TICAGRELOR NORMON 90 mg FILM-COATED TABLETS

Introduction

Prospect: Information for the User

Ticagrelor Normon 90 mg Film-Coated Tablets EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the Prospectus

1. What is Ticagrelor Normon and what is it used for
2. What you need to know before taking Ticagrelor Normon
3. How to take Ticagrelor Normon
4. Possible side effects
5. Storage of Ticagrelor Normon
6. Package contents and additional information

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

What is Ticagrelor Normon

Ticagrelor Normon contains an active ingredient called ticagrelor. It belongs to a group of medications called antiplatelet agents.

What is Ticagrelor Normon used for

Ticagrelor Normon, in combination with acetylsalicylic acid (another antiplatelet agent), should only be used in adults. You have been prescribed this medication because you have had:

• A myocardial infarction, or
• Unstable angina (chest pain or uncontrolled thoracic pain).

This medication reduces the risk of suffering another myocardial infarction, a cerebral infarction, or dying from a heart or blood vessel disease.

How Ticagrelor Normon works

Ticagrelor acts on cells called 'platelets' (also called thrombocytes). These very small blood cells help stop bleeding by clustering to block small holes in blood vessels that are cut or damaged.

However, platelets can also form clots within damaged blood vessels in the heart and brain. This can be very dangerous because:

• The clot can completely interrupt blood flow; this can cause a heart attack (myocardial infarction) or a cerebral infarction, or
• The clot can partially block the blood vessels that go to the heart; this reduces blood flow to the heart and can cause intermittent chest pain (called 'unstable angina').

Ticagrelor helps prevent platelet aggregation. This reduces the possibility of a blood clot forming that can reduce blood flow.

2. What you need to know before taking Ticagrelor Normon

Do not take Ticagrelor Normon

• If you are allergic to ticagrelor or any of the other components of this medication (listed in section 6).
• If you have a current hemorrhage.
• If you have had a cerebral infarction caused by a cerebral hemorrhage.
• If you have severe liver disease.
• If you are taking any of the following medications:
• • 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 if you are in any of the above circumstances. If you have doubts, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before taking Ticagrelor Normon:

• If you have a higher risk of bleeding due to:
• • A recent severe injury.
  • A recent surgical intervention (including dental, ask your dentist about this).
  • You have a disorder that affects blood coagulation.
  • A recent stomach or intestinal hemorrhage (such as stomach ulcers or colon 'polyps').
• If you need to undergo a surgical intervention (including dental) at any time while taking ticagrelor. This is because it increases the risk of bleeding. Your doctor may want to suspend treatment with this medication 5 days before surgery.
• If your heart rate is abnormally slow (normally less than 60 beats per minute) and you do not already have a device that regulates your heart (pacemaker).
• If you have asthma or other pulmonary problems or breathing difficulties.
• If you develop irregular breathing patterns, such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide if you need any additional evaluation.
• If you have had any liver problems or have had a previous disease that may have affected your liver.
• If you have had a blood test that shows that the amount of uric acid is higher than normal.

If any of the above applies to your case (or if you are not sure), consult your doctor or pharmacist before taking this medication.

If you are taking ticagrelor and heparin:

• Your doctor may require a blood sample for diagnostic tests if they suspect the presence of a rare platelet disorder caused by heparin. It is essential that you inform your doctor that you are taking ticagrelor and heparin, as ticagrelor may affect the diagnostic test.

Children and adolescents

Ticagrelor is not recommended for administration to children and adolescents under 18 years of age.

Other medications and Ticagrelor Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is because ticagrelor may affect the mechanism of action of some medications, and some medications may affect ticagrelor.

Inform your doctor or pharmacist if you are taking any of the following medications:

• Rosuvastatin (a medication to treat high cholesterol).
• More than 40 mg daily of simvastatin or lovastatin (medications used to treat high cholesterol levels).
• Rifampicin (an antibiotic).
• Phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures).
• Digoxin (used to treat heart failure).
• Cyclosporin (used to decrease the body's defenses).
• Quinidine and diltiazem (used to treat abnormal heart rhythms).
• Betablockers and verapamil (used to treat high blood pressure).
• Morphine and other opioids (used to treat acute pain).

In particular, inform your doctor or pharmacist if you are 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) frequently taken as pain relievers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (SSRIs) taken 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 stomach acidity), and ergot alkaloids (used to treat migraines and headaches).

Also, inform your doctor that, because you are taking ticagrelor, you may have a higher risk of bleeding if your doctor administers fibrinolytics, often referred to as 'clot dissolvers', such as streptokinase or alteplase.

Pregnancy and breastfeeding

The use of ticagrelor is not recommended if you are pregnant or may become pregnant. Women should use appropriate contraceptive methods to avoid pregnancy while taking this medication.

Consult your doctor before taking this medication if you are breastfeeding. Your doctor will explain the benefits and risks of taking ticagrelor during this period.

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and using machines

It is unlikely that ticagrelor will affect your ability to drive and use machines. If you feel dizzy or confused while taking this medication, be careful while driving or using machines.

3. How to take Ticagrelor Normon

Follow your doctor's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

How much to take

• The initial dose is two tablets at once (a loading dose of 180 mg). This dose will usually be administered in the hospital.
• After this initial dose, the normal dose is one 90 mg tablet twice a day for 12 months, unless your doctor indicates otherwise.
• Take this medication at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Normon with other blood coagulation medications

Your doctor will also usually prescribe acetylsalicylic acid. This is a substance found in many medications used to prevent blood coagulation. Your doctor will indicate how much you should take (usually between 75-150 mg daily).

How to take Ticagrelor Normon

• You can take this medication with or without food.
• For packages of 56 tablets, you can check when you took the last Ticagrelor Normon tablet by looking at the blister pack. A weekly calendar appears with a sun (for morning) and a moon (for evening). This will indicate if you have taken your dose.

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.
• Pour the powder into half a glass of water.
• Stir and drink immediately.
• To ensure that there are no remaining medication residues, rinse the empty glass with another half glass of water and drink it.

If you are in the hospital, they may administer this tablet mixed with a little water and through a tube through your nose (nasogastric tube).

If you take more Ticagrelor Normon than you should

If you take more ticagrelor than you should, consult your doctor or go to the hospital immediately. Bring the medication package with you. You may have a higher risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ticagrelor Normon

• If you forget to take a dose, just take your next dose at the usual time.
• Do not take a double dose to make up for missed doses.

If you interrupt treatment with Ticagrelor Normon

Do not interrupt ticagrelor without consulting your doctor. Take this medication regularly and for as long as your doctor indicates. If you stop taking ticagrelor, you may increase the risk of suffering another myocardial infarction or a cerebral infarction or dying from a heart or blood vessel disease.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. With this medication, the following side effects may occur:

Ticagrelor affects blood coagulation, so most side effects are related to bleeding. Bleeding can occur in any part of the body. Some level of bleeding is common (such as bruising and nosebleeds). Severe bleeding is rare but can be potentially fatal.

Tell your doctor immediately if you notice any of the following - you may need urgent medical treatment:

• A hemorrhage in the brain or within the skull is an uncommon side effect and can cause signs of a cerebral infarction, 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 or loss of balance or coordination.
  • Sudden sensation of dizziness or severe headache of unknown cause.

• Signs of bleeding, such as:

• Severe or uncontrollable bleeding.
• Unexpected or prolonged bleeding.
• Urinary tract infection with blood or urine that is pink, red, or brown.
• Vomiting blood or vomit that looks like "coffee grounds".
• Black or red stools (like tar).
• Coughing or vomiting blood.

• Fainting (syncope)

• Temporary loss of consciousness due to a sudden drop in blood flow to the brain (frequent).

• Signs of a blood coagulation problem called Thrombotic Thrombocytopenic Purpura (TTP), such as:
• • Fever and purple spots (purpura) on the skin and in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue, or confusion.

Consult your doctor if you notice any of the following:

• Difficulty breathing- this is very common. It may be due to heart disease or another cause, or it may be a side effect of ticagrelor. The difficulty breathing related to ticagrelor is generally mild and is characterized by a sudden, unexpected need for air that usually occurs at rest and may disappear in many cases. If you think your difficulty breathing has worsened or lasts a long time, inform your doctor. They will decide if you need treatment or additional investigations.

Other possible side effects

Very common (may affect more than 1 in 10 people)

• High uric acid levels in the blood (as seen in blood tests).
• Bleeding caused by blood disorders.

Common (may affect up to 1 in 10 people)

• Bruising.
• Headache.
• Feeling dizzy or like everything is spinning.
• Diarrhea or indigestion.
• Feeling unwell (nausea).
• Constipation.
• Rash.
• Itching.
• Severe joint pain and inflammation - these are signs of gout.
• Feeling dizzy or faint, or blurred vision - these are signs of low blood pressure.
• Nosebleeds.
• Bleeding more than usual after surgery or cuts (e.g., when shaving) and wounds.
• Bleeding from the stomach walls (ulcer).
• Bleeding gums.

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction - a skin rash, itching, or swelling of the face or swelling of the lips/tongue may be signs of an allergic reaction.
• Confusion.
• Vision problems caused by blood in the eye.
• Heavier or irregular vaginal bleeding, or bleeding at different times than your usual menstrual period.
• Bleeding in the joints and muscles that causes painful inflammation.
• Blood in the ear.
• Internal bleeding, which can cause dizziness or fainting.

Frequency not known (cannot be estimated from available data)

• Abnormally low heart rate (normally below 60 beats per minute).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ticagrelor Normon

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Ticagrelor Normon Composition

• The active ingredient is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other components (excipients) are:

Tablet core:mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, calcium carmellose, and magnesium stearate.

Tablet film coating:hypromellose, propylene glycol (E-1520), talc, and yellow iron oxide (E172).

Product Appearance and Package Contents

Yellow, round, and biconvex film-coated tablets, serigraphed with "90" on one side and blank on the other.

Ticagrelor Normon is available in packages containing 56 or 100 (clinical package) tablets in aluminum/PVC-PVDC blisters (with sun/moon symbols on the 56-tablet package).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the Last Revision of this Prospectus: February 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone).

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/89354/P_89354.html.