Ticagrelor liconsa

Package leaflet: Information for the patient

Ticagrelor Liconsa, 90 mg, film-coated tablets
Ticagrelorum
Please read 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 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 an active substance called ticagrelor. It belongs to a group of medicines known as antiplatelets.
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, or
• unstable angina (angina or chest pain that is not adequately controlled).

The medicine reduces the likelihood of another heart attack or stroke, or death 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 damaged blood vessel.
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 – leading to 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 causing chest pain of varying intensity (called unstable angina).

Ticagrelor Liconsa helps prevent platelets from sticking together, thereby reducing the risk of clot formation that could reduce 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 is currently experiencing 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 to the patient. 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 – advice should be sought from a dentist);
  • a disease affecting blood clotting;
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient is scheduled to undergo any surgical procedures (including dental procedures) 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 cardiac 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 apnea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a condition that could have damaged the liver;
• if blood tests have shown elevated levels of uric acid. 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 currently taken or recently taken, as well as any medicines the patient plans to take. This is necessary because Ticagrelor Liconsa may affect the action of other medicines, and other medicines may affect Ticagrelor Liconsa. Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin at 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);
• 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 the doctor or pharmacist if the patient is 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), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Ticagrelor Liconsa and the associated increased risk of bleeding if the 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 the doctor if the patient is breastfeeding. The doctor will discuss the benefits and risks of using Ticagrelor Liconsa 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 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 during treatment, 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 the medicine is considered "sodium-free".

3. How to use Ticagrelor Liconsa

This medicine should always be taken exactly as your doctor has told you. If in doubt,
contact your doctor or pharmacist.
What dose to take

• The initial dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually given in hospital.
• After this initial dose, the usual dose is one 90 mg tablet 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 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 help prevent blood clotting. Your doctor will tell you what dose to
take (usually between 75 and 150 mg daily).
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 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 and drink.

If you are being treated in hospital, the tablet may be administered through a nasogastric tube after
being dissolved in water.
Taking more Ticagrelor Liconsa than you should
If you take more Ticagrelor Liconsa than recommended, contact your doctor immediately or go to
hospital. Take the medicine packaging 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 the 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 consulting your doctor. You should take the medicine
regularly and for as long as your doctor tells you. Stopping Ticagrelor Liconsa may increase the risk
of another heart attack or stroke, or death due to heart or blood vessel disease.
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 Liconsa 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 uncommonly, but may be life-threatening.
Contact your doctor immediately if you experience any of the following symptoms – urgent medical care may be required:

• Intracranial haemorrhage (bleeding into the brain) is an uncommon adverse effect and may cause stroke-like symptoms such as:
  • sudden numbness or weakness of the arms, legs, or face, especially 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 without known cause;
• Signs of bleeding such as:
  • heavy or difficult to stop bleeding;
  • unexpected bleeding or bleeding that lasts a long time;
  • pink, red or brown urine;
  • vomiting blood or material that looks like coffee grounds;
  • red or black, tarry stools;
  • coughing up or vomiting blood clots;
• Fainting
  • temporary loss of consciousness due to 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 disorientation. Discuss with your doctor if the patient experiences:
• Shortness of breath (dyspnoea) – very common.
  This may be caused by heart disease or another condition, or may be an adverse effect of Ticagrelor Liconsa.
  Dyspnoea associated with Ticagrelor Liconsa 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 your doctor. Your doctor will decide whether treatment or further investigations are needed.

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 minor cuts (e.g. during shaving) and wounds that is more severe 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
• disorientation (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 effects

If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Adverse effects can be reported directly to the Department for Monitoring 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 effects can also be reported directly to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this 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 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 package and other information

What Ticagrelor Liconsa contains

• The active substance is ticagrelor. Each coated tablet contains 90 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.
  Coating of the tablet (90 mg): hypromellose type 2910 – 6 mPas, 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, film-coated, marked with "T" on one side and smooth on the other.
Ticagrelor Liconsa 90 mg, coated tablets are packed in:

• Blisters made of transparent PVC/PVDC/Aluminum foil containing 10, 14, 56, 60 or 100 coated tablets
• HDPE bottles with PP screw cap containing a desiccant:
  HDPE bottle 50 ml – 56, 60 coated tablets
  HDPE bottle 100 ml – 100, 105, 106 coated tablets
  HDPE bottle 250 ml – 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 European Economic Area countries under the following names:
Netherlands: Ticagrelor Liconsa 90 mg filmomhulde tabletten
Germany: Ticagrelor Liconsa 90 mg Filmtabletten
Greece: Ticagrelor 90 mg επικαλυμμένα με λεπτό υμένιο δισκία
Spain: Ticagrelor Liconsa 90 mg comprimidos recubiertos con película EFG
France: TICAGRELOR LICONSA 90 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).