Glibenclamide 2.5mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER Glibenclamide 2.5mg Tablets BP Glibenclamide 5mg Tablets BP

(Glibenclamide)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Glibenclamide Tablets are and what they are used for

2. What you need to know before you take Glibenclamide Tablets

3. How to take Glibenclamide Tablets

4. Possible side effects

5. How to store Glibenclamide Tablets

6. Contents of the pack and other information

1. What Glibenclamide tablets are and what they are used for

Glibenclamide tablets contain an active ingredient Glibenclamide. Glibenclamide belongs to a group of therapeutic medicines called sulphonylureas which are used for lowering your blood sugar. Glibenclamide Tablets are used for treatment of patients with Type ll maturity onset and non-insulin dependent diabetes that do not respond to the diet changes alone.

What you need to know before you take Glibenclamide Tablets

Do not take Glibenclamide Tablets if you:

• If you are allergic (hypersensitive) to Glibenclamide or any of the other ingredients of Glibenclamide Tablets (listed in section 6)

• If you have severe liver or kidney disease

• If you have type 1/juvenile diabetes or your diabetes is not stabilized

• If you have severe thyroid or adrenal gland problems

• If you have diabetes and have had ketosis or have experienced diabetic coma

• If you are pregnant, after delivery of your baby glibenclamide therapy may be started or resumed

• If you have a blood condition called porphyria

• If you are breastfeeding

• If you currently being treated with the medicine bosentan

• If you have insulin dependent diabetes

• When you are under unusual stress such as surgery, trauma or severe infection

You should talk to your doctor before taking this medicine if you are going to have an operation, if you have a serious accident or severe infection, which can affect your diabetes.

Warnings and precautions

Talk to your doctor or pharmacist before taking Glibenclamide Tablets if you:

• Start to have symptoms of jaundice such as yellowing of the eyes and skin. Your doctor may stop your medication

• Are elderly, seriously ill or malnourished as taking this medicine may lower your blood sugar too much.

When you are about to do strenuous exercises as this medicine can cause blood sugar levels to get too low known as “hypoglycaemia”. Early warning symptoms of low blood sugar include faintness, sweating, trembling, confusion or headache. You will need to eat and drink something sugary quickly.

Ask your doctor for more information about the symptoms of hypoglycaemia and what you should do if it happens. It is important that relatives and close work mates know that you have diabetes and are taking medication so that they can recognize the symptoms of hypoglycaemia and help if necessary.

Other medicines and Glibenclamide Tablets

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

In particular tell your doctor if you are taking a medicine called bosentan which is used to treat high blood pressure.

These medicines may increase the effect that glibenclamide has on lowering your blood sugar:

• Anabolic steroids e.g. nandrolone

• Analgesics used to treat pain e.g. aspirin, paracetamol and other Non-steroidal antiinflammatory drugs (NSAIDs) such as ibuprofen

• Antibacterials or antifungal e.g. fluconazole, sulphonamides, miconazole, chloramphenicol

• Anticoagulants to reduce blood clotting e.g. heparin, warfarin

• Cholesterol lowering agents e.g. clofibrate

• Anti-depressants e.g. MAOIs, nortriptyline

• Medicines used to treat heart conditions such as ACE inhibitors or beta-blockers e.g. captopril, enalapril, atenolol

• Medicines for stomach ulcers and dyspepsia e.g. cimetidine, ranitidine

• Drugs for obesity and gout e.g. Sulphinpyrazone

• Medicines used to treat arthritis e.g. cyclophosphamide, phenylbutazone

• Medicines used to treat tuberculosis.

These medicines may decrease the hypoglycemic effect of glibenclamide:

• Diuretics e.g. thiazide diuretics, furosemide, ethacrynic acid

• Phenothiazines used to treat schizophrenia

• Oral contraceptives containing oestrogen

• Corticosteroids

• Rifampicin, an antibiotic used to treat infections

• Ciclosporin, a medicine used after organ transplants.

These medicines may lower the body's tolerance to glucose:

• Calcium blockers used to treat heart conditions

• Lithium used to treat depression.

Taking Glibenclamide Tablets with food and drink:

Glibenclamide should be taken with or immediately after food.

Drinking alcohol while taking this medicine may affect the way that it works. Alcohol may cause flushes in some patients and can affect the levels of sugar in your blood. Talk to your doctor if you want to drink alcohol while taking this medicine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist if you are pregnant or planning to become pregnant. Consult your doctor if you are breast feeding or plan to breastfeed as small amounts of this medicine may pass into the mother's milk.

