Brilique
ticagrelor
ticagrelor
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Brilique is and what it is used for
What you need to know before you take Brilique
How to take Brilique
Possible side effects
How to store Brilique
Contents of the pack and other information
Brilique contains an active substance called ticagrelor. This belongs to a group of medicines called
antiplatelet medicines.
Brilique in combination with acetylsalicylic acid (another antiplatelet agent) is to be used in adults only. You have been given this medicine because you have had:
a heart attack, over a year ago.
It reduces the chances of you having another heart attack, stroke or dying from a disease related to
your heart or blood vessels.
Brilique affects cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged.
However, platelets can also form clots inside diseased blood vessels in the heart and brain. 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, or
the clot can partly block the blood vessels to the heart; this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina’).
Brilique helps stop the clumping of platelets. This reduces the chance of a blood clot forming that can reduce blood flow.
You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
You are bleeding now.
You have had a stroke caused by bleeding in the brain.
You have severe liver disease.
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)
Do not take Brilique if any of the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking this medicine.
Talk to your doctor or pharmacist before taking Brilique if:
You have an increased risk of bleeding because of:
a recent serious injury
recent surgery (including dental work, ask your dentist about this)
you have a condition that affects blood clotting
recent bleeding from your stomach or gut (such as a stomach ulcer or colon ‘polyps’)
You are due to have surgery (including dental work) at any time while taking Brilique. This is
because of the increased risk of bleeding. Your doctor may want you to stop taking this medicine 5 days prior to surgery.
Your heart rate is abnormally low (usually lower than 60 beats per minute) and you do not
already have in place a device that paces your heart (pacemaker).
You have asthma or other lung problems or breathing difficulties.
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.
You have had any problems with your liver or have previously had any disease which may have affected your liver.
You have had a blood test that showed more than the usual amount of uric acid.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
this medicine.
If you are taking both Brilique and heparin:
Your doctor may require a sample of your blood for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is important that you inform your doctor that you are
taking both Brilique and heparin, as Brilique may affect the diagnostic test.
Brilique is not recommended for children and adolescents under 18 years.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Brilique can affect the way some medicines work and some medicines can
have an effect on Brilique.
Tell your doctor or pharmacist if you are taking any of the following medicines:
rosuvastatin (a medicine to treat high cholesterol)
more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high cholesterol)
rifampicin (an antibiotic)
phenytoin, carbamazepine and phenobarbital (used to control seizures)
digoxin (used to treat heart failure)
cyclosporine (used to lessen your body’s defenses)
quinidine and diltiazem (used to treat abnormal heart rhythms)
beta blockers and verapamil (used to treat high blood pressure)
morphine and other opioids (used to treat severe pain)
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that increase your risk of bleeding:
‘oral anticoagulants’ often referred to as ‘blood thinners’ which include warfarin.
Non-Steroidal Anti-Inflammatory Drugs (abbreviated as NSAIDs) often taken as painkillers such as ibuprofen and naproxen.
Selective Serotonin Reuptake Inhibitors (abbreviated as SSRIs) taken as antidepressants such as paroxetine, sertraline and citalopram.
other medicines such as 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), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).
Also tell your doctor that because you are taking Brilique, you may have an increased risk of bleeding if your doctor gives you fibrinolytics, often called ‘clot dissolvers’, such as streptokinase or alteplase.
It is not recommended to use Brilique if you are pregnant or may become pregnant. Women should
use appropriate contraceptive measures to avoid pregnancy while taking this medicine.
Talk to your doctor before taking this medicine if you are breast-feeding. Your doctor will discuss with you the benefits and risks of taking Brilique during this time.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Brilique is not likely to affect your ability to drive or use machines. If you feel dizzy or confused while taking this medicine, be careful while driving or using machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is one tablet of 60 mg twice a day. Continue taking Brilique as long as your doctor tells you.
Take this medicine around the same time every day (for example, one tablet in the morning and one in the evening).
Your doctor will usually also tell you to take acetylsalicylic acid. This is a substance present in many
medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75-150 mg daily).
You can take the tablet with or without food.
You can check when you last took a tablet of Brilique by looking 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.
If you have trouble swallowing the tablet you can crush it and mix with water as follows:
Crush the tablet to a fine powder.
Pour the powder into half a glass of water.
Stir and drink immediately.
To make sure there is no medicine left, rinse the empty glass with another half a glass of water and drink it.
If you are in the hospital you may be given this tablet mixed with some water and given through a
tube via the nose (nasogastric tube).
If you take more Brilique than you should, talk to a doctor or go to hospital straight away. Take the
medicine pack with you. You may be at increased risk of bleeding.
If you forget to take a dose, just take your next dose as normal.
Do not take a double dose (two doses at the same time) to make up for the forgotten dose.
Do not stop taking Brilique without talking to your doctor. Take this medicine on a regular basis and
for as long as your doctor keeps prescribing it. If you stop taking Brilique, it may increase your chances of having another heart attack or stroke or dying from a disease related to your heart or blood vessels.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Brilique affects blood clotting, so most side effects are related to bleeding. Bleeding may occur in any part of the body. Some bleeding is common (like bruising and nosebleeds). Severe bleeding is uncommon but can be life threatening.
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
bleeding that is severe or that you cannot control
unexpected bleeding or bleeding that lasts a long time
pink, red or brown urine
vomiting red blood or your vomit looks like ‘coffee grounds’
red or black stools (look like tar)
coughing up or vomiting blood clots
a temporary loss of consciousness due to sudden drop in blood flow to the brain (common)
fever and purplish spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion
High level of uric acid in your blood (as seen in tests)
Bleeding caused by blood disorders
Bruising
Headache
Feeling dizzy or like the room is spinning
Diarrhoea or indigestion
Feeling sick (nausea)
Constipation
Rash
Itching
Severe pain and swelling in your joints – these are signs of gout
Feeling dizzy or light-headed, or having blurred vision – these are signs of low blood pressure
Nosebleed
Bleeding after surgery or from cuts (for example while shaving) and wounds more than is normal
Bleeding from your stomach lining (ulcer)
Bleeding gums
Allergic reaction – a rash, itching or a swollen face or swollen lips/tongue may be signs of an allergic reaction
Confusion
Visual problems caused by blood in your eye
Vaginal bleeding that is heavier, or happens at different times, than your normal period (menstrual) bleeding
Bleeding into your joints and muscles causing painful swelling
Blood in your ear
Internal bleeding, this may cause dizziness or light-headedness
Abnormally Low heart rate (usually lower than 60 beats per minute)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the nationalreportingsystem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
The other ingredients are:
Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b).
Tablet film-coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide black (E172), iron oxide red (E172).
Film-coated tablet (tablet): The tablets are round, biconvex, pink, film-coated marked with a “60”
above “T” on one side.
Brilique is available in:
standard blisters (with sun/moon symbols) in cartons of 60 and 180 tablets
calendar blisters (with sun/moon symbols) in cartons of 14, 56 and 168 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder: AstraZeneca AB
SE-151 85 Södertälje Sweden
Manufacturer: AstraZeneca AB Gärtunavägen
SE-151 85 Södertälje
Sweden
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB AstraZeneca Lietuva Tel: +370 5 2660550
АстраЗенека България ЕООД Teл.: +359 2 44 55 000
AstraZeneca Czech Republic s.r.o Tel: +420 222 807 111
Associated Drug Co. Ltd Tel: +356 2277 8000
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca
Tel: +372 6549 600
AstraZeneca AS
Tlf: +47 21 00 64 00
AstraZeneca A.E.
Τηλ: +30 2 106871500
AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00
AstraZeneca
Tél: +33 1 41 29 40 00
AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00
AstraZeneca Pharma SRL Tel: +40 21 317 60 41
AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100
AstraZeneca UK Limited Tel: +386 1 51 35 600
Vistor hf.
Sími: +354 535 7000
AstraZeneca S.p.A. Tel: +39 02 9801 1
AstraZeneca Oy
Puh/Tel: +358 10 23 010
Αλέκτωρ Φαρµακευτική Λτδ
AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000
SIA AstraZeneca Latvija Tel: +371 67377100
AstraZeneca UK Ltd Tel: +44 1582 836 836