Ecugra

Package leaflet: Information for the patient

Ecugra, 90 mg, 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, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, 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. 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 Ecugra is and what it is used for

What Ecugra is
Ecugra contains an active substance called ticagrelor. It belongs to a group of medicines known as 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 or
• unstable angina (chest pain or discomfort that is not adequately controlled).

The medicine reduces the likelihood of another heart attack or stroke, or death 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 when a blood vessel is cut or damaged.

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 may 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 of varying 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).
  Do not use Ecugra 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:
• recent serious injury;
• recent surgical procedures (including dental procedures – consult a dentist in this matter);
• a medical condition affecting blood clotting;
• recent gastrointestinal bleeding (such as stomach ulcer or intestinal polyps);
• if the patient will undergo any surgical procedure (including dental) during treatment with Ecugra. This is due to an increased risk of bleeding. The doctor may advise stopping the medicine 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 pacemaker implanted;
• if the patient has asthma or other lung diseases or breathing difficulties;
• if the patient develops breathing problems such as rapid breathing, slowed breathing, or apnea. The doctor will decide whether further evaluation is needed;
• 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 uric acid levels in the patient.

Talk to a doctor or pharmacist before using Ecugra if any of the above situations apply (or if you have any doubts).
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 you are currently taking or have recently taken, as well as any medicines you plan to take. 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 (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin at doses greater than 40 mg per day (medicines used to lower 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).

You should 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 there is a possibility of becoming pregnant.
Women should use appropriate contraceptive methods while taking this medicine to avoid pregnancy.
Inform your doctor if you are breastfeeding. Your doctor will discuss the benefits and risks of using Ecugra during breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that Ecugra will impair the ability to drive or operate machinery. However, if dizziness or disorientation 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 use Ecugra

This medicine should always be used exactly as prescribed by your doctor. If in doubt, contact your doctor or pharmacist.

What dose to use

• The initial dose is two tablets taken at the same time (loading dose of 180 mg). This dose is usually administered in a hospital.
• After the initial dose, the usual maintenance dose is one 90 mg tablet taken twice daily for up to 12 months, unless your doctor advises otherwise.
• 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 concomitantly. This is a substance present in many medicines that prevent blood clotting. Your doctor will advise you on the 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 has been taken, add another half glass of water, swirl and drink.
  If the patient is being treated in hospital, the tablet may be administered through a nasogastric tube after dissolving in water.

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

If you miss a dose of Ecugra

• If you miss 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 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 advises. 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 will experience 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 anywhere in the body. Some bleeding events are common (e.g. bruising and nosebleeds). Severe bleeding occurs less frequently but may be life-threatening.
You should contact your doctor immediately if any of the following symptoms occur – urgent medical attention may be required:

• Intracranial or cerebral haemorrhage is an uncommon adverse reaction and may cause stroke-like symptoms such as:
• sudden numbness or weakness in 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 without known cause;
• signs of bleeding such as:
• heavy bleeding or bleeding difficult to stop;
• unexpected bleeding or bleeding lasting a long time;
• urine discoloured pink, red, or brown;
• vomiting blood or material that looks like coffee grounds;
• stool discoloured red or black (resembling tar);
• coughing up or vomiting blood clots;
• fainting
• temporary loss of consciousness caused by a sudden reduction in blood flow to the brain (common occurrence).
• 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.

You should discuss with your 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 characterized by sudden, unexpected shortness of breath, usually occurring at rest, which may appear during the first few weeks of treatment and then may not occur for many weeks. If shortness of breath worsens or persists for a long time, contact your doctor. Your doctor will decide whether treatment or additional tests are needed.

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

• increased blood uric acid levels (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 surgery 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 the 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 not known (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, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this 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 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.
Store in the original packaging to protect from light.
PVC/PE/PVDC/Aluminium blisters: No special storage temperature requirements.
Store in the original packaging to protect from light.
Medicines must not be disposed of via the sewage system 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 starch, magnesium stearate (E470b). Tablet coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), yellow iron oxide (E172).

What Ecugra looks like and contents of the pack
Yellow, round, biconvex coated tablets with a diameter of 9 mm, marked with "90" on one side and smooth on the other side.
Ecugra 90 mg, coated tablets are available in blisters packed in a cardboard box containing 56 tablets.
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