2. What should I know before I take GLICLAZIDE MR VIATRIS?
Do not take if you have ever had an allergic reaction to gliclazide or any of the
ingredients listed at the end of the CMI.
3. What if I am taking other medicines?
4. How do I take GLICLAZIDE MR VIATRIS?
Your doctor will tell you how many tablets to take; swallow them whole with water
at the same time each day, with breakfast.
5. What should I know while taking GLICLAZIDE MR VIATRIS?
|
Things you must do
|
Tell your doctors, dentists, pharmacists and diabetes educators that you are taking
this medicine.
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia and hyperglycaemia and know how to treat them.
If you become pregnant while taking GLICLAZIDE MR VIATRIS, tell your doctor immediately.
Make sure you check your blood glucose levels regularly to tell if your diabetes is
being controlled.
|
|
Things you must not do
|
Do not skip meals while taking GLICLAZIDE MR VIATRIS.
Do not give GLICLAZIDE MR VIATRIS to anyone else, even if they have the same condition
as you.
Do not stop or change your GLICLAZIDE MR VIATRIS dose without checking with your doctor.
|
|
Driving or using machines
|
GLICLAZIDE MR VIATRIS may cause dizziness and drowsiness in some people.
GLICLAZIDE MR VIATRIS may lower your blood glucose levels may slow your reaction time
and affect your ability to drive or operate machinery.
|
|
Drinking alcohol
|
If you drink alcohol while taking GLICLAZIDE MR VIATRIS, you may get flushing, sensation
of warmth, headache, breathing difficulties, rapid heartbeat, stomach pains or feel
sick and vomit.
|
|
Looking after your medicine
|
Keep them in a cool dry place below 25°C. Protect from moisture.
Keep your tablets in the pack until it is time to take them.
|
6. Are there any side effects?
Serious side effects: skin rash, redness itching and/or hives, angioedema (rapid swelling
of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in
breathing difficulty. Common side effects: low or high blood sugar, cold-like or respiratory
symptoms (runny/blocked nose, sneezing, sinus or throat discomfort, coughing, bronchitis,
upper respiratory infection), back or joint pain, high blood pressure, chest pain,
headache, weakness, viral or urinary infections, dizziness, stomach upset (nausea,
pain, vomiting, diarrhoea, constipation), or skin blistering/peeling. For more information,
including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
gliclazide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking GLICLAZIDE MR VIATRIS. Speak to your doctor or pharmacist if you would like further information or if you
have any concerns or questions about taking GLICLAZIDE MR VIATRIS.
Where to find information in this leaflet:
1. Why am I taking GLICLAZIDE MR VIATRIS?
GLICLAZIDE MR VIATRIS contains the active ingredient gliclazide. Gliclazide belongs to a group of medicines called sulphonylureas. The medicine releases
the active ingredient gliclazide progressively over 24 hours.
It lowers blood glucose by increasing the amount of insulin (a hormone that controls
blood glucose levels) produced by your pancreas.
GLICLAZIDE MR VIATRIS 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 (NIDDM), or
maturity-onset diabetes.
GLICLAZIDE MR VIATRIS is used for Type II diabetes mellitus when diet and exercise
are not enough to control your blood glucose.
GLICLAZIDE MR VIATRIS can be used alone or together with insulin or other medicines
for treating diabetes.
How it works
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, which is also
known as hyperglycaemia. If your blood glucose is not properly controlled, you may
experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose).
High blood glucose can lead to serious problems with our heart, circulation and/or
kidneys.
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 MR
VIATRIS. This is known as hypoglycaemia.
Ask your doctor if you have any questions about why GLICLAZIDE MR VIATRIS has been
prescribed for you.
GLICLAZIDE MR VIATRIS is not addictive.
