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 taking ARX-TICAGRELOR?
ARX-TICAGRELOR contains the active ingredient ticagrelor. ARX-TICAGRELOR is used for
the prevention of heart attacks and unstable angina (angina or chest pain that is
not well controlled).
2. What should I know before I take ARX-TICAGRELOR?
Do not use if you have ever had an allergic reaction to ARX-TICAGRELOR 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 ARX-TICAGRELOR and affect how it works.
4. How do I take ARX-TICAGRELOR?
The starting dose is two tablets at the same time. This dose will usually be given
to you in the hospital. After that, the usual dose is one tablet twice a day.
Take your doses at around the same time every day. For example, one in the morning
and one in the evening. It does not matter whether you take ARX-TICAGRELOR with food
or on an empty stomach.
5. What should I know while taking ARX-TICAGRELOR?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking ARX-TICAGRELOR.
Take ARX-TICAGRELOR exactly as your doctor has told you to.
Tell your doctor if you become pregnant while you are taking ARX-TICAGRELOR.
Tell your doctor if you decide to breast feed your baby.
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Things you should not do
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Do not stop taking ARX-TICAGRELOR without talking to your doctor. Take it for as long
as your doctor keeps prescribing it. If you want to stop taking ARX-TICAGRELOR, talk
to your doctor first.
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Driving or using machines
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Be careful driving or operating machinery.
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Looking after your medicine
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Keep your tablets in the blister pack until it is time to take them.
Keep it in a cool, dry place where the temperature stays below 30°C.
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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 be serious and could
require urgent medical attention or hospitalisation. See Section
6. Are there any side effects? in the full CMI and, if you need to, ask your doctor if you have any further questions
about side effects.
Active ingredient:
ticagrelor
Consumer Medicine Information (CMI)
This leaflet provides important information about taking ARX-TICAGRELOR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking ARX-TICAGRELOR.
Where to find information in this leaflet:
1. Why am I taking ARX-TICAGRELOR?
ARX-TICAGRELOR contains the active ingredient ticagrelor. ARX-TICAGRELOR belongs to a group of medicines called anti-platelet medicines.
Platelets are very small cells in your blood that help to stop bleeding. When a blood
vessel is damaged, they clump together to help form a blood clot. This stops bleeding.
However, clots can also form inside a damaged blood vessel. This can be very dangerous
because:
the clot can cut off the blood supply completely - this can cause a heart attack (myocardial
infarction) or stroke.
the clot can partly block the blood vessels to the heart - this reduces the blood
flow to the heart. This can cause chest pain which comes and goes (called 'unstable
angina').
ARX-TICAGRELOR helps stop the clumping of platelets. This reduces the chance of a
blood clot forming that can block a blood vessel. This means that ARX-TICAGRELOR reduces
the chance of you having another heart attack, chest pain or stroke.
Your doctor will usually also tell you to take acetylsalicylic acid (aspirin). This
is another medicine, which affects platelets.
You have been given ARX-TICAGRELOR because you have had:
a heart attack, or
unstable angina (angina or chest pain that is not well controlled)
Your doctor may prescribe this medicine for another use. Ask your doctor if you want
more information.
ARX-TICAGRELOR is only available on a doctor's prescription.
There is no evidence that ARX-TICAGRELOR is addictive.
2. What should I know before I take ARX-TICAGRELOR?
Warnings
Do not take ARX-TICAGRELOR if:
you are allergic to ticagrelor, or any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may include, tightness of the chest,
wheezing, coughing or difficulty breathing, swelling of the face, lips, tongue or
other parts of the body; rash, itching or hives.
you have problems with bleeding, such as bleeding in your stomach or gut from an ulcer.
you have moderate to severe liver disease.
you have had a stroke caused by bleeding in the brain or a history of bleeding in
the brain.
you are taking any of the following medicines: ketoconazole (used to treat fungal
infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant),
ritonavir and atazanavir (used to treat HIV infection and AIDS).
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives, or dyes.
have an increased risk of bleeding because of:
- a recent serious injury
- recent surgery (including dental work)
- recent bleeding from your stomach or gut (such as stomach ulcer or colon polyps)
- you have a condition that affects blood clotting
have asthma or other lung problem or breathing difficulties.
are due to have surgery (including dental work) at any time while taking ARX-TICAGRELOR.
