1. NAME OF THE MEDICINAL PRODUCT

Glibenclamide Tablets 2.5mg Taj Pharma
Glibenclamide Tablets 5mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION 

    a) Each tablet contains:
    Glibenclamide                            2.5mg
    Excipients                                       q.s.
     

    b) Each tablet contains:
    Glibenclamide                               5mg
    Excipients                                       q.s.

For excipients, see 6.1

  1. PHARMACEUTICAL FORM

Tablet for oral use

  1. CLINICAL PARTICULARS
  • Therapeutic indications

Glibenclamide is a hypoglycaemic agent indicated in the treatment of noninsulin dependent diabetes in patients who respond inadequately to dietary measures alone.

  • Posology and method of administration

For oral administration.

Treatment of previously untreated diabetes:

Stabilisation can be started with one 5mg tablet daily with or immediately after breakfast or the first main meal. If control is satisfactory one tablet is continued as the maintenance dose. If control is unsatisfactory, the dose can be adjusted by increments of 2.5 or 5mg at weekly intervals. The total daily dosage rarely exceeds 15mg and increasing the daily dosage above this does not generally produce any additional effect.

The total daily requirement should normally be given as a single dose at breakfast, or with the first main meal. The patient’s diet and activity should be taken into account.

Children: Glibenclamide is not recommenced for use in children.

Elderly: In debilitated patients or aged patients who may be more liable to hypoglycaemia, treatment should be initiated with one 2.5mg tablet daily.

Changeover from other sulphonylureas:

The changeover to glibenclamide from other drugs with similar mode of action can be carried out without any break in therapy.

Treatment is commenced with the equivalent dose of glibenclamide without exceeding an initial dose of 10mg. If response is inadequate, the dose can be raised in a stepwise fashion to 15mg daily. One 5mg tablet of glibenclamide is approximately equivalent to 1g tolbutamine or glymidine, 250mg chlorpropamide or tolazamide, 500mg acetohexamide, 25mg glibornuride or 5mg glipizide.

Changeover from biguanides: The biguanide should be withdrawn and glibenclamide treatment started with one 2.5mg tablet. The dosage should then be adjusted by increments of 2.5mg to achieve control.

Combination with biguanides: If adequate control is not possible with diet and 15mg of glibenclamide, control may be established by combined administration of glibenclamide and a biguanide derivative.

Changeover from insulin:

While it is appreciated that most patients who are on insulin therapy will continue to need it, there may be a few patients, particularly those on low daily doses, who will remain stabilised if transferred from insulin to glibenclamide.

4.3 contraindications

  1. Those patients who have or have ever had diabetic ketoacidosis.
  2. Insulin dependent diabetes mellitus.
  • Severe impairment of renal, hepatic, thyroid or adrenocortical function.
  1. Circumstances of unusual stress such as surgery, severe infection and trauma.
  2. Hypersensitivity to glibenclamide.

4.4 special warnings and precautions for use

Care is necessary in elderly, debilitated or malnourished patients who are particularly susceptible to the hypoglycaemic effects of sulphonylureas, and during excessive exercise as hypoglycaemia may be provoked.

4.5 interaction with other medicinal products and other forms of interaction

The hypoglycaemic effect of glibenclamide may be increased by: antiinfective agents (eg: chloramphenicol, fluconazole, miconazole, sulphonamides including co-trimoxazole), anti- inflammatory/analgesic agents (e.g.: phenylbutazone, salicylates), dicoumarin anticoagulants and heparin, lipid regulating agents (e.g. clofibrate), some antidepressants (monoamine oxidase inhibitors, doxepin, nortriptyline), ACE-inhibitors captopril, enalapril, H2-blockers, cimetidine, ranitidine, fenfluramine, methyldopa and sulphinpyrazone, necessitating dosage reduction.

The hypoglycaemic effect of glibenclamide may be diminished by rifampicin, thiazide diuretics and beta-blockers, necessitating dosage increase. Betablockers may mask some of the symptoms of hypoglycaemia. Alcohol may interact with the sulphonylureas, provoking facial flushing, and has a variable effect on blood sugar levels.

Fertility, pregnancy and lactation

There is no specific information on glibenclamide in pregnancy – insulin therapy is usually substituted. Glibenclamide may be secreted in breast milk and caution should be exercised when prescribing for nursing mothers, as there is a possibility of causing hypoglycaemia in the infant.

Effects on ability to drive and use machines

None (unless there is a risk of hypoglycaemia).

4.6 undesirable effects

Hypoglycaemia occurs with all hypoglycaemic agents. Gastrointestinal disturbances (e.g.: nausea, vomiting, heartburn, anorexia, diarrhoea, metallic taste) are usually mild and dose dependant. Increased appetite and weight gain may occur, also rashes (usually hypersensitivity reactions), pruritus and photosensitivity. Severe manifestations of hypersensitivity include cholestatic jaundice, leucopenia, thrombocytopenia, aplastic anaemia, agranulocytosis, haemolytic anaemia, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis and erythema nodosum. Infrequently a syndrome of inappropriate secretion of antidiuretic hormone may be induced.

4.7 overdose

In acute poisoning the stomach should be emptied by emesis or lavage.

Hypoglycaemia should be treated urgently in the conscious patient with oral glucose. If the patient is comatose glucose should be administered as an intravenous infusion. Alternatively glucagon, administered in a dose of 1mg subcutaneously or intramuscularly may be used. The patient should be observed over several days in case hypoglycaemia recurs.

  1. PHARMACOLOGICAL PROPERTIES

5.1 pharmacodynamic   properties

Glibenclamide is an orally active hypoglycaemic agent, which acts by stimulating insulin secretion.

5.2 pharmacokinetic properties

Glibenclamide is rapidly absorbed and is extensively bound to plasma proteins, but is not readily displaced by acidic drugs. It is excreted as metabolites in the urine and bile.

5.3 preclinical safety data

There are no pre-clinical data of any relevance to the prescriber, which are additional to those already included in other sections.

  1. PHARMACEUTICAL PARTICULARS

6.1 list of excipients

Lactose monohydrate Maize Starch, Povidone, Magnesium stearate

6.2 incompatibilities

None.

6.3 shelf life

36 months

6.4 special precautions for storage

Polyethylene/polypropylene and glass containers: Do not store above 25° C. Store in the original container. Keep the container tightly closed.

Blister strips: Do not store above 25° C. Store in the original container. Keep in the outer carton.

6.5 nature and contents of container

PVC/PVDC/Al blisters.

Pack sizes:

Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg modified-release tablets.

Not all pack sizes may be marketed.

6.6 special precautions for disposal

None.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Glibenclamide Tablets 2.5mg / 5mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glibenclamide

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

IN THIS LEAFLET:

  1. What Glibenclamide is and what it is used for.
  2. Before you take Glibenclamide.
  3. How to take Glibenclamide.
  4. Possible side effects.
  5. How to store Glibenclamide.
  6. Further Information.

 

  1. WHAT GLIBENCLAMIDE IS AND WHAT IT IS USED FOR

Glibenclamide is a medicine taken by mouth to help lower blood sugar. It belongs to a group of medicines called sulfonylureas.

Glibenclamide works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels.

Glibenclamide is used to treat a certain form of diabetes (type 2 diabetes mellitus), when diet, physical exercise and weight reduction alone have not been able to control your blood sugar levels.

  1. BEFORE YOU TAKE GLIBENCLAMIDE

TABLETS

Do not take Glibenclamide Tablets if

  • you are allergic (hypersensitive) to glibenclamide, sulphonamides (medicines for bacterial infection) or any of the other ingredients of Glibenclamide.
  • you have diabetic ketoacidosis (a complication of diabetes with some of the following signs: fatigue, nausea (feeling sick), frequent urination and muscular stiffness)
  • you have experienced unusual breathing, strong smelling breath, or suffered from confusion, fainting or even coma as a result of your illness.
  • you have insulin dependent mellitus diabetes which does not respond to dietary measures alone.
  • you have juvenile or “brittle” diabetes.
  • you have sulphonylurea or sulphonamide intolerance.
  • you are pregnant or breast-feeding a baby.
  • you have kidney or liver problems, or specific hormone requirements.
  • you are taking medicines for the heart (e.g. bosentan used to treat high blood pressure)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking glibenclamide.

Take special care with Glibenclamide Tablets and talk to your doctor if

  • you have had any problems in the past with medicines used to treat a high blood sugar, sulphonamide antibiotics or if you have ever reacted badly to water tablets.
  • you have or have had major surgery or you recently suffered an infection, trauma or shock, your doctor may need to review your treatment.
  • you have an intolerance to some sugars
  • you have high levels of sugar in blood and urine
  • you have an enzyme deficiency (glucose-6-phosphate dehydrogenase) which can cause reduction in red blood cells (haemolytic anemia)
  • you have a severe liver or kidney disorder
  • you need an operation or are under part