PRAFSIA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Prafsia 5 mg film-coated tablets EFG

Prafsia 10 mg film-coated tablets EFG

prasugrel

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Prafsia and what is it used for
2. What you need to know before taking Prafsia
3. How to take Prafsia
4. Possible side effects
5. Storage of Prafsia
6. Package contents and additional information

1. What is Prafsia and what is it used for

Prafsia, whose active ingredient is prasugrel, which belongs to a group of medications 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 clump together to help form a blood clot (thrombus). Therefore, platelets are essential to help stop bleeding. The formation of clots in hardened blood vessels, such as arteries, can be very dangerous as they prevent blood from passing through, causing a heart attack (myocardial infarction), stroke, or death. Clots in arteries that supply blood to the heart can also reduce blood flow, causing unstable angina (severe chest pain).

Prasugrel inhibits platelet aggregation, thereby reducing the possibility of blood clot formation.

You have been prescribed prasugrel because you have had a heart attack or unstable angina and have been treated with a procedure to open up the clogged heart arteries. You may have had one or more stents placed in the clogged or narrowed artery to restore blood flow to the heart. Prasugrel reduces the risk of future heart attacks or strokes or the risk of death due to one of these atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (e.g., aspirin), another antiplatelet agent.

2. What you need to know before taking Prafsia

Do not take Prafsia

• If you are allergic to prasugrel or any of the other ingredients of this medication (listed in section 6). An allergic reaction 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 doctor immediately.
• If you have a condition 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 severe liver disease.

Warnings and precautions

• Before taking Prafsia:

Consult your doctor or pharmacist before starting to take this medication.

You should consult your doctor or pharmacist before starting to take prasugrel if you are in any of the following situations:

• If you are at high risk of bleeding because:

• you are 75 years or older. Your doctor should prescribe a daily dose of 5 mg, as patients over 75 years 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 had or frequently have stomach or intestinal bleeding (e.g., stomach ulcer or colon polyps).
• you weigh less than 60 kg. In this case, your doctor should prescribe a daily dose of 5 mg of prasugrel.
• you have kidney disease or moderate liver problems.
• you are taking other medications (see "Other medications and Prafsia" below).
• you are scheduled to have surgery (including some dental procedures) in the next seven days. Your doctor may instruct you to temporarily stop 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. If, after taking prasugrel, you experience an allergic reaction that can be recognized by a rash, itching, swelling of the face, swelling of the lips, or difficulty breathing, contact your doctor immediately.

• While taking Prafsia:

You should contact your doctor immediately if you develop a disease called Thrombotic Thrombocytopenic Purpura (TTP). TTP is associated with fever and bruising under the skin that appears as red spots, with or without extreme unexplained fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

Children and adolescents

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

Other medications and Prafsia

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription, dietary supplements, and herbal products.

It is especially important that you inform your doctor if you are being treated with:

• clopidogrel (an antiplatelet agent),
• warfarin (an anticoagulant),
• "non-steroidal anti-inflammatory medications" for pain and fever (such as ibuprofen, naproxen, etoricoxib).

If taken with prasugrel, these medications may increase the risk of bleeding.

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

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

Pregnancy and breastfeeding

Inform your doctor if you become pregnant or are planning to become pregnant while taking prasugrel. You should take prasugrel only after discussing the potential benefits and risks with your doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

It is unlikely that prasugrel will affect your ability to drive or use machines.

Prafsia contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Prafsia

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

The usual dose of prasugrel is 10 mg per day. Your treatment will start 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 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 at approximately the same time. Do not break or split the tablet.

It is important that you inform your doctor, dentist, and pharmacist that you are taking prasugrel.

If you take more Prafsia than you should

Contact your doctor or hospital directly, as you may be at risk of excessive bleeding. You should show your doctor the package of this medication.

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

If you forget to take Prafsia

If you forget to take your scheduled daily 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 make up for forgotten doses.

If you interrupt treatment with Prafsia

Do not interrupt your treatment without consulting your doctor, as stopping treatment with prasugrel too soon may increase the risk of heart attack.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following signs:

• 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 others.
• Sudden difficulty walking or loss of balance or coordination.
• Sudden severe headache or dizziness without a known cause.

All of these can 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 doctor immediately if you notice any of the following signs:

• Fever and bruising under the skin that appears as red spots, with or without extreme unexplained fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "What you need to know before taking Prafsia").
• A rash, itching, swelling of the face, swelling of the lips, or difficulty breathing. These can be signs of a severe allergic reaction (see section 2 "What you need to know before taking Prafsia").

Inform your doctor promptlyif you experience any of the following signs:

• Blood in urine.
• Rectal bleeding, blood in stool, or black stools.
• Uncontrolled bleeding, for example after a cut.

All of these can be signs of bleeding, the most common side effect with prasugrel. Although rare, severe bleeding can be life-threatening.

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

• Bleeding in the stomach or intestine
• Bleeding at the injection site
• Nosebleeds
• Skin rash
• Small red bruises on the skin (ecchymosis)
• Blood in urine
• Hematoma (bleeding under the skin at the injection site, or in a muscle, causing swelling)
• Low hemoglobin or red blood cell count (anemia)
• Bruising

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

• Allergic reaction (rash, itching, swelling of the lips/tongue, or difficulty breathing)
• Spontaneous bleeding in the eye, rectum, gums, or in the abdomen around the internal organs
• Bleeding after surgery
• Bleeding when coughing
• Blood in stool

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

• Low platelet count in blood
• Subcutaneous hematoma (bleeding under the skin, causing swelling)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Prafsia

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Prafsia

• The active ingredient is prasugrel.

Prafsia 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).

Prafsia 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).

• The other ingredients are:

Microcrystalline cellulose (E460), mannitol (E421), sodium croscarmellose (E468), hypromellose (E464), magnesium stearate (E470b), hydroxypropylcellulose (E463), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (only 10 mg tablets) (E172).

Appearance of the product and package contents

Prafsia 5 mg: The tablets are yellow, double-arrow shaped, approximately 9.9 mm long, 4.7 mm wide, and 2.5 mm thick, engraved with "5" on one side.

Prafsia 10 mg: The tablets are dark beige, double-arrow shaped, approximately 11.1 mm long, 5.3 mm wide, and 3.8 mm thick, engraved with "10" on one side.

Prafsia 5 mg is available in DESSIFLEX-Aluminum/PE blister packs in packages of 28 and 98 tablets.

Prafsia 10 mg is available in DESSIFLEX-Aluminum/PE blister packs in packages of 28, 30, 56, and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Pharmathen S.A.

Dervenakion 6 Str

Pallini 15351, Attiki

Greece

Manufacturer:

Pharmathen S.A.

Dervenakion 6 Str

Pallini 15351, Attiki

Greece

or

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

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

Date of last revision of this package leaflet:July 2024.

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.