BRILIQUE 90 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Brilique 90mg orodispersible tablets

ticagrelor

Read all of this 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 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.

Contents of the pack

1. What is Brilique and what is it used for
2. What you need to know before you take Brilique
3. How to take Brilique
4. Possible side effects
5. Storing Brilique
6. Contents of the pack and other information

1. What is Brilique and what is it used for

What is Brilique

Brilique contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet agents.

What Brilique is used for

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

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

This medicine reduces the risk of you having another heart attack, a stroke or of dying from a heart or blood vessel-related illness.

How Brilique works

Brilique works on cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to block tiny holes in blood vessels that are cut or damaged.

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

• the clot can completely block the blood flow; this can cause a heart attack (myocardial infarction) or a stroke, or
• the clot can partially block the blood vessels that supply the heart; this reduces blood flow to the heart and can cause intermittent chest pain (called ‘unstable angina’).

Brilique helps prevent platelets from clumping together. This reduces the chance of a blood clot forming that could block blood flow.

2. What you need to know before you take Brilique

Do not take Brilique if:

• You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• You have any current bleeding.
• 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 and AIDS)

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

Warnings and precautions

Consult your doctor or pharmacist before taking Brilique if:

• You have a higher risk of bleeding due to:

• a recent serious injury
• a recent surgery (including dental procedures, ask your dentist about this)
• a condition that affects blood clotting
• a recent stomach or intestine bleeding (such as stomach ulcer or colon ‘polyps’)

• You are due to have surgery (including dental procedures) at any time while taking Brilique. This is because it increases the risk of bleeding. Your doctor may want to stop your treatment with this medicine 5 days before surgery.
• Your heart rate is abnormally slow (usually less than 60 beats per minute) and you do not have a device that regulates 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 brief pauses in breathing. Your doctor will decide if you need any further evaluation.
• You have had any liver problems or have had a disease that may have affected your liver.
• You have had a blood test that shows you have a higher than normal level of uric acid.

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

If you are taking Brilique and heparin:

• Your doctor may need a blood sample for diagnostic tests if they suspect the presence of a rare platelet disorder caused by heparin. It is important that you 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 18 years of age.

Using Brilique with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is because Brilique may affect the way 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 levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine and phenobarbital (used to control epilepsy)
• digoxin (used to treat heart failure)
• ciclosporin (used to reduce the body’s immune response)
• quinidine and diltiazem (used to treat irregular heart rhythms)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat acute pain)

In particular, tell 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) frequently taken 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 stomach acidity), ergot alkaloids (used to treat migraines and headaches).

Tell your doctor that, because you are taking Brilique, you may have a higher risk of bleeding if your doctor gives you fibrinolytics, often referred to as ‘clot dissolvers’, such as streptokinase or alteplase.

Pregnancy and breast-feeding

Brilique should not be used if you are pregnant or can become pregnant. Women should use appropriate contraceptive methods to prevent pregnancy while taking this medicine.

Consult your doctor before taking this medicine if you are breast-feeding. Your doctor will explain 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.

Driving and using machines

Brilique is unlikely 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.

Sodium content

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

3. How to take Brilique

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

• The initial dose is two tablets at the same time (a loading dose of 180 mg). This dose will usually be given to you in hospital.
• After this initial dose, the usual dose is one 90 mg tablet twice a day for 12 months, unless your doctor tells you otherwise.
• Take this medicine at the same time every day (for example, one tablet in the morning and one in the evening).

Taking Brilique with other medicines for blood clotting

Your doctor will also usually prescribe acetylsalicylic acid for you. This is a substance found in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75-150 mg daily).

How to take Brilique

Do not open the blister until you are ready to take your medicine.

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

If you are in hospital, this tablet may be given to you mixed with a little water and through a tube in your nose (nasogastric tube).

If you take more Brilique than you should

If you take more Brilique than you should, contact your doctor or go to hospital immediately. Take the medicine pack 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 the same time) to make up for a forgotten dose.

If you stop taking Brilique

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with Brilique:

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

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

• Bleeding in the brain or inside the skull is an uncommon side effect, and can cause signs of a stroke such as:

• sudden 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 a sudden severe headache of unknown cause

• Signs of bleeding such as:

• severe or uncontrollable bleeding
• unexpected or prolonged bleeding
• urine that is pink, red or brown
• vomiting blood or vomit that looks like “coffee grounds”
• black or red stools (like tar)
• coughing or vomiting blood

• Fainting (syncope)

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

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

• fever and purple spots on the skin and in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion.

Tell your doctor if you notice any of the following:

• Difficulty breathing - this is very common.It may be due to your heart condition or another cause, or it may be a side effect of Brilique. The breathing difficulty related to Brilique is usually mild and is characterised by a sudden, unexpected need for air that usually occurs at rest and may disappear in many cases. If you think your breathing difficulty has worsened or lasts for a long time, tell your doctor. They will decide if you need any treatment or further investigations.

Other possible side effects

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

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

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Feeling dizzy or as if everything is spinning
• Diarrhoea or indigestion
• Feeling sick (nausea)
• Constipation
• Rash
• Itching
• Severe pain and swelling in the joints – these are signs of gout
• Feeling dizzy or faint, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Bleeding that is more severe than normal after surgery or cuts (for example, when shaving) and injuries
• Bleeding from the stomach lining (stomach ulcer)
• Bleeding from the gums

Uncommon (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
• Vision problems caused by bleeding in the eye
• Heavier or more frequent vaginal bleeding, or bleeding between periods
• Bleeding into the joints and muscles that causes painful swelling
• Bleeding in the ear
• Internal bleeding, this can cause dizziness or fainting

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 on the carton after EXP/CAD. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Composition ofBrilique

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

• The other ingredients are:

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

Appearance and Packaging of the Product

The buccal dispersible tablets are round, flat, with beveled edges, white to pale pink in color, marked with a "90" above a "TI" on one side.

Brilique is available in:

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

AstraZeneca AB

SE-152 57 Södertälje

Sweden

Manufacturer:

AstraZeneca AB

Gärtunavägen

SE-151 85 Södertälje

Sweden

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

Date of the Last Revision of thisLeaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.