Driving and using machines

If you experience the symptoms of low blood sugar (hypoglycaemia) you should not drive or operate machinery. Low blood sugar may occur at the beginning of treatment while your doctor is trying to find the dose that bests suits you. Your doctor will give you further advice. When your blood sugar is stabilized you may drive or operate machinery.

Glibenclamide Tablets contains lactose

This medicine contains lactose (a type of sugar), so if you have been told by your doctor that you have intolerance to some sugars such as lactose talk to your doctor about taking this medicine.

How to take Glibenclamide Tablets

Always take Glibenclamide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

These tablets should be taken orally once a day with or immediately after breakfast or the first main meal of the day.

New diabetics: The usual starting dose for Glibenclamide is 2.5 - 5mg with elderly or ill patients which can be increased by 2.5mg at intervals of one week as directed by your doctor. The maximum daily dose is 15mg. You should continue to take these tablets for as long as your doctor tells you to.

Patients changing from other sulphonylureas: The transfer can usually be carried out without a break in treatment. Initial treatment with glibenclamide is 5mg daily. If necessary this can be increased in steps of 2.5mg or 5mg. A dose of 5mg glibenclamide is equivalent to 1,000mg tolbutamide, 250mg chlorpropamide, 25mg glibomuride and 5mg

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

Children: Glibenclamide Tablets are unsuitable for children.

If you take more Glibenclamide than you should

This medicine should be taken at regular intervals, as determined by the physician. If you accidentally take too many Glibenclamide Tablets seek immediate medical advice by contacting your doctor or nearest hospital casualty department. Take your tablet pack with you. Low blood sugar (hypoglycaemia) may be treated in the conscious patient by administration of glucose or 3 or 4 lumps of table sugar in water. If the patient is comatose, glucose can be administered as an intravenous infusion.

If you forget to take Glibenclamide Tablets

If you forget to take a dose, take the missing dose as soon as you remember, with your next meal. If it is time for the next dose do not double the dose to make up for the forgotten dose.

If you stop taking Glibenclamide Tablets

Keep taking your tablets until your doctor tells you to stop. Do not stop taking your tablets just because you feel better. If you stop taking this medicine your symptoms may come back. Do not stop taking this medicine without consulting your doctor or pharmacist.

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

. POSSIBLE SIDE EFFECTS

Like all medicines, Glibenclamide Tablets can cause some side effects, although not everybody gets them.

If the following happens, STOP taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

- 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 reaction, which causes severe blistering of the skin, mouth, eyes and genitals.

- Severe hypoglycameia including loss of consciousness, seizures or coma. Some patients experienced the following side effects whilst taking this medicine. Tell your doctor if you experience any of the following symptoms:

Rare side effects (may affect up to 1 in 1,000 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 makes infections more likely)

- Red blood cells (which can make the skin pale and cause weakness or breathlessness)

Very rare side effects (may affect up to 1 in 10,000 people)

- Stomach upsets such as nausea, vomiting, abdominal pain, diarrhoea, loss of appetite or a metallic taste. Taking doses with food may reduce these problems. They often get better spontaneously so you should continue to take the tablets unless your stomach is upset and shows no sign of getting better after a few days.

- Increased appetite and weight gain

- decrease in the amount of sodium level in your blood (shown by blood tests)

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Glibenclamide Tablets

Keep out of the sight and reach of children.

Do not use your medicine after the expiry date shown on the label.

The expiry date refers to the last day of the month.

These tablets should not be stored above 25°C and should be kept in their original container to protect them from light and moisture.

Do not use this medicine if you notice any visible signs of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other ingredients

What Glibenclamide Tablets contain:

The active substance is Glibenclamide.

The 2.5mg tablet contains 2.5mg of glibenclamide and the 5.0mg tablet contains 5.0mg glibenclamide.

The other ingredients are lactose, maize starch, povidone K30 and magnesium stearate.

What Glibenclamide Tablets look like and the contents of the pack:

Glibenclamide 2.5mg Tablets BP are white, circular tablets marked 'GL 2.5' on one face and plain on the reverse.

The registered pack sizes are 10, 14, 28, 100, 500 and 1000 tablets.

Glibenclamide 5mg Tablets BP are white, dragee shaped tablets marked 'GL' and '5' either side of a break line on one face and plain on the reverse.

The registered pack sizes are 28, 100, 500 and 1000 tablets.

Marketing Authorisation Holder

Aurobindo Pharma Limited,

Ares, Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

Manufacturer

Milpharm Limited,