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Diamicron

gliclazide 80mg (pronounced gly-cla-zyde)
CONSUMER MEDICINE INFORMATION

Buy Diamicron (Gliclazide) MR Tablets 60mg (Pack of 60).

What is in this leaflet

This leaflet answers some common questions about Diamicron. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Diamicron against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine.

You may need to read it again.

What Diamicron is used for

Diamicron is used to control blood glucose in patients with Type 2 diabetes. Type 2 diabetes is also known as non-insulin dependent diabetes mellitus or maturity onset diabetes. In Type 2 diabetes, blood glucose stays too high because your body is not able to manage it properly.

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

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

How it works

Diamicron lowers blood glucose (sugar) by increasing the amount of insulin produced by your pancreas. Diamicron belongs to a group of medicines called sulphonylureas (pronounced sulf-on-ile-u-ree-as)

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

Low blood glucose can occur suddenly. Signs may include:

weakness, trembling or shaking
sweating
light-headedness, dizziness, headache or lack of concentration
feeling teary or crying
irritability
hunger
numbness around the lips and tongue.
If not treated promptly, these may progress to:
loss of co-ordination
slurred speech
confusion
loss of consciousness or fitting.
High blood glucose usually occurs more slowly than low blood glucose. Signs of high blood glucose may include:
lethargy or tiredness
headache
thirst
passing large amounts of urine
blurred vision.

Over time, high blood glucose can lead to serious problems with your heart, eyes, circulation or kidneys.

Diamicron is only available with a doctor`s prescription.

Before you take Diamicron

There are some people who shouldn`t take Diamicron. Please read the list below. If you think any of these situations apply to you or you have any questions, please consult your doctor.

When you must not take Diamicron

Do not take Diamicron if:

1.you have an allergy to
Diamicron
sulphonylureas
related medicines such as sulfur antibiotics or
thiazide diuretics (fluid tablets)
any of the ingredients listed at the end of this leaflet
2.you have or have had
Type 1 diabetes mellitus,
unstable diabetes
diabetic acidosis
diabetic coma or pre-coma
severe kidney or severe liver disease
3.you are pregnant or trying to become pregnant
4.you are breastfeeding or plan to breast-feed
5.the package is torn or shows sign of tampering
6.the expiry date (EXP) on the pack has passed.

Do not give Diamicron to children

Before you start to take it

Tell your doctor if:

1.you have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
2.you are breast-feeding or plan to breast-feed.
3.you have or have had any of the following medical conditions:
kidney problems
liver problems
a history of diabetic coma
adrenal, pituitary or thyroid problems
heart failure

Tell your doctor if you:

ever drink alcohol
do not eat regular meals
do a lot of exercise or heavy work
are ill or feeling unwell

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

Discuss these things with your doctor.

Taking other medicines

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

Some medicines may lead to low blood glucose (hypoglycaemia) by increasing the blood-glucose-lowering effect of Diamicron.

These include:

some medicines used to treat high blood pressure, depression, arthritis, pain and inflammation
other medicines used to treat diabetes
some antibiotics
medicines used to prevent blood clots
cimetidine, used to treat reflux and ulcers.

Alternatively, other medicines may lead to loss of control of your diabetes by weakening the blood-glucose-lowering effect of Diamicron.

These include:

corticosteroids
oestrogens and oral contraceptives
cimetidine, used to treat reflux and ulcers
diuretics, also known as fluid tablets
barbiturates, used for sedation

Some medicines used to treat high blood pressure may hide the symptoms of low blood sugar (hypoglycaemia).

You may need different amounts of your medicine, or you may need to take different medicines.

Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.

How to take Diamicron

The dose of Diamicron may vary from half a tablet to four tablets each day according to how you respond to the treatment. Up to two Diamicron tablets each day can be taken together in the morning. If you require more than two tablets each day, take half the number of tablets in the morning and the other half in the evening. Your doctor will tell how many tablets to take each day and your doctor may increase or decrease the dose, depending on your blood glucose levels.

It does not matter if you take Diamicron before, during or after food. However, it is important that you eat regular meals as directed by your doctor.

Swallow Diamicron tablets with a glass of water.

How long to take it

Continue taking Diamicron for as long as your doctor recommends.

Diamicron will help control your diabetes, but will not cure it. Therefore, you may have to take this medicine for a long time.

If you forget to take it

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 it as soon as you remember, and then go back to taking it as you would normally.

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

If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone in Australia: 13 11 26; in New Zealand: 03 4747 000) or go to accident and emergency at your nearest hospital, if you think you or anyone else may have taken too much Diamicron. Do this even if there are no signs of discomfort or poisoning.

If you do take too much Diamicron you will probably feel sweaty, shaky, hungry, confused, have difficulty concentrating and have blurred vision. You may have a pounding heart and a tingling sensation around the mouth. These are signs of hypoglycaemia.

If you experience any of the symptoms of hypoglycaemia, you need to raise your blood glucose urgently. You can do this by taking one of the following:

5 to 7 jelly beans
3 teaspoons of sugar or honey
half a can of ordinary (non-diet) soft drink
2-3 concentrated glucose tablets

Unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates, eg plain biscuits, fruit or milk, when over the initial symptoms. Taking this extra carbohydrate will prevent a second drop in your blood glucose level.

While you are taking Diamicron

Things you must do

If you become pregnant while you are taking Diamicron, tell your doctor.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking Diamicron.

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

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

If you experience any of the symptoms of hypoglycaemia, you need to raise your blood glucose urgently. You can do this by taking one of the following:

5 to 7 jelly beans
3 teaspoons of sugar or honey
half a can of ordinary (non-diet) soft drink
2-3 concentrated glucose tablets

The risk of hypoglycaemia is increased in the following situations:

too much Diamicron
too much or unexpected exercise
delayed meal or snack
too little food.

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

The risk of hyperglycaemia is increased in the following situations:

undiagnosed or uncontrolled diabetes
illness, infection or stress
too little Diamicron
certain other medicines
too little exercise
eating more carbohydrate than normal.

If you become ill or experience extra stress, injury, fever, infection or need surgery, tell your doctor.

Your blood glucose may become difficult to control at these times. Your doctor may decide to change your treatment and use insulin instead of Diamicron.

Make sure you 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.

Visit your doctor for regular checks of your eyes, feet, kidneys, heart, circulation, blood and blood pressure.

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

Some people who drink alcohol while taking Diamicron may get flushing, headache, breathing difficulties, rapid heart beat, stomach pains or feel sick and vomit.

Tell your doctor immediately if you notice the return of any symptoms you had before starting Diamicron.

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

Things you must not do

Do not give Diamicron to anyone else, even if they have the same condition as you.
Do not skip meals while taking Diamicron.
Do not use Diamicron to treat other complaints unless your doctor tells you to.
Do not stop taking Diamicron, or change the dosage, without checking with your doctor.
Do not stop taking your tablets because you are feeling better, unless advised by your doctor.

Things to be careful of

If you have to be alert, for example when driving, be especially 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. Drinking alcohol can make this worse. However, Diamicron by itself is unlikely to affect how you drive or operate machinery.

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

wear some form of identification that shows you have diabetes
carry some form of sugar, for example sugar sachets or jelly beans, to treat hypoglycaemia if it occurs
carry emergency food rations in case of a delay, for example dried fruit or biscuits
keep Diamicron readily available

If you become sick with a cold, fever or flu, it is very important to continue taking Diamicron.

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

Side Effects

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

Diamicron helps most people with diabetes, but it may have unwanted side effects in a few 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.

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

signs of hypoglycaemia
stomach upset including nausea (feeling sick), heartburn
constipation or a feeling of fullness in the stomach
headache.

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

rash or itching of the skin as this could mean you are allergic to sulphur drugs

Tell your doctor if you notice any other effects.

Some people may get other side effects while taking Diamicron.

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

You may not experience any of them.

After taking Diamicron

Storage

Keep your tablets in the pack until it is time to take them. Keep them in a cool, dry place where it stays below 30 degrees C. Keep them where children cannot reach them.

Disposal

If your doctor tells you to stop taking Diamicron, or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal.

Product Description

Diamicron is registered on the Australian Register of Therapeutic Goods. Its Australian Register Number is AUST R 10242.

What it looks like

Diamicron tablets are white, round tablets with bevelled edges and is cross-scored. Each box of Diamicron contains 100 tablets in five blister strips of 20 tablets.

Ingredients

Each tablet of Diamicron contains 80mg of gliclazide as the active ingredient and a number of inactive ingredients lactose, dried starch paste, magnesium stearate, starch and talc.

Manufacturer

Diamicron is a product discovered and developed by Servier Research International and is distributed in Australia by:

Servier Laboratories (Australia) Pty Ltd
8 Cato Street, Hawthorn, Victoria, 3122
ABN 54 004 838 500
The New Zealand contact address for Servier Laboratories is:
2nd Floor, 29 Union Street
Auckland, New Zealand
This leaflet was last revised in August 2001.
Servier provides additional information about diabetes. Ask your doctor if you would like any additional information.

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