Ticagrelor Liconsa

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: information for the patient

Ticagrelor Liconsa, 90 mg, coated tablets

Ticagrelor

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 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. See section 4.

Table of contents of the leaflet

• 1. What is Ticagrelor Liconsa and what is it used for
• 2. Important information before taking Ticagrelor Liconsa
• 3. How to take Ticagrelor Liconsa
• 4. Possible side effects
• 5. How to store Ticagrelor Liconsa
• 6. Contents of the pack and other information

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

What is Ticagrelor Liconsa

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

What is Ticagrelor Liconsa used for

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

• myocardial infarction, or
• unstable angina (angina or chest pain that is not adequately controlled)

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

How Ticagrelor Liconsa works

Ticagrelor Liconsa works by affecting cells called platelets in the blood (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings 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 flow of blood - this can cause a myocardial infarction (heart attack) 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 with varying intensity (known as unstable angina).

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

2. Important information before taking Ticagrelor Liconsa

When not to take Ticagrelor Liconsa

• if you are allergic to ticagrelor or any of the other ingredients of Ticagrelor Liconsa (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 Liconsa if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking the medicine.

Warnings and precautions

Before taking Ticagrelor Liconsa, 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 disease 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 Liconsa. 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 shortness of breath. Your doctor will decide whether 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. Tell your doctor or pharmacist if any of the above applies to you (or if you are in doubt).

If you are taking Ticagrelor Liconsa 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 Liconsa and heparin, as Ticagrelor Liconsa may affect the test result.

Children and adolescents

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

Ticagrelor Liconsa 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 Liconsa may affect the way other medicines work, and other medicines may affect Ticagrelor Liconsa.

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

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to lower cholesterol levels);
• 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 medicines (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 inform your doctor about taking Ticagrelor Liconsa 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 Liconsa should not be used during pregnancy or if you are planning to become pregnant. While taking the medicine, women should use effective contraception to avoid becoming pregnant.

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

If you are pregnant or breastfeeding, 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

It is unlikely that Ticagrelor Liconsa 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.

Sodium content

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

3. How to take Ticagrelor Liconsa

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

What dose 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 the hospital.
• After this 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 to take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Liconsa with other blood-thinning medicines

Your doctor will usually recommend taking 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 Liconsa

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 being treated in the hospital, the crushed tablet can be given through a nasogastric tube.

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

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

What to do if you forget to take Ticagrelor Liconsa

• 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 Liconsa

Do not stop taking Ticagrelor Liconsa without consulting your doctor. You should keep taking the medicine regularly and for as long as your doctor tells you. Stopping Ticagrelor Liconsa may increase the risk of having another myocardial infarction or stroke, or dying from a heart or blood vessel-related disease.

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

4. Possible side effects

Like all medicines, Ticagrelor Liconsa can cause side effects, although not everybody gets them.

The following side effects may occur while taking this medicine:

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

Seek medical help immediately if you experience any of the following symptoms - 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 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;
• Bleeding symptoms, such as:
• heavy or prolonged bleeding;
• unexpected or prolonged bleeding;
• pink, red, or brown urine;
• vomiting blood or coffee-ground-like material;
• red or black stools (like tar);
• coughing or vomiting blood clots;
• Fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (occurs frequently).
• 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) - occurs very commonly.It may be caused by heart disease or another cause, or it may be a side effect of Ticagrelor Liconsa. Dyspnea associated with Ticagrelor Liconsa 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 whether 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 - symptoms of gout
• dizziness or lightheadedness or blurred vision - 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 blood in the eye
• vaginal bleeding that is heavier or occurs at a different time than regular menstrual bleeding
• 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 pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 authorization holder.

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

5. How to store Ticagrelor Liconsa

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 necessary.

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 Liconsa contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• The other ingredients are: Core of the tablet: microcrystalline cellulose, mannitol, crospovidone (type A), povidone K30, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.

Coating of the tablet (90 mg): hypromellose type 2910 – 6mPas, titanium dioxide (E 171), macrogol 400, talc, yellow iron oxide (E 172).

What Ticagrelor Liconsa looks like and contents of the pack

Ticagrelor Liconsa, 90 mg, coated tablets: the tablets are round (9 mm in diameter), biconvex, yellow, coated, with the marking "T" on one side and smooth on the other.

Ticagrelor Liconsa, 90 mg, coated tablets are packaged in

• Blisters of transparent PVC/PVDC/Aluminum foil containing 10, 14, 56, 60, or 100 coated tablets
• HDPE bottles with a PP cap containing a desiccant, containing 56, 60, 100, 105, or 106 coated tablets

Marketing authorization holder

Laboratorios Liconsa, S.A.

C/ Dulcinea S/N,

28805 Alcala de Henares,

Madrid, Spain

+34 – 949 34 97 00

Manufacturer/Importer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7,

Pol. Ind. Miralcampo,

19200 Azuqueca de Henares,

Guadalajara, Spain

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

Netherlands: Ticagrelor Liconsa 90 mg film-coated tablets

Germany:
Ticagrelor Liconsa 90 mg film-coated tablets

Greece:
Ticagrelor 90 mg film-coated tablets

Spain:
Ticagrelor Liconsa 90 mg film-coated tablets EFG

France:
TICAGRELOR LICONSA 90 mg, film-coated tablet

Poland:
Ticagrelor Liconsa

Portugal:
Ticagrelor Liconsa

Date of last revision of the leaflet: April 2025

Other sources of information:

Detailed and up-to-date information on this medicine can be found on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (https://www.gov.pl/web/urpl).