Ugramel

Package Leaflet: Information for the Patient

Ugramel, 10 mg, Coated Tablets

Prasugrel

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 blood 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 blockage of blood flow, causing 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, thereby 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 you are 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, you should immediatelyinform your doctor.
• If you have a medical condition that is currently causing bleeding, such as bleeding from the stomach or intestines.
• If you have ever had a stroke or transient ischemic attack (TIA).
• If you have severe liver disease.

Warnings and precautions

If any of the following situations apply to you, you should inform your doctor before taking Ugramel:

• If you have an increased risk of bleeding, such as:
• age 75 or older. Your 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 recurring bleeding from the stomach or intestines (e.g., stomach ulcers or colon polyps)
• body weight less than 60 kg. If you weigh less than 60 kg, your doctor will recommend a daily dose 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, your doctor may recommend temporary discontinuation of Ugramel.
• If you have had allergic reactions (hypersensitivity) to clopidogrel or other antiplatelet medicines, you should inform your doctor before starting Ugramel. If you experience allergic reactions after taking Ugramel, such as rash, itching, swelling of the face, swelling of the lips or shortness of breath, you should immediatelyinform your doctor.

While taking Ugramel

You should immediatelyinform your doctor if you experience a medical condition called thrombotic thrombocytopenic purpura (TTP), which is 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

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. In particular, you should inform your doctor if you are taking clopidogrel (an antiplatelet medicine), warfarin (an anticoagulant medicine), 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. You should inform your doctor if you are taking morphine or other opioids (used to treat severe pain). While taking Ugramel, you should only take other medicines if your doctor allows it.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Ugramel should only be used after discussing the potential benefits and risks to the unborn child with your doctor.

Driving and using machines

It is unlikely that Ugramel will affect your ability to drive or use machines.

Ugramel contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Ugramel

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should ask your doctor or pharmacist. The usual dose of Ugramel is 10 mg once daily. You should start treatment with a single dose of 60 mg. If you weigh less than 60 kg or are over 75 years old, the daily dose is 5 mg. Ugramel is not available in a 5 mg dose. Your doctor will recommend a dose of acetylsalicylic acid (usually between 75 mg and 325 mg once daily). You can take Ugramel with or without food. You should take your dose at the same time every day. Do not break or crush the tablets. It is very important to inform your doctor, dentist, and pharmacist that you are taking Ugramel.

Taking more Ugramel than prescribed

You should immediatelycontact your doctor or hospital due to the increased risk of bleeding. You should show your doctor the Ugramel packaging.

Missing a dose of Ugramel

If you miss a dose, you should take it as soon as possible. If you forget to take a dose for the entire day, you should take the next dose of Ugramel at the usual time the next day. Do not take a double dose to make up for the missed dose.

Stopping Ugramel

Do not stop taking Ugramel without consulting your doctor. Stopping Ugramel too quickly may increase the risk of a heart attack. If you have any doubts about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ugramel can cause side effects, although not everybody gets them. You should immediatelycontact your doctor if you 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 headache with 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 never had a stroke or TIA before.

You should also immediatelycontact your doctor if you 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, swelling of the face, swelling of the lips or tongue, or shortness of breath. These may be symptoms of a severe allergic reaction (see section 2 "Important information before taking Ugramel"). You should as soon as possiblecontact your doctor if you 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,
• bleeding from the nose,
• rash,
• small red spots on the skin (purpura),
• blood in the urine,
• hematoma (bleeding under the skin at the injection site, or in the muscle, 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 1000 people):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ugramel

Keep out of the 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. 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 Ugramel contains

• The active substance is prasugrel. 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

White or almost white, elongated, film-coated tablet, 10.6 mm x 5.4 mm in size. Available pack sizes: 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

For further information on this medicine and its authorized names in 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:November 2024