Legrex

Package Leaflet: Information for the Patient

Legrex, 90 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. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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, which belongs to a group of antiplatelet medicines.

What is Legrex used for

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

• myocardial infarction or
• unstable angina (angina or chest pain that is not adequately controlled).

The medicine reduces the likelihood of another myocardial infarction, stroke, or death due to cardiovascular disease.

How Legrex works

Legrex 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 in injured blood vessels.

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

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

Legrex helps prevent platelets from clumping together, reducing the likelihood of a clot forming that could 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 in the brain;
• if the patient has severe liver disease;
• if the patient is 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 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 undergo surgery (including dental surgery) while taking Legrex. This is due to an increased risk of bleeding. The doctor may recommend stopping the medicine 5 days before the scheduled surgery;
• if the patient has a slow heart rate (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 that could have damaged the liver;
• if the patient's blood test shows high levels of uric acid.

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

If the patient is taking Legrex and heparin:

• the doctor may take a blood sample for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is essential to inform the doctor about taking both Legrex and heparin, as Legrex may affect the test result.

Children and adolescents

Legrex is not recommended for 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.

Inform the doctor or pharmacist about 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).

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;
• 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, 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 associated with taking Legrex during breastfeeding.

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, 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. If dizziness or disorientation occurs while taking the medicine, caution should be exercised when driving or using 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 initial dose is two tablets taken at the same time (a loading dose of 180 mg). This dose is usually given in a hospital.
• After the initial dose, the usual dose is one 90 mg tablet taken twice a day for up to 12 months, unless the doctor recommends 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 Legrex with other anti-clotting medicines

The doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance found in many anti-clotting medicines. 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, 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 ensure that all the medicine is taken, add another half 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 a hospital immediately. Take the medicine pack 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 myocardial infarction, stroke, or death due to cardiovascular disease.

If you have any further questions about taking the medicine, consult a doctor or pharmacist.

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, so most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleeding is common (e.g., bruising and nosebleeds). Severe bleeding is not very common 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 a 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 (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 confusion.

Tell your doctor if you experience:

• shortness of breath (dyspnea) - very common.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 - symptoms of gout
• dizziness or lightheadedness or blurred vision - symptoms of low blood pressure
• nosebleeds
• bleeding after surgery or from cuts and wounds that 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 disorders 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, tell your doctor or pharmacist. 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 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 stated.

No special precautions for storage are necessary.

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 90 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), talc, macrogol 400, yellow iron oxide (E 172)

What Legrex looks like and contents of the pack

Legrex is a yellow, biconvex, round film-coated tablet with a diameter of about 9.1 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: