Krusaxyl

Package leaflet: Information for the user

Krusaxyl, 60 mg, film-coated tablets
Ticagrelor
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Krusaxyl is and what it is used for
2. Important information before taking Krusaxyl
3. How to take Krusaxyl
4. Possible side effects
5. How to store Krusaxyl
6. Contents of the pack and other information

1. What Krusaxyl is and what it is used for

What Krusaxyl is
Krusaxyl contains the active substance called ticagrelor. It belongs to a group of medicines known as
antiplatelet medicines.

What Krusaxyl is used for
Krusaxyl, in combination with acetylsalicylic acid (another antiplatelet medicine), is used only in adults who have had:

• a heart attack more than one year ago. Krusaxyl reduces the likelihood of having another heart attack or stroke, or of dying due to heart- or blood vessel-related disease.

How Krusaxyl works
Krusaxyl affects blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and sealing small openings when a blood vessel is cut or damaged.

However, platelets can also form clots inside diseased blood vessels in the heart and brain. This can be very dangerous because:

• a clot may completely block blood flow; this may cause a heart attack (myocardial infarction) or stroke, or
• a clot may partially block blood vessels leading to the heart; this reduces blood flow to the heart and may cause chest pain of varying intensity (called unstable angina).

Krusaxyl helps prevent platelets from sticking together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important information before using Krusaxyl

When not to use Krusaxyl:

• If the patient is allergic to ticagrelor or any of the other ingredients of Krusaxyl (listed in section 6).
• If the patient is currently experiencing bleeding.
• If the patient has had a stroke caused by bleeding into the brain.
• If the patient has severe liver disease.
• If the patient is 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 infections)
    Do not take Krusaxyl if any of the above situations apply. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions
Before starting Krusaxyl, discuss with a doctor or pharmacist if:

• the patient has an increased risk of bleeding due to:
  • recent serious injury
  • recent surgical procedures (including dental procedures – advice from a dentist should be sought)
  • a medical condition affecting blood clotting
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps)
• the patient will undergo any surgical procedure (including dental procedures) during treatment with Krusaxyl. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned procedure.
• the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker implanted.
• the patient has asthma or other lung diseases or breathing difficulties.
• the patient develops breathing problems such as rapid breathing, slow breathing, or apnea. The doctor will decide whether further evaluation is needed.
• the patient has any liver disorders or has previously had a condition that could have damaged the liver.
• blood tests have shown that the patient has high levels of uric acid. Talk to a doctor or pharmacist before taking Krusaxyl if any of the above situations apply (or if in doubt).

If the patient is taking both Krusaxyl and heparin:

• the doctor may take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform the doctor about taking both Krusaxyl and heparin, as Krusaxyl may affect the diagnostic test result.

Children and adolescents
Krusaxyl is not recommended for use in children and adolescents under 18 years of age.
Krusaxyl and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because Krusaxyl may affect the action of other medicines, and other medicines may affect Krusaxyl.
Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to reduce cholesterol levels)
• simvastatin or lovastatin at doses greater than 40 mg per day (medicines used to reduce cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
• digoxin (used to treat heart failure)
• cyclosporine (used to suppress the immune system)
• quinidine and diltiazem (used to treat heart rhythm disorders)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain)

Especially inform the doctor or pharmacist if the patient is taking any of the following medicines, which increase the risk of bleeding:

• "oral anticoagulants", often called "blood-thinning medicines", including warfarin.
• non-steroidal anti-inflammatory drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
• selective serotonin reuptake inhibitors (SSRIs), used 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 infections), cimetidine (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Krusaxyl and the associated increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called "clot-dissolving medicines", such as streptokinase or alteplase.
Pregnancy and breastfeeding
Krusaxyl is not recommended during pregnancy or if there is a possibility of becoming pregnant.
Women should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.
Inform the doctor if the patient is breastfeeding. The doctor will discuss the benefits and risks of taking Krusaxyl while breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine.
Driving and operating machinery
It is unlikely that Krusaxyl will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs during treatment, caution should be exercised when driving or operating machinery.

3. How to use Krusaxyl

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
What dose to take
Krusaxyl 60 mg, coated tablets:

• The usual dose is one 60 mg tablet twice daily. You should continue taking Krusaxyl for as long as your doctor recommends.
• It is recommended to take the medicine at the same time each day (e.g. one tablet in the morning and one in the evening).

Taking Krusaxyl with other blood-thinning medicines
Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many medicines used to prevent blood clotting. Your doctor will advise you on the dose to take (usually between 75 and 150 mg daily).
How to take Krusaxyl

• Tablets may be taken with or without food.
• You can check when you last took a tablet by looking at the blister pack. The blister contains printed symbols indicating the sun (for morning doses) and the moon (for evening doses). These symbols help patients remember when they last took their dose.

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, it may be crushed and mixed with water as follows:

• Crush the tablet into a fine powder.
• Pour the powder into half a glass of water.
• Mix and drink immediately.
• To ensure the full dose is taken, add another half glass of water, swirl and drink. If the patient is being treated in hospital, the tablet may be dissolved in water and administered through a nasal tube (nasogastric tube).

Taking more Krusaxyl than recommended
If you take more Krusaxyl than prescribed, contact your doctor immediately or go to hospital. Bring the medicine pack with you. There may be an increased risk of bleeding.
If you miss a dose of Krusaxyl

• If you miss a dose, take the next dose at your usual time.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

Stopping Krusaxyl
Do not stop taking Krusaxyl without talking to your doctor. You must take the medicine regularly and for as long as your doctor recommends. Stopping Krusaxyl may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine:
Krusaxyl affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur at any site in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs less commonly, but may be life-threatening.
Seek immediate medical attention if any of the following symptoms occur – urgent medical care may be required:

• Intracranial bleeding (bleeding into the brain) is an uncommon adverse reaction and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the arms, legs, or face, especially on one side of the body
  • sudden confusion, difficulty speaking or understanding others
  • sudden difficulty walking, loss of balance or coordination
  • sudden dizziness or sudden severe headache with no known cause
• Signs of bleeding such as:
  • heavy bleeding or bleeding that is difficult to stop
  • unexpected bleeding or bleeding that lasts a long time
  • urine discolored pink, red, or brown
  • vomiting blood or material that looks like "coffee grounds"
  • stools discolored red or black (resembling tar)
  • coughing up or vomiting blood clots
• Fainting
  • temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common)
• Symptoms of a blood clotting disorder called thrombotic thrombocytopenic 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 disorientation

Discuss with the doctor if the patient experiences:

• Shortness of breath (dyspnea) – very common. This may be due to heart disease or another cause, or may be an adverse reaction to Krusaxyl. Dyspnea associated with Krusaxyl treatment is usually mild and characterized by sudden, unexpected breathlessness, typically occurring at rest. It may appear during the first few weeks of treatment and then not recur for many weeks. If dyspnea worsens or persists for a long time, contact the doctor. The doctor will decide whether treatment or additional tests are needed.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people)

• Increased blood uric acid levels (detected in laboratory tests)
• Bleeding due to blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or vertigo
• Diarrhea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Intensified joint pain and swelling – symptoms of gout
• Dizziness, lightheadedness, or blurred vision – symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts (e.g. while shaving) and wounds that are more severe than usual
• Bleeding from gastric mucosa (ulcer)
• Bleeding gums

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction – rash, itching, swelling of the face or lips/tongue may be signs of an allergic reaction
• Disorientation (confusion)
• Visual disturbances due to presence of blood in the eye
• Vaginal bleeding that is heavier than normal or occurs at a different time than regular menstrual bleeding
• Bleeding into joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which may cause dizziness or lightheadedness

Frequency not known (cannot be estimated from available data)

• Abnormally low heart rate (usually less than 60 beats per minute)

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Krusaxyl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Krusaxyl contains

• The active substance is ticagrelor. Each tablet contains 60 mg of ticagrelor.
• Other ingredients are:
  Tablet core: mannitol (E 421), low-substituted hydroxypropylcellulose, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose (E 463) (contains silicon dioxide), magnesium stearate (E 470b).

Tablet coating:
hypromellose 2910 (E 464), titanium dioxide (E 171), talc (E 553b), macrogol 400 (E 1521),
yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Krusaxyl looks like and contents of the pack
Pink, round, biconvex film-coated tablets (approximately 8 mm in diameter), with the engraved mark "60 and M" on one side and plain on the other side.
Krusaxyl is available in:

• Standard blisters (with sun/moon symbol) in cardboard boxes containing 60 and 180 tablets.
• Calendar blister packs (with sun/moon symbols) in cardboard boxes containing 14, 56, and 168 tablets.
• Perforated single-dose blister packs containing 10 tablets; cardboard boxes containing 60 x 1 and 180 x 1 tablet.
• Perforated single-dose blister packs containing 14 tablets; cardboard boxes containing 14 x 1, 56 x 1, and 168 x 1 tablet.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147
Manufacturer/Importer:
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta
This medicine is authorised for marketing in the European Economic Area under the following names:
Hungary: Krusaxyl 60 mg filmtabletta
Czech Republic: Krusaxyl
Poland: Krusaxyl
Slovakia: Krusaxyl 60 mg
Romania: Krusaxyl 60 mg comprimate filmate
Bulgaria: Крусаксил 60 mg филмирани таблетки