Ticagrelor Accord

Package Leaflet: Information for the Patient

Ticagrelor Accord, 60 mg, Film-Coated Tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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:

• a heart attack, more than a year ago. The medicine reduces the likelihood of having another heart attack or stroke, or dying from a heart or blood vessel condition.

How does Ticagrelor Accord work

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 the damaged area of the blood vessel.

• a blood clot can completely block the blood flow - this can cause a heart attack (myocardial infarction) or stroke, or
• a blood 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 (unstable angina).

Ticagrelor Accord helps prevent platelets from clumping together and forming blood clots that can cause a heart attack or stroke.

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 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:
• 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 this 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 - 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 diseases 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 liver disease in the past;
• if your blood test shows high levels of uric acid.

Tell your doctor or pharmacist if any of these apply to you (or if you are unsure). If you take 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. This is because Ticagrelor Accord may affect the way other medicines work, and other medicines may affect the way Ticagrelor Accord works.

• rosuvastatin (used to treat high cholesterol);
• simvastatin or lovastatin in doses greater than 40 mg per day (used to lower cholesterol);

Also, tell your doctor about taking Ticagrelor Accord and the increased risk of bleeding if your doctor prescribes you 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. While taking the medicine, women should use appropriate contraceptive methods to prevent pregnancy. Before taking this medicine, tell your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Ticagrelor Accord while breastfeeding.

Driving and using machines

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

Ticagrelor Accord 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 Accord

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

Recommended dose

• The usual dose is one 60 mg tablet twice a day. Continue taking Ticagrelor Accord for as long as your doctor recommends.
• 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 anti-clotting medicines

Your doctor will usually recommend taking acetylsalicylic acid as well. 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, you can crush it and mix it 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 the whole dose, add another half glass of water, rinse, 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 Accord than you should

If you take more Ticagrelor Accord than you should, contact your doctor or go to the hospital immediately. You may be at 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 first. You should keep taking the medicine for as long as your doctor recommends. Stopping Ticagrelor Accord may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel condition.

4. Possible side effects

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

• 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, trouble speaking or understanding,
• sudden trouble 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,
• stool that is red or black (like coal),
• coughing or vomiting blood clots;
• fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (frequent);
• 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 tiredness or confusion.

If you experience any of the following, tell your doctor:

• 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 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,
• feeling dizzy or lightheaded,
• diarrhea or indigestion,
• nausea (feeling sick),
• constipation,
• rash,
• itching,
• increased pain and swelling of the joints - these are symptoms of gout,
• feeling dizzy or lightheaded or blurred vision - these are symptoms of low blood pressure,
• nosebleeds,
• bleeding after surgery or from cuts and wounds (e.g., while shaving) 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 problems due to bleeding 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,
• bleeding in the ear,
• internal bleeding that 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 of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. 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 websiteor contact your local health authority for more information.

5. How to store Ticagrelor Accord

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 blister and carton after EXP. The expiry date refers to the last day of that month. There are no special storage conditions. 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 Accord contains

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

What Ticagrelor Accord looks like and contents of the pack

Ticagrelor Accord 60 mg is a light pink, round (8 mm diameter), biconvex film-coated tablet with the marking "KJ1" on one side. Ticagrelor Accord 60 mg is available in blisters of PVDC/PVC/Alu foil containing 14, 56, 60, 100, 168, or 180 film-coated tablets, in a cardboard box, or in calendar blisters of PVDC/PVC/Alu foil containing 14, 56, or 168 film-coated tablets, in a cardboard box, or in perforated unit dose blisters of PVDC/PVC/Alu foil 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

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