ECUGRA 90 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ecugra, 90 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 Package 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 anti-clotting 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 (frequency 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 package leaflet:

Package Leaflet: Information for the Patient

Ecugra, 90 mg, Coated Tablets

Ticagrelor

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

• Keep this package 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 Package 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:

• myocardial infarction (heart attack) or
• unstable angina (chest pain or discomfort which is not well controlled).

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

How Ecugra works

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

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

• a clot can completely block the blood flow, leading to a heart attack (myocardial infarction) or stroke, or
• a clot can partially block the blood vessels leading to the heart, reducing blood flow to the heart and causing chest pain (unstable angina).

Ecugra helps prevent platelets from clumping together and forming clots, reducing the risk of a clot blocking the 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 have active 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 apply to you. If you are 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 having surgery (including dental surgery) 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 apply 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, and any you plan to take. This is because Ecugra may affect the way other medicines work, and other medicines may affect Ecugra.
Tell 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 irregular heartbeat);
• beta-blockers and verapamil (used to treat high blood pressure);
• morphine and other opioids (used to treat severe pain).

Especially 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), 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 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 heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also tell your doctor if you are taking Ecugra and have an increased risk of bleeding if your doctor prescribes you fibrinolytic medicines, often referred to as clot-busting medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Ecugra should not be used during pregnancy or if you are planning to become pregnant.
While taking the medicine, women should use effective contraceptive methods to prevent pregnancy.
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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, which 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 starting dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually given in a hospital.
• After the starting dose, the usual dose is one 90 mg tablet twice a day for up to 12 months, unless your doctor tells you otherwise.
• 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 anti-clotting medicines

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

How to take Ecugra

• The 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, it can be crushed and mixed 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 make sure you take all the medicine, add another half glass of water, rinse and drink. If you are in 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 pack with you. You may be at risk of bleeding.

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 a forgotten dose.

What to do if you stop taking Ecugra

Do not stop taking Ecugra without talking to your doctor. You should take the medicine regularly and for as long as your doctor tells you. Stopping Ecugra may increase the risk of having another heart attack or stroke, or dying from a heart or blood vessel-related problem.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ecugra can cause side effects, although not everybody gets them.
The following side effects may occur while taking this medicine:
Ecugra affects blood clotting, and 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 occurs on 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 with no known cause;
• symptoms of bleeding, 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 tiredness or confusion.

Tell your doctor if you experience:

• shortness of breath (dyspnea) - occurs very commonly.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 tests are needed.

Other possible side effects

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

• increased uric acid levels in the blood (found in laboratory tests)
• bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or lightheadedness
• diarrhea or nausea
• nausea (nausea)
• constipation
• rash
• itching
• increased pain and swelling of the joints - symptoms of gout
• dizziness or lightheadedness or blurred vision - symptoms of low blood pressure

low blood pressure

• nosebleeds
• bleeding after surgery or from cuts and wounds (e.g., while shaving) that is more than usual
• stomach bleeding (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 problems 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 (frequency 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 Drug Safety Monitoring of the 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 that month.
PVC/PVDC/Aluminium blisters:Do not store above 30°C.
Store in the original package to protect from light.
PVC/PE/PVDC/Aluminium blisters:No special storage precautions are required. 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 90 mg of ticagrelor.
• The other ingredients are: tablet core: hypromellose (E464), mannitol (E421), microcrystalline cellulose (E460), sodium carboxymethyl cellulose, magnesium stearate (E470b). tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172).

What Ecugra looks like and contents of the pack

Yellow, round, biconvex coated tablets, 9 mm in diameter, with the marking "90" on one side and a smooth surface on the other.
Ecugra 90 mg coated tablets are available in blisters in a carton, containing 56 tablets.

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 package leaflet: