Ecugra

Package leaflet: Information for the patient

Ecugra, 60 mg, film-coated tablets
Ticagrelor
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Ecugra is and what it is used for
2. What you need to know 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 Ecugra is and what it is used for

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

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

• a heart attack more than one year ago.

The medicine reduces the likelihood of having another heart attack or stroke, or of dying due to heart or blood vessel disease.

How Ecugra works
Ecugra affects blood cells called platelets (also known as thrombocytes). Platelets are very small blood cells that help stop bleeding by clumping together and sealing small openings at the site of a cut or blood vessel injury.

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

• a clot may completely block blood flow – this can cause a heart attack (myocardial infarction) or stroke, or
• a clot may partially block blood vessels leading to the heart – reducing blood flow to the heart and causing chest pain that varies in intensity (called unstable angina).

Ecugra helps prevent platelets from clumping together, thereby reducing the risk of clot formation that could reduce blood flow.

2. Important information before using Ecugra

When not to use Ecugra

• if the patient is allergic to ticagrelor or any of the other ingredients of Ecugra (listed in section 6);
• if the patient is currently experiencing bleeding;
• if the patient has had a stroke caused by bleeding into the brain;
• if the patient has severe liver disease;
• if the patient is 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 infections).
  Ecugra must not be used if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions
Before using Ecugra, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• a recent serious injury;
• recent surgical procedures (including dental procedures – advice from a dentist should be sought in this case);
• a condition affecting blood clotting;
• recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedure (including dental procedures) during treatment with Ecugra. This is due to an increased risk of bleeding. The doctor may advise stopping the treatment 5 days before the planned procedure;
• if the patient has a slow heart rate (usually less than 60 beats per minute) and does not have a cardiac pacemaker implanted;
• if the patient has asthma or other lung diseases or breathing difficulties;
• if the patient develops breathing disorders such as rapid breathing, slow breathing, or apnoea. The doctor will decide whether further evaluation is necessary;
• if the patient has any liver disorders or has previously had a condition that may have damaged the liver;
• if blood tests have shown elevated levels of uric acid.

Talk to a doctor or pharmacist before using this medicine if any of the above situations apply (or if in doubt).
If the patient is taking both Ecugra and heparin:

• the doctor may take a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform the doctor about taking both Ecugra and heparin, as Ecugra may affect the diagnostic test result.

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

Other medicines and Ecugra
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use. This is necessary because Ecugra may affect the action of other medicines, and other medicines may affect Ecugra.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• rosuvastatin (used to reduce cholesterol levels);
• simvastatin or lovastatin at doses exceeding 40 mg daily (used to reduce cholesterol levels);
• rifampicin (an antibiotic);
• phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures);
• digoxin (used to treat heart failure);
• cyclosporine (used to suppress 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, which increase the risk of bleeding:

• oral anticoagulants, often called blood-thinning medicines, including warfarin;
• non-steroidal anti-inflammatory drugs (NSAIDs), commonly 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 infections), cimetidine (used to treat heartburn), 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 fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding
Ecugra is not recommended during pregnancy or if pregnancy is possible. Women should use appropriate contraceptive methods while taking this medicine to avoid becoming pregnant.
Inform your doctor if you are breastfeeding. The doctor will discuss the benefits and risks of using Ecugra during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that Ecugra affects the ability to drive or operate machinery. However, if dizziness or confusion occurs during treatment, caution should be exercised when driving or operating machinery.

Sodium content
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to take Ecugra

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
contact your doctor or pharmacist.

What dose to take

• The usual dose is one 60 mg tablet twice daily. You should continue taking Ecugra for as long as your doctor recommends.
• It is recommended to take the medicine at the same time each 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 an active
substance found in many medicines that prevent blood clotting. Your doctor will tell you what dose to
take (usually between 75 and 150 mg daily).

How to take Ecugra

• Tablets may be taken with or without food.

What to do if you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, it may be crushed and mixed with water as follows:

• crush the tablet into a fine powder;
• pour the powder into half a glass of water;
• mix and drink immediately;
• to ensure the entire dose is taken, add another half glass of water, swirl and drink. If the patient is being treated in hospital, the tablet, once crushed in water, may be administered through a nasal tube (nasogastric tube).

Taking more Ecugra than prescribed
If you take more Ecugra than prescribed, contact your doctor immediately or go to hospital.
Bring the medicine pack with you. There may be an increased risk of bleeding.

If you forget to take Ecugra

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

Stopping Ecugra treatment
Do not stop taking Ecugra without talking to your doctor. You should take the medicine regularly and
for as long as your doctor recommends. Stopping treatment with Ecugra may increase the risk of
another heart attack or stroke, or death due to heart or blood vessel disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine:
Ecugra affects blood clotting, therefore most adverse reactions are related to bleeding. Bleeding may occur at any site in the body. Some bleedings are common (e.g. bruising and nosebleeds). Severe bleeding is uncommon but may be life-threatening.
Contact a doctor immediately if any of the following symptoms occur – urgent medical assistance may be required:

• Intracranial haemorrhage (bleeding into the brain) is an uncommon adverse reaction and may cause stroke-like symptoms such as:
• sudden numbness or weakness of the arms, legs, or face, especially if affecting only one side of the body;
• sudden confusion, difficulty speaking or understanding others;
• sudden difficulty walking, loss of balance or coordination;
• sudden dizziness or sudden severe headache with no known cause;
• symptoms of bleeding such as:
• heavy bleeding or bleeding that is difficult to stop;
• unexpected bleeding or bleeding that lasts a very long time;
• urine discoloured pink, red or brown;
• vomiting blood or material that looks like coffee grounds;
• stools discoloured red or black (resembling tar);
• coughing or vomiting blood clots;
• fainting
• temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common).
• 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 extreme fatigue or disorientation.

Discuss with a doctor if the patient experiences:

• shortness of breath (dyspnoea) – very common. It may be caused by heart disease or another condition, or may be an adverse reaction to Ecugra. Dyspnoea associated with ticagrelor is usually mild and characterised by sudden, unexpected shortness of breath, usually occurring at rest. It may appear during the first few weeks of treatment and then not occur again for several weeks. If dyspnoea worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or additional tests are necessary.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

• bruising
• headache
• dizziness or vertigo
• diarrhoea or indigestion
• nausea
• constipation
• rash
• itching
• increased joint pain and swelling – symptoms of gout
• dizziness, lightheadedness or blurred vision – symptoms of low blood pressure
• nosebleeds
• bleeding after surgical procedures or from cuts (e.g. during shaving) and wounds, more severe than usual
• bleeding from gastric mucosa (ulcer)
• bleeding gums

Uncommon (may affect up to 1 in 100 people)

• allergic reaction – rash, itching, swelling of face or lips/tongue may be signs of an allergic reaction
• disorientation (confusion)
• visual disturbances caused by presence of blood in the eye
• vaginal bleeding that is heavier or occurs at a different time than regular menstrual bleeding
• bleeding into joints and muscles, causing painful swelling
• blood in the ear
• internal bleeding, which may cause dizziness or lightheadedness.

Frequency unknown (frequency cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Ecugra

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton
following the abbreviation EXP. The expiry date refers to the last day of the stated month.
PVC/PVDC/Aluminium blisters: Do not store above 30°C.
Keep in the original packaging to protect from light.
PVC/PE/PVDC/Aluminium blisters: No special storage temperature requirements.
Keep in the original packaging 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 in use. 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.
• Other components are: Tablet core: hypromellose (E464), mannitol (E421), microcrystalline cellulose (E460), sodium carboxymethyl starch, magnesium stearate (E470b). Tablet coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), iron oxide red (E172).

What Ecugra looks like and contents of the pack
Pink, round, biconvex coated tablets with a diameter of 8 mm, marked with "60" on one side and smooth on the other side.
Ecugra 60 mg, coated tablets are available in blister packs contained in a cardboard box, with packs containing 56 or 60 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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