Glibenclamide Tablets 5mg Taj Pharma

NAME OF THE MEDICINAL PRODUCT

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

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

PHARMACEUTICAL FORM

Tablet for oral use

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Changeover from biguanides: The biguanide should be withdrawn and glibenclamide treatment started with one 2.5mg tablet.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

Those patients who have or have ever had diabetic ketoacidosis.
Insulin dependent diabetes mellitus.

Severe impairment of renal, hepatic, thyroid or adrenocortical function.

Circumstances of unusual stress such as surgery, severe infection and trauma.
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.

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.

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.

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:

What Glibenclamide is and what it is used for.
Before you take Glibenclamide.
How to take Glibenclamide.
Possible side effects.
How to store Glibenclamide.
Further Information.

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.

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 particular stress

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking glibenclamide. Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase. The information available on the use of glibenclamide in people under 18 years of age is limited. Therefore glibenclamide is not recommended for use in children.

Important information about hypoglycaemia (low blood sugar)

When you take glibenclamide, you may get hypoglycaemia (low blood sugar). Please see below for additional information about hypoglycaemia, its signs and treatment.

Following factors could increase the risk of you getting hypoglycaemia:

Undernourishment, irregular meal time, missed or delayed meal or period of fasting
Changes to your diet
Taking more glibenclamide than needed
Having kidneys that do not work properly
Having severe liver disease
If you suffer from particular hormoneinduced disorders (disorders of the thyroid glands, of the pituitary gland or adrenal cortex)
Drinking alcohol (especially when you skip a meal)
Taking certain other medicines (See Taking other medicines below)
If you increase the amount of exercise you do and you don’t eat enough food or eat food containing less carbohydrate than usual.
If you are elderly or have adrenal or pituitary insufficiency

Signs of hypoglycaemia include:

Hunger pangs, headache, nausea, vomiting, sluggishness, sleepiness, problems sleeping, restlessness, aggression, problems with concentration, reduced alertness and reaction time, depression, confusion, problems with your speech and sight, slurred speech, shakiness, partial paralysis, dizziness, helplessness
The following signs may also occur: sweating, clammy skin, anxiety, fast or increased heart beat, high blood pressure, awareness of your heart beat, sudden strong pain in the breast that may radiate into neighbouring areas (angina pectoris and cardiac arrhythmias).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop fits, lose self control, breathing may be shallow and your heart beat slowed down, you may fall into unconsciousness. The clinical picture of a severe reduced blood sugar level may resemble that of a stroke.

Treating hypoglycaemia:

In most cases the signs of reduced blood sugar vanish very quickly when you consume some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea. You should therefore always take some form of sugar with you (e.g. sugar cubes).

Remember that artificial sweeteners are not effective.

Please contact your doctor or go to the hospital if taking sugar does not help or if the symptoms recur.

Laboratory Tests

The level of sugar in your blood or urine should be checked regularly. Your doctor may also take blood tests to monitor your blood cell levels and liver function.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Your doctor may wish to change your dose of glibenclamide if you are taking other medicines, which may weaken or strengthen the effect of glibenclamide on the level of sugar in your blood.

The following medicines can increase the blood sugar lowering effect of glibenclamide. This can lead to a risk of hypoglycaemia (low blood sugar):

Other medicines to treat diabetes mellitus (such as insulin)
Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone)
Medicines to treat urinary infections (such as some long acting sulfonamides)
Medicines to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
Medicines to inhibit blood clotting (coumarin derivatives such as warfarin)
Medicines supporting muscle build up (anabolics)
Medicines used for male sex hormone replacement therapy
Medicines to treat depression (fluoxetine, MAO-inhibitors)
Medicines lowering high cholesterol level (fibrates)
Medicines lowering high blood pressure (ACE inhibitors)

Medicines to treat gout (probenecid, sulfinpyrazone)

Medicines to treat cancer (cyclophosphamide, ifosfamide, trofosfamide)
Medicines used to reduce weight (fenfluramine)
Medicines to increase circulation when given in a high dose intravenous infusion (pentoxifylline)
Medicines to treat nasal allergies such as hay fever (tritoqualine)
Medicines called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms

The following medicines may decrease the blood sugar lowering effect of glibenclamide. This can lead to a risk of hyperglycaemia (high blood sugar level):

Medicines containing female sex hormones (oestrogens, progestogens)
Medicines to treat high blood pressure called thiazide diuretics (water tablets)
Medicines used to stimulate the thyroid gland
Medicines to treat allergies and inflammation (glucocorticoids)
Medicines to treat severe mental disorders (phenothiazine derivatives)
Medicines used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in lifethreatening emergencies (adrenaline and sympathomimetics)
Medicines to treat high cholesterol level (nicotinic acid)
Medicines to treat constipation when they are used long term (laxatives)
Medicines to treat fits (phenytoin)
Medicines to treat nervousness and sleep problems (barbiturates)
Medicines to treat increased pressure in the eye
Medicines to treat high blood pressure or lowering blood sugar (diazoxide)
Medicines to treat infections, tuberculosis (rifampicin)
Medicines to treat severe low blood sugar levels (glucagon)

The following medicines can increase or decrease the blood sugar lowering effect of glibenclamide:

Medicines to treat stomach ulcers (called H2 antagonists)
Medicines to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine and reserpine.

