Ticagrelor Bluefish

Package Leaflet: Information for the User

Ticagrelor Bluefish, 90 mg, coated tablets

Ticagrelor

Read all of 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 signs of illness are the same as yours.
• If you get 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

• 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 is Ticagrelor Bluefish

Ticagrelor Bluefish contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet medicines.

What Ticagrelor Bluefish is used for

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

• a heart attack, or
• unstable angina (chest pain or discomfort which is a sign of decreased blood flow to the heart). The medicine reduces the chance of you having another heart attack, stroke, or dying from a disease related to heart or blood vessels.

How Ticagrelor Bluefish works

Ticagrelor Bluefish works by affecting cells in the blood called platelets. Platelets are very small blood cells which help stop bleeding by clumping together to block damage to a blood vessel. However, platelets can also form clots in diseased blood vessels in the heart and brain. This can be very dangerous because:

• a clot can completely block the blood flow; this can cause a heart attack (heart muscle attack) or stroke, or
• a clot can partially block the blood vessels to the heart; this reduces blood flow to the heart and can cause chest pain that comes and goes (unstable angina).

Ticagrelor Bluefish helps prevent platelets from clumping together and forming clots. This reduces the risk of a clot forming and so reduces the risk of a heart attack or stroke.

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 have active 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:
• ketokonazole (used to treat fungal infections)
• clarithromycin (used to treat bacterial infections)
• nefazodone (an antidepressant)
• ritonavir and atazanavir (used to treat HIV infection and AIDS). Do not take Ticagrelor Bluefish if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ticagrelor Bluefish, tell your doctor or pharmacist if:

• you have an increased risk of bleeding due to:
• recent serious injury
• recent surgery (including dental surgery - consult your dentist)
• a condition that affects blood clotting
• recent bleeding from the stomach or gut (such as stomach ulcers or colon polyps).
• you are going to have surgery (including dental surgery) while taking Ticagrelor Bluefish. This is because of the increased risk of bleeding. Your doctor may advise you to stop taking the medicine 5 days before the surgery.
• your heart rate is abnormally low (usually less than 60 beats per minute) and you do not have a pacemaker.
• you have asthma or other lung disease or breathing difficulties.
• you develop breathing difficulties such as rapid breathing, slow breathing, or pauses in breathing. Your doctor will decide if further evaluation is needed.
• you have any liver problems or have had a disease in the past that may have damaged your liver.
• your blood test results show high levels of uric acid. If any of the above applies to you, consult your doctor or pharmacist before taking this medicine (or if you are in doubt).

If you are taking Ticagrelor Bluefish and heparin:

• Your doctor may need to take a blood sample to do diagnostic tests if they suspect a rare blood clotting disorder caused by heparin. It is important to tell your doctor that you are taking both Ticagrelor Bluefish and heparin, because Ticagrelor Bluefish may affect the results of the diagnostic test.

Children and adolescents

Ticagrelor Bluefish should not be used in children and adolescents under 18 years of age.

Ticagrelor Bluefish with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take. This is because Ticagrelor Bluefish may affect the way other medicines work, and other medicines may affect Ticagrelor Bluefish. In particular, tell your doctor or pharmacist if you are taking:

• rosuvastatin (used to treat high cholesterol levels)
• simvastatin or lovastatin in doses greater than 40 mg per day (used to treat high cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control seizures)
• digoxin (used to treat heart failure)
• cyclosporin (used to reduce the activity of the immune system)
• 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 severe pain).

In particular, tell your doctor or pharmacist if you are taking any of the following medicines which may increase the risk of bleeding:

• oral anticoagulants, often referred to as 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 infection and AIDS), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraine and headache).

You should also tell your doctor if, due to taking Ticagrelor Bluefish, there is an increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, often referred to as clot-busting medicines, such as streptokinase or alteplase.

Pregnancy and breast-feeding

Ticagrelor Bluefish should not be used during pregnancy or if you are planning to become pregnant. Women should use appropriate contraceptive methods to prevent pregnancy while taking this medicine. If you are breast-feeding or think you may be pregnant, consult your doctor before taking this medicine. Your doctor will discuss the potential benefits and risks of taking Ticagrelor Bluefish during breast-feeding. 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

Ticagrelor Bluefish is unlikely to affect your ability to drive or use machines. However, if you experience dizziness or confusion while taking this medicine, be careful when driving or using machines.

Ticagrelor Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially sodium-free.

3. How to take Ticagrelor Bluefish

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

How much to take

• The starting dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually given in a hospital.
• After the starting dose, the usual dose is one 90 mg tablet twice a day for up to 12 months, unless your doctor tells you otherwise.
• It is recommended that you take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Bluefish with other medicines that prevent blood clotting

Your doctor will usually also prescribe acetylsalicylic acid. 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

• The tablets can be taken with or without food.

What to do if you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, it can be crushed and mixed with water as follows:

• Crush the tablet into a fine powder.
• Put the powder into half a glass of water.
• Mix and drink immediately.
• To make sure you take all the medicine, add another half glass of water, stir, and drink. If you are being treated in a hospital, the tablet can be mixed with water and given through a nasogastric tube.

What to do if you take more Ticagrelor Bluefish than you should

If you take more Ticagrelor Bluefish than you should, contact your doctor or go to the hospital immediately. Take the medicine pack with you. You may be at risk of bleeding.

What to do if you forget to take Ticagrelor Bluefish

• If you forget to take 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 forgotten dose.

What to do if you stop taking 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 tells you. Stopping Ticagrelor Bluefish may increase the risk of you having another heart attack or stroke, or dying from a disease related to heart or blood vessels. 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. When taking this medicine, the following side effects may occur:

You should immediately contact your doctor if you experience any of the following – you may need urgent medical attention:

• Bleeding in the brain or within the skull is an uncommon side effect and may cause stroke-like symptoms such as:
• -sudden numbness or weakness of the arm, leg, or face, especially if it occurs on only one side of the body
• -sudden confusion, difficulty speaking or understanding
• -sudden difficulty walking, loss of balance or coordination
• -sudden dizziness or severe headache with no known cause
• Signs of bleeding, such as:
• -heavy or uncontrollable bleeding
• -unexpected or prolonged bleeding
• -pink, red, or brown urine
• -vomiting blood or coffee ground-like material
• -black or tarry stools
• -coughing or vomiting blood clots
• Fainting
• -temporary loss of consciousness due to a sudden decrease in blood flow to the brain (frequent)
• Signs of a blood clotting disorder called thrombotic thrombocytopenic purpura (TTP), such as:
• -fever and purple spots on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion.

Tell your doctor if you experience:

• Shortness of breath (dyspnoea) - very common.This may be due to heart disease or another cause, or it may be a side effect of Ticagrelor Bluefish. Dyspnoea associated with Ticagrelor Bluefish is usually mild and characterised by sudden, unexpected shortness of breath at rest, which may occur within the first few weeks of treatment and may resolve in many individuals. If you experience worsening or persistent dyspnoea, you should contact your doctor. Your doctor will decide whether you need treatment or further investigations.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• Increased levels of uric acid in the blood (found in laboratory tests)
• Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• Bruising
• Headache
• Dizziness or spinning sensation
• Diarrhoea or indigestion
• Nausea (feeling sick)
• Constipation
• Rash
• Itching
• Increased pain and swelling of the joints - these are symptoms of gout
• Dizziness or fainting or blurred vision - these are symptoms of low blood pressure
• Nosebleeds
• Bleeding after surgery or from cuts and wounds that is more than usual
• Bleeding from the stomach lining (stomach 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 due to bleeding in the eye
• Bleeding from the reproductive tract, which is heavier or occurs at an unusual time (e.g., heavy or irregular menstrual bleeding)
• Bleeding into the joints and muscles, causing painful swelling
• Blood in the ear
• Internal bleeding, which may cause dizziness or fainting

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you get 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 the website. By reporting side effects, you can help 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. 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. Contents of the pack and other information

What Ticagrelor Bluefish contains

• The active substance is ticagrelor.
• Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Core:mannitol (E421), croscarmellose sodium (E468), hypromellose (E464), calcium hydrogen phosphate dihydrate (E341), and magnesium stearate (E572). Coating:hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), and yellow iron oxide (E172).

What Ticagrelor Bluefish looks like and contents of the pack

Ticagrelor Bluefish 90 mg is a yellow, round, coated tablet. Ticagrelor Bluefish 90 mg is available in blisters containing 14, 56, 60, 100, or 168 coated tablets, in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden
Phone: +46 8 51 91 16 00

Manufacturer/Importer

Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden

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

Date of last revision of the leaflet: