Package Leaflet: Information for the user

Prasugrel Krka 10 mg Film-coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What Prasugrel Krka is and what it is used for

2. What you need to know before you take Prasugrel Krka

3. How to take Prasugrel Krka

4. Possible side effects

5. Storage of Prasugrel Krka

6. Contents of the pack and additional information

Prasugrel Krka contains the active ingredient prasugrel, which belongs to a group of medicines called antiplatelet agents. Platelets are very small cells that circulate in the blood. When a blood vessel is damaged, for example if it is cut, platelets aggregate to help form a blood clot (thrombus).

Therefore, platelets are essential in helping to stop bleeding. The formation of clots in hardened blood vessels, such as arteries, can be very dangerous as it prevents blood flow, causing a heart attack (myocardial infarction), stroke (cerebrovascular accident) or death. Clots in arteries that supply blood to the heart can also reduce blood flow, causing unstable angina (severe chest pain).

Prasugrel Krka inhibits platelet aggregation, thereby reducing the possibility of blood clots forming.

You have been prescribed Prasugrel Krka because you have suffered a myocardial infarction or unstable angina and have undergone a procedure to open blocked heart arteries. You may have had one or more stents placed in the blocked or narrowed artery to restore blood flow to the heart. Prasugrel Krka reduces the possibility of future myocardial infarction, stroke (cerebrovascular accident) or death due to one of these atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (e.g., aspirin), another antiplatelet agent.

Do not take Prasugrel Krka

-if you are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). A reaction to an allergen can be recognized as a skin rash, itching, swelling of the face, swelling of the lips, or difficulty breathing. If this has happened to you, consult your doctorimmediately.

-if you have a disease that is causing bleeding, such as stomach or intestinal bleeding.

-if you have ever had a stroke or a transient ischemic attack (TIA).

-if you have a severe liver disease.

Warnings and precautions

Before taking Prasugrel Krka

Consult your doctor or pharmacist before starting to take Prasugrel Krka.

Consult your doctor or pharmacist before starting to take Prasugrel Krka if you are in any of the following situations:

•If you have a high risk of bleeding because:

-you are 75 years of age or older. Your doctor should prescribe a daily dose of 5 mg as patients over 75 years of age have a higher risk of bleeding

-you have recently had a serious injury

-you have recently undergone surgery (including some dental procedures)

-you have recently or recurrently had stomach or intestinal bleeding (e.g., stomach ulcer or colon polyps)

-you weigh less than 60 kg. If you weigh less than 60 kg, your doctor should prescribe a daily dose of 5 mg of prasugrel.

-you have kidney disease or moderate liver disease

-you are taking another type of medication (see “Other medicines”)

• you are planning to undergo surgery (including some dental procedures) in the next seven days. Your doctor may instruct you to temporarily suspend treatment with prasugrel due to an increased risk of bleeding.

•If you have had allergic reactions (hypersensitivity) to clopidogrel or any other antiplatelet agent, please inform your doctor before starting treatment with Prasugrel Krka. If you experience an allergic reaction after taking Prasugrel Krka, which can be recognized by a rash, itching, swelling of the face, swelling of the lips, or difficulty breathing, contact your doctorimmediately.

While taking Prasugrel Krka:

You should contact your doctor immediately if you develop a disease called Thrombotic Thrombocytopenic Purpura (TTP) associated with fever and hematomas under the skin that may appear as localized red spots, with or without extreme fatigue, confusion, yellow discoloration of the skin or eyes (jaundice) (see section 4 “Possible side effects”)

Children and adolescents

Prasugrel Krka should not be used in children or adolescents under 18 years of age.

Other medicines and Prasugrel Krka

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription, dietary supplements, and herbal products. It is especially important to inform your doctor if you are being treated with clopidogrel (an antiplatelet agent), warfarin (an anticoagulant), or “nonsteroidal anti-inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib). If administered together with prasugrel, these medications may increase the risk of bleeding.

Inform your doctor if you have taken morphine or other opioids (used to treat acute pain).

Use other medications while taking Prasugrel Krka only if your doctor instructs you to do so.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Inform your doctor if you become pregnant or are trying to become pregnant while taking Prasugrel Krka.

You should take Prasugrel Krka only after discussing the potential benefits and any potential risks to the fetus with your doctor.

Driving and operating machines

Prasugrel Krka is unlikely to affect your ability to drive and operate machines.

Prasugrel Krka contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of prasugrel is 10 mg per day. Your treatment will begin with a single dose of 60 mg.

If your weight is less than 60 kg or you are over 75 years old, the dose is 5 mg of Prasugrel Krka per day.

Your doctor will also instruct you to take acetylsalicylic acid and the exact dose you should take (usually between 75 mg and 325 mg per day).

You can take prasugrel with or without food. Take your dose every day approximately at the same time. Swallow the tablet whole, do not break or crush the tablet.

It is essential that you inform your doctor, dentist, and pharmacist that you are taking Prasugrel Krka.

If you take more Prasugrel Krka than you should

Contact your doctor or hospital directly as you may be at risk of excessive bleeding. You must show your doctor the Prasugrel Krka packaging.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Prasugrel Krka

If you forgot to take your daily scheduled dose, take prasugrel when you remember.

If you forget to take your dose for an entire day, take your usual dose of prasugrel the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Prasugrel Krka

Do not stop your treatment without consulting your doctor, if you stop treatment with prasugrel too soon, the risk of suffering a myocardial infarction may increase.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctorimmediatelyif you experience any of the following symptoms:

•Numbness or sudden weakness of the arm, leg, or face, especially if it only affects one side of the body.

•Sudden confusion, difficulty speaking, or understanding other people.

•Sudden difficulty walking or loss of balance or coordination.

•Severe dizziness or headache without a known cause.

These may be signs of a stroke. A stroke is a rare side effect of prasugrel in patients who have never had a stroke or a transient ischemic attack (TIA).

You should also contact your doctorimmediatelyif you notice any of the following symptoms:

•Fever and skin rash that appear as localized red spots, with or without extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before starting to take Prasugrel Krka”).

•Rash, itching, or swelling of the face, lips/lips, or difficulty breathing. These may be signs of a severe allergic reaction (see section 2 “What you need to know before starting to take Prasugrel Krka”).

Inform your doctorrapidlyif you experience any of the following symptoms:

•Blood in urine.

•Rectal bleeding, blood in stool, or black stool.

•Uncontrolled bleeding, for example after a cut.

These may be signs of bleeding, the most common side effect of prasugrel. Although rare, severe bleeding can be fatal.

Frequent side effects (may affect up to 1 in 10 people)

•Gastrointestinal bleeding

•Bleeding at the injection site

•Nasal bleeding

•Skin rash

•Small red spots on the skin (petechiae)

•Blood in urine

•Hematoma (bleeding under the skin at the injection site, or in a muscle, causing swelling)

•Anemia (low red blood cell count)

•Ecchymosis (bruising)

Rare side effects (may affect up to 1 in 100 people)

•Allergic reaction (rash, itching, swelling of lips/lips, or difficulty breathing)

•Spontaneous bleeding of the eye, rectum, gums, or around internal organs

•Bleeding after surgery

•Bleeding when coughing

•Blood in stool

Very rare side effects (may affect up to 1 in 1,000 people)

•Low platelet count in the blood

•Subcutaneous hematoma (bleeding under the skin, causing swelling)

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above30°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Prasugrel Krka

The active ingredient is prasugrel. Each film-coated tablet contains 10 mg of prasugrel.

The other components are:

• Core: Microcrystalline cellulose, macrogol 4000, poloxamer 188, fumaric acidto adjust the pH, croscarmellose sodium, colloidal silicon dioxide, mannitol, magnesium stearate.

Coating: Hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, and iron oxide red (E172)

Appearance of the product and contents of the package

The tablets are pink, oval, slightly biconvex, film-coated, with a length of approximately 10.5 mm and a width of approximately 5.5 mm.

It is available in packages of 28, 30, 84, and 90film-coated tablets in blisters.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

KRKA d.d. Novo mesto, smarjeska cesta 6 8501 Novo mesto, Slovenia

Responsible manufacturer

KRKA d.d. Novo mesto, smarjeska cesta 6 8501 Novo mesto, Slovenia

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

KRKA Pharmaceutical, S.L.,

C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:December 2022

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/