Ticagrelor accord

Package leaflet: Information for the patient

Ticagrelor Accord, 90 mg, film-coated tablets
Ticagrelorum
Please 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, pharmacist, or nurse.
• 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 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 taking 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 an 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 had:

• a heart attack, or
• unstable angina (chest pain or discomfort that is not adequately controlled).

The medicine reduces the likelihood of having another heart attack or stroke, or of dying from a heart- or blood vessel-related condition.

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 cuts or damage in blood vessels.

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 — which can cause a heart attack (of the heart muscle) or stroke, or
• a clot may partially block blood vessels leading to the heart — reducing blood flow to the heart and causing chest pain of varying 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
Before taking Ticagrelor Accord, consult a 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 regarding this);
  • the patient's 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) while taking Ticagrelor Accord. This is due to an increased risk of bleeding. The doctor may advise 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 disorders such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is necessary;
• if the patient has any liver disorders or has previously had a disease that could have damaged the liver;
• if blood tests have shown elevated levels of uric acid in the patient. Talk to a doctor or pharmacist before taking the 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 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 levels);
• simvastatin or lovastatin at doses higher than 40 mg daily (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 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), 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 your doctor if 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 pregnancy.
Before taking this medicine, inform your doctor if you are breastfeeding. The doctor will discuss the benefits and risks associated with using Ticagrelor Accord during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking 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 disorientation occurs during treatment, caution should be exercised when driving or operating machinery.

Ticagrelor Accord contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Ticagrelor Accord

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose

• 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 maintenance dose is one 90 mg tablet taken twice daily for up to 12 months, unless your 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 Ticagrelor Accord with other anticoagulant medicines
Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance present in many medicines used to prevent blood clots. Your doctor will advise you on the dose to take (usually between 75 and 150 mg daily).

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 you are being treated in hospital, the crushed tablet may be administered through a nasogastric tube after being dispersed in water.

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

If you miss a dose of Ticagrelor Accord

• 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 Accord
Do not stop taking Ticagrelor Accord without speaking to your doctor. You should take the medicine regularly and for as long as your doctor advises. Stopping Ticagrelor Accord may increase the risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related condition.

If you have any further questions about the use of 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:
Ticagrelor Accord 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 attention may be required:

• Bleeding into the brain or intracranial haemorrhage is an uncommon adverse effect and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the arms, legs or face, particularly 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 very long time,
  • urine that is pink, red or brown in colour,
  • vomiting blood or material that looks like coffee grounds,
  • stools that are red or black (resembling tar),
  • coughing up or vomiting blood clots;
• Fainting
  • temporary loss of consciousness due to a sudden reduction in blood flow to the brain (this is 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) – this is very common. It may be caused by heart disease or another condition, or it may be an adverse effect of Ticagrelor Accord. Dyspnoea associated with Ticagrelor Accord is usually mild and characterised by sudden, unexpected breathlessness, usually occurring at rest. It may appear during the first few weeks of treatment and then not recur for many weeks. If breathlessness worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or additional 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 due to blood disorders.

Common (may affect up to 1 in 10 people)

• bruising,
• headache,
• dizziness or vertigo,
• diarrhoea or indigestion,
• nausea,
• constipation,
• rash,
• itching,
• increased 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 is heavier than usual,
• bleeding from the 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 unknown (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, tell your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 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 pack and the cardboard box following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ticagrelor Accord contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are:
  Tablet core: microcrystalline cellulose (E 460), sodium croscarmellose (E 468), povidone, sodium stearyl fumarate.

Coating of the tablet: hypromellose (E 464), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b),
yellow iron oxide (E 172).

What Ticagrelor Accord looks like and contents of the pack
Ticagrelor Accord 90 mg are light yellow, round (9 mm in diameter), biconvex, film-coated tablets
marked with "KJ2" on one side.
Ticagrelor Accord 90 mg is available in PVDC/PVC/Alu blisters containing 14, 56, 60, 100, 168,
or 180 film-coated tablets, in a cardboard box; or in calendar blister packs made of PVDC/PVC/Alu
containing 14, 56, or 168 film-coated tablets, in a cardboard box; or in perforated single-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 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

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

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice, Poland
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht, 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: