60 mg film-coated tablets
tikagrelor
1. What Brilique is and what it is used for
What Brilique is
Brilique contains an active substance called tikagrelor. It belongs to a group of medicines called antiplatelet drugs.
What Brilique is used for
Brilique, in combination with acetylsalicylic acid (another antiplatelet drug), should only be used by adults. You have been given this medicine because you have had:
- a heart attack, over a year ago.
It reduces the risk of you having another heart attack or stroke or dying from cardiovascular disease.
How Brilique works
Brilique affects cells called “platelets” (or platelets ). It is very small blood cells that help stop bleeding. They do this by clumping together so that they can plug the small holes in blood vessels that have been damaged.
But platelets can also form blood clots inside diseased blood vessels in the heart and brain. It can be very dangerous because
- the blood clot can turn off the blood flow completely; which can cause a heart attack (heart attack) or a stroke , or
- the blood clot can partially block the blood vessels to the heart; then the blood flow to the heart becomes less. It can cause chest pain that comes and goes (so-called “unstable angina”).
Brilique helps so that the platelets do not clot. This reduces the risk of a blood clot forming which can reduce blood flow.
2. What you need to know before taking Brilique
Do not take Brilique
- if you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
- if you are bleeding right now.
- if you have had a stroke where the cause was a brain haemorrhage.
- if you have severe liver disease.
- if you are taking any of the following medicines:
- ketoconazole (used to treat fungal infections)
- clarithromycin (used against bacterial infections)
- nefazodone (an antidepressant drug)
- ritonavir and atazanavir (used for HIV – infection and AIDS ).
Do not use Brilique if any of the above apply to you. If you have any further questions, ask your doctor or pharmacist before taking this medicine.
Warnings and cautions
Talk to your doctor or pharmacist before taking Brilique
- if you have an increased risk of bleeding due to
- that you have recently been seriously injured
- that you have recently had surgery (including procedures involving the teeth, ask your dentist about this)
- that you have a disease that affects blood coagulation
- that you have recently had bleeding from the stomach or intestines (for example stomach ulcers or colon polyps)
- if you are going to have surgery (including dental procedures) at any time while you are taking Brilique. The reason is the increased risk of bleeding. Your doctor may want you to stop taking this medicine 5 days before the operation.
- if your heart rate is abnormally low (usually below 60 beats per minute) and you have not already had a small device implanted that makes the heart beat at the right pace (a pacemaker).
- if you have asthma or other lung problems or breathing problems.
- if you have had liver problems or have previously had a disease that may have affected your liver.
- if a blood test has shown that you have more uric acid in your blood than usual.
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
If you take both Brilique and heparin:
- Your doctor may need to take a blood test for a diagnostic test if he / she suspects an unusual platelet disease caused by heparin . It is important that you tell your doctor that you are taking both Brilique and heparin , as Brilique may affect the diagnostic test.
Children and young people
Brilique is not recommended for children and adolescents under 18 years.
Other medicines and Brilique
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The reason is that Brilique can affect how certain medicines work and certain medicines can affect 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 treat seizures)
- digoxin (used for heart failure )
- cyclosporine (used to reduce the body’s defense mechanisms)
- 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 the risk of bleeding:
- “Oral anticoagulants” – often called “blood thinners” and include warfarin .
- non-steroidal anti-inflammatory drugs (often abbreviated NSAIDs ), which are often used as painkillers, such as ibuprofen and naproxen .
- selective serotonin reuptake inhibitors ( SSRIs ) used as antidepressants, such as paroxetine , sertraline and citalopram
- other drugs ketoconazole (used against fungal infections), clarithromycin (used for bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used for HIV – infection and AIDS ), cisapride (used for heartburn), ergot alkaloids (used against migraine and headache).
Because you are taking Brilique you may have an increased risk of bleeding. Therefore, you should tell your doctor that you are taking Brilique if he or she gives you fibrinolytics (often called ‘blood clotting agents’), such as streptokinase or alteplas.
Pregnancy and breastfeeding
The use of Brilique is not recommended if you are pregnant or could become pregnant. Women should use appropriate contraception to avoid pregnancy while taking this medicine.
Before taking this medicine, talk to your doctor if you are breast-feeding. Your doctor will discuss the benefits and risks of taking Brilique with you 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 or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Brilique will affect your ability to drive or use machines. If you feel dizzy or confused when taking this medicine, be careful when driving or using machines.
Sodium content
This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie essentially ‘ sodium-free’.
3. How to take Brilique
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
This is how much you should take
- The usual dose is one 60 mg tablet twice a day. Keep taking Brilique for as long as your doctor tells you to.
- Take this medicine at about the same time each day (for example, one tablet in the morning and one in the evening).
Taking Brilique with other medicines to prevent blood clots
Usually your doctor will also tell you to take acetylsalicylic acid . It is a substance found in many medicines used to prevent blood clots. Your doctor will tell you how much to take (usually 75-150 mg a day).
How to take Brilique
- You can take the tablet with or without food.
- You can check when you last took a Brilique tablet by looking at the blister map. There is a sun (for the morning) and a moon (for the evening). This way you can see if you have taken a dose or not.
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 to a fine powder
- Pour the powder into half a glass of water
- Stir and drink immediately
- To make sure there is no medicine left, rinse the empty glass with another half glass of water and drink it
If you are hospitalized, you can get this tablet, mixed with a little water, given with a tube through your nose (nasogastric tube) into your stomach.
If you take more Brilique than you should
If you take more Brilique than you should, contact a doctor or go to the hospital immediately. Bring the medicine pack. You may have an increased risk of bleeding.
