Brand name Brilique

Form tablets, film-coated

Active substance / Dosage

TICAGRELOR

Prescription type Prescription only

ATC code

B01AC24

Registration number 040546

Manufacturer ASTRAZENECA AB

Table of Contents

Package leaflet: Information for the user
Brilique 60 mg film-coated tablets
1. What Brilique is and what it is used for
2. What you should know before taking Brilique
3. How to take Brilique
4. Possible side effects
5. How to store Brilique
6. Package contents and other information
Package leaflet: information for the user
Brilique 90 mg film-coated tablets
1. What Brilique is and what it is used for
2. What you need to know before taking Brilique
3. How to take Brilique
4. Possible side effects
5. How to store Brilique
6. Package contents and other information
Package leaflet: information for the user
Brilique 90 mg orodispersible tablets
1. What Brilique is and what it is used for
2. What you need to know before taking Brilique
3. How to take Brilique
4. Possible side effects
5. How to store Brilique
6. Package contents and other information

Package leaflet: Information for the user

Brilique 60 mg film-coated tablets

ticagrelor
Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Brilique is and what it is used for
What you need to know before taking Brilique
How to take Brilique
Possible side effects
How to store Brilique
Contents of the pack and other information

1. What Brilique is and what it is used for

What Brilique is
Brilique contains an active substance called ticagrelor, which belongs to a group of medicines known as
antiplatelet agents.

What Brilique is used for
Brilique, in combination with acetylsalicylic acid (another antiplatelet agent), should only be used in adult patients. You have been prescribed this medicine because you have had:

a heart attack more than one year ago. This medicine reduces the likelihood that you will suffer another heart attack, stroke, or die from heart or blood vessel disease.

How Brilique works
Brilique acts on blood cells called 'platelets' (also known as thrombocytes). These are very small blood cells that help stop bleeding by clumping together to seal tiny holes in cut or damaged blood vessels.
However, platelets can also form clots inside diseased blood vessels of the heart and brain. This can be very dangerous because:

the clot may completely block the blood supply; this can cause a heart attack (myocardial infarction) or a stroke, or
the clot may partially block the blood vessels supplying the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (called 'unstable angina').

Brilique helps prevent platelets from clumping together. This reduces the likelihood of blood clot formation, which could otherwise reduce blood flow.

2. What you should know before taking Brilique

Do not take Brilique if:

You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
You are currently experiencing active bleeding.
You have had a stroke caused by bleeding in the brain.
You have severe liver problems.
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 and AIDS infection)

Do not take Brilique if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Brilique if:

You have an increased risk of bleeding due to:
- a serious recent injury
- recent surgery (including dental procedures; please consult your dentist)
- a blood clotting disorder
- recent gastrointestinal bleeding (e.g., due to gastric ulcer or colon "polyps")
You are scheduled to undergo surgery (including dental procedures) at any time while taking Brilique. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before surgery.
Your heart rate is unusually slow (typically less than 60 beats per minute) and you do not already have a heart rhythm-regulating device implanted (pacemaker).
You suffer from asthma or another lung condition or have breathing difficulties.
You develop irregular breathing patterns such as periods of rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
You have previously had liver problems or any illness affecting your liver.
You have previously had blood tests showing higher than normal levels of uric acid.

If any of the above situations apply to you (or if you are unsure), talk to your doctor or pharmacist before taking this medicine.

If you are taking both Brilique and heparin:

Your doctor may request a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder caused by heparin) is suspected. It is important to inform your doctor that you are taking both Brilique and heparin, as Brilique may affect the diagnostic test.

Children and adolescents
Brilique is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Brilique
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. This is because Brilique may affect how some medicines work, and some medicines may affect Brilique.

Tell your doctor or pharmacist if you are taking any of the following medicines:

rosuvastatin (a medicine used to treat high cholesterol)
more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
rifampicin (an antibiotic)
phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
digoxin (used to treat heart failure)
cyclosporine (used to suppress the immune system)
quinidine and diltiazem (used to treat abnormal heart rhythm)
beta-blockers and verapamil (used to treat high blood pressure)
morphine and other opioids (used to treat severe pain)

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that increase the risk of bleeding:

'Oral anticoagulants', often referred to as 'blood thinners', including warfarin.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
Selective Serotonin Reuptake Inhibitors (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 and AIDS infection), cisapride (used to treat heartburn), or ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, because you are taking Brilique, you may have an increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called 'thrombolytics', such as streptokinase or alteplase.

Pregnancy and breastfeeding
The use of Brilique is not recommended if you are pregnant or suspect you may be pregnant. Women of childbearing potential should use appropriate contraceptive methods to prevent pregnancy while taking this medicine.

Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss with you the benefits and risks of treatment with Brilique during this period.

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
It is unlikely that Brilique will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Brilique, exercise caution when driving or operating machinery.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Brilique

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Brilique to take

The usual dose is one 60 mg tablet twice daily. Continue taking Brilique for the entire duration prescribed by your doctor.
Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

If you are taking Brilique together with other blood-thinning medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This is a substance found in
many medicines used to prevent blood clotting. Your doctor will tell you how much to take
(generally between 75 and 150 mg per day).
How to take Brilique

You may take the tablet with or without food.
You can check when you took your last dose of Brilique by looking at the blister pack. There is a sun symbol (for the morning) and a moon symbol (for the evening). These will help you remember whether you have taken your dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

Crush the tablet into a fine powder.
Pour the powder into half a glass of water.
Stir and drink immediately.
To ensure no medicine is left behind, rinse the empty glass with another half glass of water and drink it. If you are in hospital, the tablet may be given to you crushed and mixed with a small amount of water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Brilique than you should
If you have taken more Brilique than you should, contact your doctor or go to hospital
immediately. Take the medicine pack with you. You may be at increased risk of
bleeding.
If you forget to take Brilique

If you forget to take a dose, take the next dose at your usual time.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Brilique
Do not stop taking Brilique without first talking to your doctor. Take this medicine regularly
and for as long as your doctor prescribes it. If you stop taking Brilique, your risk of having another heart attack or stroke may increase, or you may die from a condition related to heart or blood vessel problems.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur with this medicine:
Brilique affects blood clotting, therefore many side effects are related to bleeding. Bleeding can occur in any part of the body. Some bleeding events are common (such as bruising and nosebleeds). Severe bleeding is uncommon in frequency, but may be life-threatening.
Seek immediate medical attention if you experience any of the following symptoms – you may need urgent
medical treatment:

Bleeding in the brain or within the skull is an uncommon side effect and may cause signs of stroke such as:
sudden numbness or weakness in the arms, legs, or face, especially on one side of the body
sudden confusion, difficulty speaking or understanding others
sudden difficulty walking, loss of balance, or lack of coordination
sudden dizziness or sudden, severe headache with no known cause
Signs of bleeding such as:
severe bleeding or bleeding that cannot be controlled
unexpected bleeding or bleeding that lasts longer than usual
pink, red, or brown urine
vomit that is red or looks like coffee grounds
red or black stools (resembling tar)
coughing up or vomiting blood clots
Fainting (syncope)
temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
Signs of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) such as:
fever and purple 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

Contact your doctor if you experience any of the following symptoms:

Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it could represent a side effect of Brilique. Dyspnea (shortness of breath) due to Brilique is generally mild and characterized by a sudden, unexpected need for air, which usually occurs at rest and may appear within the first weeks of treatment; for many, it may resolve over time. If your shortness of breath worsens or persists, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

Other possible side effects
Very common (may affect more than 1 in 10 people)

High levels of uric acid in the blood (as shown by laboratory tests)
Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

Bruising
Headache
Dizziness or sensation of spinning
Diarrhea or indigestion
Feeling unwell (nausea)
Constipation
Rash
Itching
Severe joint pain and swelling – signs of gout
Dizziness, mental confusion, or blurred vision – signs of low blood pressure
Nosebleeds
Bleeding after surgery or cuts (e.g. during shaving) and wounds, greater than normal
Bleeding from the stomach lining (ulcer)
Bleeding gums

Uncommon (may affect up to 1 in 100 people)

Allergic reaction – rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
Confusion
Vision problems caused by bleeding in the eyes
Heavier vaginal bleeding or bleeding occurring at times different from the normal menstrual cycle
Bleeding into joints and muscles, which may cause painful swelling
Bleeding in the ears
Internal bleeding, which may cause dizziness or mental confusion

Not known (frequency cannot be estimated from available data)

Abnormally slow heart rate (usually less than 60 beats per minute)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brilique

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton, following the abbreviation EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Brilique contains

The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
The other components are:
Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b)
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, black iron oxide (E172), red iron oxide (E172).

Description of the appearance of Brilique and contents of the pack
Film-coated tablet: the tablets are round, biconvex, pink in colour, film-coated, with '60' imprinted above a 'T' on one side.

Brilique is available in:

standard blisters (with sun/moon symbols) in cartons containing 60 and 180 tablets
calendar blisters (with sun/moon symbols) in cartons containing 14, 56 and 168 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AstraZeneca AB
SE-151 85
Södertälje
Sweden

Manufacturer:
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Teл.: +359 244 55 000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 80 90 34100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 2 106871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: information for the user

Brilique 90 mg film-coated tablets

ticagrelor
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Brilique is and what it is used for
What you need to know before taking Brilique
How to take Brilique
Possible side effects
How to store Brilique
Contents of the pack and other information

1. What Brilique is and what it is used for

What Brilique is
Brilique contains an active substance called ticagrelor, which belongs to a group of medicines known as
antiplatelet agents.

What Brilique is used for
Brilique, in combination with acetylsalicylic acid (another antiplatelet agent), should only be used in adult patients. You have been prescribed this medicine because you have had:

a heart attack, or
unstable angina (angina or chest pain that is not well controlled).

This medicine reduces the likelihood of you having another heart attack or stroke, or of dying from heart disease or blood vessel-related conditions.

How Brilique works
Brilique acts on blood cells called 'platelets' (also known as thrombocytes). These are very small blood cells that help stop bleeding by clumping together to seal tiny holes in cut or damaged blood vessels.

However, platelets can also form clots inside diseased blood vessels of the heart and brain. This can be very dangerous because:

the clot may completely block the blood supply; this can cause a heart attack (myocardial infarction) or a stroke, or
the clot may partially block the blood vessels supplying the heart; this reduces blood flow to the heart and can cause chest pain that comes and goes (called 'unstable angina').

Brilique helps prevent platelets from sticking together. This reduces the risk of blood clot formation that could reduce blood flow.

2. What you need to know before taking Brilique

Do not take Brilique if:

You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
You are currently bleeding.
You have had a stroke caused by bleeding in the brain.
You have severe liver problems.
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 and AIDS)

Do not take Brilique if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Brilique if:

You have an increased risk of bleeding due to:
- a recent serious injury
- recent surgery (including dental procedures; consult your dentist)
- a blood clotting disorder
- recent gastrointestinal bleeding (e.g., due to gastric ulcer or colon "polyps")
You are scheduled for surgery (including dental procedures) at any time while taking Brilique. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before surgery.
Your heart rate is unusually low (typically less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
You suffer from asthma or another lung condition or have breathing difficulties.
You develop irregular breathing patterns such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
You have previously had liver problems or any liver disease.
You have previously had blood tests showing elevated levels of uric acid.

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking both Brilique and heparin:

Your doctor may request a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform your doctor that you are taking both Brilique and heparin, as Brilique may interfere with the diagnostic test.

Children and adolescents
Brilique is not recommended for children and adolescents under 18 years of age.

Other medicines and Brilique
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Brilique may affect how some medicines work, and some medicines may affect Brilique.

Inform your doctor or pharmacist if you are taking any of the following medicines:

rosuvastatin (a medicine used to treat high cholesterol)
more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
rifampicin (an antibiotic)
phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
digoxin (used to treat heart failure)
cyclosporine (used to suppress the immune system)
quinidine and diltiazem (used to treat abnormal heart rhythm)
beta-blockers and verapamil (used to treat high blood pressure)
morphine and other opioids (used to treat severe pain)

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that increase the risk of bleeding:

'Oral anticoagulants', often referred to as 'blood thinners', including warfarin.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
Selective Serotonin Reuptake Inhibitors (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 and AIDS), cisapride (used to treat heartburn), or ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, because you are taking Brilique, you may have an increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called 'thrombolytics', such as streptokinase or alteplase.

Pregnancy and breastfeeding
The use of Brilique is not recommended if you are pregnant or suspect you may be pregnant. Women should use appropriate contraceptive methods to avoid pregnancy while taking this medicine.

Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss with you the benefits and risks of treatment with Brilique during this period.

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
It is unlikely that Brilique will affect your ability to drive or use machinery. However, if you experience dizziness or confusion while taking Brilique, exercise caution when driving or operating machinery.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Brilique

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How much Brilique to take

The initial dose is two tablets taken at once (a loading dose of 180 mg). This dose is normally administered in hospital.
After this initial dose, the usual dose is one 90 mg tablet twice daily for up to 12 months, unless your doctor tells you otherwise.
Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

If you take Brilique with other blood-thinning medicines
Your doctor will usually instruct you to also take acetylsalicylic acid. This is an active substance found in
many medicines used to prevent blood clotting. Your doctor will advise you how much to take
(generally between 75 and 150 mg per day).
How to take Brilique

You may take the tablet with or without food.
You can check when you took your last Brilique tablet by looking at the blister pack. There is a sun (for the morning) and a moon (for the evening). This will help you remember whether you have taken your dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

Crush the tablet into a fine powder.
Pour the powder into half a glass of water.
Stir and drink immediately.
To ensure you do not leave any medicine behind, rinse the empty glass with half a glass of water and drink it. If you are in hospital, the tablet may be given to you mixed with a small amount of water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Brilique than you should
If you have taken more Brilique than you should have, contact your doctor or go to hospital
immediately. Take the medicine pack with you. You may be at increased risk of
bleeding.
If you forget to take Brilique

If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Brilique
Do not stop taking Brilique without first talking to your doctor. Take this medicine regularly
and for as long as your doctor prescribes it. If you stop taking Brilique, this may increase the
risk of having another heart attack or stroke, or of dying from a condition related to heart or blood vessel problems.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur with this medicine:
Brilique affects blood clotting; therefore, many of the side effects are related to bleeding. Bleeding can occur in any part of the body. Some bleeding events are common (such as bruising and nosebleeds). Serious bleeding is uncommon in frequency but can be life-threatening.
Seek immediate medical advice if you notice any of the following symptoms – you may need urgent medical treatment:

Bleeding in the brain or within the skull is an uncommon side effect and may cause signs of stroke such as:
sudden numbness or weakness of arms, legs, or face, especially on one side of the body
sudden confusion, difficulty speaking or understanding others
sudden difficulty walking or loss of balance or coordination
sudden dizziness or sudden, severe headache without known cause
Signs of bleeding such as:
severe bleeding or bleeding that cannot be controlled
unexpected bleeding or bleeding that lasts a long time
pink, red or brown urine
vomit that is red or looks like coffee grounds
red or black stools (which look like tar)
coughing up or vomiting blood clots
Fainting (syncope)
a temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
Signs of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) such as:
fever and purple 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

Contact your doctor if you notice any of the following symptoms:

Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it could represent a side effect of Brilique. Dyspnea (shortness of breath) due to Brilique is usually mild and characterized by a sudden, unexpected need for air, which generally occurs at rest and may appear during the first weeks of therapy; for many, it may resolve spontaneously. If your shortness of breath worsens or persists over time, inform your doctor. Your doctor will decide whether treatment is needed or further investigations should be carried out.

Other possible side effects
Very common (may affect more than 1 in 10 people)

High levels of uric acid in the blood (shown by laboratory tests)
Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

Bruising
Headache
Dizziness or sensation of spinning (vertigo)
Diarrhea or indigestion
Feeling unwell (nausea)
Constipation
Rash
Itching
Severe joint pain and swelling – these are signs of gout
Dizziness or mental confusion, or blurred vision – these are signs of low blood pressure
Nosebleeds
Bleeding after surgery or cuts (e.g. during shaving) and wounds, greater than normal
Bleeding from the stomach lining (ulcer)
Bleeding gums

Uncommon (may affect up to 1 in 100 people)

Allergic reaction – rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
Confusion
Vision problems caused by bleeding in the eyes
Heavier vaginal bleeding or bleeding occurring at different times than normal menstrual bleeding
Bleeding into joints and muscles, which may cause painful swelling
Bleeding in the ears
Internal bleeding, which may cause dizziness or mental confusion

Not known (frequency cannot be estimated from available data)

Abnormally slow heart rate (usually less than 60 beats per minute)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brilique

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 the abbreviation EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Brilique contains

The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
The other components are:
Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b)
Tablet coating: hypromellose (E464), titanium dioxide (E171), talc, macrogol 400,
iron oxide yellow (E172).

Description of the appearance of Brilique and pack contents
Film-coated tablet (tablet): the tablets are round, biconvex, yellow, film-coated, with '90' printed over a 'T' on one side.
Brilique is available in:

Standard blisters (with sun/moon symbols) in cartons containing 60 and 180 tablets
Calendar blisters (with sun/moon symbols) in cartons containing 14, 56 and 168 tablets
Perforated unit dose blisters in a carton containing 100x1 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AstraZeneca AB
SE-151 85
Södertälje
Sweden

Manufacturer:
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Tel: +359 244 55 000 Tél/Tel: +32 2 370 48 11