Brilique 90 mg film-coated tablets

 

What is it and how is it used?

What Brilique is
Brilique contains the active substance called ticagrelor. This belongs to a group of medicines called anti-platelet medicines.

How Brilique works
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.

What Brilique is used for
Brilique is to be used in adults only. You have been given Brilique because you have had:

  • a heart attack, or
  • unstable angina (angina or chest pain that is not well controlled). Brilique reduces the chances of you having another heart attack or a stroke or of dying from a disease related to your heart or blood vessels.

What do you have to consider before using it?

Do not take Brilique if:

  • You are allergic (hypersensitive) to ticagrelor or any of the other ingredients of Brilique (listed in Section 6: Further information).
  • You are bleeding now or have bled recently inside your body, such as bleeding in your stomach or gut from an ulcer.
  • You have moderate to 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).
  • You have had a stroke caused by bleeding in the brain. 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 Brilique.

Take special care with Brilique
Check with your doctor, pharmacist or dentist before taking Brilique if:

  • You have an increased risk of bleeding because of:
  • a recent serious injury
  • recent surgery (including dental work)
  • 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 Brilique 7 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 problem or breathing difficulties.
  • 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, pharmacist or dentist before taking Brilique.

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

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription, dietary supplements and herbal remedies. 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:

  • 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), dexamethasone (used to treat inflammatory and auto immune conditions), digoxin (used to treat heart failure), cyclosporin (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).

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 pain killers 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.

Taking Brilique with food and drink
You can take Brilique with or without food.

Pregnancy and breast-feeding
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 Brilique if you are breast-feeding. Your doctor will discuss with you the benefits and risks of taking Brilique during this time.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines
Brilique is not likely to affect your ability to drive or use machines.

How is it used?

Always take Brilique exactly as your doctor has told you. You should talk with your doctor or pharmacist if you are not sure.

How much to take

  • The starting dose is two tablets at the same time (loading dose of 180 mg). This dose will usually be given to you in the hospital.
  • After this starting dose, the usual dose is one tablet of 90 mg twice a day for up to 12 months unless your doctor tells you differently. Take Brilique around the same time everyday (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).

How to take Brilique

  • 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 take more Brilique than you should
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 Brilique

  • 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.

If you stop taking Brilique
Do not stop taking Brilique without talking to your doctor. Take Brilique 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.

What are possible side effects?

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

The frequency of possible side effects listed below is defined using the following convention: common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000)

See a doctor straight away if you notice any of the following – you may need urgent medical treatment:

  • Signs of a stroke such as:
  • 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 These are signs of a kind of stroke caused by bleeding into the brain. This is uncommon.
  • Bleeding – some bleeding is common. However, severe bleeding is uncommon, but can be life threatening. Bleeding of many different kinds can be increased, for example:
  • nosebleed (common)
  • blood in your urine (uncommon)
  • black stools or blood in your stools (common)
  • blood in your eye (uncommon)
  • coughing up or bringing up blood (uncommon)
  • vaginal bleeding that is heavier, or happens at different times, to your normal period (menstrual) bleeding (uncommon)
  • bleeding after surgery or from cuts and wounds that is more than normal (common)
  • bleeding from your stomach lining (ulcer) (uncommon).
  • bleeding gums (uncommon)
  • blood in your ear (rare)
  • internal bleeding (rare)
  • bleeding into joints causing painful swelling (rare)

Discuss with your doctor if you notice any of the following:

  • Feeling short of breath - this is common. It might be due to your heart disease or another cause, or it might be a side effect of Brilique. If your feeling of shortness of breath gets worse or lasts a long time, tell your doctor. Your doctor will decide if it needs treatment or further investigations.

Other possible side effects

Common (affects 1 to 10 users in 100)

  • Bruising

Uncommon (affects 1 to 10 users in 1,000)

  • Headache
  • Feeling dizzy or like the room is spinning
  • Abdominal pain
  • Diarrhoea or indigestion
  • Feeling or being sick
  • Rash
  • Itching
  • Inflamed stomach (gastritis)

Rare (affects 1 to 10 users in 10,000)

  • Constipation
  • A tingling feeling
  • Confusion

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, but do not stop taking Brilique until you have spoken to them.

How should it be stored?

Keep out of the reach and sight of children.
Do not use Brilique 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.
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 to protect the environment.

What is it?

Brilique is a medicine that contains the active substance ticagrelor. It is available as round, yellow tablets (90 mg).

What is it used for?

Brilique is used together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes. It is used in adults who have had a heart attack or have unstable angina (a type of chest pain caused by problems with the blood flow to the heart).

The medicine can only be obtained with a prescription.

How is it used?

The starting dose of Brilique is two tablets taken at once, followed by a regular dose of one tablet taken twice a day. Patients should also be taking aspirin as directed by their doctor. The doctor may, for health reasons, tell them not to take aspirin. They should continue treatment for up to a year unless, the doctor asks them to stop taking the medicine.

How does it work?

The active substance in Brilique, ticagrelor, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent a stroke or another heart attack.

How has it been studied?

The effects of Brilique were first tested in experimental models before being studied in humans.

Brilique was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina. The patients also took aspirin and were treated for up to a year. The main measure of effectiveness was based on the number of patients having another heart attack, a stroke or dying from a cardiovascular disease.

What benefits has it shown during the studies?

Brilique was shown to be beneficial to patients who have had a heart attack or unstable angina. In the main study, 9.3% of the patients taking Brilique had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.

What is the risk associated?

The most common side effects with Brilique (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bleeding in the skin or below the skin, bruising, and bleeding at the procedural site (where a blood vessel has been punctured). For the full list of all side effects reported with Brilique, see the package leaflet.

Brilique should not be used in people who may be hypersensitive (allergic) to ticagrelor or any of the other ingredients. It must not be used in patients who have moderate to severe liver disease or are currently bleeding, or in patients who have had a stroke caused by bleeding within the brain. It must also not be used in patients taking other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4). These are medicines such as ketoconazole (used to treat fungal infections), clarithromycin (an antibiotic), atazanavir and ritonavir (medicines used in HIV-positive patients) and nefazodone (used to treat depression).

Why has it been approved?

The CHMP noted that the main study showed that, compared with clopidogrel, Brilique reduces the risk of heart attacks and cardiovascular deaths. However Brilique was not more effective than clopidogrel in reducing the risk of stroke.

The CHMP decided that Brilique’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Brilique to AstraZeneca on 03 December 2010. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Brilique, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2010.