Ticagrelor accord

Package leaflet: Information for the patient

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

• Keep this leaflet. You may need to read it again.
• Please contact your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to other people. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

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

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

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

How Ticagrelor Accord works
Ticagrelor Accord 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 blood vessel injury.

However, platelets may 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 that varies in intensity (called unstable angina).

Ticagrelor Accord helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important information before using Ticagrelor Accord

When not to use Ticagrelor Accord

• if the patient is allergic to ticagrelor or any of the other ingredients of Ticagrelor Accord (listed in section 6);
• if the patient is currently 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 Ticagrelor Accord if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Talk to a doctor or pharmacist before taking Ticagrelor Accord:

• if the patient has an increased risk of bleeding due to:
  • a recent serious injury;
  • recent surgical procedures (including dental procedures – consult a dentist in this matter);
  • a condition affecting blood clotting;
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedures (including dental procedures) during treatment with Ticagrelor Accord. This is due to an increased risk of bleeding. The doctor may recommend stopping the medicine 5 days before the planned procedure;
• if the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker implanted;
• if the patient has asthma or other lung diseases or breathing difficulties;
• if the patient develops breathing problems such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a disease that may have damaged the liver;
• if blood tests have shown that the patient has high levels of uric acid.

Talk to a doctor or pharmacist before taking this medicine if any of the above situations apply to the patient (or if in doubt).

If the patient is taking both Ticagrelor Accord 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 Ticagrelor Accord and heparin, as Ticagrelor Accord may affect the diagnostic test result.

Children and adolescents

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

Other medicines and Ticagrelor Accord

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

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

• rosuvastatin (a medicine used to treat high cholesterol);
• simvastatin or atorvastatin at doses greater than 40 mg per day (medicines used to reduce cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control 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 you are 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).

You should also inform your doctor that you are taking Ticagrelor Accord and are at increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Accord 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 becoming pregnant.

Inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of using Ticagrelor Accord during breastfeeding.

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

Driving and using machines

It is unlikely that Ticagrelor Accord will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs while taking this medicine, caution should be exercised when driving or operating machinery.

Ticagrelor Accord contains sodium

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

3. How to take Ticagrelor Accord

This medicine should always be taken exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.

Recommended dose

• The usual dose of this medicine is one 60 mg tablet twice daily. You should continue taking Ticagrelor Accord 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 Accord with other blood-thinning medicines

Your doctor will usually recommend that you also take acetylsalicylic acid. This is a substance found in many medicines that prevent blood clotting. Your doctor will advise you on the dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Accord

• 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, 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;
• stir and drink immediately;
• to ensure the entire dose is taken, add another half glass of water, swirl the glass, and drink.

If the patient is being treated in hospital, the crushed tablet mixed with water may be administered through a nasogastric tube.

Taking more Ticagrelor Accord than recommended

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

If you forget to take Ticagrelor Accord

• 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 Ticagrelor Accord

Do not stop taking Ticagrelor Accord without talking to your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Accord 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur during treatment with this medicine:
Ticagrelor Accord affects blood clotting, therefore most side 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 attention may be required:

• Bleeding into the brain or intracranial haemorrhage is an uncommon side effect and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the arms, legs, or face, especially if affecting only 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 discoloured pink, red or brown,
  • vomiting blood or material that looks like coffee grounds,
• stools that are red or black (resembling tar),
• coughing up or vomiting blood;
  • 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 a doctor if the patient experiences:

• shortness of breath (dyspnoea) – very common. This may be caused by heart disease or another condition, or may be a side effect of Ticagrelor Accord. Dyspnoea associated with Ticagrelor Accord is usually mild and characterised by sudden, unexpected shortness of breath, usually occurring at rest. It may occur during the first few weeks of treatment and then disappear 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 side effects:
Very common (may affect more than 1 in 10 people)

• increased levels of uric acid in the blood (detected in laboratory tests),
• bleeding due to blood disorders.

Common (may affect up to 1 in 10 people)

• bruising,
• headache,
• feeling dizzy or lightheaded,
• diarrhoea or indigestion,
• nausea,
• constipation,
• rash,
• itching,
• increased pain and swelling of joints – symptoms of gout,
• feeling dizzy, lightheaded or blurred vision – symptoms of low blood pressure,
• nosebleeds,
• bleeding after surgery or from cuts (e.g. while shaving) and wounds that bleed more 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,
• disorientation (confusion),
• visual disturbances caused by presence of 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 (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 nurse. Side 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
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 Accord

Keep the medicine out of the 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 instructions apply.
Medicines should not be disposed of via the sewage system 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 Ticagrelor Accord contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are:
  Tablet core: microcrystalline cellulose (E 460), sodium croscarmellose (E 468), povidone, sodium stearyl fumarate.
  Tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), red iron oxide (E 172), black iron oxide (E 172).

What Ticagrelor Accord looks like and contents of the pack
Ticagrelor Accord 60 mg are light pink, round (8 mm in diameter), biconvex coated tablets, marked with "KJ1" on one side.
Ticagrelor Accord 60 mg is available in PVDC/PVC/Alu blisters containing 14, 56, 60, 100, 168 or 180 coated tablets in a cardboard box, or in calendar blisters made of PVDC/PVC/Alu containing 14, 56 or 168 coated tablets in a cardboard box, or in perforated unit-dose blisters made of PVDC/PVC/Alu containing 14 x 1, 56 x 1, 60 x 1, 100 x 1, 168 x 1 or 180 x 1 coated tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Tel: + 48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht, The Netherlands
Laboratori Fundació Dau
C/ C, 12-14 Pol.
Ind. Zona Franca
Barcelona, 08040, Spain
Pharmadox Healthcare Limited,
KW20A Kordin Industrial Park
Paola, PLA 3000, Malta

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