Ugramel

Package leaflet: Information for the patient

Ugramel, 5 mg, film-coated tablets
Ugramel, 10 mg, film-coated tablets
Prasugrel
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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. Do not pass it on to others. This medicine may harm others 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 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 blood cells circulating in the bloodstream. When a blood vessel is damaged, for example by a cut, platelets clump together to help 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 a heart attack (myocardial infarction), stroke, or death. The presence of a clot in the 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 keep the blocked or narrowed artery supplying blood to the heart open.
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 medicine.

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). Allergic reactions may include 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 following situations apply to the patient, he or she should inform the doctor before using
Ugramel:

• If there is an increased risk of bleeding, such as:
• age 75 years or older. The treating doctor will recommend a daily dose of 5 mg, because in patients aged over 75 years the risk of bleeding is higher.
• 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 doctor will recommend a daily dose of Ugramel of 5 mg
• moderate kidney or moderate liver disease
• use of certain medicines (see below "Ugramel and other medicines")
• planned surgical procedure (including dental surgery) within the next seven days. Due to increased risk of bleeding, the doctor may advise temporarily stopping Ugramel.
• If the patient has previously experienced allergic reactions (hypersensitivity) to clopidogrel or other antiplatelet medicines, 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 doctor.

While using Ugramel
Immediately inform the treating doctor if the patient develops a medical condition called thrombotic
thrombocytopenic purpura (TTP), which may present with symptoms such as fever and skin bruising
that may appear as small red spots, 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 and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as
any medicines the patient plans to use. In particular, inform the doctor about 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).
While using Ugramel, only take medicines approved by the doctor.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a 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 machinery.

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

3. How to use Ugramel

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
The usual dose of Ugramel is 10 mg once daily. Treatment should normally 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 of Ugramel is 5 mg. The treating physician will recommend the appropriate dose of acetylsalicylic acid (usually between 75 mg and 325 mg per day).
Ugramel may be taken with or without food. 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 recommended
Seek immediate medical advice from your doctor or go to hospital due to increased risk of bleeding. Show the doctor the Ugramel packaging.
Missing a 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 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 about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this one may cause adverse reactions, although not everyone experiences 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 headaches 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).

You should 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, or 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 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):

• gastrointestinal bleeding (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 red blood cell count (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,
• coughing up blood-stained 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 Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland. 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 Ugramel

Keep out of 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 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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), monohydrate lactose, 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 the imprint "5" on one side, approximately 6.1 mm in diameter.
Ugramel 10 mg: white or almost white, oblong film-coated tablet, dimensions 10.6 mm x 5.4 mm.
Ugramel 5 mg: available pack sizes: 28, 30 or 98 tablets.
Ugramel 10 mg: available pack sizes: 28, 30 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
Manufacturer
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 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 medicinal product 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: