30 mg Tablets
Modified Release tablets containing the active ingredient gliclazide
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about gliclazide. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Gliclazide MR. It contains the active ingredient gliclazide.
The tablets release the gliclazide gradually over 24 hours.
The medicine is used to control, blood glucose in patients with Type II diabetes mellitus.
This type of diabetes is also known as non-insulin-dependent diabetes mellitus (NIDDM) or maturity onset diabetes.
Gliclazide is used when diet and exercise are not enough to control your blood glucose.
Gliclazide can be used alone, or together with other medicines for treating diabetes
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Gliclazide belongs to a group of medicines called the sulfonylureas.
Gliclazide lowers high blood glucose by increasing the amount of insulin produced by your pancreas.
Glucose is used by the body as fuel, and all people have glucose circulating in their blood.
In diabetes, levels of blood glucose are higher than is needed. This is called hyperglycaemia.
A section at the end of this leaflet contains advice about recognising and treating hyperglycaemia.
It is very important to control high blood glucose whether or not you feel unwell. This really helps to avoid serious long-term health problems, which can involve the heart, eyes, circulation, and/or kidneys.
As with many medicines used for the treatment of diabetes, there is a possibility that blood glucose levels may become very low during treatment with gliclazide.
This is known as hypoglycaemia.
A section at the end of this leaflet contains advice about recognising and treating hypoglycaemia.
There is no evidence that this medicine is addictive.
Be careful driving or operating machinery until you know how gliclazide affects you.
Gliclazide may cause dizziness and drowsiness in some people.
Use in children
This medicine should not be used in children.
Before you take this medicine
When you must not take it
Do not take this medicine if:
You have or have had any of the following:
Type I diabetes mellitus (insulin dependent diabetes mellitus, also known as IDDM, or juvenile or growth onset diabetes)
unstable or brittle diabetes
diabetic ketoacidosis (a problem which affects the acidity of your blood and can lead to coma)
diabetic coma or pre-coma/coma
severe kidney disease
severe liver disease
You are pregnant or planning to become pregnant.
Gliclazide may affect your developing baby if you take it during pregnancy. Your doctor will usually replace gliclazide with insulin while you are pregnant.
You are breastfeeding or plan to breastfeed.
It is not known whether gliclazide passes into human breast milk.
You are using miconazole to treat fungal infections.
You are taking medicines called phenylbutazone or danazol. You should not take these while taking gliclazide.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
You are hypersensitive to, or have had an allergic reaction to:
gliclazide or other sulfonylureas
antibiotics called sulfonamides
thiazide diuretics (a type of "fluid" or "water" tablet)
any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin; fainting or hayfever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
any other medicines
any other substances, such as foods, preservatives or dyes.
2.You have or have had any medical conditions, especially the following:
kidney problems
liver problems
a growth in your pancreas, called an insulinoma
adrenal, pituitary or thyroid problems
heart failure
a condition called Glucose-6-Phosphate dehydrogenase Deficiency (G6PD)
3.You have any medical condition, or do anything, that may increase the risk of hyperglycaemia (high blood sugar) - for example:
you are ill or feeling unwell (especially with fever or infection)
you are injured
you are having surgery
you are taking less gliclazide than prescribed
you are doing less exercise than normal
you are eating more carbohydrate than normal.
4.You are taking a medicine called a beta-blocker.
Taking this may mask the symptoms of diabetes.
5.You have any medical condition, or do anything, that may increase the risk of hypoglycaemia (low blood sugar) - for example:
drinking alcoholic drinks
not eating regular meals, including breakfast
doing more exercise than usual
eating less carbohydrate than normal.
Alcohol, diet, exercise, and your general health all strongly affect the control of your diabetes.
6.You do not have regular meals
7.You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Taking other medicines
Some medicines may interact with gliclazide. These include:
other medicines used to treat diabetes (tablets and insulin)
some medicines used to treat high blood pressure and other heart conditions, such as beta-blockers, ACE inhibitors
some hormones used in hormone replacement therapy and oral contraceptives (oestrogens and progestogens)
monoamine oxidase inhibitors (MAOIs), used for treating depression, Parkinsons Disease or infections
some medicines used for mental illness (e.g. chlorpromazine)
clofibrate, a medicine for lowering cholesterol
medicines used to treat arthritis, pain and inflammation (e.g. oxyphenbutazone, phenylbutazone, high dose salicylates)
antibiotics called quinolones, sulfonamides, or chloramphenicol
miconazole, or fluconazole, used to treat fungal infections
some medicines used to prevent blood clots (warfarin and similar medicines)
cimetidine and similar medicines used to treat acid reflux and stomach ulcers
steroid medicines called glucocorticoids (e.g. prednisolone, cortisone)
barbiturates, medicines used for sedation
some medicines for hormonal disturbances (such as danazol)
salbutamol and terbutaline (intravenous), medicines for asthma.
St Johns wort (hypericum perforatum), a medicine used to treat depression
If you are taking any of these you may need a different dose or you may need to take different medicines.
Remember to keep checking your blood glucose levels.
Drinking alcohol can also affect your blood sugar levels and how well gliclazide works. If taken with gliclazide, it can also cause flushing of the face, throbbing headache, giddiness, fast breathing, fast heart rate, angina, stomach pains or feeling sick or vomiting.
Other medicines not listed above may also interact with gliclazide.
How to take this medicine
Follow carefully all directions given to you by your doctor or pharmacist or diabetes educator.
Their instructions may be different to the information in this leaflet.
How much to take
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
The starting dose is usually 30 mg per day. This will be adjusted slowly over several weeks, depending on how well your body responds to the dose.
The usual dose of this medicine may vary from one to four tablets taken daily.
Your doctor may increase or decrease the dose, depending on your blood glucose levels.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
Swallow the tablets whole with a glass of water.
Do not crush the tablets or break them.
When to take it
Take it at about the same time each day, usually with breakfast.
Taking these tablets with food can help to minimise the risk of hypoglycaemia.
It will also help you remember when to take them.
Do not skip meals while taking these tablets.
How long to take it for
Gliclazide can help to control your blood glucose level, but it cannot cure your Type 2 diabetes.
Gliclazide treatment is usually for a long period of time - so you should keep taking the tablets regularly unless advised otherwise by your doctor.
Make sure you have enough of this medicine to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you double a dose, this may cause hypoglycaemia (low blood glucose).
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much gliclazide 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, loss of consciousness and fitting.
At the first signs of hypoglycaemia (low blood glucose), raise your blood glucose quickly by following the instructions at the end of this leaflet.
Note that artificial sweeteners will NOT help to raise your blood sugar levels.
While you are taking this medicine
Things you must do
Follow carefully all directions given to you by your doctor.
Otherwise you may not get the full benefits from treatment.
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, pharmacist or diabetes educator will show you how and when to do this.
Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia (low blood glucose) and hyperglycaemia (high blood glucose) and know what to do.
Instructions at the end of this leaflet can help you with this.
Visit your doctor for regular blood tests and checks of your eyes, feet, kidneys, heart, circulation, blood, and blood pressure.
Carefully follow your doctor's and dietician's advice on diet, drinking alcohol and exercise.
Tell your doctor immediately if you notice the return of any symptoms of hyperglycaemia that you had before starting gliclazide, or if your blood sugar levels are high.
These may be signs that gliclazide is no longer working, even though you may have been taking it successfully for some time.
If you are elderly or are taking other medicines for diabetes such as insulin or metformin, the risk of hypoglycaemia (low blood glucose) is increased.
The risk of hypoglycaemia (low blood glucose) is also increased in the following situations:
too much gliclazide
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 (high blood glucose) is increased in the following situations:
undiagnosed or uncontrolled diabetes
illness,