2. What should I know before I take GLICLAZIDE MR VIATRIS?
Warnings
Do not take GLICLAZIDE MR VIATRIS if:
you are allergic to:
gliclazide, or any of the ingredients listed at the end of this leaflet
other sulphonylureas,
GLICLAZIDE MR VIATRIS related medicines such as sulfa antibiotics or to thiazide diuretics
(a type of "fluid" or "water" tablet)
Symptoms of an allergic reaction to GLICLAZIDE MR VIATRIS or to these medicines may
include:
skin rash, itchiness or hives,
shortness of breath, swelling of the face, lips or tongue,
muscle pain or tenderness or joint pain.
If you are not sure if you have an allergy to GLICLAZIDE MR VIATRIS, check with your
doctor.
Always check the ingredients to make sure you can take GLICLAZIDE MR VIATRIS.
you have Type 1 diabetes mellitus (also known as insulin dependent diabetes (IDDM),
or juvenile-onset diabetes)
you have unstable diabetes
you have diabetic ketoacidosis (a problem which affects the acidity of your blood
and can lead to coma - which is mainly associated with Type 1 diabetes)
you have severe kidney disease
you have severe liver disease
you are taking an antibiotic medicine containing the active ingredient miconazole
the expiry date printed on the pack has passed
If you take it after the expiry date has passed, it may not work as well.
the packaging is torn or shows signs of tampering.
If it is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking GLICLAZIDE MR VIATRIS, talk to
your doctor.
Check with your doctor if you:
are allergic to any of the ingredients listed at the end of this leaflet; to any other
medicines; or to any other substances, such as foods, preservatives or dyes
have a family history of or know you have the hereditary condition glucose-6- phosphate
dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the
haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur
have had any of the following medical conditions:
kidney disease
liver disease
a history of diabetic coma
adrenal, pituitary or thyroid problems
heart failure
take any medicines for any other condition
have any medical condition, or do anything, that may increase the risk of hyperglycaemia
- 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 MR VIATRIS than prescribed
you are taking on less exercise than normal
you are eating more carbohydrate than normal.
drinking alcoholic drinks
not eating regular meals
taking on more exercise than usual.
If you have not told your doctor, pharmacist or diabetes educator about any of the
above, tell them before you start taking GLICLAZIDE MR VIATRIS.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take GLICLAZIDE MR VIATRIS if are pregnant or trying to become pregnant.
GLICLAZIDE MR VIATRIS may affect your developing baby if you take it during pregnancy.
Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor
will usually replace GLICLAZIDE MR VIATRIS with insulin while you are pregnant.
Do not take GLICLAZIDE MR VIATRIS are breastfeeding or plan to breastfeed.
GLICLAZIDE MR VIATRIS is not recommended while you are breastfeeding. It is not known
whether GLICLAZIDE MR VIATRIS passes into breast milk.
Use in children
Do not give GLICLAZIDE MR VIATRIS to a child.
There is no experience with the use of GLICLAZIDE MR VIATRIS in children.
Use in older people
Elderly people can generally use GLICLAZIDE MR VIATRIS safely.
There are no special instructions for older people taking GLICLAZIDE MR VIATRIS.
3. What if I am taking other medicines?
Tell your doctor, pharmacist or diabetes educator if you are taking any other medicines,
including any medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
Taking GLICLAZIDE MR VIATRIS may change the effect of some medicines, and some medicines
may affect how well GLICLAZIDE MR VIATRIS works.
Some medicines may lead to low blood glucose (hypoglycemia) by increasing the blood-glucose-lowering
effect of GLICLAZIDE MR VIATRIS. These include:
some medicines used to treat fungal or yeast infections (miconazole which is contraindicated)
alcohol
other medicines used to treat diabetes (such as biguanides and insulin)
some medicines used to treat high blood pressure and other heart conditions (including
angiotensin receptor blocker, beta-blockers)
some medicines used to treat depression and other mental illness (MAOIs)
some cholesterol-lowering medicines (clofibrate)
some medicines used to treat arthritis, pain and inflammation (including high dose
aspirin, ibuprofen, phenylbutazone)
some antibiotics (chloramphenicol; clarithromycin; sulphonamides)
some medicines used to treat acid reflux and stomach ulcers
some medicines used to treat gout (probenecid)
some medicines used to treat tuberculosis.
Some medicines may lead to high blood glucose levels (hyperglycaemia) by weakening
the blood glucose-lowering effect of GLICLAZIDE MR VIATRIS. These include:
alcohol
some medicines for epilepsy (danazol)
some medicines used to treat depression and other mental illness (chlorpromazine)
St John's Wort (Hypericum perforatum) preparations used to treat depression
some hormones used in hormone replacement therapy and oral contraceptives (oestrogen,
progesterone)
some medicines for asthma (salbutamol, intravenous terbutaline)
barbiturates, medicines used for sedation
glucocorticoids
some medicines for fluid retention (thiazides, furosemide)
nicotinic acid.
Some medicines may lead to unstable blood glucose (low blood sugar and high blood
sugar) when taken at the same time as GLICLAZIDE MR VIATRIS, especially in elderly
patients. These include:
a class of antibiotics called fluoroquinolones.
GLICLAZIDE MR VIATRIS may change the effects of some other medicines. These include:
some medicines used to prevent blood clots (warfarin).
You may need different amounts of your medicine or you may need to take different
medicines. Your doctor, pharmacist or diabetes educator can tell you what to do if
you are taking any of these medicines. They also have a more complete list of medicines
to be careful with or avoid while taking GLICLAZIDE MR VIATRIS.
Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect GLICLAZIDE MR VIATRIS.
4. How do I take GLICLAZIDE MR VIATRIS?
How much to take
Follow all directions given to you by your doctor, pharmacist, and diabetes educator
carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
Your doctor will tell you how many tablets to take each day. They may increase or
decrease the dose, depending on your blood glucose levels.
When to take GLICLAZIDE MR VIATRIS
Swallow the tablets whole with a glass of water. GLICLAZIDE MR VIATRIS tablets should
not be crushed or chewed.
Crushing or chewing the tablets may change the effectiveness of the tablet.
GLICLAZIDE MR VIATRIS tablets do not have a break bar and should not be broken in
half.
It is important to take your GLICLAZIDE MR VIATRIS at the same time each day - usually
with breakfast. Taking GLICLAZIDE MR VIATRIS with food can help to minimise the risk
of hypoglycaemia.
Do not skip meals while taking GLICLAZIDE MR VIATRIS.
How long to take GLICLAZIDE MR VIATRIS
Continue taking GLICLAZIDE MR VIATRIS for as long as your doctor recommends. Make
sure you keep enough GLICLAZIDE MR VIATRIS to last over weekends and holidays.
GLICLAZIDE MR VIATRIS will help control your diabetes but will not cure it. Therefore,
you may have to take it for a long time.
If you forget to take GLICLAZIDE MR VIATRIS
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 you remember (with food), then go back to taking your tablets
as you would normally.
Missed doses can cause high blood glucose (hyperglycaemia).
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for the dose you missed.
If you double a dose, this may cause low blood glucose (hypoglycaemia).
If you take too much GLICLAZIDE MR VIATRIS
If you think that you or anyone else has taken too much GLICLAZIDE MR VIATRIS, urgent
medical attention may be needed.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning.
If you take too much GLICLAZIDE MR VIATRIS together with other medicines for diabetes
or alcohol, you may experience symptoms of low blood glucose (hypoglycaemia).
If not treated quickly, these symptoms may progress to loss of co-ordination, slurred
speech, confusion, loss of consciousness and fitting.
If you experience any of these symptoms, immediately get medical help.
5. What should I know while taking GLICLAZIDE MR VIATRIS?
Things you must do
If you become pregnant while you are taking GLICLAZIDE MR VIATRIS, tell your doctor.
Tell all doctors, dentists, pharmacists and diabetes educators who are involved with
your treatment that you are taking GLICLAZIDE MR VIATRIS.
If you are about to start taking any new medicines, tell you doctor and pharmacist
that you are taking GLICLAZIDE MR VIATRIS.
Take GLICLAZIDE MR VIATRIS 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 and hyperglycaemia and know how to treat them.
Visit your doctor regularly so that they can check on your progress.
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 MR VIATRIS.
These may include lethargy or tiredness, headache, thirst, passing large amounts of
urine and blurred vision. These may be signs that GLICLAZIDE MR VIATRIS is no longer
working, even though you may have been taking it successfully for some time.
Remind any doctor, dentist or pharmacist you visit that you are taking GLICLAZIDE
MR VIATRIS.
Things you must not do
Do not give GLICLAZIDE MR VIATRIS to anyone else, even if they have the same condition
as you.
Do not take GLICLAZIDE MR VIATRIS to treat other complaints unless your doctor tells
you to.
Do not stop taking GLICLAZIDE MR VIATRIS, or change the dosage, without checking with
your doctor.
Do not skip meals while taking GLICLAZIDE MR VIATRIS.
Things to be careful of
Protect your skin when you are in the sun, especially between 10am and 3pm.
Sulphonylureas (the group of medicines that GLICLAZIDE MR VIATRIS belongs to) 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 SPF 30+ sunscreen. If your skin does
appear to be burning, tell your doctor immediately.
If you are travelling, it is a good idea to:
wear some form of identification 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
keep GLICLAZIDE MR VIATRIS readily available
If you become sick with a cold, fever or flu, it is very important to continue taking
GLICLAZIDE MR VIATRIS, 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.
Your diabetes educator or dietician can give you a list of foods to use for sick days.
Recognising and treating hyPOglycaemia (very LOW blood sugar levels)
Hypoglycaemia may occur during GLICLAZIDE MR VIATRIS treatment.
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 eating 5 to 7 jelly beans, 3 teaspoons of sugar or honey, drinking half
a can of non-diet soft drink, taking 2-3 glucose tablets or a tube of glucose gel.
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 sugar levels)
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.
If you experience any of the signs of hyperglycaemia (high blood glucose) contact
your doctor or diabetes educator for advice immediately.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how GLICLAZIDE
MR VIATRIS affects you.
Also, be especially careful not to let your blood glucose levels fall too low.
GLICLAZIDE MR VIATRIS may cause dizziness and drowsiness in some people. Low blood
glucose levels may also slow your reaction time and affect your ability to drive or
operate machinery. Section
5. What should I know while taking GLICLAZIDE MR VIATRIS? contains advice about recognising and treating hypoglycaemia.
Drinking alcohol can make this worse. If either of these occurs, do not drive, operate
machinery or do anything else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol while taking GLICLAZIDE MR VIATRIS, you may get flushing, sensation
of warmth, headache, breathing difficulties, rapid heartbeat, stomach pains or feel
sick and vomit.
Looking after your medicine
Keep them in a cool dry place below 25°C. Protect from moisture.
Keep your tablets in the pack until it is time to take them.
GLICLAZIDE MR VIATRIS will not keep as well outside its blister packaging.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
If you do not feel well while you are taking GLICLAZIDE MR VIATRIS then tell your
doctor, pharmacist, or diabetes educator as soon as possible.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
However if you do - or if you notice anything else that is making you feel unwell
- you should consult your doctor or pharmacist.
Less serious side effects
Serious side effects
Tell your doctor, pharmacist or diabetes educator if you notice anything else that
may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What GLICLAZIDE MR VIATRIS contains
|
Active ingredient
(main ingredient)
|
gliclazide 30 mg
|
|
Other ingredients
(inactive ingredients)
|
hypromellose
magnesium stearate
microcrystalline cellulose
|
Do not take this medicine if you are allergic to any of these ingredients.
What GLICLAZIDE MR VIATRIS looks like
GLICLAZIDE MR VIATRIS 30 mg tablets are white to off-white, oblong, biconvex tablet
debossed with ‘M’ on one side of the tablet and 'GL 30' on the other side (AUST R
295541).
They are available in blister packs of 100 tablets.
Who distributes GLICLAZIDE MR VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in December 2025.
GLICLAZIDE MR VIATRIS_cmi\Dec25/00