BRILIQUE 60 mg FILM-COATED TABLETS
How to use BRILIQUE 60 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Brilique 60mg film-coated 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 symptoms are the same as yours.
- If you experience 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
- What is Brilique and what is it used for
- What you need to know before you take Brilique
- How to take Brilique
- Possible side effects
- Storing Brilique
- 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, more than a year ago.
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 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 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 go to 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 an increased risk of bleeding due to:
- a recent severe 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 need 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 high levels 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 how some medicines work and some medicines may affect Brilique.
Tell your doctor or pharmacist if you are taking any of the following medicines:
- more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
- 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).
Also 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 breastfeeding
Brilique should not be used if you are pregnant or may 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 time.
If you are pregnant or breastfeeding, 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. If you are unsure, consult your doctor or pharmacist.
How much to take
- The usual dose is one 60 mg tablet twice a day. Keep taking Brilique for as long as your doctor recommends.
- Take this medicine at the same time every day (e.g. 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
- You can take this medicine with or without food.
- You can check when you last took a Brilique tablet by looking at the blister pack. A sun symbol (for morning) and a moon symbol (for evening) will appear. This will tell you if you have taken your dose.
If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:
- Crush the tablet into a fine powder
- Pour the powder into half a glass of water
- Stir and drink immediately
- To make sure you get all the medicine, rinse the empty glass with another half a glass of water and drink it
If you are in hospital, this tablet may be given to you mixed with a little water and given through a tube in your 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 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 forgotten doses.
If you stop taking Brilique
Do not stop taking Brilique without talking to your doctor. Take this medicine regularly and for as long as your doctor recommends. If you stop taking Brilique, you may increase your risk of having another heart attack or stroke or of dying from a heart or blood vessel-related illness.
If you have any further questions on the use of this product, 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 happen with this medicine:
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 occurs on 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 severe headache of unknown cause
- Signs of bleeding such as:
- severe or uncontrolled bleeding
- unexpected or prolonged bleeding
- urine that is pink, red or brown
- vomiting blood or vomit that looks like “coffee grounds”
- stools that are black or red (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), extreme tiredness or confusion.
Tell your doctor if you notice any of the following:
- Feeling short of breath - this is very common.It may be due to your heart condition or another cause, or it may be a side effect of Brilique. Shortness of breath related to Brilique is usually mild and is characterised by a sudden, unexpected need for air that usually occurs at rest and may occur in the first few weeks of treatment and in many cases may disappear. If you think your shortness of breath has worsened or is lasting 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 levels 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 heavier than normal after surgery or cuts (e.g. 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, 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 irregular 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
Reporting of side effects
If you experience 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. Container contents and additional information
Composition ofBrilique
- The active ingredient is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
- The other ingredients are:
Tablet core:mannitol (E421), calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch type A, hydroxypropylcellulose (E463), magnesium stearate (E470b).
Tablet film coating:hypromellose (E464), titanium dioxide (E171), macrogol 400, black iron oxide (E172), red iron oxide (E172).
Appearance and container contents of the product
Film-coated tablet (tablet): The tablets are round, biconvex, pink, film-coated, and marked with a "60" over a "T" on one side.
Brilique is available in:
- standard blisters (with sun/moon symbols) in packs of 60 and 180 tablets.
- calendar blisters (with sun/moon symbols) in packs of 14, 56, and 168 tablets.
Only some 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-151 85 Södertälje
Sweden
Manufacturer:
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield, Cheshire, SK10 2NA
United Kingdom
For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
Belgium/Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11 | Lithuania UAB AstraZeneca Lietuva Tel: +370 5 2660550 |
Bulgaria AstraZeneca Bulgaria EOOD Tel: +359 2 44 55 000 | Luxembourg/Luxemburg NV AstraZeneca SA Tél/Tel: +32 2 370 48 11 |
Czech Republic AstraZeneca Czech Republic s.r.o Tel: +420 222 807 111 | Hungary AstraZeneca kft Tel.: +36 1 883 6500 |
Denmark AstraZeneca A/S Tlf: +45 43 66 64 62 | Malta Associated Drug Co. Ltd Tel: +356 2277 8000 |
Germany AstraZeneca GmbH Tel: +49 41 03 7080 | Netherlands AstraZeneca BV Tel: +31 79 363 2222 |
Estonia AstraZeneca Tel: +372 6549 600 | Norway AstraZeneca AS Tlf: +47 21 00 64 00 |
Greece AstraZeneca A.E. Τηλ: +30 2 106871500 | Austria AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 |
Spain AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00 | Poland AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00 |
France AstraZeneca Tél: +33 1 41 29 40 00 | Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00 |
Croatia AstraZeneca d.o.o. Tel: +385 1 4628 000 | Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41 |
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100 | Slovenia AstraZeneca UK Limited Tel: +386 1 51 35 600 |
Iceland Vistor hf Sími: +354 535 7000 | Slovakia AstraZeneca AB o.z. Tel: +421 2 5737 7777 |
Italy AstraZeneca S.p.A. Tel: +39 02 98011 | Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 |
Cyprus Αλ?κτωρ Φαρµακευτικ? Λτδ Τηλ: +357 22490305 | Sweden AstraZeneca AB Tel: +46 8 553 26 000 |
Latvia SIA AstraZeneca Latvija Tel: +371 67377 100 | United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836 |
Date of 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.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to BRILIQUE 60 mg FILM-COATED TABLETSDosage form: TABLET, 60mgActive substance: ticagrelorManufacturer: Astrazeneca AbPrescription requiredDosage form: ORALLY DISINTEGRATING TABLET/LIOTAB, 90 mgActive substance: ticagrelorManufacturer: Astrazeneca AbPrescription requiredDosage form: TABLET, 90 mgActive substance: ticagrelorManufacturer: Astrazeneca AbPrescription required
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