Ticagrelor Aristo

Package Leaflet: Information for the User

Ticagrelor Aristo, 60 mg, Film-Coated Tablets

Ticagrelor

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Ticagrelor Aristo is and what it is used for
• 2. What you need to know before you take 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 the active substance ticagrelor. It belongs to a group of medicines called antiplatelet medicines.

What Ticagrelor Aristo is used for

This medicine is used in combination with acetylsalicylic acid (another antiplatelet medicine) in adults who have had a heart attack (myocardial infarction) more than a year ago. It reduces the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

How Ticagrelor Aristo works

This medicine works by preventing the formation of blood clots. It does this by blocking a chemical that is involved in the formation of blood clots.

• Blood clots can block an artery, which can lead to a heart attack or stroke.

2. What you need to know before you take Ticagrelor Aristo

Do not take Ticagrelor Aristo

• if you are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6);
• if you have active 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:
• ketokonazol (used to treat fungal infections);
• klarytromycyna (used to treat bacterial infections);
• nefazodon (an antidepressant);
• rytonawir and atazanawir (used to treat HIV and AIDS). Do not take Ticagrelor Aristo if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ticagrelor Aristo, tell your doctor or pharmacist:

• if you have an increased risk of bleeding due to:
• a recent serious injury
• recent surgery (including dental surgery; you should ask your dentist for advice)
• a condition that affects blood clotting
• recent bleeding from the stomach or intestines (such as a stomach ulcer or intestinal polyps);
• if you are going to have surgery (including dental surgery) while taking Ticagrelor Aristo. This is because of an 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 disease or breathing difficulties;
• if you have any liver problems or have had a disease that may have damaged your liver;
• if your blood test results show high levels of uric acid. If any of the above applies to you (or if you are in doubt), you should talk to your doctor or pharmacist before taking this medicine.

If you are taking Ticagrelor Aristo and heparin:

• your doctor may take a blood sample to do laboratory tests if they suspect a rare blood clotting disorder caused by heparin. It is important to tell your doctor that you are taking both Ticagrelor Aristo and heparin, as Ticagrelor Aristo may affect the result of the diagnostic test.

Children and adolescents

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

Ticagrelor Aristo 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 Aristo may affect the way other medicines work, and other medicines may affect the way Ticagrelor Aristo works.

• rosuwastatin (used to treat high cholesterol)
• simvastatin or lovastatin at doses greater than 40 mg per day (used to treat high cholesterol)
• 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 irregular heartbeat)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat severe pain).

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that may increase the risk of bleeding:

• oral anticoagulants, often referred to as blood thinners, 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 atazanavir (used to treat HIV and AIDS), cisapride (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Fibrinolytic medicines, often referred to as clot-dissolving medicines, such as streptokinase or alteplase, may increase the risk of bleeding if taken with Ticagrelor Aristo. Tell your doctor if you are taking Ticagrelor Aristo.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Ticagrelor Aristo if you are pregnant or think you may be pregnant. Women should use appropriate contraceptive methods to prevent pregnancy while taking this medicine.

Before taking this medicine, tell your doctor if you are breast-feeding. Your doctor will discuss the benefits and risks of taking Ticagrelor Aristo while breast-feeding.

Driving and using machines

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

Ticagrelor Aristo contains sodium

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

3. How to take Ticagrelor Aristo

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

How much to take

• The usual dose is one 60 mg tablet twice a day. You should keep taking Ticagrelor Aristo for as long as your doctor recommends.
• It is recommended that you take the medicine at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Aristo with other anti-clotting medicines

Your doctor will usually recommend that you also take acetylsalicylic acid. This is a substance found in many medicines and is used to prevent blood clotting. Your doctor will tell you what dose to take (usually between 75 and 150 mg per day).

How to take Ticagrelor Aristo

You can take the tablets 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.
• Put the powder into half a glass of water.
• Mix and drink immediately.
• To make sure you take all the medicine, add another half glass of water, stir, and drink. If you are in the hospital, the crushed tablet can be given to you through a nasogastric tube.

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

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

What to do if you forget to take Ticagrelor Aristo

• 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 Aristo

Do not stop taking Ticagrelor Aristo without discussing it with your doctor. You should keep taking the medicine regularly and for as long as your doctor recommends. Stopping Ticagrelor Aristo may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.

4. Possible side effects

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

Seek medical help immediately if you have any of the following side effects

• 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 only 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;
• urine that is pink, red, or brown;
• vomiting blood or coffee ground-like material;
• black or tarry stools (like coal);
• coughing or vomiting blood clots;
• Fainting
• temporary loss of consciousness due to 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 (purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion.

Tell your doctor if you have any of the following side effects

• Shortness of breath (dyspnea) - very common. It may be caused by heart disease or another cause, or it may be a side effect of this medicine. Dyspnea associated with Ticagrelor Aristo 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, you should 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 feeling of spinning
• diarrhea or indigestion
• feeling sick (nausea)
• constipation
• rash
• itching
• increased pain and swelling of the joints - these are symptoms of gout
• dizziness or fainting or blurred vision - these are symptoms of low blood pressure
• nosebleeds
• more bleeding than usual after surgery or from cuts and wounds (e.g., during shaving)
• 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
• vision disturbances due to blood in the eye
• bleeding from the reproductive tract, which is heavier or occurs at an unusual time (e.g., heavy or irregular menstrual bleeding)
• bleeding into the joints and muscles, causing painful swelling
• blood in the ear
• internal bleeding, which may cause dizziness or fainting.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Ticagrelor Aristo

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 instructions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ticagrelor Aristo contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Tablet core: mannitol, calcium hydrogen phosphate dihydrate, carmellose sodium (type A), hypromellose 2910, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), iron oxide black (E 172).

What Ticagrelor Aristo looks like and contents of the pack

Tablet (film-coated tablet): round, biconvex, pink tablets with "60" engraved on one side and a diameter of 8 mm.

Carton containing a transparent blister of PVC/PVDC/Aluminum containing 56, 60, or 168 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aristo Pharma Sp. z o.o.

Baletowa 30

02-867 Warsaw

Phone: 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

Date of last revision of the leaflet:August 2024