Sigrada

Package Leaflet: Information for the Patient

Sigrada, 5 mg, coated tablets

Sigrada, 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Sigrada and what is it used for

Sigrada, 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, can be 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). Sigrada prevents platelets from clumping together, reducing the risk of blood clots. Sigrada 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 the heart open. Sigrada reduces the risk of another heart attack, stroke, or death from one of these events. Your doctor will also recommend taking acetylsalicylic acid (such as aspirin), which is also an antiplatelet medicine.

2. Important information before taking Sigrada

When not to take Sigrada

• if you are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash, itching, swelling of the face, swelling of the lips or shortness of breath. If you experience these symptoms, tell your doctor immediately.

if you have a condition that is currently causing bleeding, such as bleeding from the stomach or intestines. if you have had a stroke or transient ischaemic attack (TIA). if you have severe liver disease.

Warnings and precautions

Before taking Sigrada:

Before taking Sigrada, discuss it with your doctor. If any of the following situations apply to you, tell your doctor before taking Sigrada:

• If you have an increased risk of bleeding, such as:
• age 75 or over. Your doctor will recommend a daily dose of 5 mg, as the risk of bleeding is higher in patients over 75 years of age.
• recent severe injury
• recent surgery (including dental surgery)
• recent or recurring bleeding from the stomach or intestines (such as 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 Sigrada of 5 mg.
• moderate kidney or liver disease
• taking certain medicines (see below "Sigrada and other medicines")
• planned surgery (including dental surgery) within the next seven days. Due to the increased risk of bleeding, your doctor may recommend temporary discontinuation of Sigrada.
• If you have had allergic reactions (hypersensitivity) to clopidogrel or other antiplatelet medicines, inform your doctor before taking Sigrada. If you experience allergic reactions after taking Sigrada, such as rash, itching, swelling of the face, swelling of the lips or shortness of breath, tell your doctor immediately.

During treatment with Sigrada:

Tell your doctor immediately if you experience a condition called thrombotic thrombocytopenic purpura (or TTP), which can cause symptoms such as fever, purple spots under the skin, which can look like red pinpoint spots, with or without symptoms of extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

Children and adolescents

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

Sigrada and other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about any medicines you plan to take, including those obtained without a prescription, dietary supplements, or herbal medicines. In particular, inform your doctor if you 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 prasugrel may increase the risk of bleeding. Inform your doctor if you are taking morphine or other opioids (used to treat severe pain). During treatment with Sigrada, only take other medicines if your doctor recommends them.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. If you become pregnant or plan to become pregnant while taking Sigrada, inform your doctor. Sigrada can 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 Sigrada will affect your ability to drive or use machines.

Sigrada contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. Sigrada contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Sigrada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is 10 mg once a day. Start treatment with a single dose of 60 mg. If you weigh less than 60 kg or are over 75 years of age, the daily dose of Sigrada is 5 mg. Your doctor will recommend the appropriate dose of acetylsalicylic acid (usually between 75 mg and 325 mg once a day). Sigrada can be taken with or without food. Take the dose at the same time each day. Do not break or crush the tablets. It is very important to inform your doctor, dentist, and pharmacist that you are taking Sigrada.

Taking more Sigrada than prescribed

Contact your doctor or hospital immediately, as there is an increased risk of bleeding. Show your doctor the Sigrada packaging.

Forgetting to take Sigrada

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as possible. If you forget to take a dose for the whole day, take the next dose at the usual time the next day. Do not take two doses on the same day.

Stopping treatment with Sigrada

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

4. Possible side effects

Like all medicines, Sigrada can cause side effects, although not everybody gets them. Contact your doctor immediately 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 headaches of unknown cause. All these events can be symptoms of a stroke. A stroke is an uncommon side effect in patients taking Sigrada who have not had a stroke or TIA before.

Also, contact your doctor immediately if you experience:

• fever and purple spots under the skin, which can look like red pinpoint spots, with or without symptoms of extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "Important information before taking Sigrada"),
• rash, itching, swelling of the face, swelling of the lips or tongue, or shortness of breath. These can be symptoms of a severe allergic reaction (see section 2 "Important information before taking Sigrada").

Contact your doctor as soon as possible if you experience:

• blood in the urine,
• bleeding from the anus, blood in the stool, or black stools,
• uncontrolled bleeding, for example, from a cut.

All these symptoms can indicate bleeding, the most common side effect when taking Sigrada. 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,
• nosebleeds,
• rash,
• small red spots on the skin (purpura),
• blood in the urine,
• bruising (bleeding under the skin or into muscles, causing swelling),
• low haemoglobin or red blood cell count (anaemia),
• 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, anus, 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,
• bruising (bleeding under the skin, causing swelling).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Post-Marketing Surveillance 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. You can also report side effects to the marketing authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sigrada

Keep this 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 that month. Do not store above 30°C. Store in the original package to protect from moisture. 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 Sigrada contains

The active substance is prasugrel. Each coated tablet contains 5 mg or 10 mg of prasugrel. The other ingredients are: microcrystalline cellulose, macrogol 4000, poloxamer 188, fumaric acid - as a pH adjuster, sodium croscarmellose, hydrophobic colloidal silica, mannitol (E 421), magnesium stearate in the tablet core, and also hypromellose 15cP, lactose monohydrate, titanium dioxide (E 171), triacetin, iron oxide yellow (E 172) - only for 5 mg coated tablets, iron oxide red (E 172) - only for 10 mg coated tablets, in the tablet coating. See section 2 "Sigrada contains lactose and sodium".

What Sigrada looks like and contents of the pack

5 mg, coated tablets (tablets) Light brown-yellow, oval, biconvex coated tablets, 8.5 mm x 4.5 mm in size. 10 mg, coated tablets (tablets) Pink, oval, slightly biconvex coated tablets, 10.5 mm x 5.5 mm in size. Sigrada is available in packs containing 28 coated tablets, in blisters. Blister (OPA/Aluminium/PE+desiccant/Aluminium/PE), in a cardboard box.

Marketing authorisation holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia For more detailed information on this medicine, contact the local representative of the marketing authorisation holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw phone: +48 22 573 75 00

Date of last revision of the leaflet: