Legrex

Package leaflet: Information for the patient

Legrex, 90 mg, coated tablets
Ticagrelor
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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 only. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet

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

What Legrex is
Legrex contains the active substance called ticagrelor. It belongs to a group of medicines known as antiplatelet agents.
Why Legrex is used
Legrex, 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 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 at the site of a cut or damaged blood vessel.
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 – which can lead to 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).

Legrex helps prevent platelets from sticking together, thereby reducing the risk of clot formation that could impair blood flow.

2. Important information before using Legrex

When not to use 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 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).

Legrex 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 taking Legrex, 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 regarding this);
  • a disease 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 Legrex. This is due to an increased risk of bleeding. The doctor may recommend 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, slow breathing, or apnea. The doctor will decide whether further evaluation is needed;
• if the patient has any liver disorders or has previously had a disease that may have damaged the liver;
• if blood tests have shown elevated levels of uric acid above normal.

Talk to a doctor or pharmacist before taking Legrex if any of the above situations apply (or if you have any doubts).

If the patient is taking both Legrex 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 Legrex and heparin, as Legrex may affect the diagnostic test result.

Children and adolescents

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

Legrex with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because Legrex may affect the action of other medicines, and other medicines may affect Legrex. Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• rosuvastatin (a medicine used to lower cholesterol levels);
• simvastatin or lovastatin in doses exceeding 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 the doctor or pharmacist if the patient is 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 the doctor about taking Legrex and the increased risk of bleeding if the doctor prescribes fibrinolytic medicines, often called clot-dissolving medicines, such as streptokinase or alteplase.

Pregnancy and breastfeeding

Legrex 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 the doctor before using this medicine if you are breastfeeding. The doctor will discuss the benefits and risks of using Legrex 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 Legrex will impair the ability to drive or operate machinery. However, if dizziness or confusion occurs during treatment, caution should be exercised when driving or operating machinery.

3. How to take Legrex

This medicine should always be taken as directed by the doctor. If in doubt, contact the doctor or pharmacist.

How much medicine to take

• The initial dose is two tablets taken at the same time (loading dose 180 mg). This dose is usually administered in hospital.
• After the initial dose, the usual maintenance dose is one 90 mg tablet taken twice daily for up to 12 months, unless the 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 Legrex with other blood-thinning medicines
The doctor will usually recommend taking acetylsalicylic acid at the same time. This is a substance present in many medicines that prevent blood clotting. The doctor will advise on the dose to be taken (usually between 75 and 150 mg daily).

How to take Legrex
The 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;
• Stir 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 may be administered via a nasogastric tube after dissolving in water.

Taking more Legrex than recommended
If more Legrex has been taken than recommended, contact a doctor or go to hospital immediately. Take the medicine packaging with you. There may be an increased risk of bleeding.

If you miss a dose of Legrex

• If a dose is missed, 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 Legrex treatment
Do not stop taking Legrex without consulting your doctor. The medicine should be taken regularly and for as long as prescribed by the doctor. Stopping Legrex treatment may increase the risk of recurrent 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine.
Legrex affects blood clotting, therefore most adverse effects are related to bleeding. Bleeding may occur anywhere in the body. Some bleeding events 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 care may be required:

• Bleeding into the brain or intracranial haemorrhage is an uncommon adverse effect and may cause stroke-like symptoms such as:
  • sudden numbness or weakness in the arms, legs or face, especially on one side of the body;
  • sudden confusion, difficulty speaking or understanding speech;
  • sudden difficulty walking, loss of balance or coordination;
  • sudden dizziness or sudden severe headache with no known cause;
• Signs of bleeding such as:
  • heavy bleeding or bleeding that is difficult to stop;
  • unexpected bleeding or bleeding that lasts a long time;
  • urine that is pink, red or brown in colour;
  • vomiting blood or material that looks like coffee grounds;
  • stools that are red or black in colour (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).
• 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 – very common. This may be due to heart disease or another cause, or may be an adverse effect of Legrex. Shortness of breath associated with Legrex is usually mild and characterised by sudden, unexpected breathlessness, usually at rest, which may occur during the first few weeks of treatment and then may not recur for many weeks. If shortness of breath worsens or persists for a long time, contact a doctor. The doctor will decide whether treatment or further investigations are necessary.

Other possible adverse effects
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) that is heavier 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)
• visual disturbances caused by blood in the eye
• vaginal bleeding that is heavier than normal 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 effects
If any adverse effects occur, including any not listed in this leaflet, tell a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store the medicine 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 stated month.
No special storage conditions are required.
Medicines must 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 coated tablet contains 90 mg of ticagrelor.
• Other ingredients are:
  Tablet core: mannitol, calcium hydrogen phosphate dihydrate, crospovidone (type A), hypromellose (type 2910), magnesium stearate
  Tablet coating: hypromellose (type 2910), titanium dioxide (E 171), talc, polyethylene glycol 400, iron oxide yellow (E 172)

What Legrex looks like and contents of the pack
Legrex is yellow, biconvex, round, coated tablets with a diameter of approximately 9.1 mm.
Each pack contains 56 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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