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Glyade

CLICK TO BUY GENRX-GLICLAZIDE TAB 80MG 100

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contains the active ingredient gliclazide

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Glyade.

It does not contain all of the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Glyade against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Glyade is used for

Glyade is used to control blood glucose (the amount of sugar in the blood) in people with Type 2 diabetes mellitus. This type of diabetes is also known as non-insulin dependent diabetes mellitus (NIDDM) or maturity onset diabetes.

Glyade is used when diet and exercise are not enough to control your blood glucose.

It can be used alone, or together with insulin or other medicines for treating diabetes.

How Glyade works

Glyade belongs to a group of medicines called sulfonylureas. These medicines lower blood glucose by increasing the amount of insulin produced by your pancreas.

If your blood glucose is not properly controlled, you may experience or hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose).

HYPOGLYCAEMIA

Hypoglycaemia (low blood glucose) can occur suddenly. Signs may include:

• weakness, trembling or shaking
• sweating
• lightheadedness, dizziness, headache or lack of concentration
• irritability, tearfulness or crying
• hunger
• numbness around the lips and tongue.

If not treated quickly, these may progress to:

• sweating
• loss of co-ordination
• slurred speech
• confusion
• fits or loss of consciousness.

HYPERGLYCAEMIA

Hyperglycaemia (high blood glucose) usually occurs more slowly than hypoglycaemia. Signs of hyperglycaemia may include:

• lethargy or tiredness
• headache
• thirst
• passing large amounts of urine
• blurred vision.

Long-term hyperglycaemia can lead to serious health problems such as heart disease, blindness, poor blood circulation, gangrene and kidney damage.

Glyade is available only with a doctor`s prescription.

Before you take Glyade

When you must not take it

Do not take Glyade if you are allergic to:

• medicines containing gliclazide (e.g. Diamcron, Nidem)
• sulfonamide (“sulfa”) antibiotics or “sulfa” medicines including sulfamethoxazole (e.g. contained in Bactrim, Septrin) and acetazolamide (Diamox).
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing and shortness of breath.

Do not take Glyade if you have any of the following medical conditions:

• Type 1 diabetes mellitus, also known as insulin dependent diabetes or juvenile onset diabetes
• unstable diabetes that is not well controlled
• diabetic ketoacidosis, or a history of repeated episodes of ketoacidosis (this a symptom of uncontrolled diabetes, in which substances called ketone bodies build up in the blood – you may notice this as an unusual fruity odour on your breath, difficulty breathing, confusion and frequent urination)
• diabetic coma or pre-coma, which may follow on from diabetic ketoacidosis mentioned above
• severe kidney disease
• severe liver disease.

Do not take Glyade if you are pregnant or plan to become pregnant.

Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor will replace Glyade with insulin while you are pregnant.

Do not take Glyade if you are breastfeeding or plan to breastfeed.

Glyade is not recommended while you are breastfeeding.

Do not give Glyade to children.

There is not enough experience with the use of Glyade in children.

Do not take Glyade if the expiry date (EXP) printed on the pack has passed.

Do not take Glyade if the packaging shows signs of tampering or the tablets do not look quite right.

If you are not sure whether you should start taking Glyade ask your doctor.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you have any medical conditions, especially the following:

• kidney problems
• liver problems
• a history of diabetic coma
• adrenal, pituitary or thyroid problems
• heart failure.

Tell your doctor if you:

• drink alcohol
• do not eat regular meals
• do a lot of exercise
• are ill or feeling unwell.

Alcohol, diet, exercise and your general health all strongly affect the control of your diabetes. Discuss these with your doctor.

If you have not told your doctor about any of the above, tell them before you start taking Glyade.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by Glyade, or may affect how well it works. These include:

• other medicines used to treat diabetes, including insulin and metformin (e.g. Diabex, Diaformin)
• medicines that contain alcohol, such as cough and cold syrups
• beta blockers, a group of medicines used to treat high blood pressure and other heart conditions, such as atenolol (e.g. Tenormin, Noten) and metoprolol (e.g. Betaloc, Minax)
• monoamine oxidase inhibitors (MAOIs), a group of medicines used to treat depression, such as tranylcypromine (Parnate) and phenelzine (Nardil)
• non-steroidal anti-inflammatory drugs (NSAIDs), a group of medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis, such as ibuprofen (e.g. Nurofen, Rafen)
• medicines used to prevent blood clots such as warfarin (Coumadin, Marevan)
• cimetidine (e.g. Tagamet, Magicul), a medicine used to treat reflux and ulcers
• clofibrate (Atromid-S), a medicine used to reduce high blood fat levels
• corticosteroids such as prednisone (Panafcort, Sone) and cortisone (Cortate)
• oestrogens in oral contraceptives and hormone replacement therapy
• certain types of fluid tablets (thiazide diuretics), used to treat high blood pressure and swelling, such as hydrochlorothiazide (Dithiazide) and chlorthalidone (Hygroton)
• barbiturates, medicines used to treat epilepsy or for sedation, such as phenobarbitone.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have more information on medicines to be careful with or avoid while taking Glyade.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

How to take Glyade

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist.

How much to take

The dose varies from person to person.

The usual starting dose is half a tablet once a day. Your doctor may increase this dose up to four tablets a day, depending on how you respond to Glyade.

How to take Glyade

Swallow the tablets with a glass of water.

The tablets can be divided in half along the breakline, if advised by your doctor or pharmacist.

When to take Glyade

Do not skip meals while taking Glyade.

It does not matter if you take Glyade before, during or after food. However, it is important that you take it at the same time each day.

If you need to take more than two tablets per day, take them as two divided doses, in the morning and evening.

How long to take Glyade for

Keep taking Glyade for as long as your doctor recommends.

Glyade will help control diabetes but will not cure it. Most people will need to take Glyade for a long period of time.

If you forget to take Glyade

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much Glyade (overdose)

Immediately telephone your doctor, the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Glyade. Do this even if there are no signs of discomfort or poisoning.

If you take too much Glyade, you may experience symptoms of hypoglycaemia (low blood glucose).

If not treated quickly, these symptoms may progress to loss of co-ordination, slurred speech, confusion, fits or loss of consciousness.

At the first signs of hypoglycaemia, raise your blood glucose quickly by eating jelly beans, sugar or honey, drinking a non-diet soft drink or taking glucose tablets.

While you are taking Glyade

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking Glyade.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Glyade.

If you become pregnant while taking Glyade, tell your doctor immediately.

Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia and know how to treat them.

HYPOGLYCAEMIA

If you experience any of the symptoms of hypoglycaemia (low blood glucose), you need to raise your blood glucose immediately. You can do this by doing one of the following:

• eating 5 to 7 jelly beans
• eating 3 teaspoons of sugar or honey
• drinking half a can of non-diet soft drink
• taking 2 to 3 concentrated glucose tablets.

Unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates such as plain biscuits, fruit or milk.

Taking this extra carbohydrate will prevent a second drop in your blood glucose level.

HYPERGLYCAEMIA

If you experience any of the signs of hyperglycaemia (high blood glucose), contact your doctor immediately.

The risk of hyperglycaemia is increased in the following situations:

• uncontrolled diabetes
• illness, infection or stress
• taking less Glyade than prescribed
• taking certain other medicines
• too little exercise
• eating more carbohydrates than normal.

Tell your doctor if you:

• become ill
• are injured
• have a fever
• have an infection
• having surgery.

Your blood glucose may become difficult to control at these times. Your doctor may replace Glyade with insulin.

Visit your doctor regularly so that they can check on your progress.

Your doctor may want to check your eyes, feet, circulation, kidneys, heart, and blood pressure.

Check your blood glucose levels regularly.

This is the best way to tell if your diabetes is being controlled properly. Your doctor or diabetes educator will show you how and when to do this.

Carefully follow your doctor`s and dietitian`s advice on diet, drinking alcohol and exercise.

If you drink alcohol while taking Glyade, you may get flushing, headache, breathing difficulties, rapid heart beat, stomach pains or feel sick and vomit. The combination of alcohol and Glyade also increases the risk of hypoglycaemia occurring.

Tell your doctor immediately if you notice the return of any symptoms of hyperglycaemia you have experienced before starting Glyade.

These may include lethargy or tiredness, headache, thirst, passing large amounts of urine and blurred vision. These may be signs that Glyade is no longer working, even though you may have been taking it successfully for some time.

Things you must not do

Do not skip meals while taking Glyade.

Do not stop taking Glyade, or change the dose, without checking with your doctor.
Do not give Glyade to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Glyade affects you.

Glyade may cause dizziness in some people. Drinking alcohol can make this worse. If either of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Be careful not to let your blood glucose levels fall too low.

Low blood glucose levels may slow your reaction time and affect your ability to drive or operate machinery.

If you become sick with a cold, fever or flu, it is very important to continue taking Glyade and eating your normal meals.

If you have trouble eating solid food, use sugar-sweetened drinks as a carbohydrate substitute or eat small amounts of bland food.

Your diabetes educator or dietician can give you a list of foods to eat on sick days.

When you are travelling, it is a good idea to:

• wear some form of identification (e.g. bracelet) showing you have diabetes
• carry some form of sugar to treat hypoglycaemia if it occurs, for example, sugar sachets or jelly beans
• carry emergency food rations in case of a delay, for example, dried fruit, biscuits or muesli bars
• bring enough Glyade with you, so you don`t miss any doses.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Glyade.

Glyade helps most people with diabetes, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor if you notice any of the following and they worry you:

• signs of hypoglycaemia which may include weakness, trembling or shaking, sweating, lightheadedness, headache, dizziness, irritability and tearfulness
• stomach upset including nausea (feeling sick), heartburn
• constipation or a feeling of fullness in the stomach
• headache
• tiredness, weariness.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

• skin rash, itching, hives
• swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing; or shortness of breath.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After taking Glyade

Storage

Keep Glyade where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they will not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30 degrees C.
Do not store Glyade or any other medicine in the bathroom or near a sink. Do not leave Glyade in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Glyade, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Glyade is a round, white tablet that is cross-scored on one side.

Each pack contains 100 tablets.

Ingredients

The active ingredient in Glyade is gliclazide. Each Glyade tablet contains 80 mg of gliclazide.

The tablets also contain the following inactive ingredients:

• lactose
• maize starch
• pregelatinised maize starch
• magnesium stearate
• purified talc.

The tablets do not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Glyade is supplied by:

Alphapharm Pty Limited

• (ABN 93 002 359 739)
• Chase Building 2
• Wentworth Park Road
• Glebe NSW 2037
• Phone: (02) 9298 3999
• www.alphapharm.com.au
• Medical Information
• Phone: 1800 028 365
• Australian registration number:
• AUST R 70433
• This leaflet was prepared on
• 5 March 2004.

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