PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

The 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 cut, platelets clump together to help form a blood clot. Therefore, platelets are essential to help stop bleeding. The formation of clots in hardened blood vessels, such as arteries, can be very dangerous because they prevent blood from flowing, 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 clumping, which reduces the chance 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 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 chance of having another heart attack or stroke, or of dying from one of these events. Your doctor will also prescribe acetylsalicylic acid (e.g., aspirin), another antiplatelet agent.

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

Do not take Prasugrel Vivanta

• If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of this medicine. 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.
• If you have severe liver disease.

Warnings and precautions

• Before taking prasugrel:

Consult your doctor before starting to take prasugrel.

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 old or older. Your doctor should prescribe a daily dose of 5 mg since patients over 75 years old 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 recurrent 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 "Using other medications").
  • you are scheduled to have surgery (including some dental procedures) in the next seven days. Your doctor may advise you to temporarily stop treatment with Prasugrel Vivanta 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 you experience an allergic reaction after taking prasugrel, which can be recognized by a rash, itching, swelling of the face, swelling of the lips, or difficulty breathing, contact your doctor immediately.

• While taking prasugrel:

You should contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (TTP). TTP is associated with fever and bruising (hematomas) under the skin that appear as localized red spots, with or without unexplained extreme 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 medicines and Prasugrel Vivanta

Tell your doctor 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 drugs" for pain and fever (such as ibuprofen, naproxen, etoricoxib).

If these medications are administered with prasugrel, they may increase the risk of bleeding.

Tell 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 tells you to.

Pregnancy and breastfeeding

Tell your doctor if you become pregnant or are trying 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.

Prasugrel Vivanta contains lactose

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

Prasugrel Vivanta contains sodium

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

3. How to take/use Prasugrel Vivanta

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, 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 advise 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 Prasugrel Vivanta than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Prasugrel Vivanta

If you forget to take your scheduled 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 Prasugrel Vivanta

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 about 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 immediatelyif 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 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.

You should also contact your doctor immediatelyif you notice any of the following signs:

• Fever and bruising (hematomas) under the skin that appear as localized red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "What you need to know before you take prasugrel").
• 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 prasugrel").

Tell your doctor promptlyif 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 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 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. Storage of Prasugrel Vivanta

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

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prasugrel Vivanta

• The active substance is prasugrel.

Prasugrel Vivanta 5 mg: Each tablet contains 5.490 mg of prasugrel hydrochloride, equivalent to 5 mg of prasugrel.

• The other ingredients are:

Core of the tablet: microcrystalline cellulose, mannitol (E421), sodium croscarmellose, hypromellose (E464), magnesium stearate.

Coating of the tablet: lactose monohydrate, HPMC 2910 / hypromellose, titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172), and talc.

Appearance of the product and contents of the pack

Prasugrel Vivanta 5 mg: Yellow, oval, biconvex film-coated tablets with "5" engraved on one side and "M" on the other.

Prasugrel Vivanta is available in aluminum blisters in packs of 14, 28, 30, 30 (x1), 56, 84, 90 (x1), and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Manufacturer:

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park

Paola, PLA3000

Malta

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

Local Representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

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

Netherlands Prasugrel Vivanta 5 mg film-coated tablets

Germany Prasugrel Vivanta 5 mg film-coated tablets

Spain Prasugrel Vivanta 5 mg film-coated tablets EFG

Portugal Prasugrel Vivanta

Date of last revision of this leaflet: July 2023

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