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 you.

• You should 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 Package 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 and thus reduces 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 open up blocked arteries in your heart. You may have had a procedure where one or more stents were inserted to keep the blocked or narrowed artery that supplies blood to the heart open. Sigrada reduces the risk of another heart attack, stroke, or death due to 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, lips, or difficulty breathing. If you experience any of these symptoms, you should immediately inform your doctor.

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 a transient ischaemic attack (TIA). if you have severe liver disease.

Warnings and precautions

Before taking Sigrada:

Before taking Sigrada, you should discuss it with your doctor. If any of the following situations apply to you, you should inform 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 temporarily stopping Sigrada.
• If you have had allergic reactions (hypersensitivity) to clopidogrel or other antiplatelet medicines, you should inform your doctor before taking Sigrada. If you experience allergic reactions after taking Sigrada, such as a rash, itching, swelling of the face, lips, or difficulty breathing, you should immediately inform your doctor.

While taking Sigrada:

You should immediately inform your doctor if you experience a condition called thrombotic thrombocytopenic purpura (or TTP), which can cause symptoms such as fever, bruising under the skin that may 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

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, including those that are available without a prescription, dietary supplements, or herbal medicines. In particular, you should 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. You should inform your doctor if you are taking morphine or other opioids (used to treat severe pain). While taking Sigrada, you should 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, you should consult your doctor or pharmacist before taking this medicine. If you become pregnant or plan to become pregnant while taking Sigrada, you should 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 diagnosed with an intolerance to some sugars, you should consult 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

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist. The recommended dose is 10 mg once a day. You should 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. 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 Sigrada.

If you take more Sigrada than you should

You should immediately contact your doctor or hospital due to the increased risk of bleeding. You should show your doctor the package of Sigrada.

If you forget to take Sigrada

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

If you stop taking Sigrada

You should 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, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sigrada can cause side effects, although not everybody gets them. You should immediately contact 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 of unknown cause. All of 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 transient ischaemic attack before.

You should also immediately contact your doctor if you experience:

• fever and bruising under the skin that may 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, lips, or tongue, or difficulty breathing. These can be symptoms of a severe allergic reaction (see section 2 "Important information before taking Sigrada").

You should 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 of 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,
• nasal bleeding,
• rash,
• small red bruises on the skin (purpura),
• blood in the urine,
• haematoma (bleeding under the skin at the injection site, or in the muscle, 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 difficulty breathing),
• 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,
• haematoma (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, pharmacist, or nurse. You can also report side effects 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.: +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

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is 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.

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 further information about this medicine, you should contact the local representative of the marketing authorisation holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw telephone: +48 22 573 75 00

Date of last revision of the package leaflet: