Ugramel

Leaflet attached to the packaging: patient information

Ugramel, 5 mg, film-coated tablets

Ugramel, 10 mg, film-coated tablets

Prasugrel

Read the 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ugramel and what is it used for

Ugramel, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet medicines. Platelets are very small cells that circulate in the blood. When a blood vessel is damaged, for example, cut, platelets clump together to help form a blood clot. Platelets play a crucial role in stopping bleeding. The formation of a blood clot in a hardened, atherosclerotic blood vessel, such as an artery, is very dangerous, as it can lead to a heart attack (myocardial infarction), stroke, or death. The presence of a blood clot in the arteries that supply blood to the heart can limit blood flow and cause unstable angina (severe chest pain). Ugramel prevents platelets from clumping together, reducing the risk of blood clots. Ugramel has been prescribed by your doctor because you have had a heart attack or unstable angina, and you have previously undergone a procedure to unblock clogged arteries in your heart. You may have had a procedure where one or more stents were placed to keep a blocked or narrowed artery that supplies blood to your heart open. Ugramel reduces the risk of another heart attack, stroke, or death due to one of these events. Your doctor will also recommend taking acetylsalicylic acid (e.g., aspirin), which is also an antiplatelet medicine.

2. Important information before taking Ugramel

When not to take Ugramel

• If the patient is allergic (hypersensitive) to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, swelling of the lips or shortness of breath. If such symptoms occur, the patient should immediatelyinform their doctor.
• If the patient has a medical condition that is currently causing bleeding, such as bleeding from the stomach or intestines.
• If the patient has had a stroke or transient ischemic attack (TIA) in the past.
• If the patient has severe liver disease.

Warnings and precautions

If any of the following situations apply to the patient, they should inform their doctor before taking Ugramel:

• If there is an increased risk of bleeding, such as:
• age 75 or older. The doctor will recommend a daily dose of 5 mg, as the risk of bleeding is higher in patients over 75 years old.
• recent severe injury
• recent surgery (including dental surgery)
• recent or recurrent bleeding from the stomach or intestines (e.g., stomach ulcer or colon polyps)
• body weight less than 60 kg. If the patient weighs less than 60 kg, the doctor will recommend a daily dose of Ugramel of 5 mg
• moderate kidney or liver disease
• taking certain medicines (see below "Ugramel and other medicines")
• planned surgery within the next seven days (including dental surgery). Due to the increased risk of bleeding, the doctor may recommend temporarily stopping Ugramel.
• If the patient has had allergic reactions (hypersensitivity) to clopidogrel or other antiplatelet medicines, they should inform their doctor before starting Ugramel. If allergic reactions occur after taking Ugramel, such as rash, itching, swelling of the face, swelling of the lips or shortness of breath, the patient should immediatelyinform their doctor.

During treatment with Ugramel

The patient should immediatelyinform their doctor if they experience a condition called thrombotic thrombocytopenic purpura (or TTP), characterized by: fever and bruising under the skin, which may look like red pinpoint spots, with or without symptoms of extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

Children and adolescents

Ugramel should not be used in children and adolescents under 18 years of age.

Ugramel and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, they should inform their doctor if they are taking clopidogrel (an antiplatelet medicine), warfarin (an anticoagulant), or "non-steroidal anti-inflammatory drugs" used to treat pain and fever (such as ibuprofen, naproxen, etoricoxib). Taking these medicines with Ugramel may increase the risk of bleeding. The patient should inform their doctor if they are taking morphine or other opioids (used to treat severe pain). During treatment with Ugramel, the patient can only take medicines that their doctor has approved.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Ugramel can only be used after discussing the potential benefits and risks with the doctor.

Driving and using machines

It is unlikely that Ugramel will affect the patient's ability to drive or operate machinery.

Ugramel contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Ugramel.

3. How to take Ugramel

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The usual dose of Ugramel is 10 mg once daily. Treatment should be started with a single dose of 60 mg. If the patient weighs less than 60 kg or is over 75 years old, the daily dose of Ugramel is 5 mg. The doctor will recommend the appropriate dose of acetylsalicylic acid (usually between 75 mg and 325 mg once daily). Ugramel can be taken with or without food. The dose should be taken at the same time every day. The tablets should not be broken or crushed. It is very important to inform the doctor, dentist, and pharmacist about taking Ugramel.

Taking a higher dose of Ugramel than recommended

The patient should immediatelycontact their doctor or hospital due to the increased risk of bleeding. The patient should show their doctor the packaging of Ugramel.

Missing a dose of Ugramel

If a dose is missed, the patient should take it as soon as possible. If the patient forgets to take a dose for the entire day, they should take the next dose of Ugramel at the usual time the next day. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Ugramel

The patient should not stop taking Ugramel without consulting their doctor. Stopping Ugramel too quickly may increase the risk of a heart attack. If the patient has any doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ugramel can cause side effects, although not everybody gets them. The patient should immediatelycontact their doctor if they experience:

• sudden numbness or weakness of the arm, leg, or face, especially if it occurs on one side of the body,
• sudden confusion, difficulty speaking or understanding others,
• sudden difficulty moving, loss of balance or coordination,
• sudden dizziness or severe headaches of unknown cause. All of the above events may be symptoms of a stroke. A stroke is an uncommon side effect in patients taking Ugramel who have not had a stroke or TIA before.

The patient should also immediatelycontact their doctor if they experience:

• fever and bruising under the skin, which may look like red pinpoint spots, with or without symptoms of extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "Important information before taking Ugramel"),
• rash, itching, or swelling of the face, lips, or tongue, or shortness of breath. These may be symptoms of a severe allergic reaction (see section 2 "Important information before taking Ugramel"). The patient should as soon as possiblecontact their doctor if they experience:
• blood in the urine,
• bleeding from the rectum, blood in the stool, or black stools,
• uncontrolled bleeding, e.g., from a cut.

All of the above symptoms may indicate bleeding, the most common side effect of Ugramel. Severe bleeding, although uncommon, can be life-threatening. Common side effects(may affect up to 1 in 10 people):

• bleeding from the stomach or intestines,
• bleeding from the injection site,
• nasal bleeding,
• rash,
• small red spots on the skin (petechiae),
• blood in the urine,
• hematoma (bleeding under the skin at the injection site, or intramuscular bleeding causing swelling),
• low hemoglobin or red blood cell count (anemia),
• bruising.

Uncommon side effects(may affect up to 1 in 100 people):

• allergic reaction (rash, itching, swelling of the lips or tongue, or shortness of breath),
• spontaneous bleeding into the eye, rectum, gums, or abdomen around internal organs,
• bleeding after surgery,
• coughing up blood-stained sputum,
• blood in the stool.

Rare side effects(may affect up to 1 in 1,000 people):

• low platelet count,
• subcutaneous hematoma (bleeding under the skin causing swelling).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or their representative in Poland. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Ugramel

Keep out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and packaging (EXP). The expiry date refers to the last day of the month. Store in a temperature below 25°C. Store in the original packaging to protect from moisture and light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ugramel contains

• The active substance is prasugrel. Ugramel 5 mg: each tablet contains 5 mg of prasugrel (as hydrochloride). Ugramel 10 mg: each tablet contains 10 mg of prasugrel (as hydrochloride).
• The other ingredients are mannitol, microcrystalline cellulose (112, 200), lactose monohydrate, magnesium stearate, hypromellose 2910/5, macrogol 6000, titanium dioxide (E171), talc.

What Ugramel looks like and contents of the pack

Ugramel, 5 mg: white or almost white, round, film-coated tablet, with "5" engraved on one side, approximately 6.1 mm in diameter. Ugramel, 10 mg: white or almost white, oval, film-coated tablet, 10.6 mm x 5.4 mm. Ugramel, 5 mg: available pack sizes are 28, 30, or 98 tablets. Ugramel, 10 mg: available pack sizes are 28, 30, or 98 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva k.s., U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic, S.C. Zentiva S.A., 50 Theodor Pallady Blvd., District 3, 032266, Bucharest, Romania

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact:

Zentiva Polska Sp. z o. o., ul. Bonifraterska 17, 00-203 Warsaw, Tel. (22) 375 92 00

Date of revision of the leaflet: