GLIBENESE™ TABLETS (glipizide) PATIENT INFORMATION LEAFLET 

What is in your medicine?

Glibenese tablets are white capsular shaped tablets with a score line across them to assist in breaking the tablets should this be necessary. Each tablet contains 5mg glipizide. The tablet also contains lactose, maize starch, microcrystalline cellulose and stearic acid.

The tablets come in packs of 56 tablets.

What type of medicine is Glibenese?

Glibenese is one of a group of medicines called sulphonylureas. It is an anti-diabetic medicine which is taken by mouth.

What is your medicine for?

Glibenese is used to lower blood sugar (glucose) in patients with non-insulin-dependent diabetes mellitus (NIDDM for short). This is also called maturity-onset (adult) or Type II diabetes.

It is always used in conjunction with a diet which restricts sugars and fats.

Before you use Glibenese.

Be sure to tell your doctor if:

• You have been told you are allergic to Glibenese or any of the ingredients in Glibenese.
• You have insulin dependent (Type I) diabetes.
• You have ketone bodies and sugar in your urine (this may mean you have ketoacidosis).
• You have liver or kidney problems
• You have thyroid problems
• You are about to have major surgery or you have recently suffered a severe illness or infection. At such times diabetic control may be lost.
• You are pregnant or trying to become pregnant
• You are breast feeding
• You are under 16 years of age
• You are taking miconazole

If any of the above applies to you this medicine may not be suitable for you to use. Your doctor will advise you.

How to take your medicine

Glibenese should only be taken by mouth. It is important that you take your tablets according to the instructions of your doctor. These will be written on the label of the pack. Do not take more Glibenese than your doctor has recommended. The following dosage recommendations are only guidelines.

The usual starting dose is one 5mg tablet taken approximately half hour before breakfast or the midday meal.

If you are elderly, have mild diabetes or suffer from liver or kidney problems you may be started on 2.5mg daily.

If your doctor feels your dose needs to be increased, he will instruct you to adjust the dose in small increments - usually in 2.5 - 5mg steps.

The maximum recommended dose is 20mg daily.

The label on the pack will tell you what dose YOU should take and how often to take it. If you are still not sure, ask your doctor or pharmacist.

Do not stop taking the tablets or adjust your dosage without seeing your doctor. Stopping the medicine may make the diabetes worse. It is important that you eat regular meals, follow your doctor's advice about the foods you eat, take regular exercise and test your blood glucose regularly.

 

Regular carbohydrate intake is important to avoid a hypoglycaemic event.

Does your medicine cause undesirable effects?

The most common effect is low blood sugar (hypoglycaemia), in rare cases this can be serious.

Hypoglycaemia may cause faintness, sweating, shaking, weakness and confusion.

It may be due to lack of food or too high a dose of the medicine.

It can be put right by eating or drinking something sugary. If this occurs you should tell your doctor.

If you suffer any of the effects listed below tell your doctor if they are troublesome, severe, or do not wear off as treatment goes on:

• Nausea
• Diarrhoea
• Constipation
• Pain in the stomach
• Vomiting
• Itchy skin (allergic), skin rash or eczema

The following may in addition be symptoms of hypoglycaemia

• Confusion
• Malaise
• Tremor
• Vision impairment (blurred or double vision) and decreased vision
• Sensitivity to light
• Dizziness
• Drowsiness
• Headache

The following effects have occurred in patients being given this medicine, but they may not be due to the drug:

• Abnormalities in liver function or other biochemical tests.

The following effects have also been experienced in patients taking glipizide: Cholestatic jaundice (itching, pale stool or dark urine, yellowing of the skin and whites of the eyes), discontinue treatment if this occurs. Liver damage, liver failure or hepatitis (inflammation of the liver), reduction in white blood cells (which may result in fever or sore throat), red blood cell damage (unusual bleeding or bruising), hepatic porphyria (a rare inherited blood disorder occurring in the liver), and dehydration (reduction in blood sodium).

Check with your doctor as soon as possible if they occur.

Serious undesirable effects are rare.

Hypersensitivity effects A few patients are allergic to medicines. This may cause sudden wheeziness, rash or itching all over the body. If any of these effects occur when you take Glibenese you should check with your doctor immediately.

It is important to tell your doctor or pharmacist if you suffer any other undesirable effects which are not listed above.

Look after your medicine

This treatment is for YOU. Do not give it to others. It may not suit them

Do not take this medicine after the date stamped on the pack.

Further information

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet is about Glibenese only.