PRAFSIA 5 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Prafsia and what is it used for
2. What you need to know before you take Prafsia
3. How to take Prafsia
4. Possible side effects
5. Storing Prafsia
6. Contents of the pack and other information

1. What is Prafsia and what is it used for

Prafsia, whose active substance is 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 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 supply, causing unstable angina (severe chest pain).

Prasugrel inhibits platelet clumping, which reduces the possibility of forming blood clots.

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 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 reduces the risk of having further heart attacks or strokes or the risk of dying from 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 you take Prafsia

Do not take Prafsia

• If you are allergic to prasugrel or any of the other ingredients of this medicine (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, contact 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:

Talk to your doctor or pharmacist before starting this medicine.

You should tell 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 had 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 medicines (see "Other medicines and Prafsia" below)
• you are scheduled to have surgery (including some dental procedures) in the next seven days. Your doctor may tell you to temporarily stop taking 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 you can recognize by 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 condition called Thrombotic Thrombocytopenic Purpura (or TTP). TTP is associated with fever and bruising under the skin that appears as red dots, with or without extreme unexplained tiredness, 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 medicines and Prafsia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, 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 medicines" for pain and fever (such as ibuprofen, naproxen, etoricoxib).

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

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

Use other medicines while taking prasugrel only if your doctor tells you to.

Pregnancy and breastfeeding

Tell your doctor if you become pregnant or are planning to become pregnant while taking prasugrel. You should take prasugrel only after talking to your doctor about the potential benefits and any potential risk to the fetus.

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

Driving and using machines

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

Prafsia contains sodium

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

3. How to take Prafsia

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose of prasugrel is 10 mg once daily. 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, the dose is 5 mg of prasugrel once daily. Your doctor will also tell you to take acetylsalicylic acid and the exact dose you should take (usually between 75 mg and 325 mg once daily).

You can take prasugrel with or without food. Take your dose every day at about the same time. Do not break or split the tablet.

It is important that you tell 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 have a risk of excessive bleeding. You should show your doctor the pack of this medicine.

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 medicine and the amount taken.

If you forget to take Prafsia

If you forget to take your daily dose, take prasugrel when you remember. If you forget to take your dose for a whole day, take your usual dose of prasugrel the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Prafsia

Do not stop your treatment without consulting your doctor, if you stop taking prasugrel too soon, the risk of having a heart attack may increase.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 known cause.

All 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 dots, with or without extreme unexplained tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "What you need to know before you take 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 you take Prafsia").

Tell your doctor quicklyif you experience any of the following signs:

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

All these can be signs of bleeding, the most common side effect with prasugrel. Although rare, severe bleeding can cause death.

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 stools

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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Prafsia

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 and blister after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Prafsia contains

• The active substance 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 and packaging

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 blisters in packs of 28 and 98 tablets.

Prafsia 10 mg is available in DESSIFLEX-Aluminum/PE blisters in packs 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:July 2024.

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