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 BRILINTA?
BRILINTA contains the active ingredient ticagrelor. BRILINTA 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 BRILINTA?
Do not use if you have ever had an allergic reaction to BRILINTA 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 BRILINTA and affect how it works.
4. How do I take BRILINTA?
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 BRILINTA with food or
on an empty stomach.
5. What should I know while taking BRILINTA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking BRILINTA.
Take BRILINTA exactly as your doctor has told you to.
Tell your doctor if you become pregnant while you are taking BRILINTA.
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 BRILINTA without talking to your doctor. Take it for as long as
your doctor keeps prescribing it. If you want to stop taking BRILINTA, 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
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking BRILINTA. 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 BRILINTA.
Where to find information in this leaflet:
1. Why am I taking BRILINTA?
BRILINTA contains the active ingredient ticagrelor. BRILINTA 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').
BRILINTA helps stop the clumping of platelets. This reduces the chance of a blood
clot forming that can block a blood vessel. This means that BRILINTA 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 BRILINTA 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.
BRILINTA is only available on a doctor's prescription.
There is no evidence that BRILINTA is addictive.
2. What should I know before I take BRILINTA?
Warnings
Do not take BRILINTA 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 BRILINTA.
This is because of the increased risk of bleeding. Your doctor may want you to stop
taking BRILINTA 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 BRILINTA. Your doctor will discuss the risks and
benefits of taking BRILINTA during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not recommended that you take BRILINTA. Your doctor will discuss the risks and
benefits of taking BRILINTA during breast feeding.
Children
BRILINTA 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 BRILINTA.
They will have more information on medicines to be careful with or avoid while taking
BRILINTA.
4. How do I take BRILINTA?
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.
BRILINTA film-coated tablets
Swallow each tablet whole with a drink of water.
If you have trouble swallowing BRILINTA 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.
BRILINTA orodispersible tablets
Do not open the blister until it is time to take your medicine.
To take out the tablet, tear open the blister foil - do not push it through the foil
because the tablet may break.
Put the tablet on your tongue and let it disintegrate. Please ensure your hands are
dry.
Once the tablet has disintegrated, you can then swallow it with or without water.
Do not use carbonated water.
If you are using a nasogastric tube because you cannot swallow at all:
Disperse the tablet in water and administer the liquid through the nasogastric tube.
Flush the nasogastric tube with water to deliver any remaining contents of the tube
into the stomach.
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 BRILINTA 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 BRILINTA
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 BRILINTA for as long as your doctor tells you to.
If you forget to take BRILINTA
BRILINTA 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 BRILINTA
If you think that you have taken too much BRILINTA, 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 BRILINTA tablets you may be at increased risk of bleeding.
5. What should I know while taking BRILINTA?
Things you should do
Take BRILINTA exactly as your doctor has told you to.
Tell all doctors, dentists and pharmacists who are treating you that you are taking
BRILINTA.
If you are about to start taking any new medicines, tell your doctor and pharmacist
that you are taking BRILINTA.
Tell your doctor if you become pregnant while you are taking BRILINTA.
Tell your doctor if you decide to breast feed your baby.
Things you should not do
Do not stop taking BRILINTA without talking to your doctor. Take it for as long as
your doctor keeps prescribing it. If you want to stop taking BRILINTA, talk to your
doctor first.
This is because the benefits of BRILINTA are based on you taking it all the time.
If you stop taking BRILINTA without talking to your doctor it may increase the chance
of a heart attack or stroke or a blood clot forming.
Do not take BRILINTA 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.
BRILINTA 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 BRILINTA 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 BRILINTA 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
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Less serious side effects
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What to do
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Feeling shortness of breath
This is very common (affects more than 1 in 10 people). It might be due to your heart
disease or another cause, or it might be a side effect of BRILINTA. If your feeling
of shortness of breath gets worse or lasts a long time, tell your doctor. Your doctor
will decide if it needs treatment or further investigations.
Bruising
Nosebleed
Headache
Stomach pain
Constipation, diarrhoea or indigestion
Feeling of being sick
Rash
Inflamed stomach (gastritis)
A tingling feeling
Fainting
Slow and/or irregular heart rate
Signs of irregular breathing (central sleep apnoea and Cheyne-Stokes respiration)
This has been reported in a small number of patients taking BRILINTA (frequency cannot
be estimated from the available data). Central sleep apnoea is associated with irregular
breathing and may occur in patients with heart disease, stroke or other causes. Tell
your doctor if you develop irregular breathing patterns such as speeding up, slowing
down or short pauses in breathing. Your doctor will decide if you need further evaluation.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
The level of uric acid in your blood may increase while taking BRILINTA.
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 BRILINTA 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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BRILINTA film-coated tablets
Mannitol
Calcium hydrogen phosphate dihydrate
Sodium starch glycollate
Hydroxypropylcellulose
Magnesium stearate
Hyprolose
Titanium dioxide
Purified talc
Macrogol 400
Iron oxide yellow
BRILINTA orodispersible tablets
Mannitol
Microcrystalline cellulose
Crospovidone
Xylitol
Calcium hydrogen phosphate
Sodium stearylfumarate
Hyprolose
Colloidal anhydrous silica
BRILINTA does not contain gluten.
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Do not take this medicine if you are allergic to any of these ingredients.
What BRILINTA looks like
BRILINTA 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 blister packs of 14 (not marketed) and
56 tablets (AUST R 167237).
BRILINTA orodispersible tablets
Round, flat, bevelled edged, white to pale pink, orodispersible tablets for oral use
with "90" above "TI" on one side and plain on the reverse. Available in blister packs
of 56 tablets (AUST R 303878).
Who distributes BRILINTA
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: 1800 805 342
This leaflet was prepared in October 2023.
BRILINTA is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca 2023
Doc ID-002470482 V9.0