Ticagrelor bluefish

Package leaflet: Information for the user

Ticagrelor Bluefish, 60 mg, film-coated tablets
Ticagrelorum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

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

Table of contents

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

1. What Ticagrelor Bluefish is and what it is used for

What Ticagrelor Bluefish is
Ticagrelor Bluefish contains an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.

What Ticagrelor Bluefish is used for
Ticagrelor Bluefish, in combination with acetylsalicylic acid (another antiplatelet medicine), should be used only in adults. This medicine has been prescribed because you have had:

• a heart attack more than one year ago. The medicine reduces the likelihood of another heart attack, stroke, or death due to heart or blood vessel disease.

How Ticagrelor Bluefish works
Ticagrelor Bluefish 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 at the site of a cut or damaged blood vessel.

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 to the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (called unstable angina).

Ticagrelor Bluefish helps prevent platelets from clumping together. This reduces the risk of blood clots forming, which could reduce blood flow.

2. Important information before taking Ticagrelor Bluefish

When not to take Ticagrelor Bluefish

• If you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• If you are currently bleeding.
• If you have had a stroke caused by bleeding in the brain.
• If you have severe liver disease.
• If 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 infections).

Do not take Ticagrelor Bluefish if any of the above apply to you. If in doubt, consult your doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions
Before starting Ticagrelor Bluefish, talk to your doctor or pharmacist if:

• you have an increased risk of bleeding due to:
  • recent serious injury
  • recent surgical procedures (including dental procedures – consult your dentist)
  • a condition affecting your blood’s ability to clot
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps).
• you are scheduled to undergo surgery (including dental procedures) while taking Ticagrelor Bluefish. This is due to an increased risk of bleeding. Your doctor may advise you to stop taking the medicine 5 days before the planned procedure.
• your heart rate is abnormally slow (usually less than 60 beats per minute) and you do not have a pacemaker implanted.
• you have asthma or other lung diseases or breathing difficulties.
• you develop breathing problems such as rapid breathing, slow breathing, or apnoea. Your doctor will decide whether further evaluation is needed.
• you have any liver problems or have had a condition in the past that may have damaged your liver.
• a blood test has shown that your uric acid level is above normal.

If any of the above apply to you, talk to your doctor or pharmacist before taking this medicine (or if you are in any doubt).

If you are taking Ticagrelor Bluefish and heparin at the same time:

• Your doctor may need to take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform your doctor that you are taking both Ticagrelor Bluefish and heparin, as Ticagrelor Bluefish may affect the results of diagnostic tests.

Children and adolescents
Ticagrelor Bluefish is not recommended for use in children and adolescents under 18 years of age.

Ticagrelor Bluefish and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. This is necessary because Ticagrelor Bluefish may affect the action of other medicines, and other medicines may affect Ticagrelor Bluefish.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to treat high cholesterol levels),
• simvastatin or lovastatin in doses higher than 40 mg per day (medicines used to treat high cholesterol levels),
• rifampicin (an antibiotic),
• phenytoin, carbamazepine, and phenobarbital (used to control seizures),
• digoxin (used to treat heart failure),
• cyclosporine (used to reduce the body's immune response),
• 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).

In particular, tell your doctor or pharmacist if you are 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 that you are taking Ticagrelor Bluefish and that there is an increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding
Ticagrelor Bluefish is not recommended during pregnancy or if you are planning to become pregnant. Women taking this medicine should use an appropriate method of contraception to avoid pregnancy.

Before taking this medicine, inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of using Ticagrelor Bluefish during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines
It is unlikely that Ticagrelor Bluefish will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking this medicine, take care when driving or operating machinery.

Ticagrelor Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to take Ticagrelor Bluefish

Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

What dose to take

• The usual dose is one 60 mg tablet twice daily. You should continue taking Ticagrelor Bluefish 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 Ticagrelor Bluefish 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 that prevent blood clotting. Your doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Bluefish

• Tablets may be taken with or without food.

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may 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.
• Mix and drink immediately.
• To ensure the full dose is taken, add another half glass of water, swirl, and drink.
  If you are being treated in hospital, the crushed tablet mixed with water may be administered through a nasogastric tube.

Taking more Ticagrelor Bluefish than recommended
If you take more Ticagrelor Bluefish than recommended, contact your doctor or go to a hospital immediately. Take the medicine pack with you. There may be an increased risk of bleeding.

If you miss a dose of Ticagrelor Bluefish

• If you miss a dose, 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 Ticagrelor Bluefish
Do not stop taking Ticagrelor Bluefish without talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Bluefish 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 using this medicine, 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 during treatment with this medicine:
Ticagrelor Bluefish affects blood clotting, therefore most side effects are related to bleeding.
Bleeding can occur anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding is uncommon, but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical care may be needed:

• Bleeding into the brain or intracranial bleeding is an uncommon side effect and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the arm, leg 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 control
  • unexpected bleeding or bleeding that lasts a very long time
  • urine that is pink, red or brown in colour
  • vomiting blood or vomiting material that looks like coffee grounds
  • stool that is red or black in colour (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 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 confusion.

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 a side effect of Ticagrelor Bluefish. Dyspnoea associated with Ticagrelor Bluefish is usually mild and characterised by sudden, unexpected shortness of breath, usually occurring at rest, and typically appearing during the first few weeks of treatment, and may resolve in many people. If shortness of breath worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or additional tests are needed.

Other possible side 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
• Feeling dizzy or lightheaded
• Diarrhoea or indigestion
• Nausea
• Constipation
• Rash
• Itching
• Severe joint pain and swelling – symptoms of gout
• Feeling dizzy, lightheaded or blurred vision – symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts (e.g. during shaving) and wounds that is heavier than usual
• Bleeding from the stomach lining (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
• Confusion (disorientation)
• Vision disturbances caused by blood in the eye
• Bleeding from the genital tract 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 (frequency cannot be estimated from available data)

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ticagrelor Bluefish
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ticagrelor Bluefish contains

• The active substance is ticagrelor.
• Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are:

Tablet core: mannitol (E421), sodium croscarmellose (E468), hypromellose (E464), calcium hydrogen phosphate dihydrate (E341), and magnesium stearate (E572).
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), and iron oxide red (E172).

What Ticagrelor Bluefish looks like and contents of the pack
Ticagrelor Bluefish 60 mg are round, pink, film-coated tablets.
Ticagrelor Bluefish 60 mg is available in blister packs containing 14, 56, 60 or 168 film-coated tablets, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Tel. +46 8 51 91 16 00

Manufacturer/Importer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

This medicinal product is authorised in the Member States of the European Economic Area under the following names: