Ticagrelor Aristo

Package Leaflet: Information for the User

Ticagrelor Aristo, 90 mg, Film-Coated Tablets

Ticagrelor

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, as You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed to a Specific Person. Do Not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Side Effects, including those not Listed in this Package Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Ticagrelor Aristo and What is it Used for
• 2. Important Information Before Taking Ticagrelor Aristo
• 3. How to Take Ticagrelor Aristo
• 4. Possible Side Effects
• 5. How to Store Ticagrelor Aristo
• 6. Package Contents and Other Information

1. What is Ticagrelor Aristo and What is it Used for

What is Ticagrelor Aristo

Ticagrelor Aristo Contains the Active Substance Ticagrelor, which Belongs to a Group of Antiplatelet Medications.

What is Ticagrelor Aristo Used for

Ticagrelor Aristo, in Combination with Acetylsalicylic Acid (Another Antiplatelet Medication), is Used Only in Adults who have Experienced:

• Myocardial Infarction
• Unstable Angina (Angina or Chest Pain that is not Properly Controlled). The Medication Reduces the Risk of Another Myocardial Infarction, Stroke, or Death Due to Heart or Blood Vessel Disease.

How Ticagrelor Aristo Works

Ticagrelor Aristo Affects Blood Platelets (also Known as Thrombocytes). Blood Platelets are Very Small Blood Cells that Help Stop Bleeding by Clumping Together and Blocking Small Holes in Blood Vessels. However, Blood Platelets can also Form Clots Inside Diseased Blood Vessels in the Heart and Brain, which can be Life-Threatening.

• A Clot can Completely Block Blood Flow, Causing a Myocardial Infarction (Heart Muscle) or Stroke, or
• A Clot can Cause Partial Blockage of Blood Vessels Leading to the Heart, Reducing Blood Flow to the Heart and Causing Chest Pain of Varying Severity (Known as "Unstable Angina").

Ticagrelor Aristo Helps Prevent Blood Platelets from Clumping Together. This Reduces the Risk of a Clot Forming, which can Reduce Blood Flow.

2. Important Information Before Taking Ticagrelor Aristo

When Not to Take Ticagrelor Aristo

• If the Patient is Allergic to Ticagrelor or any of the Other Ingredients of this Medication (Listed in Section 6);
• If the Patient is Currently Bleeding;
• If the Patient has Experienced a Stroke Caused by Bleeding into the Brain;
• If the Patient has Severe Liver Disease;
• If the Patient is Taking any of the Following Medications:
• Ketoconazole (Used to Treat Fungal Infections);
• Clarithromycin (Used to Treat Bacterial Infections);
• Nefazodone (An Antidepressant Medication);
• Ritonavir and Atazanavir (Used to Treat HIV and AIDS Infections). Do Not Take Ticagrelor Aristo if any of these Situations Apply to the Patient. In Case of Doubt, Consult a Doctor or Pharmacist Before Starting Treatment with this Medication.

Warnings and Precautions

Before Starting Ticagrelor Aristo, Discuss the Following with a Doctor or Pharmacist:

• If the Patient has an Increased Risk of Bleeding Due to:
• Recent Severe Injury
• Recent Surgery (Including Dental Surgery; Consult a Dentist)
• A Condition that Affects Blood Clotting
• Recent Bleeding from the Stomach or Intestines (Such as a Stomach Ulcer or Intestinal Polyps)
• If the Patient will Undergo Surgery (Including Dental Surgery) While Taking Ticagrelor Aristo. This is Due to an Increased Risk of Bleeding. The Doctor may Advise Stopping the Medication 5 Days Before the Scheduled Surgery;
• If the Patient has a Heart Rate that is Too Slow (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 Disorders or has had a Disease that may have Damaged the Liver;
• If the Patient's Blood Test Shows High Levels of Uric Acid. If any of these Situations Apply to the Patient (or in Case of Doubt), Consult a Doctor or Pharmacist Before Taking the Medication.

If the Patient is Taking Ticagrelor Aristo and Heparin:

• The Doctor may Take a Blood Sample for Laboratory Tests if they Suspect a Rare Platelet Disorder Caused by Heparin. It is Essential to Inform the Doctor about Taking both Ticagrelor Aristo and Heparin, as Ticagrelor Aristo may Affect the Test Results.

Children and Adolescents

Ticagrelor Aristo is Not Recommended for Children and Adolescents Under 18 Years of Age.

Ticagrelor Aristo and Other Medications

Tell the Doctor or Pharmacist About all Medications the Patient is Currently Taking or has Recently Taken, as Well as any Medications the Patient Plans to Take. This is Necessary Because Ticagrelor Aristo may Affect the Action of Other Medications, and Other Medications may Affect Ticagrelor Aristo.

• Rosuvastatin (Used to Treat High Cholesterol)
• Simvastatin or Lovastatin in 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 Heart Rhythm Disorders)
• Beta-Blockers and Verapamil (Used to Treat High Blood Pressure)
• Morphine and Other Opioids (Used to Treat Severe Pain)

Particularly, Inform the Doctor or Pharmacist About Taking any of the Following Medications that Increase the Risk of Bleeding:

• Oral Anticoagulants, Often Referred to as Blood Thinners, Including Warfarin;
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Often Used as Pain Relievers, Such as Ibuprofen and Naproxen;
• Selective Serotonin Reuptake Inhibitors (SSRIs), Used as Antidepressants, Such as Paroxetine, Sertraline, and Citalopram;
• Other Medications, 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)

Fibrinolytic Medications, Often Referred to as "Clot-Busting" Medications, Such as Streptokinase or Alteplase, may Increase the Risk of Bleeding if Taken with Ticagrelor Aristo. Inform the Doctor if the Patient is Taking Ticagrelor Aristo.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or Plans to Have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication. Do Not Take Ticagrelor Aristo if the Patient is Pregnant or Thinks they may be Pregnant. During Treatment with this Medication, Women Should Use Appropriate Contraceptive Methods to Avoid Becoming Pregnant. Before Taking this Medication, Inform the Doctor About Breastfeeding. The Doctor will Discuss the Benefits and Risks of Taking Ticagrelor Aristo During Breastfeeding.

Driving and Operating Machines

It is Unlikely that Ticagrelor Aristo will Affect the Ability to Drive or Operate Machines. However, if the Patient Experiences Dizziness or Disorientation While Taking the Medication, they Should Exercise Caution When Driving or Operating Machines.

Ticagrelor Aristo Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which Means it is Considered "Sodium-Free".

3. How to Take Ticagrelor Aristo

Always Take this Medication Exactly as Prescribed by a Doctor or Pharmacist. In Case of Doubt, Consult a 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 a Hospital.
• After the Initial Dose, the Usual Dose is One 90 mg Tablet Taken Twice a Day for Up to 12 Months, Unless the Doctor Prescribes Otherwise.
• It is Recommended to Take the Medication at the Same Time Every Day (e.g., One Tablet in the Morning and One in the Evening).

Taking Ticagrelor Aristo with Other Blood-Thinning Medications

The Doctor will Usually Prescribe Acetylsalicylic Acid to be Taken at the Same Time. This is a Substance Found in Many Medications and is Used to Prevent Blood Clotting. The Doctor will Inform About the Dose to Take (Usually Between 75 and 150 mg per Day).

How to Take Ticagrelor Aristo

The Tablets can be Taken with or Without Food.

What to Do if the Patient has Difficulty Swallowing the Tablet

If the Patient has Difficulty Swallowing the Tablet, it can 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 that all the Medication is Taken, Refill the Glass with Half a Glass of Water, Rinse, and Drink. If the Patient is in the Hospital, the Tablet can be Dissolved in Water and Given Through a Nasogastric Tube.

What to Do if the Patient Takes More Ticagrelor Aristo than Prescribed

If the Patient Takes More Ticagrelor Aristo than Prescribed, they Should Immediately Contact a Doctor or Go to the Hospital. They Should Bring the Medication Packaging with them. There may be an Increased Risk of Bleeding.

What to Do if the Patient Misses a Dose of Ticagrelor Aristo

• If a Dose is Missed, the Next Dose Should be Taken at the Usual Time.
• Do Not Take a Double Dose (Two Doses at the Same Time) to Make Up for the Missed Dose.

What to Do if the Patient Wants to Stop Taking Ticagrelor Aristo

Do Not Stop Taking Ticagrelor Aristo Without Discussing it with a Doctor. The Medication Should be Taken Regularly and for as Long as the Doctor Prescribes. Stopping Ticagrelor Aristo may Increase the Risk of Another Myocardial Infarction, Stroke, or Death Due to Heart or Blood Vessel Disease. In Case of Further Doubts About Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Ticagrelor Aristo can Cause Side Effects, although Not Everybody Gets them. The Following Side Effects may Occur While Taking this Medication:

Ticagrelor Aristo Affects Blood Clotting, and Most Side Effects are Related to Bleeding. Bleeding can Occur Anywhere in the Body. Some Bleeding is Common (Such as Bruising and Nosebleeds). Severe Bleeding is Less Common but can be Life-Threatening.

Seek Immediate Medical Attention if the Patient Experiences any of the Following Symptoms - it may be Necessary to Seek Emergency Medical Attention:

• Bleeding into 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 Affects 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 Without a Known Cause.
• Signs of Bleeding Such as:
• Heavy or Prolonged Bleeding;
• Unexpected or Prolonged Bleeding;
• Urinary Tract Infection with Blood;
• Vomiting Blood or Coffee Ground-Like Material;
• Black or Reddish-Colored Stool (Similar to Tar);
• Coughing or Vomiting with Blood Clots.
• Fainting
• Temporary Loss of Consciousness Due to a Sudden Drop in Blood Flow to the Brain (Common).
• Signs of 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.

Tell the Doctor if the Patient Experiences:

• Shortness of Breath (Dyspnea) - Very Common. It may be Caused by Heart Disease or Another Cause, or it may be a Side Effect of Ticagrelor Aristo. Dyspnea Associated with Ticagrelor Aristo is Usually Mild and Characterized by Sudden, Unexpected Shortness of Breath, Often at Rest, and may Occur During the First Few Weeks of Treatment, and then may Not Occur for Many Weeks. If Dyspnea Worsens or Persists, Consult a Doctor. The Doctor will Decide if Treatment or Further Tests are Necessary.

Other Possible Side Effects

Very Common(May Affect More than 1 in 10 People)

• Increased Uric Acid Levels in the Blood (Detected in Laboratory Tests)
• Bleeding Caused by Blood Disorders

Common(May Affect Up to 1 in 10 People)

• Bruising
• Headaches
• Dizziness or Lightheadedness
• Diarrhea or Indigestion
• Nausea (Feeling Sick)
• Constipation
• Rash
• Itching
• Increased Pain and Swelling of the Joints - These are Symptoms of Gout
• Dizziness or Lightheadedness or Blurred Vision - These are Symptoms of Low Blood Pressure
• Nosebleeds
• More than Usual Bleeding After Surgery or from Cuts (e.g., While Shaving) and Wounds
• Bleeding from the 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
• Disorientation
• Visual Disturbances Caused by Blood in the Eye
• Bleeding from the Genital Tract, which is More than Usual 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

Reporting Side Effects

If the Patient Experiences any Side Effects, Including those not Listed in this Package Leaflet, they Should Inform their Doctor or Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring 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. Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, it is Possible to Gather More Information on the Safety of this Medication.

5. How to Store Ticagrelor Aristo

Keep the Medication Out of Sight and Reach of Children. Do Not Take this Medication After the Expiration Date Stated on the Blister and Carton After: EXP. The Expiration Date Refers to the Last Day of the Month. No Special Storage Conditions are Required. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist How to Dispose of Medications that are No Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Ticagrelor Aristo Contains

• The Active Substance is Ticagrelor. Each Film-Coated Tablet Contains 90 mg of Ticagrelor.
• The Other Ingredients are:

Tablet Core: Mannitol, Calcium Hydrogen Phosphate Dihydrate, Carboxymethylcellulose Sodium (Type A), Hypromellose 2910, Magnesium Stearate. Tablet Coating: Hypromellose, Titanium Dioxide (E 171), Macrogol 400, Yellow Iron Oxide (E 172), Talc.

What Ticagrelor Aristo Looks Like and What the Package Contains

Film-Coated Tablet (Tablet): Yellow, Round, Biconvex Tablets with "90" Engraved on One Side and a Diameter of 9 mm. Carton Containing a Transparent Blister of PVC/PVDC/Aluminum Foil Containing 14, 56, 60, 100, or 168 Film-Coated Tablets. Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Sp. z o.o. ul. Baletowa 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. Date of Last Revision of the Package Leaflet:August 2024