ECUGRA 60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ecugra, 60 mg, Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Ecugra and what is it used for
   1. What is Ecugra
   2. What is Ecugra used for
   3. How Ecugra works
4. Important information before taking Ecugra
   1. When not to take Ecugra
   2. Warnings and precautions
   3. Children and adolescents
   4. Other medicines and Ecugra
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Sodium content
5. How to take Ecugra
   1. How much to take
   2. Taking Ecugra with other blood-thinning medicines
   3. How to take Ecugra
   4. What to do if you have difficulty swallowing the tablet
   5. What to do if you take more Ecugra than you should
   6. What to do if you forget to take Ecugra
   7. What to do if you stop taking Ecugra
6. Possible side effects
   1. Seek immediate medical attention if you experience any of the following symptoms - you may need urgent medical attention:
   2. Tell your doctor if you experience:
   3. Other possible side effects
   4. Very common (may affect more than 1 in 10 people)
   5. Common (may affect up to 1 in 10 people)
   6. Uncommon (may affect up to 1 in 100 people)
   7. Frequency not known (cannot be estimated from the available data)
   8. Reporting side effects
7. How to store Ecugra
8. Contents of the pack and other information
   1. What Ecugra contains
   2. What Ecugra looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Ecugra, 60 mg, Coated Tablets

Ticagrelor

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ecugra and what is it used for
• 2. Important information before taking Ecugra
• 3. How to take Ecugra
• 4. Possible side effects
• 5. How to store Ecugra
• 6. Contents of the pack and other information

1. What is Ecugra and what is it used for

What is Ecugra

Ecugra contains the active substance ticagrelor, which belongs to a group of medicines called antiplatelet medicines.

What is Ecugra used for

Ecugra is used in combination with acetylsalicylic acid (another antiplatelet medicine) only in adults who have had:

• a heart attack, more than a year ago.

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

How Ecugra works

Ecugra works by affecting cells called platelets in the blood (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and blocking small openings in damaged blood vessels.

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

• a clot can completely block the flow of blood, which can cause a heart attack (myocardial infarction) or stroke, or
• a clot can cause partial blockage of the blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain that changes in severity (known as unstable angina).

Ecugra helps prevent platelets from clumping together, reducing the likelihood of a clot forming that could reduce blood flow.

2. Important information before taking Ecugra

When not to take Ecugra

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

Warnings and precautions

Before taking Ecugra, consult your doctor or pharmacist:

• if you have an increased risk of bleeding due to:
• a recent serious injury;
• recent surgery (including dental surgery - consult your dentist);
• a condition that affects blood clotting;
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps);
• if you will be undergoing surgery (including dental surgery) at any time while taking Ecugra. This is because of the increased risk of bleeding. Your doctor may advise you to stop taking the medicine 5 days before the planned surgery;
• if you have a slow heart rate (usually less than 60 beats per minute) and do not have a pacemaker;
• if you have asthma or other lung diseases or breathing difficulties;
• if you develop breathing difficulties such as rapid breathing, slow breathing, or shortness of breath. Your doctor will decide if further evaluation is needed;
• if you have any liver problems or have had a disease that may have damaged your liver;
• if your blood test shows high levels of uric acid.

Tell your doctor or pharmacist if any of the above applies to you (or if you are unsure). If you are taking Ecugra and heparin:

• your doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking both Ecugra and heparin, as Ecugra may affect the test result.

Children and adolescents

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

Other medicines and Ecugra

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. This is necessary because Ecugra may affect the way other medicines work, and other medicines may affect Ecugra. Inform your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin in doses greater than 40 mg per day (medicines used to lower cholesterol levels);
• 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).

Especially inform 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), often used as painkillers, such as ibuprofen and naproxen;
• selective serotonin reuptake inhibitors (SSRIs), used as antidepressants, such as paroxetine, sertraline, and citalopram;
• other medicines, such as ketokonazole (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 heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also, inform your doctor about taking Ecugra and the increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, also known as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ecugra should not be taken during pregnancy or if you are planning to become pregnant. While taking the medicine, women should use appropriate contraceptive methods to avoid becoming pregnant. Before taking this medicine, inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of taking Ecugra while breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

It is unlikely that Ecugra will affect your ability to drive or use machines. If you experience dizziness or disorientation while taking the medicine, be cautious when driving or using machines.

Sodium content

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

3. How to take Ecugra

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

How much to take

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

Taking Ecugra with other blood-thinning medicines

Your doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many blood-thinning medicines. Your doctor will inform you about the dose to take (usually between 75 and 150 mg per day).

How to take Ecugra

• Tablets can be taken with or without food.

What to do 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;
• add the powder to half a glass of water;
• mix and drink immediately;
• to ensure that all the medicine is taken, refill the glass with half a glass of water, rinse, and drink. If you are being treated in a hospital, the crushed tablet can be given through a nasogastric tube.

What to do if you take more Ecugra than you should

If you take more Ecugra than you should, contact your doctor or go to the hospital immediately. Take the medicine package with you. You may experience increased bleeding risk.

What to do if you forget to take Ecugra

• If you forget to take a dose, take the next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

What to do if you stop taking Ecugra

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

4. Possible side effects

Like all medicines, Ecugra can cause side effects, although not everybody gets them. While taking this medicine, the following side effects may occur:

Ecugra affects blood clotting, so most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding occurs frequently (e.g., bruising and nosebleeds). Severe bleeding occurs less frequently but can be life-threatening.

Seek immediate medical attention if you experience any of the following symptoms - you may need urgent medical attention:

• Bleeding into the brain or within 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;
• Bleeding symptoms, such as:
• heavy or prolonged bleeding;
• unexpected or prolonged bleeding;
• urine that is pink, red, or brown;
• vomiting blood or coffee ground-like material;
• stool that is red or black (like tar);
• coughing or vomiting blood clots;
• Fainting
• temporary loss of consciousness due to a sudden decrease in blood flow to the brain (occurs frequently).
• Symptoms related to 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 severe fatigue or disorientation.

Tell your doctor if you experience:

• Shortness of breath (dyspnea) - occurs very frequently.It may be caused by heart disease or another cause, or it may be a side effect of Ecugra. Dyspnea associated with ticagrelor is usually mild and characterized by sudden, unexpected shortness of breath, often at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If shortness of breath worsens or persists, contact your doctor. Your doctor will decide if treatment or further testing is needed.

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
• headache
• dizziness or lightheadedness
• diarrhea or indigestion
• nausea (feeling sick)
• constipation
• rash
• itching
• increased pain and swelling of the joints - symptoms of gout
• dizziness or lightheadedness or blurred vision - symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts and wounds, which is more than usual
• bleeding from the stomach lining (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 (confusion)
• vision disturbances caused by blood in the eye
• vaginal bleeding that is heavier 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.

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

• abnormally low heart rate (usually less than 60 beats per minute)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 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, you can help provide more information on the safety of this medicine.

5. How to store Ecugra

Keep out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. PVC/PVDC/Aluminum blisters:Do not store above 30°C. Store in the original package to protect from light. PVC/PE/PVDC/Aluminum blisters:No special storage precautions. Store in the original package to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ecugra contains

• The active substance is ticagrelor. Each coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Tablet core: hypromellose (E464), mannitol (E421), microcrystalline cellulose (E460), sodium carboxymethylcellulose, magnesium stearate (E470b). Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide red (E172).

What Ecugra looks like and contents of the pack

Pink, round, biconvex coated tablets, 8 mm in diameter, with "60" marked on one side and smooth on the other. Ecugra 60 mg coated tablets are available in blisters in a carton, containing 56 or 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland, tel.: +48 17 865 51 00

Manufacturer

Genepharm S.A, 18th km Marathonos Avenue, 153 51 Pallini Attiki, Greece

Date of last revision of the leaflet: