Leaflet: information for the user

Brilique 90buccodispersible tablets

ticagrelor

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

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1. What isBriliqueand what it is used for

2. What you need to knowbefore starting totakeBrilique

3. How to takeBrilique

4. Possible side effects

5. Storage ofBrilique

6. Contents of the pack and additional information

What is Brilique

Brilique contains an active ingredient called ticagrelor. It belongs to a group of medications called antiplatelet agents.

What is Brilique used for

Brilique in combination with acetylsalicylic acid (another antiplatelet agent) should only be used in adults. This medication has been prescribed because you have had:

• a myocardial infarction, or
• unstable angina (chest pain or uncontrolled chest discomfort).

This medication reduces the risk of having another myocardial infarction, a cerebral infarction, or dying from a heart or blood vessel disease.

How Brilique works

Brilique acts on cells called 'platelets' (also called thrombocytes). These very small blood cells help stop bleeding by grouping together to block small holes in blood vessels that are cut or damaged.

However, platelets can also form clotsinsidedamaged blood vessels in the heart and brain. This can be very dangerous because:

• the clot can completely block blood flow; this can cause a heart attack (myocardial infarction) or a cerebral infarction, or
• the clot can partially block blood vessels that go to the heart; this reduces blood flow to the heart and can cause intermittent chest pain (known as 'unstable angina').

Brilique helps prevent platelet aggregation. This reduces the likelihood of a blood clot forming that can reduce blood flow.

Do not take Brilique if:

• You are allergic to ticagrelor or any of the other components of this medication (listed in section6).
• You have a current hemorrhage.
• You have had a cerebral infarction caused by a cerebral hemorrhage.
• You have severe liver disease.
• You are taking any of the following medications:

• 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 you are in any of the above circumstances. If you have doubts, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before taking Brilique if:

• You have a higher risk of hemorrhage due to:

• a recent severe injury
• a recent surgical intervention (including dental, ask your dentist about this)
• You have a disorder that affects blood coagulation
• a recent hemorrhage of the stomach or intestine (such as stomach ulcer or 'polyps' of the colon)

• You are to undergo a surgical intervention (including dental) at any time while taking Brilique. This is because it increases the risk of hemorrhage. Your doctor may want to suspend treatment with this medication 5days before surgery.
• Your heart rate is abnormally slow (usually less than 60 beats per minute) and you do not already have an implanted device that regulates your heart (pacemaker).
• You have asthma or other respiratory problems or difficulty breathing.
• You develop irregular breathing patterns, such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide if you need additional evaluation.
• You have had any liver problems or have had a previous condition that may have affected your liver.
• You have had a blood test that shows that the amount of uric acid is higher than normal.

If any of the above applies to your case (or if you are unsure), consult your doctor or pharmacist before taking this medication.

If you are taking Brilique and heparin:

• Your doctor may require a blood sample for diagnostic testing if they suspect the presence of a rare platelet disorder caused by heparin. It is essential to inform your doctor that you are taking Brilique and heparin, as Brilique may affect the diagnostic test.

Children and adolescents

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

Use of Brilique with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.This is because Brilique may affect the mechanism of action of some medications and some medications may affect Brilique.

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

• Rosuvastatin (a medication to treat high cholesterol)
• more than 40mg daily of simvastatin or lovastatin (medications used to treat high cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• ciclosporin (used to reduce the 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 acute pain)

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that increase the risk of hemorrhage:

• 'oral anticoagulants', often referred to as 'blood thinners', including warfarin.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), often taken as analgesics, such as ibuprofen and naproxen.
• Selective serotonin reuptake inhibitors (SSRIs), taken as antidepressants, such as paroxetine, sertraline, and citalopram.
• Other medications, 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 stomach acid), and ergot alkaloids (used to treat migraines and headaches).

Also inform your doctor that, due to taking Brilique, you may have a higher risk of bleeding if your doctor administers fibrinolytics, often referred to as 'clot dissolvers', such as streptokinase or alteplase.

Pregnancy and breastfeeding

Brilique is not recommended if you are pregnant or may become pregnant. Women should use appropriate contraceptive methods to avoid pregnancy while taking this medication.

Consult your doctor before taking this medication if you are breastfeeding. Your doctor will explain the benefits and risks of taking Brilique during this period.

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

Driving and operating machinery

Brilique is unlikely to affect your ability to drive and operate machinery. If you feel dizzy or confused while taking this medication, be careful while driving or operating machinery.

Sodium content

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially 'sodium-free'.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

• The initial dose is two tablets at once (180 mg loading dose). This dose will be administered normally in the hospital.
• After this initial dose, the normal dose is one tablet of 90 mg twice a day for 12 months, unless your doctor tells you otherwise.
• Take this medication at the same time every day (for example, one tablet in the morning and one at night).

Brilique with other medications for blood clotting

Your doctor will also normally prescribe acetylsalicylic acid. This is a substance present in many medications used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75-150 mg per day).

How to take Brilique

Do not open the blister pack until the time you are going to take your medication.

• To extract the tablet, open the blister pack - do not push it through the blister pack because the tablet could break.
• Place the tablet on your tongue and let it dissolve.
• You can then swallow it with or without water.
• You can take this medication with or without food.

If you are in the hospital, they may administer this tablet mixed with a little water and through a tube through your nose (nasogastric tube).

If you take more Brilique than you should

If you take more Brilique than you should, consult your doctor or go to the hospital immediately. Bring the medication packaging with you. You may have a higher risk of bleeding.

If you forget to take Brilique

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

If you interrupt Brilique treatment

Do not stop Brilique without consulting your doctor. Take this medication regularly and for as long as your doctor tells you to. If you stop taking Brilique, you may increase the risk of having another heart attack or a stroke or dying from a heart or blood vessel disease.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. This medicine can cause the following side effects:

Brilique affects blood clotting, so most side effects are related to bleeding. Bleeding can occur anywhere in the body. A certain level of bleeding is common (such as bruises and nosebleeds). Severe bleeding is rare but can be potentially life-threatening.

Inform your doctor immediately if you notice any of the following - you may need urgent medical treatment:

• Brain or intracranial bleeding is a rare side effect, and can cause signs of a stroke such as:

• numbness or weakness of the arms, legs, or face, especially if it affects only one side of the body
• sudden confusion, difficulty speaking or understanding others
• sudden difficulty walking or loss of balance or coordination
• sudden feeling of dizziness or intense, unexplained headache

• Signs of bleeding such as:

• severe or uncontrolled bleeding
• unexpected or prolonged bleeding
• urine that is pink, red, or brown
• vomiting with blood or vomiting that looks like "coffee grounds"
• black or red stools (appear like tar)
• coughing or vomiting with blood

• Loss of consciousness (syncope)

• temporary loss of consciousness due to a sudden drop in blood flow to the brain (frequent)

• Signs of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) such as:

• fever and purple spots (called purpura) on the skin and in the mouth, with or without yellowing of the skin or eyes (jaundice), extreme fatigue, or confusion

Consult your doctor if you notice any of the following:

• Difficulty breathing - this is very common.This may be due to heart disease or another cause, or it may be a side effect of Brilique. Difficulty breathing related to Brilique is generally mild and is characterized by a sudden, unexpected need for air that occurs normally at rest and may occur in the first weeks of treatment and in many cases may resolve. If you think your difficulty breathing has worsened or lasts a long time, inform your doctor. He or she will decide if you need treatment or further investigations.

Other possible side effects

Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

• Bruises
• Headache
• Dizziness or feeling like everything is spinning
• Diarrhea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Intense pain and inflammation in the joints - these are signs of gout
• Dizziness or feeling faint, or blurred vision - these are signs of low blood pressure
• Nosebleeds
• Bleeding more than usual after surgery or cuts (e.g., shaving) and wounds
• Stomach ulcers
• Gum bleeding

Rare (may affect up to 1 in 100 people)

• Allergic reaction - a skin rash, itching, or swelling of the face or swelling of the lips/tongue may be signs of an allergic reaction
• Confusion
• Visual problems caused by blood in the eye
• Heavier or more frequent vaginal bleeding, or bleeding at times other than your usual menstrual period
• Bleeding into the joints and muscles that causes painful inflammation
• Blood in the ear
• Internal bleeding, which can cause dizziness or fainting

Frequency unknown (cannot be estimated from available data)

• Abnormally low heart rate (usually below 60 beats per minute)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the outer packaging after EXP/CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition ofBrilique

• The active ingredient is ticagrelor. Each buccal tablet contains 90mg of ticagrelor.

• The other components are:

mannitol (E421),microcrystalline cellulose (E460), crospovidone (E1202), xylitol (E967), calcium hydrogen phosphate anhydrous (E341), stearate and sodium fumarate, hydroxypropyl cellulose (E463),anhydrous colloidal silica.

Appearance of the product and contents of the pack

The buccal tablets are round, flat, with beveled edges, white to pale pink in color, marked with a “90” over a “TI” on one face.

Brilique is available in:

• unit dose blister packs in packs of 10 x 1, 56 x 1 and 60 x 1buccal tablets

Only some pack sizes may be marketed.

Marketing authorization holder andresponsible manufacturer

Marketing authorization holder:

AstraZeneca AB

SE‑152 57 Södertälje

Sweden

Responsible manufacturer:

AstraZeneca AB

Gärtunavägen

SE‑151 85 Södertälje

Sweden

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Last update of thissummary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.