Ticagrelor Accord

Package Leaflet: Information for the Patient

Ticagrelor Accord, 90 mg, Film-Coated Tablets

Ticagrelor
Read the package leaflet carefully before taking the medicine, as it contains important information for you.
This information is important for you.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• 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, please tell your doctor or pharmacist or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Ticagrelor Accord and what is it used for
• 2. Important information 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 is Ticagrelor Accord and what is it used for

What is Ticagrelor Accord

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

What is Ticagrelor Accord used for

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

• heart attack, or
• unstable angina (chest pain or discomfort that is not well controlled). The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel condition.

How Ticagrelor Accord works

Ticagrelor Accord works by affecting cells in the blood called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small holes in blood vessels when they are cut or damaged.

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 (of the heart muscle) or stroke, or
• a clot can cause partial blockage of the blood vessels leading to the heart - this reduces blood flow to the heart and can cause chest pain of changing intensity (known as unstable angina).

Ticagrelor Accord helps prevent platelets from clumping together, reducing the likelihood of a clot forming that could block blood flow.

2. Important information before taking Ticagrelor Accord

When not to take Ticagrelor Accord

• if you are allergic to ticagrelor or any of the other ingredients of Ticagrelor Accord (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:
• ketokonazole (used to treat fungal infections);
• clarithromycin (used to treat bacterial infections);
• nefazodone (an antidepressant);
• ritonavir and atazanavir (used to treat HIV and AIDS). Do not take Ticagrelor Accord if any of these apply to you. If you are in doubt, consult your doctor or pharmacist before taking the medicine.

Warnings and precautions

Before taking Ticagrelor Accord, tell your doctor or pharmacist:

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

If you are taking Ticagrelor Accord and heparin:

• your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking both Ticagrelor Accord and heparin, as Ticagrelor Accord may affect the test result.

Children and adolescents

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

Other medicines and Ticagrelor Accord

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.

• rosuvastatin (a medicine used to treat high cholesterol);
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to lower cholesterol);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control seizures);
• digoxin (used to treat heart failure);
• cyclosporin (used to weaken 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).

Particularly, tell your doctor or pharmacist if you are taking any of the following medicines that 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 ketokonazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

You should also tell your doctor if you are taking Ticagrelor Accord and have an increased risk of bleeding if your doctor advises you to take fibrinolytic medicines, also known as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Accord should not be used during pregnancy or if you are planning to become pregnant.

Women should use appropriate contraceptive methods to avoid becoming pregnant while taking the medicine.

Before taking this medicine, you should tell your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Ticagrelor Accord while breastfeeding.

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

Driving and using machines

It is unlikely that Ticagrelor Accord will affect your ability to drive or use machines. If you experience dizziness or confusion while taking the medicine, be careful when driving or using machines.

Ticagrelor Accord contains sodium

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

3. How to take Ticagrelor Accord

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

Recommended dose

• The starting dose is two tablets taken at the same time (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 taken twice a day for up to 12 months, unless your doctor tells you otherwise.
• It is recommended to take the medicine at the same time every 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 advise you to take 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 Accord

• 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;
• add the powder to half a glass of water;
• mix and drink immediately;
• to make sure you take all the medicine, add another half glass of water, rinse, and drink. If you are in the hospital, the tablet can be mixed with water and given through a nasogastric tube.

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

If you take more Ticagrelor Accord than you should, contact your doctor or go to the hospital immediately. Take the medicine packaging with you. You may experience increased risk of bleeding.

What to do if you forget to take Ticagrelor Accord

• 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 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 tells you. Stopping Ticagrelor Accord may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel condition.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ticagrelor Accord can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Ticagrelor Accord affects blood clotting, and most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is less common but can be life-threatening.

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

• bleeding in the brain or inside the skull 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 it occurs on one side of the body,
• sudden confusion, difficulty speaking or understanding others,
• sudden difficulty walking, loss of balance or coordination,
• sudden dizziness or severe headache with no known cause;
• symptoms of bleeding, such as:
• heavy or prolonged bleeding,
• unexpected or prolonged bleeding,
• urine that is pink, red, or brown,
• vomiting blood or coffee-ground-like material,
• stools that are black or tarry,
• coughing or vomiting blood clots;
• fainting
• temporary loss of consciousness due to a sudden decrease 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 severe fatigue or confusion.

Tell your doctor if you experience:

• shortness of breath (dyspnea) - very common.It may be caused by heart disease or another cause, or it may be a side effect of Ticagrelor Accord. Dyspnea associated with Ticagrelor Accord is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If dyspnea worsens or persists, contact your doctor. Your doctor will decide if treatment or further tests are needed.

Other possible side effects:

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

• increased uric acid levels 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 lightheadedness,
• diarrhea or indigestion,
• nausea (feeling sick),
• constipation,
• rash,
• itching,
• increased pain and swelling of the joints - these are symptoms of gout,
• dizziness or lightheadedness or blurred vision - these are symptoms of low blood pressure,
• nosebleeds,
• bleeding after surgery or from cuts and wounds (e.g., during shaving) that is 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,
• confusion (disorientation),
• vision disturbances due to blood in the eye,
• vaginal bleeding that is heavier or occurs at a different time than your regular menstrual period,
• bleeding into the 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 the available data)

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. You can also report side effects directly to the national reporting system via the contact details listed below.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ticagrelor Accord

Keep 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 month.

No special storage precautions are required.

Medicines should 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 pack and other information

What Ticagrelor Accord contains

• The active substance is ticagrelor. Each film-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.

tablet coating: 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 is a yellow, round (9 mm diameter), biconvex film-coated tablet with the marking "KJ2" on one side.

Ticagrelor Accord 90 mg is available in blisters of PVC/PVDC/Alu containing 14, 56, 60, 100, 168, or 180 film-coated tablets, in a cardboard box, or in calendar blisters of PVC/PVDC/Alu containing 14, 56, or 168 film-coated tablets, in a cardboard box, or in perforated unit dose blisters of PVC/PVDC/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.

ul. Taśmowa 7

02-677 Warszawa

Tel: + 48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

95-200 Pabianice

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

Date of last revision of the package leaflet: July 2025