If you forget to take Brilique
- If you forget to take a dose , just take the next dose as usual.
- Do not take a double dose (two doses at the same time) to compensate for a missed dose .
If you stop taking Brilique
Do not stop taking Brilique without talking to your doctor. Take this medicine regularly and as long as your doctor continues to prescribe it. If you stop taking Brilique, it may increase the risk of you having another heart attack or stroke or dying from cardiovascular disease.
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 occur with this medicine:
Brilique affects blood coagulation, so most side effects have to do with bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (such as bruising and nosebleeds). Severe bleeding is less common, but can be life-threatening.
Contact a doctor immediately if you notice any of the following – you may needurgent medical attention:
- Bleeding in the brain or on the inside of the skull is a less common side effect and can be a sign of a stroke such as:
- sudden numbness or weakness in the arm, leg or face, especially if it only affects one side of the body
- sudden confusion, difficulty speaking or understanding others
- sudden difficulty walking or impaired balance or coordination
- sudden dizziness or sudden severe headache for no known reason
- Signs of bleeding such as:
- severe bleeding or bleeding over which you have no control
- unexpected bleeding or bleeding that lasts a long time
- pink, red or brown urine
- vomiting of red blood or if the vomit looks like coffee grounds
- red or black stools (tar-like)
- cough or vomiting containing blood
- Fainting ( syncope )
- a temporary loss of consciousness due to a sudden decrease in blood supply to the brain (common)
- Signs of problems with the blood’s ability to coagulate called the thrombotic thrombocytope 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 fatigue or confusion
Talk to your doctor if you notice any of the following:
- Shortness of breath – this is very common. It could be due to your heart disease or something else, or be a side effect of Brilique. Shortness of breath due to Brilique is usually mild and is described as a sudden, unexpected need for air. This usually occurs at rest and can occur during the first weeks of treatment and can pass in many people. If shortness of breath gets worse or lasts longer, talk to your doctor. The doctor decides if it needs to be treated or examined further.
Other possible side effects are
Very common (may affect more than 1 user in 10)
- High level of uric acid in the blood (seen during blood tests)
- Bleeding caused by blood disorders
Common (may affect up to 1 in 10 people)
- Bruises
- Headache
- Dizziness or a feeling that the room is spinning
- Diarrhea or indigestion
- Nausea
- Constipation
- Rash
- Itching
- Severe pain and swelling in the joints – signs of gout
- Feeling of dizziness or dizziness, or blurred vision – signs of low blood pressure
- Nasal blood
- Heavier bleeding than normal after surgery or from injuries (eg shaving) or wounds
- Bleeding from inside the stomach ( stomach ulcer )
- Bleeding gums
Uncommon (may affect up to 1 in 100 people)
- Allergic reaction – skin rash, itching or swollen face or swollen lips / swollen tongue may be signs of an allergic reaction
- Confusion
- Vision problems due to blood in the eye
- Vaginal bleeding that is heavier, or comes at a different time, than your regular menstrual bleeding
- Bleeding in joints and muscles that cause painful swelling
- Blood in the ear
- Internal bleeding, which may cause dizziness or dizziness
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
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 expiration date is the last day of the specified month.
No special storage instructions.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is tikagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
- The other ingredients are Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b) Film coating: hypromellose (E464), titanium dioxide (E171 (nitrous oxide)) ).
What the medicine looks like and contents of the pack
Film-coated tablets (hereinafter referred to as tablets): The tablets are round, biconvex, pink, film-coated and marked with “60” above “T” on one side.
Brilique is marketed 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
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
AstraZeneca AB
Manufacturer:
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield, Cheshire, SK10 2NA
UK
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 | LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550 |
| BulgariaAstrology Bulgaria BODYTel: +359 2 44 55 000 | Luxembourg / LuxemburgNV AstraZeneca SA / NVTel: + 32 2 370 48 11 |
| Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 | HungaryAstraZeneca KftTel .: + 36 1 883 6500 |
| DenmarkAstraZeneca A / STel: +45 43 66 64 62 | MaltaAssociated Drug Co. Ltd.Tel: + 356 2277 8000 |
| GermanyAstraZeneca GmbHTel: + 49 41 03 7080 | The NetherlandsAstraZeneca BVTel: +31 79 363 2222 |
| EestiAstraZenecaTel: +372 6549 600 | NorwayAstraZeneca ASTel: + 47 21 00 64 00 |
| GreeceAstraZeneca AE:Ηλ: + 30 2 106871500 | AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0 |
| SpainAstraZeneca Pharmacéutica Spain, SATel: + 34 91 301 91 00 | PolandAstraZeneca Pharma Poland Sp. z ooTel .: + 48 22 245 73 00 |
| FranceAstraZenecaTel: + 33 1 41 29 40 00 | PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: + 351 21 434 61 00 |
| CroatiaAstraZeneca dooTel: +385 1 4628 000 | RomaniaAstraZeneca Pharma SRLTel: + 40 21 317 60 41 |
| IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: + 353 1609 7100 | SloveniaAstraZeneca UK LimitedTel: + 386 1 51 35 600 |
| IcelandVistor hfPhone: + 354 535 7000 | Slovak RepublicAstraZeneca AB ozTel: + 421 2 5737 7777 |
| ItalyAstraZeneca SpATel: + 39 02 98011 | Finland / FinlandAstraZeneca OyPuh / Tel: + 358 10 23 010 |
| ΚύπροςAlexander the Great:Ηλ: +357 22490305 | |
| LatviaSIA AstraZeneca LatvijaTel: + 371 67377100 | United KingdomAstraZeneca UK LtdTel: + 44 1582 836 836 |