Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using ONGLYZA?
ONGLYZA contains the active ingredient saxagliptin. ONGLYZA is used to lower blood
sugar levels in patients with type 2 diabetes mellitus.
2. What should I know before I use ONGLYZA?
Do not use if you have ever had an allergic reaction to ONGLYZA or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ONGLYZA and affect how it works.
4. How do I use ONGLYZA?
The usual dose of ONGLYZA is one 5 mg tablet once a day
If you have kidney problems, your doctor may prescribe a lower daily dose of 2.5
mg.
5. What should I know while using ONGLYZA?
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Things you should do
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Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking ONGLYZA.
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia and hyperglycaemia and know how to treat them.
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Things you should not do
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Do not take ONGLYZA to treat any other complaints unless your doctor tells you do.
Do not give this medicine to anyone else, even if their symptoms seem similar or they
have the same condition as you.
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Driving or using machines
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Be careful driving or operating machinery until you know how ONGLYZA affects you.
Make sure you know how you react to ONGLYZA before you drive a car, operate machinery
or do anything else that could be dangerous if you are dizzy or lightheaded.
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Looking after your medicine
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Keep it in a cool dry place where the temperature stays below 30°C.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave
it in the car or on a window sill.
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6. Are there any side effects?
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.
Active ingredient(s):
saxagliptin
Consumer Medicine Information (CMI)
This leaflet provides important information about using ONGLYZA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ONGLYZA.
Where to find information in this leaflet:
1. Why am I using ONGLYZA?
ONGLYZA contains the active ingredient saxagliptin. ONGLYZA is a member of a class of medicines you take by mouth called DPP-4 inhibitors
(dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in patients with
type 2 diabetes mellitus.
ONGLYZA helps to improve the levels of insulin after a meal.
ONGLYZA decreases the amount of sugar made by the body.
ONGLYZA works when blood sugar is high, especially after a meal. This is when the
body needs the greatest amount of help in lowering blood sugar. ONGLYZA also lowers
blood sugar between meals.
ONGLYZA by itself is unlikely to cause low blood sugar (hypoglycaemia) because it
does not work when your blood sugar is low.
ONGLYZA is used to lower blood sugar levels in patients with type 2 diabetes mellitus. ONGLYZA is used
in combination with certain other medicines (metformin, medicines such as rosiglitazone
and pioglitazone, insulin, a sulfonylurea medicine such as glimepiride or glibenclamide
or metformin plus a sulfonylurea or a SGLT2 inhibitor such as dapagliflozin) to help
lower blood sugar levels. ONGLYZA is used when diet plus exercise and the single medicine
do not provide adequate blood sugar level control.
Type 2 diabetes mellitus
Type 2 diabetes mellitus is a condition in which your body does not make enough insulin
and the insulin that your body produces does not work as well as it should. Your body
can also make too much sugar. When this happens, sugar (glucose) builds up in the
blood and can lead to serious medical problems.
The main goal of treating diabetes is to lower your blood sugar to a normal level.
Lowering and controlling blood sugar may help prevent or delay complications of diabetes,
such as heart disease, kidney disease, blindness and amputation.
ONGLYZA is not addictive.
2. What should I know before I use ONGLYZA?
Warnings
Do not use ONGLYZA if:
you are allergic to saxagliptin, the active ingredient in ONGLYZA or any of the ingredients
listed at the end of this leaflet. Some of the symptoms of an allergic reaction may
include shortness of breath, wheezing or difficulty breathing, swelling of the face,
lips, tongue or other parts of the body; rash, itching or hives on the skin or you
may feel faint.
you are allergic to any other DPP-4 inhibitor.
you are lactose intolerant. ONGLYZA tablets contains lactose
Do not take ONGLYZA after the use by (expiry) date printed on the pack.
Do not take ONGLYZA if the packaging is torn or shows signs of tampering. If it is
expired or is damaged, return it to your pharmacist for disposal.
Do not use in children. There is not enough information on its effects in children.
Check with your doctor if you:
if you have been prescribed this medicine for another reason.
if you are not sure if you should start taking ONGLYZA.
if you have any questions about why ONGLYZA has been prescribed for you.
If you have allergies to any other medicines
If you have allergies to any other substances such as food, dyes or preservatives
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
Check with your doctor if you are pregnant or intend to become pregnant.
ONGLYZA is not recommended for use during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
ONGLYZA should not be used while breastfeeding or if planning to breastfeed.
Tell your doctor or pharmacist if you have, or have had, any medical conditions, especially
the following:
type 1 diabetes or a condition called diabetic ketoacidosis.
Heart failure
Kidney problems; your doctor will do some tests for kidney function at the start of
treatment and regularly while you are on treatment.
3. What if I am taking other medicines?
Tell your doctor or pharmacist 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.
ONGLYZA can be taken with most other medicines.
If you have not told your doctor about any of these things, tell them before you take
any ONGLYZA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ONGLYZA.
4. How do I use ONGLYZA?
How much to take / use
The usual dose of ONGLYZA is one 5 mg tablet once a day.
If you have kidney problems, your doctor may prescribe a lower daily dose of 2.5 mg.
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
If you do not understand the instructions on the pack ask your doctor or pharmacist
for help.
Continue taking the tablets for as long as your doctor tells you. Make sure you keep
enough ONGLYZA to last over weekends and holidays.
ONGLYZA helps control your condition, but does not cure it. Therefore you must take
ONGLYZA every day.
When to take / use ONGLYZA
ONGLYZA should be taken once a day, at approximately the same time each day.
Taking your tablets at the same time each day will have the best effect. It will also
help you remember when to take the tablets.
ONGLYZA tablets can be taken with or without food.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
How to take ONGLYZA
Swallow your ONGLYZA tablets whole with a full glass of water.
ONGLYZA tablets should not be split or cut.
If you forget to use ONGLYZA
If you miss your dose at the usual time and 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 your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
If you use too much ONGLYZA
If you think that you have used too much ONGLYZA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using ONGLYZA?
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking ONGLYZA.
Call your doctor straight away if you:
If you are about to be started on any new medicines, inform that you are taking ONGLYZA
Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia and hyperglycaemia and know how to treat them.
It is important to have regular check ups with your doctor or the diabetes centre.
If you become pregnant while taking ONGLYZA, tell your doctor immediately.
If you need to have any medical tests while you are taking ONGLYZA, tell your doctor.
ONGLYZA may affect the results of some tests.
Visit your doctor regularly for check-ups.
Your doctor may want to perform blood tests to check your kidneys while you are taking
ONGLYZA.
Remind any doctor, dentist or pharmacist you visit that you are using ONGLYZA.
Things you should not do
Do not stop using this medicine suddenly.
Do not take ONGLYZA to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if their symptoms seem similar or they
have the same condition as you.
Hypoglycemia
ONGLYZA does not normally cause hypoglycaemia, although you may experience it if you
take certain other medicines. Such as insulin or a sulphonylurea.
Hypoglycaemia can occur suddenly. Initial signs may include:
weakness, trembling or shaking
sweating
lightheadedness, dizziness, headache or lack of concentration
hunger
numbness around the lips and tongue
If not treated promptly, these may progress to:
loss of co-ordination
slurred speech
confusion
fits or loss of consciousness.
If you experience any of the symptoms of hypoglycaemia, you need to raise your blood
glucose immediately.
You can do this by doing one of the following:
eating 5 to 7 jelly beans
eating 3 teaspoons of sugar or honey
drinking half a can of non-diet soft drink
taking 2 to 3 concentrated glucose tablets
Unless you are within 10 to 15 minutes of your next meal or snack, follow up with
extra carbohydrates such as plain biscuits, fruit or milk.
Taking this extra carbohydrate will prevent a second drop in your blood glucose level.
Hyperglycaemia
If you notice the return of any of the signs of hyperglycaemia, contact your doctor
immediately.
Your doctor may need to consider additional or other treatments for your diabetes.
The risk of hyperglycaemia is increased in the following situations:
uncontrolled diabetes
illness, infection or stress
taking less ONGLYZA than prescribed
taking certain other medicines
too little exercise
eating more carbohydrates than normal.
Tell your doctor if you:
become ill
become dehydrated
are injured
have a fever
have a serious infection
are having surgery (including dental surgery).
Your blood glucose may become difficult to control at these times.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ONGLYZA
affects you.
ONGLYZA may cause dizziness in some people. Low blood sugar levels may also slow your
reaction time and affect your ability to drive or operate machinery.
Make sure you know how you react to ONGLYZA before you drive a car, operate machinery
or do anything else that could be dangerous if you are dizzy or lightheaded.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your ONGLYZA tablets in the blister pack until it is time to take them.
If you take ONGLYZA out of the blister pack it will not keep well.
Keep it in a cool dry place where the temperature stays below 30°C.
Heat and dampness can destroy some medicines.
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.
Keep it where young children cannot reach it.
When to discard your medicine
If your doctor tells you to stop taking ONGLYZA or the tablets have passed their expiry
date, ask your pharmacist what to do with any that are left over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ONGLYZA.
Less serious side effects
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Less serious side effects
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What to do
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headache
signs of an infection in the breathing passages including runny nose, sore throat
and cough
soreness in the back of the nose and throat and discomfort when swallowing
difficulty breathing or tightness in the chest
vomiting or diarrhoea
stomach pain or discomfort
swelling of hands, ankles or feet
signs of urinary tract infection such as an urge to urinate frequently and in small
amounts, and painful burning when passing urine
rash
feeling depressed or anxious
joint pain
signs of anaemia such as tiredness, headaches, being short of breath when exercising,
dizziness and looking pale
back pain.
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Speak to your doctor if you have any of these less serious side effects and they worry
you or go to Accident and Emergency at your nearest hospital.
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Serious side effects
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Serious side effects
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What to do
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Hypoglycaemia:
Low blood sugar that persist despite administering sugar as described under WHILE
YOU ARE TAKING ONGLYZA in this leaflet. Signs of hypoglycaemia may include weakness,
trembling or shaking, sweating, light-headedness, headache, dizziness, rapid heart
beat, lack of concentration, tearfulness or crying, irritability, hunger and numbness
around the lips and fingers. Do not drive a car if you have signs of low blood sugar.
Allergic reaction:
severe allergic reaction (may include shortness of breath, wheezing or severe difficulty
in breathing, shock, swelling of the face, lips, tongue or other parts of the body,
skin rash, itching or hives on the skin, hayfever, or you may feel faint).
Other serious side effects:
severe upper stomach pain, often with nausea and vomiting
signs and symptoms of heart failure. Signs of heart failure may include, increasing
shortness of breath, rapid increase in weight and swelling of the feet.
develop blisters or the breakdown of your skin (erosion). These symptoms could be
a sign of a skin reaction called bullous pemphigoid that can require treatment in
a hospital. Your doctor may tell you to stop taking ONGLYZA.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Occasionally, ONGLYZA may be associated with changes in your blood. These can only
be found when your doctor does tests from time to time to check your progress.
Other side effects not listed here may occur in some people.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
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 ONGLYZA contains
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Active ingredient
(main ingredient)
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Saxagliptin 2.5 mg/5 mg
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Other ingredients
(inactive ingredients)
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Lactose monohydrate
microcrystalline cellulose
croscarmellose sodium
magnesium stearate
polyvinyl alcohol
macrogol 3350
titanium dioxide
purified talc
iron oxide red CI77491 (5 mg tablet only)
iron oxide yellow CI77492 (2.5mg tablet only)
Opacode Blue (printing ink)
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Potential allergens
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Nil
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Do not take this medicine if you are allergic to any of these ingredients.
What ONGLYZA looks like
ONGLYZA 2.5 mg tablet is a pale yellow to light yellow, round, film coated tablets
with "2.5" printed on one side and "4214" printed on the other side, in blue ink (Aust
R 211214).
ONGLYZA 5 mg tablet pink, biconvex, round, film coated tablets with "5" printed on
one side and "4215" printed on the other side, in blue ink (AUST R 157907).
Who distributes ONGLYZA
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in May 2024.
ONGLYZA is a registered trademark of the AstraZeneca group of companies.
© AstraZeneca 2024
VV-RIM-01383768 V11.0