CROALCRIL 60 mg Film-Coated Tablets

Contents of the leaflet

1. Introduction
2. Package Leaflet: Information for the User
3. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
4. Contents of the pack and other information
5. What is Croalcril and what is it used for
6. What is Croalcril
7. What Croalcril is used for
8. How Croalcril works
9. What you need to know before you take Croalcril
10. Do not take Croalcril if:
11. Warnings and precautions
12. Children and adolescents
13. Other medicines and Croalcril
14. Pregnancy, breast-feeding, and fertility
15. Driving and using machines
16. Sodium content
17. How to take Croalcril
18. How much to take
19. Taking Croalcril with other medicines for blood clotting
20. How to take Croalcril
21. If you have difficulty swallowing the tablet
22. If you take more Croalcril than you should
23. If you forget to take Croalcril
24. If you stop taking Croalcril
25. Possible side effects
26. Tell your doctor immediately if you notice any of the following - you may need urgent medical treatment:
27. Tell your doctor if you notice any of the following:
28. Other possible side effects
29. Common (may affect up to 1 in 10 people)
30. Uncommon (may affect up to 1 in 100 people)
31. Frequency not known (cannot be estimated from the available data)
32. Reporting of side effects
33. Storage of Croalcril
34. Contents of the pack and further information
35. Composition of Croalcril
36. Appearance of the Product and Packaging Contents
37. Date of Last Revision of this Leaflet: March 2024

Introduction

Package Leaflet: Information for the User

Croalcril60 mg film-coated tablets EFG

Ticagrelor

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 is Croalcril and what is it used for
2. What you need to know before you take Croalcril
3. How to take Croalcril
4. Possible side effects

5 Storage of Croalcril

1. Contents of the pack and further information

1. What is Croalcril and what is it used for

What is Croalcril

Croalcril contains the active substance ticagrelor. It belongs to a group of medicines called antiplatelet agents.

What Croalcril is used for

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

• a heart attack, more than a year ago.

This medicine reduces the risk of you having another heart attack, a stroke, or of dying from a heart or blood vessel-related disease.

How Croalcril works

Croalcril works on cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to block tiny 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 the blood flow; this can cause a heart attack (myocardial infarction) or a stroke, or
• the clot can partially block the blood vessels going to the heart; this reduces blood flow to the heart and can cause intermittent chest pain (called ‘unstable angina’).

Croalcril helps prevent platelets from clumping together. This reduces the chance of a blood clot forming that could block blood flow.

2. What you need to know before you take Croalcril

Do not take Croalcril if:

• You are allergic to ticagrelor or any of the other ingredients of this medicine (listed in section 6).
• You have any current bleeding.
• You have had a stroke caused by bleeding in the brain.
• You have severe liver disease.
• You are taking any of the following medicines:
• • 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 this medicine if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine 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 intestine bleeding (such as stomach ulcer or colon polyps)
• You need to have surgery (including dental procedures) at any time while taking ticagrelor. This is because it increases the risk of bleeding. Your doctor may want to stop your treatment with this medicine 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).
• You have asthma or other lung problems or breathing difficulties.
• You develop irregular breathing patterns, such as rapid, slow, or brief pauses in breathing. Your doctor will decide if you need any further evaluation.
• You have had any liver problems or have had a disease that may have affected your liver.
• You have had a blood test showing high levels of uric acid.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

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 important that you inform your doctor that you are taking ticagrelor and heparin, as ticagrelor may affect the diagnostic test.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Croalcril

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is because ticagrelor may affect the way some medicines work and some medicines may affect ticagrelor.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Rosuvastatin (a medicine to treat high cholesterol)
• more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol levels)
• rifampicin (an antibiotic)
• phenytoin, carbamazepine, and phenobarbital (used to control epilepsy seizures)
• digoxin (used to treat heart failure)
• cyclosporin (used to reduce the body's immune response)
• quinidine and diltiazem (used to treat irregular heart rhythms)
• beta-blockers and verapamil (used to treat high blood pressure)
• morphine and other opioids (used to treat acute pain)

In particular, tell your doctor or pharmacist if you are taking any of the following medicines 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 painkillers, such as ibuprofen and naproxen.
• Selective Serotonin Reuptake Inhibitors (SSRIs) taken 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 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 gives you fibrinolytics, often referred to as ‘clot dissolvers’, such as streptokinase or alteplase.

Pregnancy, breast-feeding, and fertility

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.

Ticagrelor should not be used if you are pregnant or may become pregnant. Women should use appropriate contraceptive methods to prevent pregnancy while taking this medicine.

Ask your doctor before taking this medicine if you are breast-feeding. Your doctor will explain the benefits and risks of taking ticagrelor during this period.

Driving and using machines

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

Sodium content

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

3. How to take Croalcril

Always take this medicine exactly as your doctor has told you. If you are unsure, check with your doctor or pharmacist.

How much to take

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

Taking Croalcril with other medicines for blood clotting

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

How to take Croalcril

• You can take this medicine with or without food.

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 make sure you get all the medicine, rinse the empty glass with another half glass of water and drink it.

If you are in the hospital, this tablet may be given to you mixed with a little water through a tube in your nose (nasogastric tube).

If you take more Croalcril than you should

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

If you forget to take Croalcril

• 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 forgotten doses.

If you stop taking Croalcril

Do not stop taking this medicine without talking to your doctor. Take this medicine regularly and for as long as your doctor recommends. If you stop taking this medicine, you may increase the risk of having another heart attack or stroke, or of dying from a heart or blood vessel-related disease.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

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). Serious bleeding is rare but can be life-threatening.

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

• A bleed 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 (called purpura) on the skin and in the mouth, with or without yellowing of the skin or eyes (jaundice), extreme unexplained tiredness, or confusion.

Tell 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 usually 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, tell your doctor. They will decide if you need treatment or further investigations.

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 swelling 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 injuries
• Bleeding from the stomach lining (stomach 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 bleeding in the eye
• Heavier or more prolonged vaginal bleeding, or bleeding at times other than your usual menstrual period
• Bleeding into the joints and muscles that causes painful swelling
• Bleeding in the ear
• Internal bleeding, which can cause dizziness or fainting

Frequency not known (cannot be estimated from the available data)

• Abnormally slow heart rate (usually below 60 beats per minute)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Croalcril

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 carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Croalcril

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Mannitol, Calcium hydrogen phosphate dihydrate, Sodium carmellose, Hydroxypropylcellulose, Magnesium stearate, Hypromellose, Titanium dioxide (E171), Macrogol 6000, Red iron oxide (E172).

Appearance of the Product and Packaging Contents

Film-coated tablets, red, round, biconvex, smooth on both sides, with a diameter of approximately 8 mm.

PVC/PVdC/Aluminum blisters in boxes of 14, 56, 60, 168 or 180 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Medochemie Ltd,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Manufacturer

Medochemie Ltd,

Factory Az, Agios Athanassios Industrial Area, Michali Irakleous 2,

Agios Athanasios,

4101 Limassol,

Cyprus

This medicinal product is authorized in the EEA Member States under the following names:

Date of Last Revision of this Leaflet: March 2024

Other Sources of Information

Detailed and updated 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/).