Chemmart Gliclazide

Contains the active ingredient gliclazide
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Chemmart Gliclazide. It does not contain all the information that is known about Chemmart Gliclazide. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is Chemmart Gliclazide. It contains the active ingredient gliclazide.
It is used to:
control blood glucose (sugar) 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 called 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.

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 acidosis or ketosis
diabetic coma or pre-coma
a history of repeated ketoacidosis or 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 breast-feeding or plan to breast-feed.
It is not known whether gliclazide passes into human breast milk.
You are using miconazole, a medicine used to treat fungal infections.
You are taking medicines called phenylbutazone or danazol.
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, other sulfonylureas, sulphonamides, or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, 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 hay fever-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:

1. You have allergies to:

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
a history of diabetic coma
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 glucose) - 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 have any medical condition, or do anything, that may increase the risk of hypoglycaemia (low blood glucose) - 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.

5. You are taking a medicine called a beta-blocker.

Taking this may mask the symptoms of diabetes.

6. You are currently pregnant or you plan to become pregnant.

Do not take this medicine whilst pregnant.

7. You are currently breast-feeding or you plan to breast-feed.

Do not take this medicine whilst breast-feeding.

8. You suffer from lactose intolerance or malabsorption.

These tablets contain lactose

9. 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.
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)
some medicines for epilepsy such as phenobarbitone
clofibrate, a medicine for lowering cholesterol
medicines used to treat arthritis, pain and inflammation (e.g. oxyphenbutazone, phenylbutazone, high dose salicylates)
antibiotics called 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)
some medicines for hormonal disturbances (such as danazol)
salbutamol and terbutaline, medicines for asthma
diuretics, also known as fluid tablets (e.g. chlorothiazide).
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 glucose levels and how well gliclazide works.
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.
Their instructions may be different to the information in this leaflet.

How much to take

Your doctor 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 40 mg (half a tablet) per day. This will be adjusted slowly over several weeks, depending on how well your body responds to the dose.
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.

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

Continue taking your medicine for as long as your doctor tells you.
Gliclazide can help control your diabetes but cannot cure it. Therefore you may have to take it for a long time.
Make sure you have enough to last over weekends and holidays.

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 (with food), then go back to taking your tablets as you would normally.
Missed doses can cause hyperglycaemia (high blood glucose).
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 the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively 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.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breastfeeding or are planning to breast-feed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
Take your tablets exactly as your doctor has prescribed. 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 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 how to treat them. 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.
Follow carefully your doctor's advice on diet, drinking alcohol and exercise.
Tell your doctor immediately if you notice the return of any symptoms of hyperglycaemia (high blood glucose) that you had before starting gliclazide.
These may include lethargy or tiredness, headache, thirst, passing large amounts of urine and blurred vision.
These may be signs that gliclazide is no longer working, even though you may have been taking it successfully for some time.
If you become sick with a cold, fever or flu, it is very important to continue taking gliclazide, even if you fell unable to eat your normal meal. If you have trouble eating solid food, use sugar-sweetened drinks as a carbohydrate substitute or eat small amounts of bland food.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to
Stop taking your medicine, or change the dosage, without first checking with your doctor
Skip meals while taking gliclazide.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.
Gliclazide may cause dizziness and drowsiness in some people.
Be careful not to let your blood glucose levels fall too low.
Hypoglycaemia (low blood glucose) may slow your reaction time and affect your ability to drive or operate machinery. A section at the end of this leaflet contains advice about recognising and treating hypoglycaemia.
If you drink alcohol while taking gliclazide, you may get flushing, headache, breathing difficulties, rapid heart beat, stomach pains or feel sick and vomit.
Gliclazide may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness, or a severe sunburn.
If outdoors, wear protective clothing and use a 30+ sunscreen. If your skin does appear to be burning, tell your doctor immediately.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking gliclazide or if you have any questions or concerns.
Do not be alarmed by the following list of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Gliclazide helps most people with Type II diabetes, but it may sometimes have side effects. These can include:
Hypoglycaemia. A section at the end of this leaflet contains advice about recognising and treating hypoglycaemia.
Stomach upset with symptoms like feeling sick, heartburn, diarrhoea or constipation.
If you notice anything else that is making you feel unwell you should tell your doctor as soon as possible.
Other side effects have been reported and you may wish to discuss this with your doctor.

Allergic reactions

If you think you are having an allergic reaction to gliclazide, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, 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
hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine 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.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What Chemmart Gliclazide looks like

White, round, flat-sided tablets with bevelled edges, engraved "APO" over "80" on one side, cross-scored on the other side.
Blister packs of 100 tablets.

Ingredients

Each tablet contains 80 mg of gliclazide as the active ingredient.
It also contains the following inactive ingredients:
croscarmellose sodium
magnesium stearate
colloidal anhydrous silica
lactose
microcrystalline cellulose,
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

Chemmart Gliclazide
80 mg Tablets
Blister Packs
AUST R 80085

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Chemmart is a registered trademark of Symbion Pty Ltd.

Recognising and treating hypoglycaemia (low blood glucose)

Hypoglycaemia may occur during treatment with gliclazide.
The first signs of hypoglycaemia are usually weakness, trembling or shaking, sweating, lightheadedness, dizziness, headache or lack of concentration, irritability, tearfulness, hunger, and/ or numbness around the lips and tongue.
At the first signs of hypoglycaemia take some sugar to raise your blood sugar level quickly.
Do this by taking one of the following:
5-7 jelly beans
3 teaspoons of sugar or honey
half a can of ordinary (non-diet) soft drink
2-3 concentrated glucose tablets
A tube of glucose gel
Note that taking artificial sweeteners will not help raise your blood sugar levels.
Then take some extra carbohydrates such as plain biscuits, fruit or milk - unless you are within 10-15 minutes of your next meal. Taking this extra carbohydrate will help to prevent a second drop in your blood glucose level.
If not treated quickly, hypoglycaemia symptoms may progress to loss of co-ordination, slurred speech, confusion, fits or loss of consciousness.
If hypoglycaemia symptoms do not get better straight away after taking sugar, then go to the Accident and Emergency department at your nearest hospital - if necessary by calling an ambulance.
Contact your doctor or diabetes educator for advice if you are concerned about hypoglycaemia.

Recognising and treating hyperglycaemia (high blood glucose)

Some people may feel fine when their glucose levels are high. Others notice symptoms of hyperglycaemia like tiredness, lack of energy, thirst, passing large amounts of urine, headache, and/or blurred vision.
If you notice symptoms of hyperglycaemia, or your blood sugar levels are high, tell your doctor immediately.
You may need adjustments of the dose or type of medicines you are taking.
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.
This leaflet was last updated in:
September 2012