InfoCons Consumer Protection informs you – Brilique – Package Leaflet

Before anything else

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 ar e 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.

ℹ️ 1. What Brilique is and what it is used for

What Brilique is Brilique contains an active substance called ticagrelor. This belongs to a group of medicines called antiplatelet medicines.

What Brilique is used for

Brilique in combination with acetylsalicyli c acid (another antiplate let agent )is to be used in adults only. You have been given this medicine because you have had: a heart attack, or unstable angina (angina or chest pain that is not well controlled).

It reduces the chances of you having another heart attack, stroke or dying from a disease related to your heart or blood vessels.

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.

⚠️ 2. What you need to know before you take Brilique

104Do not take Brilique if: You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6). You are bleeding now. 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 antide pressant) -ritonavir and atazanavir (used to treat HIV infection and AIDS) 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 this medicine.

Warnings and precautions

Talk to your do ctor or pha rmacist before taking Brilique if: You have an increased risk of bleeding because of: -a recent serious injury -recent surgery (including dental work, ask your dentist about this) -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 this medi cine 5days 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 problems or breathing difficulties. You develop irregular breathing patterns such as speeding up, slowing down or short pauses in breathing. Your doctor will decide if you need further evaluation. You have had any problems with your liver or have previously had any disease which may have affecte d your liver. 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 or pharmacist before taking this medicine.

Ifyou are taking both Brilique and heparin : Your doctor may require a sample of your blood for diagnostic tests if they suspect 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.

Other medicines and Brilique

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines . 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: rosuvastatin (a medicine to treat high cholesterol) 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) digoxin (used to treat heart failure) 105cyclosporine (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) morphine and other opioids (used to treat severe pain) 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 (a bbreviated as NSAIDs) often taken as painkillers 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 (us ed 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 migrai nes 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.

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 this medicine if you are breast -feeding. Your doctor will discuss with you 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 o rpharmacist for advice before taking this medicine.

Driving and using machines

Brilique is not likely 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 sodium (23 mg) per dose, that is to say that it 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 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 tel ls you differently. Take this medicine around 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 106Your 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 -150mg daily).

How to take Brilique Do not open the blister until it is time to take your medicine. To take out the tablet, tear open the blister foil -do not push it through the foil because the tablet may break. Put the tablet on your tongue and let it disintegrate. You can then swallow it with or without water. You can take the tablet with or without food.

If you are in the hospital you may be given this tablet mixed with some water and given through a tube via the nose (nasogastric tube).

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. T ake this medicine 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 pharmacis t.

❗ 4. Possible side effects

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

Brilique affects blood clotting, so most side effects are related to bleeding. Bleeding may occur in any part of the body. Some bleeding is common (like bruising and nosebleeds). Severe bleeding is uncommon but can be life threatening.

See a doctor straig ht away if you notice any of the following –you may need urgent medical treatment: Bleeding into the brain or inside the skull is an uncommon side effect, and may cause signs of a stroke such as: -sudden numbness or weakness of your arm, leg or face, espec ially 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 Signs of bleeding such as: -bleeding that is severe or that you cannot control -unexpected bleeding or bleeding that lasts a long time -pink, red or brown urine -vomiting red blood or your vomit looks like ‘coffee grounds ’ 107-red or black stools (look like tar) -coughing up or vomiting blood clots Fainting (syncope) -a temporary l oss of consciousness due to sudden drop in blood flow to the brain (common) Signs of a blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP) such as: -fever and purplish 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 Discuss with your doctor if you notice any of the following: Feeling short of breath -this is very common. It mightbe due to your heart disease or another cause, or it might be a side effect of Brilique. Brilique -related breathlessness is generally mild and characterised as a sudden, unexpected hunger for air usually occurring at rest and may appear in the first weeks of therapy and for many may disappear. 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

Very common ( may affect more than 1 in10people )

High level of uric acid in your blood (as seen in tests) Bleeding caused by blood disorder s

Common ( may affect up to 1 in10people )

Bruising Headache Feeling dizzy or like the room is spinning Diarrhoea or indigestion Feeling sick (nausea) Constipation Rash Itching Sever e pain and swelling in your joints –these are signs of gout Feeling dizzy or light -headed, or having blurred vision –these are signs of low blood pressure Nosebleed Bleeding after surgery or from cuts (for ex ample while shaving) and wounds more than is normal Bleeding from your stomach lining (ulcer) Bleeding gums

Uncommon ( may affect up to 1 in100people )

Allergic reaction –a rash, itching or a swollen face or swollen lips/tongue may be signs of an allergic reaction Confusion Visual problems caused by blood in your eye Vaginal bleeding that is heavier, or happens at different times, than your normal period (menstrual) bleeding Bleeding into your joints and muscles causing painful swelling Blood in yo ur ear Internal bleeding , this may cause dizziness or light -headedness

Not known (frequency cannot be estimated from the available data)

108Abnormally Low heart rate (usually lower than 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. How to store 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 carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicin es via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

📦 6. Contents of the pack and other information

What Brilique contains

The active substance is ticagrelor. Each orodispersible 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), colloidal anhydrous silica.

What Brilique looks like and contents of the pack

The orodispersible tablet sare round, flat, bevelled edged, white to pale pink , marked with a “90” above “TI” on one side.

Brilique is available in: perforated unitdose blisters in cartons of 10 x1, 56 x1 and 60 x1 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

AstraZeneca AB SE-151 85 Södertälje Sweden

Manufacturer

AstraZeneca AB Gärtunavägen SE-152 57 Södertälje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

109België/Belgique/Belgien AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 България АстраЗенека България ЕООД Teл.: +359 2 44 55 000Luxembourg/Luxemburg AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11 Česká republika AstraZeneca Czech Republic s.r.o Tel: +420 222 807 111Magyarország AstraZeneca Kft.

Tel.: +36 1 883 6500 Danmark AstraZeneca A/S Tlf: +45 43 66 64 62Malta Associated Drug Co. Ltd Tel: +356 2277 8000 Deutschland AstraZeneca GmbH Tel: +49 4 0 809034100Nederland AstraZeneca BV Tel: +31 85 808 9900 Eesti AstraZeneca Tel: +372 6549 600Norge AstraZeneca AS Tlf: +47 21 00 64 00 Ελλάδα AstraZeneca A.E.

Τηλ: +30 2 106871500Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 España AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00Polska AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00 France AstraZeneca Tél: +33 1 41 29 40 00Portugal AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00 Hrvatska AstraZeneca d.o.o.

Tel: +385 1 4628 000România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 Ísland Vistor hf.

Sími: +354 535 7000Slovenská republika AstraZeneca AB, o.z.

Tel: +421 2 5737 7777 Italia AstraZeneca S.p.A.

Tel: +39 02 00704500Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 Κύπρος Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305Sverige AstraZeneca AB Tel: +46 8 553 26 000 110Latvija SIA AstraZeneca Latvija Tel: +371 67377100United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 836

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Brilique (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/10/655).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.