These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines

Glibenclamide may either increase or weaken the effects of the following medicines:

Medicines inhibiting blood clotting (coumarin derivatives such as warfarin)

Taking Glibenclamide Tablets with food and drink

Alcohol intake may increase or decrease the blood sugar lowering action of Glibenclamide in an unpredictable way..

Pregnancy and breast-feeding

Glibenclamide should not be taken during pregnancy and while breast-feeding. Ask you doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your ability to concentrate or react may be reduced if your blood sugar is lowered (hypoglycaemia), or raised (hyperglycaemia) or if you develop visual problems as a result of such conditions.

Bear in mind that you could endanger yourself or others (e.g. when driving a car or using machines). Please ask your doctor whether you can drive a car if you:

have frequent episodes of hypoglycaemia,
have fewer or no warning signals of hypoglycaemia

Important information about some of the ingredients of Glibenclamide Tablets

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

HOW TO TAKE GLIBENCLAMIDE TABLETS

Always take Glibenclamide Tablets exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.

Taking this medicine

Take this medicine by mouth, just before or with the first main meal of the day (usually breakfast). If you do not have breakfast you should take the product on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on glibenclamide.

Swallow the tablets whole with at least half glass of water. Do not crush or chew the tablets

How much to take

The dose of Glibenclamide depends on your needs, condition and results of blood and urine sugar tests and is determined by your doctor. Do not take more tablets than your doctor has prescribed.

The usual starting dose is one 5mg tablet daily.
If necessary, your doctor may increase the dose after each 1 – 2 weeks of treatment.
If you are run down or are elderly, you will usually start by taking a lower dose.
Your dose of Glibenclamide may need to be adjusted if you change weight, change your lifestyle, or if you are under a lot of stress. Please speak to your doctor if any of these situations apply to you.
If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor.

If you take more Glibenclamide Tablets than you should

If you happen to have taken too much glibenclamide or an additional dose there is a danger of hypoglycaemia (signs of hypoglycaemia see Section 2 – Take special care with glibenclamide ) and therefore you should instantly consume enough sugar (e.g. a small bar of sugar cubes, sweet juice, sweetened tea) and inform a doctor immediately.

When treating hypoglycaemia due to accidental intake in children, the quantity of sugar given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia. Persons in a state of unconsciousness must not be given food or drink.

Since the state of hypoglycaemia may last for some time it is very important that the patient is carefully monitored until there is no more danger. Admission into hospital may be necessary, also as a measure of precaution. Show the doctor the package or remaining tablets, so the doctor knows what has been taken.

Severe cases of hypoglycaemia accompanied by loss of consciousness and coma are cases of medical emergency requiring immediate medical treatment and admission into hospital. It may be helpful to tell your family and friends to call a doctor immediately if this happens to you.

If you forget to take Glibenclamide Tablets

If you forget to take a dose, do not take a double dose to make up for forgotten doses. Take your normal dose as soon as you remember and continue as normal. If you are unsure or are concerned contact your doctor to discuss.

If you stop taking Glibenclamide Tablets

Stopping or interrupting your medicine before finishing the course of treatment may cause your symptoms to return.

It is important not to stop taking your medicine without prior discussion with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, glibenclamide can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following symptoms:

Allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock.
Abnormal liver function including yellowing of the skin and eyes (jaundice), problems with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure.
Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions.
Severe hypoglycaemia including loss of consciousness, seizures or coma Some patients experienced the following side effects whilst taking glibenclamide:

Rare side effects (affects more than 1 patient in 10,000 and less than 1 patient in 1000 people)

Lower blood sugar than normal (hypoglycaemia) (See Section 2 – Take special care with glibenclamide )
Decrease in the number of blood cells.
Blood platelets (which increases risk of bleeding or bruising)
White blood cells (which makes infections more likely)
Red blood cells (which can make the skin pale and cause weakness or breathlessness) These problems generally get better after you stop taking glibenclamide .

Very rare side effects (affects less than 1 patient in 10,000)

Allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock. If you experience any of these symptoms, tell your doctor immediately.

Abnormal liver function including yellowing of the skin and eyes (jaundice), impairment of the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, tell your doctor immediately.
Feeling or being sick, diarrhoea, feeling full or bloated, and abdominal pain
Decrease in the amount of sodium level in your blood (shown by blood tests)

Other side effects include:

Allergy (hypersensitivity) of the skin may occur such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of your lips, throat or tongue. Therefore in the event of one of these side effects, tell your doctor immediately.
Problems with your sight may occur when beginning treatment with glibenclamide. This is due to changes in blood sugar levels and should soon improve

Increased liver enzymes

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 pharmacist.

HOW TO STORE GLIBENCLAMIDE TABLETS

This medicinal product does not require any special storage conditions.

Keep out of the reach and sight of children.

Do not use Glibenclamide Tablets after the expiry date which is stated on the carton and on the label or blister. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION

What Glibenclamide Tablets contain
a) Each tablet contains:
Glibenclamide 5mg
Excipients q.s.

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

The other ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate and talc.

What Glibenclamide Tablets look like and contents of the pack
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.