TICAGRELOR INTAS 60 mg FILM-COATED TABLETS

Introduction

Prospect: information for the user

Ticagrelor Intas 60mg 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, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are side effects not listed in this prospectus. See section 4.

Contents of the prospectus

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

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

What is Ticagrelor Intas

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

What is Ticagrelor Intas used for

Ticagrelor 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, more than a year ago.

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

How Ticagrelor Intas works

Ticagrelor acts on cells called 'platelets' (also called thrombocytes). These very small blood cells help stop bleeding by clustering to plug 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 Intas

Do not take Ticagrelor Intas if:

• You are allergic to ticagrelor or any of the other components of this medication (listed in section 6).
• You have a current bleeding disorder.
• You have had a cerebral infarction caused by a cerebral hemorrhage.
• You have severe liver disease.
• 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)

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 this medication 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)
• a disorder that affects blood coagulation
• a recent stomach or intestinal bleeding (such as stomach ulcer or colon 'polyps')

• 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.
• Your heart rate is abnormally slow (normally less than 60 beats per minute) and you do not have a device that regulates your heart (pacemaker) implanted.
• You have asthma or other pulmonary problems or breathing difficulties.
• You develop irregular breathing patterns, such as acceleration, slowing, or brief pauses in breathing. Your doctor will decide if you need any additional evaluation.
• You have had any liver problems or have had a disease that may have affected your liver in the past.
• 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 this medication can 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 Intas

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. This is because ticagrelor can affect the mechanism of action of some medications, and some medications can 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)
• cyclosporine (used to decrease the body's immune response)
• quinidine and diltiazem (used to treat abnormal heart rhythms)
• beta-blockers 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), 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and using machines

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

Sodium content

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

3. How to take Ticagrelor Intas

Follow the administration instructions of this medication indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist again.

How much to take

• The usual dose is one 60 mg tablet twice a day. Continue taking ticagrelor as long as your doctor indicates.
• Take this medication at the same time every day (e.g., one tablet in the morning and one in the evening).

Taking Ticagrelor Intas with other blood coagulation medications

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

How to take Ticagrelor Intas

• You can take this medication with or without food.
• You can check when you took the last ticagrelor tablet by looking at the blister pack. A sun (for morning) and a moon (for evening) appear. 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, this tablet may be administered to you mixed with a little water and through a tube through your nose (nasogastric tube).

If you take more Ticagrelor Intas than you should

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

If you forget to take Ticagrelor Intas

• If you forget to take a dose, just take your next dose at the usual time.

• Do not take a double dose (two doses at once) to make up for missed doses.

If you interrupt treatment with Ticagrelor Intas

Do not interrupt this medication 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 uncommon but can be potentially life-threatening.

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

• A bleeding 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 feeling of dizziness or severe headache of unknown cause

• Signs of bleeding such as:

• severe or uncontrollable bleeding
• unexpected or prolonged bleeding
• urine that is pink, red, or brown
• vomiting blood or vomit that looks like "coffee grounds"
• stools that are black or red (like tar)
• coughing or vomiting blood

• Fainting (syncope)

• temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)

• Signs of a blood coagulation problem called Thrombotic Thrombocytopenic Purpura (TTP) such as:

• fever and purple spots (called purpura) on the skin and in the mouth, with or without yellowing of the skin or eyes (jaundice), 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 breathing difficulty 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 breathing difficulty 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 as if everything is spinning
• Diarrhea or indigestion
• Feeling unwell (nausea)
• Constipation
• Rash
• Itching
• Severe pain and inflammation in the joints - 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 times other 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 possible side effects 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 Intas

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 packaging after EXP/CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ticagrelor Intas

• The active ingredient is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.

• The other ingredients are:

Core of the tablet: microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone K30, sodium stearyl fumarate.

Coating of the tablets: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553B), red iron oxide (E172), black iron oxide (E172).

Appearance of the Product and Container Content

Ticagrelor Intas 60 mg are film-coated tablets of light pink color, round (8 mm in diameter), biconvex, with the inscription «KJ1» on one side.

Ticagrelor Intas 60 mg is presented in blisters containing 14, 56, 60, 100, 168 or 180 film-coated tablets, calendar blisters containing 14, 56 or 168 film-coated tablets, or single-dose precut blisters containing 14 x 1, 56 x 1, 60 x 1, 100 x 1, 168 x 1 or 180 x 1 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Intas Third Party Sales 2005 S.L.

Moll Barcelona s/n, World Trade Center, Edifici Est, 6th Floor

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp. z.o.o.

Ul. Lutomierska 50, 95-200,

Pabianice, Poland

or

Accord Healthcare B.V.

Winthontlaan 200, 3526 KV

Utrecht, Netherlands

or

Laboratori Fundació Dau

C/ C, 12-14 Pol.

Ind. Zona Franca,

Barcelona, 08040, Spain

or

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park,

Paola, PLA 3000,

Malta

Date of Last Revision of this Leaflet: 12/2024

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