GLIBENCLAMIDE 2.5 MG TABLETS BP, LIAMID 2.5 MG TABLETS, GLIKEN 2.5 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - GLIBENCLAMIDE 2.5 MG TABLETS BP, LIAMID 2.5 MG TABLETS, GLIKEN 2.5 MG 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.
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.

2. what you need to know before you take glibenclamide tabletsdo not take glibenclamide tablets if you: are allergic to glibenclamide or any of the other ingredients of glibenclamide tablets (listed in section 6)

Have type 1/juvenile diabetes or your diabetes is not stabilized
Have diabetes and have had ketosis or have experienced diabetic coma
Have thyroid problems
Have kidney problems or liver disease
Have functional problems with your adrenal glands
Are pregnant, after delivery of your baby glibenclamide therapy may be started or resumed
Have a blood condition called porphyria
Are breastfeeding
Currently being treated with the medicine bosentan
Have insulin dependent diabetes
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 seriously ill or malnourished as taking this medicine may lower your blood sugar too much.
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.
Have been told that you have problems with your adrenal or pituitary glands
Have kidney problems, your doctor may give you a lower dose and monitor your

response to Glibenclamide Tablets

Are elderly. Patients aged 65 years and older are particularly sensitive to hypoglycemic action of glibenclamide and are therefore more at risk of hypoglycaemia. In the elderly, low blood sugar may be somewhat difficult to recognise. The initial dose and the maintenance dose of glibenclamide, must be set by your doctor carefully in order to avoid hypoglycemic reactions.

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 or might take 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. warfarin and coumarin derivatives
Medicines used to reduce weight e.g. fenfluramine.
Anti-depressants e.g. MAOIs, nortriptyline
Medicines used to treat heart conditions such as ACE inhibitors or beta-blockers e.g. captopril, atenolol
Cimitidine used to treat ulcers
Sulphinpyrazone used to treat gout
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. Talk to your doctor if you want to drink alcohol while taking this medicine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice if you are pregnant or planning to become pregnant or planning on becoming pregnant before taking this medicine.

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

This medicine may make you feel dizzy, shaky, confused, weak and sleepy. These are some of the signs of low blood sugar. If you experience any of these then you should not 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.

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3. 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.

Taking this medicine

Take this medicine by mouth
Take with or immediately after food.

The usual dose for:

New diabetics : Patients should be started with 5mg daily or 2.5mg with elderly or ill patients. The doses may be increased by 2.5mg at intervals of one week as directed by your doctor. The maximum daily dose is 15mg.

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 glipizide.

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 have forgotten to take a dose, leave out that dose completely. Do not take a double dose to makeup for a forgotten dose. Take your next dose at the normal time. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

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.

4. 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,
– Allergic skin rashes may also occur such as erythema multiforme (red bullseye/ target lesions with dark centre surrounded by pale pink ring and bright red outer ring, which may appear on the palms or soles of the feet). Stevens-Johnson syndrome (rash with flushing, fever, blisters or ulcers), toxic epidermal necrolysis (reddening, peeling and swelling that resembles burns), exfoliative dermatitis (peeling of the skin over large areas of the body) and erythema nodosum (red lumps underneath the skin surface)
– Severe hypoglycaemia including loss of consciousness, seizures or coma. Other signs of severe hypoglycaemia can include sweating, clammy skin, anxiety, high blood pressure, chest pain (angina) and faster, stronger or irregular heart beat.
– There have been reports of changes to the blood including thrombocytopenia, agranulocytosis and anaemia. If you notice that you have started to bruise more easily, you have bleeding gums or you bleed for a long time after injury and you feel very tired and are pale, you should contact your doctor as soon as possible. If you become more susceptible to infections and develop mouth and throat ulcers, you should contact your doctor straight away.

Some patients have experienced the following side effects whilst taking this medicine.

Tell your doctor if you experience any of the following:

Lower blood sugar than normal (hypoglycaemia) (see section 2)
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 in your blood (shown by blood tests)
Temporary vision problems
Sensitivity to light (photosensitivity)

5. 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 ingredientswhat 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

Milpharm Limited

Ares, Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

Manufacturer

Milpharm Limited,