This is because of the increased risk of bleeding. Your doctor may want you to stop
taking ARX-TICAGRELOR for a short time.
have or have had high uric acid.
have a low heart rate.
have or have had any medical conditions.
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.
It is not recommended that you take ARX-TICAGRELOR. Your doctor will discuss the risks
and benefits of taking ARX-TICAGRELOR during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not recommended that you take ARX-TICAGRELOR. Your doctor will discuss the risks
and benefits of taking ARX-TICAGRELOR during breast feeding.
Children
ARX-TICAGRELOR is not recommended for children under 18 years of age, as its safety
and effectiveness in children have not been established.
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.
Tell your doctor or pharmacist if you are taking any of the following medicines:
rosuvastatin or more than 40 mg daily of simvastatin (used to treat high cholesterol).
rifampin (an antibiotic).
phenytoin, carbamazepine and phenobarbital (used to control seizures), dexamethasone
(used to treat inflammatory and auto immune conditions).
digoxin (used to treat heart failure).
cyclosporin (used to lessen your body's defences).
quinidine and diltiazem (used to treat abnormal heart rhythms).
adenosine (used to treat irregular heart rate).
ergotamine (used to treat migraine).
beta blockers and verapamil (used to treat high blood pressure).
morphine (used to relieve pain).
Tell your doctor or pharmacist if you are taking any medicines that may increase your
risk of bleeding. These medicines include:
"Oral anticoagulants", often referred to as "blood thinners", which include aspirin,
warfarin, clopidogrel and prasugrel.
"Fibrinolytics" and "thrombolytics", often referred to as "clot-dissolvers", which
include streptokinase and tenecteplase.
Non-steroidal anti-inflammatory drugs (NSAIDs), often taken as pain killers such as
ibuprofen and naproxen.
Selective serotonin reuptake inhibitors (SSRIs), often taken as antidepressants such
as paroxetine, sertraline, and citalopram.
You may need different amounts of your medicines or may need to take different 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 ARX-TICAGRELOR.
They will have more information on medicines to be careful with or avoid while taking
ARX-TICAGRELOR.
4. How do I take ARX-TICAGRELOR?
Follow all directions given to you by your doctor carefully. They may differ from
the information contained in this leaflet.
If you do not understand the instructions in this leaflet, ask your doctor or pharmacist
for help.
How much to take
The starting dose is two tablets at the same time. This dose will usually be given
to you in the hospital. After that, the usual dose is one tablet twice a day.
ARX-TICAGRELOR film-coated tablets
Swallow each tablet whole with a drink of water.
If you have trouble swallowing ARX-TICAGRELOR film-coated tablets you can crush them
and mix with water as follows:
Crush the tablet(s) to a fine powder using a mortar and pestle or other crushing device.
Add half a glass of water (approximately 100 mL) to the mortar and pestle/crushing
device and stir before pouring the liquid into a glass and drinking immediately.
For the remaining medicine, add another 100 mL to mortar and pestle/crushing device
and stir. Pour the liquid into a glass and drink it immediately. Make sure you also
stir the liquid in the glass before you drink it.
If you are using a nasogastric tube because you cannot swallow at all:
Crush tablets in mortar and pestle/crushing device to a fine powder.
Add 50 mL of water to the mortar and pestle/crushing device and stir before withdrawing
the mixture into a syringe and administering the liquid through a nasogastric tube.
For the remaining medicine, add another 50 mL to mortar and pestle/crushing device
and stir before withdrawing the mixture into the syringe and administering through
a nasogastric tube.
Your doctor will usually also tell you to take acetylsalicylic acid (aspirin). Your
doctor will tell you how much to take (usually 100 mg but may vary between 75-150
mg).
It does not matter whether you take ARX-TICAGRELOR with food or on an empty stomach.
Take your doses at around the same time every day. For example, one in the morning
and one in the evening.
Taking your tablets at the same time each day will have the best effect. It will also
help you to remember when to take it. You can check the day when you last took a ARX-TICAGRELOR
film-coated tablet by looking at days on the blister. There is a sun (for the morning)
and a moon (for the evening). This will tell you whether you have taken the dose.
How long to take it
You should take ARX-TICAGRELOR for as long as your doctor tells you to.
If you forget to take ARX-TICAGRELOR
ARX-TICAGRELOR should be used regularly at the same time each day. If you miss your
dose at the usual time, take your next dose as normal. Then go back to taking it as
you would normally.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much ARX-TICAGRELOR
If you think that you have taken too much ARX-TICAGRELOR, 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.
If you take too many ARX-TICAGRELOR tablets you may be at increased risk of bleeding.
5. What should I know while taking ARX-TICAGRELOR?
Things you should do
Take ARX-TICAGRELOR exactly as your doctor has told you to.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
ARX-TICAGRELOR.
If you are about to start taking any new medicines, tell your doctor and pharmacist
that you are taking ARX-TICAGRELOR.
Tell your doctor if you become pregnant while you are taking ARX-TICAGRELOR.
Tell your doctor if you decide to breast feed your baby.
Things you should not do
Do not stop taking ARX-TICAGRELOR without talking to your doctor. Take it for as long
as your doctor keeps prescribing it. If you want to stop taking ARX-TICAGRELOR, talk
to your doctor first.
This is because the benefits of ARX-TICAGRELOR are based on you taking it all the
time. If you stop taking ARX-TICAGRELOR without talking to your doctor it may increase
the chance of a heart attack or stroke or a blood clot forming.
Do not take ARX-TICAGRELOR to treat any other complaint unless your doctor advises
you to.
Do not give this medicine to anyone else, even if they have symptoms that seem similar
to yours.
Driving or using machines
Be careful driving or operating machinery.
ARX-TICAGRELOR is not likely to affect your ability to drive or use machines. You
are being treated because you had a heart attack or unstable angina and you may experience
dizziness and confusion. If you have these symptoms, you should be cautious while
driving or using machines.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
If you take ARX-TICAGRELOR out of the blister pack it will not keep well.
Store it in a cool dry place below 30°C and 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
Ask your pharmacist what to do with any ARX-TICAGRELOR tablets you have left over
if your doctor tells you to stop taking them, or you find that the expiry date has
passed.
Do not take 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.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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Signs of a stroke, such as:
sudden numbness or weakness of your arm, leg or face, especially if only on one side
of the body.
sudden confusion, difficulty speaking or understanding others.
sudden difficulty in walking or loss of balance or co-ordination.
suddenly feeling dizzy or sudden severe headache with no known cause.
These are signs of a kind of stroke caused by bleeding into the brain. This is uncommon
(affects less than 1 in 100 people).
Signs of bleeding, including:
Blood in your urine.
Black stools or blood in your stools.
Bleeding after surgery or from cuts and wounds that is more than normal.
Some bleeding is common (affects less than 1 in 10 people). However, severe bleeding
is uncommon (affects less than 1 in 100 people), but can be life threatening.
Signs of blood clotting, such as:
Fever and purplish spots on the skin or in the mouth, with or without yellowing of
the skin or eyes, unexplained extreme tiredness or confusion.
Signs of serious allergic reaction, such as:
tightness of the chest, wheezing, coughing or difficulty breathing.
swelling of the face, lips, tongue or other parts of the body.
severe skin reaction which may include rash, itching, redness, blistering or peeling
of the skin.
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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.
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The level of uric acid in your blood may increase while taking ARX-TICAGRELOR.
Your doctor may order blood tests to monitor the level of uric acid in your blood.
Tell your doctor or pharmacist 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 ARX-TICAGRELOR contains
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Active ingredient
(main ingredient)
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Each tablet contains ticagrelor 90 mg as the active ingredient.
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Other ingredients
(inactive ingredients)
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ARX-TICAGRELOR film-coated tablets
Mannitol
Calcium hydrogen phosphate dihydrate
Sodium starch glycollate
Hydroxypropylcellulose
Magnesium stearate
Hyprolose
Titanium dioxide
Purified talc
Macrogol 400
Iron oxide yellow
ARX-TICAGRELOR does not contain gluten.
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Do not take this medicine if you are allergic to any of these ingredients.
What ARX-TICAGRELOR looks like
ARX-TICAGRELOR film-coated tablets
Round, biconvex, yellow, film-coated tablets for oral use with "90" above "T" on one
side and plain on the reverse. Available in a blister pack of 56 tablets (AUST R 445790).
Who distributes ARX-TICAGRELOR
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: 1800 805 342
This leaflet was prepared in August 2024.
© AstraZeneca 2024
VV-RIM-06712742 v1.0