Brilique 90 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Brilique 90 mg orodispersible tablets

ticagrelor

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. 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. It 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 adults. You have been prescribed this medicine because you have had:

• a myocardial infarction (heart attack), or
• unstable angina (chest pain or discomfort not adequately controlled).

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

How Brilique works

Brilique acts on cells called 'platelets' (also known as thrombocytes). These small blood cells help stop bleeding by clumping together to plug small 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 may completely block blood flow; this can cause a heart attack (myocardial infarction) or a stroke, or
• the clot may partially block blood vessels leading to the heart; this reduces blood flow to the heart and may cause intermittent chest pain (known as 'unstable angina').

Brilique helps prevent platelets from clumping together. This reduces the chance of a blood clot forming, which could otherwise 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 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 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 a higher risk of bleeding due to:

• a serious recent injury

• a recent surgery (including dental procedures; ask your dentist about this)

• a disorder affecting blood clotting

• a recent stomach or intestinal bleed (such as a stomach ulcer or colon ‘polyps’)

• You need to undergo surgery (including dental procedures) at any time while taking Brilique. This is because your risk of bleeding may increase. Your doctor may decide to stop 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 already have a device implanted to regulate your heart rhythm (pacemaker).

• You have asthma or other lung problems or breathing difficulties.

• You develop irregular breathing patterns, such as periods of fast breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether you need further evaluation.

• You have had liver problems or previously had a condition that may have affected your liver.

• You have had a blood test showing elevated levels of uric acid.

If any of the above apply 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 to take a blood sample for diagnostic testing if he or she suspects 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.

Children and adolescents

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

Taking Brilique with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• ciclosporin (used to suppress the immune system)
• 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)

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 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 infection and AIDS), cisapride (used to treat stomach acid), ergot alkaloids (used to treat migraines and headaches).

Also inform your doctor that, because you are taking Brilique, you may have an increased risk of bleeding if you are given fibrinolytic agents, often called ‘clot dissolvers’, such as streptokinase or alteplase.

Pregnancy and breastfeeding

The use of Brilique is not recommended if you are pregnant or could 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 breastfeeding. Your doctor will explain the benefits and risks of taking Brilique during this period.

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

Driving and using machines

Brilique is unlikely to affect your ability to drive or operate machinery. However, if you feel dizzy or confused while taking this medicine, take care when driving or using machines.

Sodium content

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

3. How to take Brilique

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take

• The initial dose is two tablets 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 12 months, unless your doctor tells you otherwise.
• Take this medicine at the same time each day (for example, one tablet in the morning and one at night).

Taking Brilique with other blood-thinning medicines

Your doctor will usually also prescribe acetylsalicylic acid. 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 pack until it is time to take your medicine.

• To remove the tablet, push through the foil of the blister pack — do not push the tablet through the foil as it may break.
• Place the tablet on your tongue and allow it to disintegrate.
• You may then swallow it with or without water.
• You may take this medicine with or without food.

If you are in hospital, this tablet may be administered mixed with a small amount of water through a tube inserted via the 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 an increased risk of bleeding.

If you forget to take Brilique

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

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 to. If you stop taking Brilique, your risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related condition, may increase.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine:

Brilique affects blood clotting, so most adverse effects are related to bleeding. Bleeding may occur in any part of the body. Some degree of bleeding is common (such as bruising and nosebleeds). Serious bleeding is rare but can be potentially fatal.

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

• Bleeding in the brain or within the skull is an uncommon adverse effect, and may cause signs of stroke such as:

• sudden numbness or weakness in the arms, legs, or face, especially if affecting only 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 of unknown cause

• Signs of bleeding such as:

• severe or uncontrollable bleeding

• unexpected bleeding or bleeding that lasts a long time

• pink, red or brown urine

• vomiting blood or vomit that looks like "coffee grounds"

• black or red stools (resembling tar)

• coughing up blood 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 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.

Consult your doctor if you notice any of the following:

• Shortness of breath – this is very common. It may be due to heart disease or another cause, or may be a side effect of Brilique. Shortness of breath related to Brilique is usually mild and is characterized by a sudden, unexpected need for air, typically occurring at rest, and may appear within the first weeks of treatment; in many cases, it may resolve on its own. If you think your shortness of breath has worsened or lasts a long time, inform your doctor. Your doctor will decide whether you need treatment or further investigations.

Other possible adverse effects

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

• High level of uric acid in blood (as seen in blood 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 pain and swelling in the joints – these are signs of gout
• Dizziness, lightheadedness, or blurred vision – these are signs of low blood pressure
• Nosebleeds
• Heavier bleeding after surgery or cuts (e.g., while shaving) and wounds
• Bleeding from the stomach lining (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – 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 vaginal bleeding, or bleeding occurring at different times than your usual menstrual period
• Bleeding into joints and muscles causing painful swelling
• Blood in the ear
• Internal bleeding, which may cause dizziness or lightheadedness

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 outer packaging after EXP/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Brilique

• The active substance is ticagrelor. Each orodispersible tablet contains 90 mg of ticagrelor.

• The other components are:

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

Appearance of the product and contents of the pack

The orodispersible tablets are round, flat, with bevelled edges, white to pale pink in colour, marked with a "90" over a "TI" on one side.

Brilique is available in:

• unit-dose perforated blister packs in packs of 10 x 1, 56 x 1 and 60 x 1 orodispersible tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

AstraZeneca AB
SE‑152 57 Södertälje
Sweden

Manufacturer:

AstraZeneca AB
Gärtunavägen
SE‑151 85 Södertälje
Sweden

Further information about this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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