TICAGRELOR INTAS 90 mg FILM-COATED TABLETS

Introduction

Prospect: Information for the User

Ticagrelor Intas 90mg 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 the active substance 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 you suffering another myocardial infarction, a stroke, or dying from a heart or blood vessel disease.

How Ticagrelor Intas works

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

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

• the clot can completely block blood flow; this can cause a heart attack (myocardial infarction) or a stroke, 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 likelihood 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 stroke 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 procedure (including dental procedures, ask your dentist about this)
• a disorder that affects blood clotting
• a recent stomach or intestinal bleeding (such as stomach ulcers or colon polyps)

• You need to undergo a surgical procedure (including dental procedures) at any time while taking ticagrelor. This is because it increases the risk of bleeding. Your doctor may want to stop 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 pacemaker implanted.
• You have asthma or other lung problems or breathing difficulties.
• You develop irregular breathing patterns, such as rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide if you need any additional evaluation.
• You have had liver problems or have had a disease that may have affected your liver.
• You have had a blood test that shows high levels of uric acid.

If any of the above applies to your case (or if you are unsure), 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 may affect the diagnostic test.

Children and adolescents

Ticagrelor is not recommended for 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 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 reduce the body's defenses)
• 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

Ticagrelor is not recommended during pregnancy or if you 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

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 for this medication exactly as indicated by your doctor. If you have doubts, consult your doctor or pharmacist again.

How much to take

• The initial dose is two tablets at the same time (a loading dose of 180 mg). This dose will usually be administered in the hospital.
• After this initial dose, the usual 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 Intas with other blood clotting medications

Your doctor will also usually prescribe acetylsalicylic acid. This is a substance found in many medications used to prevent blood clotting. Your doctor will indicate how much you should 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 symbol (for morning) and a moon symbol (for evening) will 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 no medication remains, rinse the empty glass with another half glass of water and drink it

If you are in the hospital, you may be given this tablet mixed with a little water through a tube in 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 the same time) to make up for missed doses.

If you stop taking Ticagrelor Intas

Do not stop taking 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 stroke 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. The following side effects can occur with this medication:

Ticagrelor affects blood clotting, so most side effects are related to bleeding. Bleeding can occur anywhere in 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 inside the skull is an uncommon side effect and can cause signs of a stroke, 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 uncontrolled bleeding
• unexpected or prolonged bleeding
• 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 (common)

• Signs of a blood clotting 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), 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. Breathing difficulties related to ticagrelor are generally mild and are characterized by a sudden, unexpected need for air that usually occurs at rest and may disappear in many cases. If you think your breathing difficulties have worsened or last a long time, inform your doctor. They will decide if you need treatment or further investigation.

Other possible side effects

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

• High levels of uric acid 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 sick (nausea)
• Constipation
• Rash
• Itching
• Severe pain and inflammation in the joints - these are signs of gout
• Feeling dizzy or lightheaded, 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 (ulcers)
• 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 bleeding in the eye
• Heavier or more prolonged vaginal bleeding than your usual menstrual period
• Bleeding into the joints and muscles that causes painful inflammation
• Blood in the ear
• Internal bleeding, which can cause dizziness or lightheadedness

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 Medication Surveillance System for Human Use: 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 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 any unused medication in the SIGRE collection point at the pharmacy. If you have doubts, ask your pharmacist how to dispose of the packaging and medication 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 coated tablet contains 90 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), yellow iron oxide (E172).

Appearance of the Product and Container Content

Ticagrelor Intas 90 mg are film-coated tablets of light yellow color, round (9 mm in diameter), biconvex, with the inscription «KJ2» on one side.

Ticagrelor Intas 90 mg is available 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/.