Modified release tablets containing gliclazide (pronounced gli-cla-zide)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about GLICLAZIDE MR VIATRIS.
It does not contain all the available information
Reading this leaflet 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
GLICLAZIDE MR VIATRIS against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor, pharmacist,
or diabetes educator.
Keep this leaflet with the medicine.
You may need to read it again.
What GLICLAZIDE MR VIATRIS is
The name of your medicine is 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.
What GLICLAZIDE MR VIATRIS is used for
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).
Why GLICLAZIDE MR VIATRIS is used for Type II diabetes mellitus
GLICLAZIDE MR VIATRIS is used 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.
A section at the end of this leaflet contains advice about recognising and treating
hyperglycaemia.
GLICLAZIDE MR VIATRIS is used when diet and exercise are not enough to control your
blood glucose properly. It lowers blood glucose by increasing the amount of insulin
(a hormone that controls blood glucose levels) produced by your pancreas.
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.
A section at the end of this leaflet contains advice about recognising and treating
hypoglycaemia.
GLICLAZIDE MR VIATRIS is available only with a doctor's prescription.
GLICLAZIDE MR VIATRIS is not addictive
Ask your doctor if you have any questions about why GLICLAZIDE MR VIATRIS has been
prescribed for you.
Before you take GLICLAZIDE MR VIATRIS
There are some people who should not take GLICLAZIDE MR VIATRIS. Please read the lists
below.
If you think any of these situations apply to you, or you have any questions, please
consult your doctor, pharmacist, or diabetes educator.
Do not take GLICLAZIDE MR VIATRIS if
you are allergic to: gliclazide, or any of the other ingredients listed at the end
of this leaflet.
you have had an allergic reaction to any other sulphonylureas, or 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.
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.
are breastfeeding or plan to breast-feed.
GLICLAZIDE MR VIATRIS is not recommended while you are breastfeeding. It is not known
whether GLICLAZIDE MR VIATRIS passes into breast milk.
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 (EXP) printed on the pack.
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.
For children
Do not give GLICLAZIDE MR VIATRIS to a child.
There is no experience with the use of GLICLAZIDE MR VIATRIS in children.
For older people
Elderly people can generally use GLICLAZIDE MR VIATRIS safely.
There are no special instructions for older people taking GLICLAZIDE MR VIATRIS.
Tell your doctor straight away if:
you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
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
If you 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.
you have had any of the following medical conditions:
kidney disease
liver disease
a history of diabetic coma.
adrenal, pituitary or thyroid problems
heart failure
you 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 less exercise than normal
you are eating more carbohydrate than normal.
drinking alcoholic drinks.
not eating regular meals.
taking 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.
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 a 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. You may need different amounts of
your medication or to take different medicines.
Some medicines may lead to low blood glucose (hypoglycaemia) 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.
How to take GLICLAZIDE MR VIATRIS
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 it
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 30 mg 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 it
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 it
If 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 have missed.
If you double a dose, this may cause low blood glucose (hypoglycaemia).
If you take too much (overdose)
Immediately telephone your doctor, Diabetes Australia or Poisons Information Centre
(telephone in Australia: 13 11 26) for advice if you think that you or anyone else
may have taken too much GLICLAZIDE MR VIATRIS. Do this even if there are no signs
of discomfort or poisoning.
You may need urgent medical attention.
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.
At the first signs of hypoglycaemia, raise your blood glucose quickly by following
the instructions at the end of this leaflet.
If you experience any of these symptoms, immediately get medical help.
While you are 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.
Instructions at the end of this leaflet can help you with this.
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.
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 use 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
If you drink alcohol while taking GLICLAZIDE MR VIATRIS, you may get flushing, sensation
of warmth, headache, breathing difficulties, rapid heart beat, stomach pains or feel
sick and vomit.
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 30+ sunscreen. If your skin does appear
to be burning, tell your doctor immediately.
Be careful driving or operating machinery 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. A section at the end of this leaflet 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.
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.
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. Most of the time they are not serious but sometimes
they can be.
GLICLAZIDE MR VIATRIS helps most people with Type 2 diabetes, but it may sometimes
have unwanted side effects. These can include:
Hypoglycaemia and hyperglycaemia. A section at the end of this leaflet contains advice
about recognising and treating hypoglycaemia and hyperglycaemia
runny or blocked nose, sneezing, facial pressure or pain, bronchitis, sore throat
and discomfort when swallowing, upper respiratory infection, coughing,
back pain, arthralgia, arthrosis,
high blood pressure, chest pain,
Headache, unusual weakness,
Viral infection, urinary tract infection,
dizziness
stomach upset with symptoms like feeling sick, stomach pain, vomiting, diarrhoea or
constipation.
decrease in the number of cells in the blood (e.g. platelets, red and white blood
cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever
have been reported. These symptoms usually vanish when the treatment is discontinued.
Increase of some hepatic enzymes levels, and exceptionally a liver disease,
your vision may be affected for a short time especially at the start of treatment.
This effect is due to changes in blood sugar levels.
Other side effects are usually mild when they occur. 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.
Other uncommon side effects have been reported and you may wish to discuss this issue
with your doctor, pharmacist, or diabetes educator.
If any of the signs below occur then tell your doctor immediately or go to the Accident
and Emergency department at your nearest hospital:
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)
have been reported. The rash may progress to widespread blistering or peeling of the
skin and may be the first sign of rare life threatening conditions (e.g. Stevens-Johnson
syndrome (SJS), toxic epidermal necrolysis (TEN) and severe hypersensitivity reactions
(DRESS). Exceptionally, DRESS have been reported: initially as flu-like symptoms and
a rash on the face then an extended rash with a high temperature.
As for other sulphonylureas, the following adverse events have been observed: cases
of severe changes in the number of blood cells and allergic inflammation of the wall
of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of acute pancreatitis,
symptoms of liver impairment (e.g. jaundice) which in most cases disappeared after
withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in
isolated cases.
After taking GLICLAZIDE MR VIATRIS
Storage
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.
Keep them in a cool dry place where the temperature stays below 25°C.
Do not store medicines in the bathroom or near a sink. Do not leave them in a car
or on a windowsill.
Heat and dampness can destroy some medicines.
Keep GLICLAZIDE MR VIATRIS tablets where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Disposal
If your doctor tells you to stop taking GLICLAZIDE MR VIATRIS, or the tablets have
passed their expiry date, return any leftover tablets to your pharmacist for disposal.
Product description
What it 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. They are
available in blister packs of 100 tablets.
Ingredients
Each tablet of GLICLAZIDE MR VIATRIS contains 30 mg of gliclazide as the active ingredient
and a number of inactive ingredients.
The inactive ingredients in GLICLAZIDE MR VIATRIS tablets include hypromellose, magnesium
stearate and microcrystalline cellulose.
Supplier
GLICLAZIDE MR VIATRIS is supplied in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
GLICLAZIDE MR VIATRIS is registered on the Australian Register of Therapeutic Goods.
Australian Register Number:
30 mg blister
AUST R 295541
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.
This leaflet was prepared in July 2024.
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