Ugramel

Package leaflet: Information for the patient

Ugramel, 10 mg, coated tablets
Prasugrel
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Ugramel is and what it is 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 Ugramel is and what it is used for

Ugramel contains the active substance prasugrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells circulating in the blood. When a blood vessel is injured, for example by a cut, platelets stick together, helping to form a blood clot.
Thus, platelets play a key role in stopping bleeding. However, the formation of a clot inside an atherosclerotic blood vessel, such as an artery, is very dangerous because it may block blood flow, leading to heart attack (myocardial infarction), stroke, or death. The presence of a clot in arteries supplying blood to the heart may restrict blood flow and cause unstable angina (increased chest pain).
Ugramel inhibits platelet aggregation and thereby reduces the risk of clot formation.
Ugramel has been prescribed by your doctor because you have had a myocardial infarction or unstable angina, and you have previously undergone a procedure to open blocked arteries in the heart. You may have undergone a procedure during which one or more stents were placed to maintain the patency of a blocked or narrowed artery supplying blood to the heart.
Ugramel reduces the risk of recurrent myocardial infarction, stroke, or death due to these events. Your doctor will also recommend taking acetylsalicylic acid (e.g., aspirin), which is also an antiplatelet agent.

2. Important information before using Ugramel

When not to use Ugramel

• If the patient has a known allergy (hypersensitivity) to prasugrel or any of the other ingredients of this medicine (listed in section 6).
• An allergic reaction may present as rash, itching, facial swelling, lip swelling or shortness of breath. If any of these symptoms occur, immediately inform the doctor.
• If the patient currently has a medical condition causing bleeding, e.g. gastrointestinal bleeding.
• If the patient has ever had a stroke or transient ischaemic attack (TIA).
• If the patient has severe liver disease.

Warnings and precautions
If any of the situations listed below apply to the patient, they should inform their doctor before using Ugramel:

• If there is an increased risk of bleeding, such as:
• age 75 years or older. The treating physician will recommend a daily dose of 5 mg, as the risk of bleeding is higher in patients over 75 years of age.
• recent severe trauma
• recent surgical procedure (including dental surgery)
• recent or recurrent gastrointestinal bleeding (e.g. gastric ulcer or colon polyps)
• body weight less than 60 kg. If the patient weighs less than 60 kg, the treating physician will recommend a daily dose of 5 mg
• moderate kidney or liver disease
• use of certain medications (see below "Ugramel with other medicines")
• planned surgical procedure (including dental surgery) within the next seven days. Due to increased risk of bleeding, the doctor may recommend temporarily discontinuing Ugramel.
• If the patient has previously experienced allergic reactions (hypersensitivity) to clopidogrel or other antiplatelet drugs, they should inform the doctor before starting Ugramel. If allergic reactions occur after taking Ugramel, such as rash, itching, facial swelling, lip swelling or difficulty breathing, immediately inform the treating physician.

While using Ugramel
The treating physician should be informed immediately if the patient develops a condition called thrombotic thrombocytopenic purpura (TTP), which may present with symptoms such as fever and skin bruising appearing as small red spots, along with or without symptoms of extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

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

Ugramel with other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to use. In particular, inform the doctor about the use of 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 together with Ugramel may increase the risk of bleeding.

Inform the doctor if the patient is taking morphine or other opioids (used to treat severe pain).

Only medicines approved by the doctor should be taken while using Ugramel.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Ugramel may be used only after discussing with the doctor the potential benefits and risks to the unborn child.

Driving and operating machinery
It is unlikely that Ugramel will affect the ability to drive or operate mechanical equipment.

Ugramel contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Ugramel

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The usual dose of Ugramel is 10 mg once daily. Treatment should be initiated with a single
60 mg dose.
If the patient weighs less than 60 kg or is over 75 years of age, the daily dose is 5 mg. Ugramel is not available in a 5 mg strength. The treating physician will recommend the appropriate dose of acetylsalicylic acid (usually between 75 mg and 325 mg once daily).
Ugramel may be taken with or between meals. The dose should be taken at the same time each day. Do not break or crush the tablet.
It is very important to inform your doctor, dentist, and pharmacist that you are taking Ugramel.
Taking more Ugramel than prescribed
Contact your doctor or go to hospital immediately due to increased risk of bleeding. Show the Ugramel packaging to the doctor.
Missed dose of Ugramel
If a dose is missed, take it as soon as possible. If the patient forgets to take the dose for the entire day, take the next dose of Ugramel the following day at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Ugramel
Do not stop taking Ugramel without consulting your doctor. Stopping treatment with Ugramel too early may increase the risk of heart attack.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this one may cause adverse reactions, although not everyone will experience them.

Immediately contact your doctor if any of the following occur:

• sudden numbness or weakness of the arm, leg, or face, especially on one side of the body,
• sudden confusion, difficulty speaking or understanding others,
• sudden difficulty moving, loss of balance or coordination,
• sudden dizziness or sudden severe headache of unknown cause.

All of the above symptoms may be signs of stroke. Stroke is an uncommon adverse reaction in patients taking Ugramel who have never previously had a stroke or transient ischaemic attack (TIA).

Also immediately contact your doctor if any of the following occur:

• fever and bruising under the skin, which may appear as small 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, swelling of the lips or tongue, or difficulty breathing. These may be symptoms of a severe allergic reaction (see section 2 "Important information before taking Ugramel").

Contact your doctor promptly if any of the following occur:

• blood in the urine,
• rectal bleeding, blood in the stool, or black stools,
• uncontrolled bleeding, e.g. from a cut wound.

All of the above symptoms may indicate bleeding, which is the most common adverse reaction during treatment with Ugramel. Severe bleeding, although uncommon, may be life-threatening.

Common adverse reactions (may occur in 1 out of 10 people):

• bleeding from the stomach or intestines,
• bleeding at the site of needle puncture,
• nosebleeds,
• rash,
• small red bruises on the skin (petechiae),
• blood in the urine,
• haematoma (subcutaneous bleeding at the injection site or intramuscular bleeding causing swelling),
• low haemoglobin levels or low number of red blood cells (anaemia),
• bruising.

Uncommon adverse reactions (may occur in 1 out of 100 people):

• allergic reaction (rash, itching, swelling of lips or tongue, or difficulty breathing),
• spontaneous bleeding into the eye, rectum, gums, or into the abdominal cavity around internal organs,
• bleeding after surgical procedures,
• cough with bloody sputum,
• blood in the stool.

Rare adverse reactions (may occur in 1 out of 1000 people):

• low platelet count,
• subcutaneous haematoma (subcutaneous bleeding causing swelling).

Reporting of adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorisation holder or its representative in Poland.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Ugramel

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging indicated by
the abbreviation used for its description (EXP). The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from moisture and light.
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 the medicine Ugramel contains

• The active substance is prasugrel. Each tablet contains 10 mg of prasugrel (as hydrochloride).
• Other components of the medicine are mannitol, microcrystalline cellulose (112, 200), lactose monohydrate, magnesium stearate, hypromellose 2910/5, macrogol 6000, titanium dioxide (E171), talc.

What the medicine Ugramel looks like and contents of the pack
White or almost white, film-coated, elongated tablet, 10.6 mm x 5.4 mm in size.
Pack sizes: 28, 30 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 about 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: November 2024