KRUSAXYL

Package leaflet: Information for the user

Krusaxyl, 90 mg, film-coated tablets
Ticagrelor
Please read this leaflet carefully before 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, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Krusaxyl is and what it is used for
2. What you need to know 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, or
• unstable angina (chest pain or discomfort that is not adequately controlled).

Krusaxyl reduces the likelihood of having another heart attack, stroke, or death due to heart or blood vessel disease.

How Krusaxyl works
Krusaxyl acts on blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and sealing small holes at the site of cuts or blood vessel injury.

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, leading to a heart attack (myocardial infarction) or stroke, or
• a clot may cause partial blockage of blood vessels leading to the heart, reducing blood flow to the heart and potentially causing chest pain that varies in 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 your doctor or pharmacist if:

• The patient has an increased risk of bleeding due to:
  • recent serious injury
  • recent surgical procedures (including dental procedures – consult a dentist)
  • a medical condition affecting blood clotting
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps)
• The patient will undergo any surgical procedures (including dental) during treatment with Krusaxyl. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 5 days before a planned procedure.
• The patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker.
• The patient has asthma or other lung diseases or breathing difficulties.
• The patient develops breathing problems such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is needed.
• The patient has any liver disorders or has previously had a condition that may have damaged the liver.
• Blood tests show the patient has high levels of uric acid. Talk to your doctor or pharmacist before taking Krusaxyl if any of the above situations apply (or if you are 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, has recently taken, or plans to take. This is necessary because Krusaxyl may affect the action of other medicines, and other medicines may affect Krusaxyl.
Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels)
• simvastatin or lovastatin at doses greater than 40 mg per day (medicines used to lower 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 your doctor or pharmacist if the patient is taking any of the following medicines, which increase the risk of bleeding:

• "oral anticoagulants", often called "blood thinners", including warfarin.
• non-steroidal anti-inflammatory drugs (NSAIDs), often 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).

You should also inform your doctor about taking Krusaxyl and the associated increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called "clot-busting 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 your doctor if you are breastfeeding. The doctor will discuss the benefits and risks of using Krusaxyl during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using 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 take Krusaxyl
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
What dose to take
Krusaxyl 90 mg, film-coated tablets:

• The initial dose is two tablets taken together (a loading dose of 180 mg). This dose is usually given in hospital.
• After the initial dose, the usual dose is one 90 mg tablet taken twice daily for up to 12 months, unless the doctor advises otherwise.
• 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
The doctor will usually recommend taking acetylsalicylic acid (aspirin) at the same time. This substance is present in many medicines that prevent blood clotting. The doctor will advise on the dose to take (usually between 75 and 150 mg per day).
How to take Krusaxyl

• Tablets may be taken with or without food.
• The patient can check when the last tablet was taken 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 a 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 crushed tablet mixed with water may be administered via a nasogastric tube.

Taking more Krusaxyl than prescribed
If more Krusaxyl is taken than prescribed, contact a doctor or go to hospital immediately. Bring the medicine packaging with you. There may be an increased risk of bleeding.
Missing a dose of Krusaxyl

• If a dose is missed, take the next dose at the 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. The medicine should be taken 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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine:
Krusaxyl affects blood clotting, therefore most adverse effects 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 frequently but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical assistance may be required:

• Intracranial bleeding (bleeding into the brain) is an uncommon adverse effect 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
• Symptoms of bleeding such as:
  • heavy bleeding or bleeding difficult to stop
  • unexpected bleeding or bleeding lasting a long time
  • urine discoloured pink, red or brown
  • vomiting blood or material that looks like "coffee grounds"
  • stools coloured red or black (resembling tar)
  • coughing or vomiting blood clots
• Fainting
  • temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common)
• Symptoms related to 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 (dyspnoea) – very common. It may be caused by heart disease or another condition, or may be an adverse effect of Krusaxyl. Dyspnoea associated with Krusaxyl treatment is usually mild and characterized by sudden, unexpected breathlessness, usually at rest, which may occur during the first few weeks of treatment and then not recur for several weeks. If shortness of breath worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or further investigations are necessary.

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

• Increased blood uric acid levels (detected in laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or vertigo
• Diarrhoea 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. during 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 caused by blood in the eye
• Vaginal bleeding that is heavier 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Krusaxyl

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 90 mg of ticagrelor.
• The 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), macrogol 400 (E 1521), talc (E 553b),
iron oxide yellow (E 172).

What Krusaxyl looks like and contents of the pack
Yellow, round, biconvex film-coated tablets (approximately 9 mm in diameter), embossed with the marking "90 and M" on one side and smooth on the other.
Krusaxyl is available in:

• standard blisters (with sun/moon symbol) in cardboard cartons containing 60, 100 and 180 tablets.
• calendar blister packs (with sun/moon symbols) in cardboard cartons containing 14, 56 and 168 tablets.
• perforated, single-dose blister packs containing 10 tablets; cardboard cartons containing 60 x 1, 100 x 1 and 180 x 1 tablet.
• perforated, single-dose blister packs containing 14 tablets; cardboard cartons containing 14 x 1, 56 x 1, 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 medicinal product is authorised in the European Economic Area countries under the following names:
Hungary: Krusaxyl 90 mg filmtabletta
Czech Republic: Krusaxyl
Poland: Krusaxyl
Slovakia: Krusaxyl 90 mg
Romania: Krusaxyl 90 mg comprimate filmate
Bulgaria: Крусаксил 90 mg филмирани таблетки