during therapy or the patient's lifestyle changes. Those symptoms of hypoglycaemia (excessive reduction blood sugar) which reflect the body's adrenergic counter regulation (see under "Adverse Reaction") 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 person 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 hypolycaemia 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 situation (e.g. trauma, surgery, febrile infections) blood glucose regulation any deteriorate, and a temporary change to insulin may be necessary to maintain good metabolic control.
Persons allergic to sulphonamide derivates may develop an allergic reaction to glibenclamide as well.

Pregnancy and Lactation 
Daonil/Semi 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/Semi Daonil 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 Daonil/Semi-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, lost of self control,delirium, cerebral convulsions, somnolence and lost of consciousness up to and including coma, shallow respiration and slow heart rate (bradycardia).
In addition, signs of adrenergic counterregulation may be present such as sweating, clammy skin, anxiety, rapid heart rate (tachycardia), hypertension, palpitations, angina pectoris, and cardiac arrhytmias. 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 bloodsugar 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/Semi-Daonil. In isolated cases there may be elevation of liver enzyme levels and even impairment of liver function ego with impaired excretion of bile pigment (cholestasis) and jaundice and hepatitis which can regress after withdrawal of glibenc1amide, 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 cases haemolytic anaemia, erythrocytepenia, leucopenia, granulocytopenia, agranulocytosis and ( e.g. due to mylosuppression) pancytopenia
In principle, these reactions are reversible once Daonil/Semi-Daonil has been withdrawn.

Other adverse reaction
Occasionally, allergic or pseudo allergic 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 it self, but may alternatively be triggered by one of the excipients. Allergy to sulphonamide derivated 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
Alertness and reaction may be impaired by hypoglycaemic or hyperglycaemic episodes, especially when beginning or after altering treatment or when Daonil/Semi-Daonil is not taken regularly. This may for example, effect the ability to drive a vehicle or cross the road safely, or to operate machinery.

Interactions
Patient who take or discontinue taking certain other medicines while undergoing treatment with Daonil/ Semi-Daonil may experience changes in blood sugar control. Potentiation of the blood-sugar lowering effect and thus in some instances hypoglycaemia (excessive reduction in blood sugar) may occur when taking other drugs, including insulin and other (Oral) antidiabetics, ACE inhibitor, anabolic steroid and male sex hormones, azapropazone, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, ifosfamide, MAO-inhibitors, miconazole, oxyphenbutazone, para-aminosalicylic acid, pentoxifylline (high dose parenteral), phenylbutazone. probenecid, quinolones, salicylates, sulfinpyrazone, sulphonamides, sympatholytic agents( such as beta blockers and guanethidine), tetracycline, tritoqualine, trofosfamide. Weakening of the blood-sugar-lowering effect and, thus raised blood sugar levels may occur when taking other drugs, including: acetazolamide, barbiturates, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetic agents, glucagon,corticosteroids, laxatives (after protracted use), nicotinic acid (in high doses), oestrogens and progestogens, phenothiazines, phenytoin, 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 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 in take may potentiate or weaken the blood sugar-lowering action of glibeclamide in an unpredictable fashion. Glibenclamide may either potentiate or weaken the effect of coumarin derivatives.

Dosage and Administration
In principle, the dosage of Daonil/ Semi Daonil is governed by the desired blood sugar level. The dosage of Daonil/Semi Daonil must be the lowest which is effective. Treatment with Daonil/Semi-Daonil must be initiated and monitored by a doctor. The patients must take Daonil/Semi Daonil at the time and in the doses prescribed by the doctor. Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a large 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 Daonil/Semi Daonil has taken, doctor must be notified immediately.

Initial dose and dose titration
The usual initial dosage is ½ to 1 tablet Daonil or 1 to 2 tablet Semi Daonil once daily. It is recommended that treatment be started with the smallest possible dose. This applies in particular to patients who are prone to hypoglycaemia (excessive reduction in blood sugar) or who weight less than 50 kg.

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) tablet and at intervals of one to two weeks, and that the increase be guided by regular blood sugar monitoring
Dose range in patients with well controlled diabetes & maximum doses. The usual single dose is ½ to 2 tablets Daonil or 1 to 4 Semi Daonil. A single dose of 2 tablets Daonil or 4 tablets Semi-Daonil must not be exceeded.

Large daily doses must be divided into at least two separate single doses. the usual daily doses is 1 to 2 tablets Daonil or 2 to 4 tablets Semi Daonil. Exceeding a total daily dose of 3 tablets Daonil or 6 tablets Semi-Daonil is not recommended because higher daily doses of up to 4 tablets Daonil or 8 tablets Semi-Daonil 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 Daonil/Semi-Daonil is sufficient. It is recommended that daily doses of up to 2 tablets Daonil or 4 tablets Semi-Daonil 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. It is very important not to skip meals after the tablets have been taken.

Secondary dosage adjustment
Glibenclamide requirements may fall as treatment proceeds. To avoid hypoglycaemia timely dose reduction or cessation of Daonil/Semi-Daonil 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 increased susceptibility to hypoglycaemia or hyperglycaemia (see under "Precautions")

Duration of treatment 
Treatment with Daonil/Semi-Daonil is normally a long-term therapy

Changeover from other oral antidiabetics to Daonil/Semi-Daonil 
There is exact dosage relationship between Daonil/Semi-Daonil and other oral anti diabetics when substituting Daonil/Semi-Daonil for other oral anti diabetics (drugs to lower blood sugar), it is recommended that the procedure be the same as for initial dosage starting with daily doses of ½ to 1 tablets Daonil or 1 to 2 tablets Semi-Daonil This applies even in cases where the patient is being switched from the maximum dose of another oral anti diabetic.
Consideration must be given to the potency and duration of action of the previous anti diabetic agent A break from medication may be required to avoid any summation of effects entailing a risk of hypoglycaemia.

Administration
Daonil/Semi-Daonil tablets must be swallowed whole with sufficient amounts of liquid, e.g. with roughly half to one glass of water.

Expiry date
Do not use later than date of expiry.

Keep medicines out of the reach of children

Storage:
Store below 25°C

This packaged insert is continually up dated. Please read carefully before using a new pack.

Presentation:
Daonil:
Boxes of 10 blisters x 10 tablets of 5 mg glibenclamide.
Reg. No. DKL0121203910A1

Semi-Daonil:
Boxes of 10 blisters x 10 tablets of 2.5 mg glibenclamide.
Reg. No. DKL0121203910B1

ON MEDICAL PRESCRIPTION ONLY 
HARUS DENGAN RESEP DOKTER

Manufactured by
PT Aventis Pharma, Jakarta, Indonesia

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