Brilique 90 mg film-coated tablets

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.

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.

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.

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.

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 Brilique contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Tablet core: mannitol (E421), dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl-cellulose (E463), magnesium stearate (E470b)

Tablet film coating: hypromellose (E464), titanium dioxide (E171), talc,
polyethylene--glycol 400, and ferric oxide yellow (E172).

What Brilique looks like and contents of the pack

Film-coated tablet (tablet): The tablets are round, biconvex, yellow, film-coated marked with a ?90? above ?T? on one side.

Brilique is available in:

• standard blisters (with sun/moon symbols) in cartons of 60 and 180 tablets
• calendar blisters (with sun/moon symbols) in cartons of 14, 56 and 168 tablets
• perforated blisters in a carton of 100x1 tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
AstraZeneca AB
S-151 85
Södertälje
Sweden

Manufacturer:

AstraZeneca AB

Gärtunavägen

SE-151 85

Södertälje

Sweden

Manufacturer:

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield, Cheshire, SK10 2NA

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien NV AstraZeneca SA Tel 32 2 370 48 11 LuxembourgLuxemburg NV AstraZeneca SA TélTel 32 2 370 48 11

T AstraZeneca UK Limited Te. 359 2 971 25 33 Magyarország AstraZeneca kft Tel. 36 1 883 6500

eská republika AstraZeneca Czech Republic s.r.o Tel 420 222 807 111 Malta Associated Drug Co. Ltd Tel 356 2277 8000

Danmark AstraZeneca AS Tlf 45 43 66 64 62 Nederland AstraZeneca BV Tel 31 79 363 2222

Deutschland AstraZeneca GmbH Tel 49 41 03 7080 Eesti AstraZeneca Tel 372 654 96 00 Norge AstraZeneca AS Tlf 47 21 00 64 00 Österreich AstraZeneca Österreich GmbH Tel 43 1 711 31 0

AstraZeneca A.E. 30 2 10 68 71 500 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel. 48 22 874 35 00

España AstraZeneca Farmacéutica Spain, S.A. Tel 34 91 301 91 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel 351 21 434 61 00

France AstraZeneca Tél 33 1 41 29 40 00 România AstraZeneca Pharma SRL Tel 40 21 317 60 41 Ireland AstraZeneca Pharmaceuticals Ireland Ltd Tel 353 1 609 7100 Slovenija AstraZeneca UK Limited Tel 386 1 51 35 600

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

Italia AstraZeneca S.p.A. Tel 39 02 980111 SuomiFinland AstraZeneca Oy PuhTel 358 10 23 010

Sverige AstraZeneca AB

357 22490305 Tel 46 8 553 26 000

Latvija AstraZeneca AB prstvniecba Latvij Tel 371 67377 100 United Kingdom AstraZeneca UK Ltd Tel 44 1582 836 836

Lietuva
UAB AstraZeneca
Tel: +370 5 2660550

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