Ticagrelor aristo

Package leaflet: Information for the user

Ticagrelor Aristo, 90 mg, film-coated tablets
Ticagrelorum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

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

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

• a heart attack, or
• unstable angina (chest pain or discomfort that is not adequately controlled).

The medicine reduces the risk of another heart attack or stroke, or death due to heart or blood vessel disease.

How Ticagrelor Aristo works
Ticagrelor Aristo 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 cuts or damage in blood vessels. 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 cause partial blockage of blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain of varying intensity (known as "unstable angina").

Ticagrelor Aristo helps prevent platelets from sticking together. This reduces the risk of clot formation, which could reduce blood flow.

2. Important information before using Ticagrelor Aristo

When not to use Ticagrelor Aristo

• if the patient is allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently 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 atazanawir (used to treat HIV and AIDS infections).
    Do not take Ticagrelor Aristo 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 starting Ticagrelor Aristo, discuss with 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)
  • a condition affecting blood clotting
  • recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps).
• if the patient will undergo any surgical procedures (including dental procedures) while taking Ticagrelor Aristo. This is due to an increased risk of bleeding. The doctor may recommend stopping the medicine 5 days before a planned procedure;
• if the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a pacemaker;
• if the patient has asthma or other lung diseases or breathing difficulties;
• if the patient has any liver problems or has previously had a disease that may have damaged the liver;
• if blood tests have shown that the patient has high levels of uric acid.
  If any of the above situations apply to the patient (or if in doubt), talk to a doctor or pharmacist before taking this medicine.

If the patient is taking both Ticagrelor Aristo and heparin:

• the doctor may take a blood sample for laboratory testing if heparin-induced thrombocytopenia (a rare platelet disorder caused by heparin) is suspected. It is important to inform the doctor about taking both Ticagrelor Aristo and heparin, as Ticagrelor Aristo may affect the diagnostic test result.

Children and adolescents
Ticagrelor Aristo is not recommended for use in children and adolescents under 18 years of age.
Ticagrelor Aristo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because Ticagrelor Aristo may affect the action of other medicines, and other medicines may affect Ticagrelor Aristo.
Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to treat high cholesterol levels)
• simvastatin or lovastatin at doses greater than 40 mg per day (medicines used to treat high 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).

In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines that increase the risk of bleeding:

• oral anticoagulants, often called blood-thinning medicines, 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 ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanawir (used to treat HIV and AIDS infections), cyproheptadine (used to treat indigestion), ergot alkaloids (used to treat migraines and headaches).

Also inform the doctor about taking Ticagrelor Aristo and the increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called "clot-busting" medicines, such as streptokinase or alteplase.
Pregnancy and breastfeeding
Ticagrelor Aristo is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women 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 Aristo during breastfeeding.
Driving and operating machinery
It is unlikely that Ticagrelor Aristo will impair the ability to drive or operate machinery. However, if dizziness or disorientation occurs while taking this medicine, caution should be exercised when driving or operating machinery.
Ticagrelor Aristo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Ticagrelor Aristo

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
What dose should be taken

• The initial dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually administered in hospital.
• After the initial dose, the usual maintenance dose is one 90 mg tablet taken 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 Aristo with other blood-thinning medicines
Your doctor will usually recommend that you also take acetylsalicylic acid. This is a substance
present in many medicines and used to prevent blood clotting. Your doctor will advise you on the
dose to take (usually between 75 and 150 mg daily).
How to take Ticagrelor Aristo
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, 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.
• Mix and drink immediately.
• To ensure the entire dose is taken, add another half glass of water, swirl, and drink. If the patient is in hospital, the tablet, once dispersed in water, may be administered through a nasogastric tube.

Taking more Ticagrelor Aristo than recommended
If you take more Ticagrelor Aristo than recommended, contact your doctor or go to hospital immediately.
Bring the medicine packaging with you. There may be an increased risk of bleeding.
If you miss a dose of Ticagrelor Aristo

• 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 Aristo
Do not stop taking Ticagrelor Aristo without discussing it with your doctor. The medicine should be taken regularly and for as long as your doctor recommends. Stopping Ticagrelor Aristo 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Ticagrelor Aristo affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events are common (such as bruises and nosebleeds). Severe bleeding occurs less frequently, but may be life-threatening.
Contact your doctor immediately if any of the following symptoms occur – urgent medical attention may be required:

• Bleeding into the brain or intracranial haemorrhage 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 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 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 long time;
  • urine that is pink, red, or brown in colour;
  • vomiting blood or vomit that looks like coffee grounds;
  • red or black, tarry stools;
  • coughing or vomiting blood clots.
• Fainting
  • temporary loss of consciousness caused by a sudden drop 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. It may be caused by heart disease or another cause, or may be an adverse reaction to Ticagrelor Aristo. Dyspnoea associated with Ticagrelor Aristo treatment is usually mild and characterised by sudden, unexpected breathlessness, usually occurring at rest, which may appear during the first few weeks of treatment and then not occur again for many weeks. If shortness of breath worsens or persists for a long time, contact your doctor. Your doctor will decide whether treatment or additional tests are necessary.

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

• increased blood uric acid levels (detected in laboratory tests)
• bleeding caused by blood disorders.

Common (may affect up to 1 in 10 people)

• bruising
• headaches
• dizziness or spinning sensation
• 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
• more severe than usual bleeding after surgery or from cuts (e.g. while shaving) and wounds
• 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
• visual disturbances caused by presence of blood in the eye
• bleeding from the reproductive tract that is heavier 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 (frequency cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Ticagrelor Aristo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions required for this medicinal product.
Medicines must not be disposed of via the sewage system 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 package and other information

What Ticagrelor Aristo contains

• The active substance is ticagrelor. Each coated tablet contains 90 mg of ticagrelor.
• Other ingredients are:
  Tablet core: mannitol, calcium hydrogen phosphate dihydrate, sodium carboxymethyl starch (type A), hypromellose 2910, magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 400, yellow iron oxide (E 172), talc.

What Ticagrelor Aristo looks like and contents of the pack
Coated tablet (tablet): round, biconvex, yellow tablets, embossed with "90" on one side, 9 mm in diameter.
Carton box containing a transparent blister made of PVC/PVDC/Aluminium foil with 14,
56, 60, 100 or 168 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
tel. 22 855 40 93

Manufacturer
PGF Pharma International d.o.o.
Ulica Roberta Frangesa-Mihanovica 9,
10110, Zagreb
Croatia

KeVaRo GROUP Ltd.
9, Tsaritsa Eleonora Str.,
office 23,
Sofia 1618,
Bulgaria

Adalvo Limited
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate
San Gwann, SGN 3000
Malta