Ticagrelor liconsa

Package leaflet: Information for the patient

Ticagrelor Liconsa, 60 mg, film-coated tablets
Ticagrelorum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

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

• a heart attack more than one year ago.

The medicine reduces the likelihood of having another heart attack or stroke, or of dying due to heart or blood vessel disease.

How Ticagrelor Liconsa works
Ticagrelor Liconsa 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 — reducing blood flow to the heart and possibly causing chest pain of varying intensity (known as unstable angina).

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

2. Important information before using Ticagrelor Liconsa

When not to use Ticagrelor Liconsa

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

Warnings and precautions

Before taking Ticagrelor Liconsa, 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 on this matter);
  • a disease affecting blood clotting;
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient is scheduled to undergo any surgical procedure (including dental) during treatment with Ticagrelor Liconsa. 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 problems such as rapid breathing, slowed 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 may have damaged the liver;
• if blood tests have shown elevated uric acid levels above normal. Talk to a doctor or pharmacist before taking the medicine if any of the above situations apply (or if in doubt).

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

Children and adolescents

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

Ticagrelor Liconsa and other medicines

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

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin at doses higher than 40 mg per day (medicines used to lower 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-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), 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 associated increased risk of bleeding if your doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ticagrelor Liconsa is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women of childbearing potential should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.

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

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

Driving and operating machinery

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

Sodium content

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

3. How to use Ticagrelor Liconsa

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should contact your doctor or pharmacist.

How much medicine to take

• The usual dose is one 60 mg tablet twice daily. You should continue taking Ticagrelor Liconsa for as long as your doctor recommends.
• It is recommended to take the medicine at the same time each day (for example, one tablet in the morning and one in the evening).

Taking Ticagrelor Liconsa with other medicines that inhibit blood clotting

Your doctor will usually recommend that you take acetylsalicylic acid at the same time. This is a substance found in many medicines used to prevent blood clotting. Your doctor will inform you of the dose you should take (usually between 75 and 150 mg daily).

How to take Ticagrelor Liconsa

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, you may crush it and mix it 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 that all the medicine is taken, add another half glass of water to the container, swirl, and drink.

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

Taking more Ticagrelor Liconsa than recommended

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

If you miss a dose of Ticagrelor Liconsa

• 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 Liconsa

Do not stop taking Ticagrelor Liconsa without first consulting your doctor. You should take the medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Liconsa 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 how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Ticagrelor Liconsa affects blood clotting, therefore most adverse reactions are related to bleeding.
Bleeding may occur at any site in the body. Some bleeding occurs frequently (e.g. bruising and nosebleeds).
Severe bleeding occurs uncommonly but may be life-threatening.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical care may be required:

• Intracranial haemorrhage (bleeding into the brain) is an uncommon adverse reaction and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the arms, legs, or face, especially if on 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;
  • pink, red, or brown urine;
  • vomiting blood or material that looks like coffee grounds;
  • red or black stools (resembling tar);
  • coughing up or vomiting blood clots;
• 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 confusion.

You should discuss with your doctor if the patient experiences:

• Shortness of breath (dyspnoea) – very common. This may be caused by heart disease or another cause, or may be an adverse reaction to Ticagrelor Liconsa. Dyspnoea associated with Ticagrelor Liconsa is usually mild and is characterised by sudden, unexpected shortness of breath, usually occurring at rest. It may appear during the first few weeks of treatment and then not occur for several weeks. If shortness of breath worsens or persists for a long time, contact your doctor. Your doctor will decide whether treatment or further investigations are needed.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people)

• increased uric acid levels in blood (detected in laboratory tests)
• bleeding caused by 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. while shaving) and wounds that is heavier than usual
• bleeding from the stomach 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
• confusion
• visual disturbances caused by blood in the eye
• vaginal bleeding that is heavier than usual 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 (cannot be estimated from available data)

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

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department for 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ticagrelor Liconsa

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
following the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. You should ask
your pharmacist how to dispose of medicines you no longer use. 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 60 mg of ticagrelor.
• The other ingredients are:

Tablet core: microcrystalline cellulose, mannitol, crospovidone (type A), povidone K30,
sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
Tablet coating (60 mg): hypromellose type 2910 – 6 mPas, titanium dioxide (E 171), macrogol 400,
iron oxide red (E 172), iron oxide black (E 172).

What Ticagrelor Liconsa looks like and contents of the pack
Ticagrelor Liconsa 60 mg coated tablets: round (8 mm in diameter), biconvex, pink, film-coated tablets, marked with "I" on one side and smooth on the other side.
Ticagrelor Liconsa 60 mg coated tablets are packed in:

• Blister packs made of transparent PVC/PVDC/Aluminium foil containing 10, 14, 56, 60 or 100 coated tablets
• HDPE bottles with PP screw cap containing a moisture-absorbing agent:
  • 35 ml HDPE bottle – 56 or 60 coated tablets
  • 50 ml HDPE bottle – 100, 105, or 106 coated tablets
  • 100 ml HDPE bottle – 168 coated tablets

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
Netherlands: Ticagrelor Liconsa 60 mg filmomhulde tabletten
Germany: Ticagrelor Liconsa 60 mg Filmtabletten
Greece: Ticagrelor 60 mg επικαλυμμένα με λεπτό υμένιο δισκία
Spain: Ticagrelor Liconsa 60 mg comprimidos recubiertos con película EFG
France: TICAGRELOR LICONSA 60 mg, comprimé pelliculé
Poland: Ticagrelor Liconsa
Portugal: Ticagrelor Liconsa

Other sources of information:
Detailed and up-to-date information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (https://www.gov.pl/web/urpl).