LEGREX 60 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Legrex, 60 mg, Film-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 Legrex and what is it used for
   1. What is Legrex
   2. What is Legrex used for
   3. How Legrex works
4. Important information before taking Legrex
   1. When not to take Legrex
   2. Warnings and precautions
   3. Children and adolescents
   4. Legrex and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to take Legrex
   1. What dose to take
   2. Taking Legrex with other blood-thinning medicines
   3. How to take Legrex
   4. What to do if you have difficulty swallowing the tablet
   5. What to do if you take more Legrex than you should
   6. What to do if you forget to take Legrex
   7. What to do if you stop taking Legrex
6. Possible side effects
   1. Seek medical help immediately 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 Legrex
8. Contents of the pack and other information
   1. What Legrex contains
   2. What Legrex 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

Legrex, 60 mg, Film-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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Legrex and what is it used for

What is Legrex

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

What is Legrex used for

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

• a heart attack, more than a year ago. The medicine reduces the likelihood of another heart attack or stroke, or death due to heart or blood vessel disease.

How Legrex works

Legrex 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 injured blood vessels.

• a blood clot can completely block the blood flow - this can cause a heart attack (myocardial infarction) or stroke, or
• a blood clot can cause partial blockage of the blood vessels leading to the heart - which reduces blood flow to the heart and can cause chest pain of varying intensity (known as unstable angina).

Legrex helps prevent platelets from clumping together, reducing the likelihood of a blood clot forming, which can reduce blood flow.

2. Important information before taking Legrex

When not to take Legrex

• if the patient is allergic to ticagrelor or any of the other ingredients of Legrex (listed in section 6);
• if the patient is currently 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:
• ketokonazol (used to treat fungal infections);
• klarytromycyna (used to treat bacterial infections);
• nefazodon (an antidepressant);
• rytonawir and atazanawir (used to treat HIV and AIDS infections).

Do not take Legrex if any of the above situations apply to the patient. In case of doubt, consult a doctor or pharmacist before starting treatment with this medicine.

Warnings and precautions

Before taking Legrex, consult a doctor or pharmacist:

• if the patient has an increased risk of bleeding due to:
• a recent serious injury;
• recent surgery (including dental surgery - consult a dentist);
• a disease that affects blood clotting;
• recent bleeding from the stomach or intestines (such as stomach ulcers or intestinal polyps);
• if the patient will be undergoing surgery (including dental surgery) at any time while taking Legrex. This is because of the increased risk of bleeding. The doctor may advise stopping the medicine 5 days before the planned surgery;
• if the patient has a heart rate that is too slow (usually less than 60 beats per minute) and does not have a pacemaker;
• 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 apnea. The doctor will decide on the need for further evaluation;
• if the patient has any liver disorders or has had a disease in the past that could have damaged the liver;
• if the patient's blood test shows elevated uric acid levels.

Consult a doctor or pharmacist before taking the medicine if any of the above situations apply to the patient (or in case of doubt).

Children and adolescents

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

Legrex and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take. This is necessary because Legrex may affect the action of other medicines, and other medicines may affect Legrex.

• rosuwastatyna (a medicine used to lower cholesterol levels);
• simvastatyna or lowastatyna in doses greater than 40 mg per day (medicines used to lower cholesterol levels);
• ryfampicyna (an antibiotic);
• fenytoina, karbamazepina, and fenobarbital (used to control seizures);
• digoksyna (used to treat heart failure);
• cyklosporyna (used to weaken the immune system);
• chinidyna and diltiazem (used to treat heart rhythm disorders);
• beta-adrenolityki and werapamil (used to treat high blood pressure);
• morfina and other opioids (used to treat severe pain).

Particularly, inform the doctor or pharmacist about taking any of the following medicines that increase the risk of bleeding:

• oral anticoagulants, often referred to as blood thinners, including warfarin;
• nonsteroidal 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 ketokonazol (used to treat fungal infections), klarytromycyna (used to treat bacterial infections), nefazodon (an antidepressant), rytonawir and atazanawir (used to treat HIV and AIDS infections), cyzapryd (used to treat heartburn), and ergot alkaloids (used to treat migraines and headaches).

Also, inform the doctor about taking Legrex and the increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often referred to as clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Legrex is not recommended during pregnancy or if there is a possibility of becoming pregnant. Women should use appropriate contraceptive methods to avoid becoming pregnant while taking the medicine.

Before taking this medicine, inform the doctor about breastfeeding. The doctor will discuss the benefits and risks of taking Legrex during breastfeeding.

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

It is unlikely that Legrex will affect the ability to drive or use machines. However, if dizziness or disorientation occurs while taking the medicine, be cautious when driving or operating machines.

3. How to take Legrex

Always take this medicine exactly as the doctor has told you. If you are not sure, consult a doctor or pharmacist.

What dose to take

• The usual dose is one 60 mg tablet twice a day. Continue taking Legrex for as long as the 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 Legrex with other blood-thinning medicines

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

How to take Legrex

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, 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;
• 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 the patient is being treated in a hospital, the crushed tablet can be given through a nasogastric tube.

What to do if you take more Legrex than you should

If you take more Legrex than you should, contact a doctor or go to the hospital immediately. Take the medicine package with you. There may be an increased risk of bleeding.

What to do if you forget to take Legrex

• 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 Legrex

Do not stop taking Legrex without consulting a doctor. The medicine should be taken regularly and for as long as the doctor recommends. Stopping Legrex may increase the risk of another heart attack or stroke, or death due to heart or blood vessel disease.

4. Possible side effects

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

Legrex 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 medical help immediately 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 without a 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 coal 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 extreme fatigue or confusion.

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 Legrex. Dyspnea associated with Legrex is usually mild and characterized by sudden, unexpected shortness of breath, usually at rest, which may occur during the first few weeks of treatment and then not occur for many weeks. If dyspnea worsens or persists, consult a doctor. The 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 indigestion
• nausea (vomiting)
• constipation
• rash
• itching
• increased pain and swelling of the joints - these are symptoms of gout
• dizziness or lightheadedness or blurred vision - these are symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts (e.g., while shaving) and wounds that is more abundant 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 disorders caused by blood in the eye
• vaginal bleeding that is more abundant 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 can 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 any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Legrex

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP.

The expiry date refers to the last day of the month.

There are no special storage precautions.

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 Legrex contains

• The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
• The other ingredients are: Core:mannitol, calcium hydrogen phosphate dihydrate, crospovidone (type A), hypromellose (type 2910), magnesium stearate Coating:hypromellose (type 2910), titanium dioxide (E 171), macrogol 400, iron oxide red (E 172)

What Legrex looks like and contents of the pack

Legrex is pink, biconvex, round film-coated tablets with the inscription "EL1" on one side and a diameter of about 8.1 mm.

Each pack contains 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, ELPEN Pharmaceutical Co., Inc, Marathonos Ave. 95, Pikermi Attiki, 19009, Greece

Date of last revision of the leaflet