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PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS

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About the medicine

How to use PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/.

Online doctors for PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS

Discuss questions about PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

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Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
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  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
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  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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Frequently Asked Questions

Is a prescription required for PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS?
PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS?
The active ingredient in PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS is prasugrel. This information helps identify medicines with the same composition but different brand names.
Who manufactures PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS?
PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS is manufactured by Vivanta Generics S.R.O.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to PRASUGREL VIVANTA 5 mg FILM-COATED TABLETS?
Other medicines with the same active substance (prasugrel) include EFIENT 10 mg FILM-COATED TABLETS, EFIENT 10 mg FILM-COATED TABLETS, EFIENT 5 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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