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AMCHAFIBRIN 500 mg INJECTABLE SOLUTION

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About the medicine

How to use AMCHAFIBRIN 500 mg INJECTABLE SOLUTION

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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

Patient Information Leaflet

Amchafibrin 500 mg solution for injection

tranexamic acid

Read all of this leaflet carefully before you start using 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.
  • If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

  1. What Amchafibrin 500 mg solution for injection is and what it is used for
  2. What you need to know before you use Amchafibrin 500 mg solution for injection
  3. How to use Amchafibrin 500 mg solution for injection
  4. Possible side effects
  5. Storage of Amchafibrin 500 mg solution for injection
  6. Contents of the pack and other information

1. What Amchafibrin 500 mg solution for injection is and what it is used for

Amchafibrin contains tranexamic acid, which belongs to a group of medicines called antihemorrhagics, antifibrinolytics, amino acids.

Amchafibrin is used in adults and children over one year of age for the prevention and treatment of blood loss due to a process that inhibits blood coagulation called fibrinolysis.

The specific indications include:

  • Heavy menstrual bleeding in women
  • Gastrointestinal bleeding
  • Hemorrhagic disorders of the urinary tract, after prostate surgery or surgical procedures that affect the urinary tract
  • Ear, nose, and throat surgery
  • Heart, abdominal, or gynecological surgery
  • Bleeding after being treated with another medicine to dissolve blood clots
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 use Amchafibrin 500 mg solution for injection

Do not useAmchafibrin 500 mgif:

  • You are allergic to tranexamic acid or any of the other components of this medicine (listed in section 6).
  • You currently have a disease that causes the formation of blood clots
  • You have a problem called 'consumption coagulopathy' in which the blood throughout the body begins to clot
  • You have kidney problems
  • You have a history of seizures

Due to the risk of cerebral edema and seizures, intrathecal and intraventricular injection and intracerebral application are not recommended.

If you think any of the above circumstances apply to you or you have any doubts, inform your doctor before taking Amchafibrin 500 mg.

Warnings and precautions

Consult your doctor if any of these circumstances apply to you before starting to use Amchafibrin 500 mg:

  • If you have blood in your urine, Amchafibrin 500 mg may cause obstruction of the urinary tract.
  • If you are at risk of forming blood clots.
  • If you have an excess of clot formation or bleeding in the body (disseminated intravascular coagulation), Amchafibrin 500 mg may not be suitable for you, unless you have a severe acute hemorrhage and blood tests show that the process that inhibits blood coagulation called fibrinolysis has been activated.
  • If you have had seizures, Amchafibrin 500 mg should not be administered. Your doctor should use the lowest possible dose to avoid seizures after treatment with Amchafibrin 500 mg.
  • If you are on long-term treatment with Amchafibrin 500 mg, attention should be paid to possible alterations in color vision, and if necessary, treatment should be suspended. With the long-term continuous use of Amchafibrin 500 mg solution for injection, it is indicated to perform periodic ophthalmological examinations (eye exams such as visual acuity, color vision, fundus study, visual field, etc.). In the event of pathological ophthalmic changes, especially retinal diseases, your doctor should decide, after consulting with a specialist, on the need for long-term use of the Amchafibrin 500 mg solution for injection in your case.

Other medicines andAmchafibrin 500 mg

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription, vitamins, minerals, herbal products, or dietary supplements.

In particular, you should inform your doctor if you are taking:

  • other medicines that help blood to clot, called antifibrinolytic medicines
  • medicines that prevent blood coagulation, called thrombolytic medicines
  • oral contraceptives. They may increase the risk of blood clots.

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, consult your doctor before using Amchafibrin 500 mg.

Tranexamic acid is excreted in human milk. Therefore, the use of Amchafibrin 500 mg is not recommended during breast-feeding.

Driving and using machines

No studies have been performed on the ability to drive and use machines.

3. How to use Amchafibrin 500mg

Use in adults

Amchafibrin will be administered to you by slow injection into a vein.

Your doctor will decide the correct dose for you and for how long you should receive it.

Use in children

If Amchafibrin is administered to a child over one year of age, the dose should be based on the child's weight. Your doctor will decide the correct dose for the child and for how long they should receive it.

Use in elderly patients

No dose reduction is necessary unless there is evidence of renal insufficiency.

Use in patients with kidney problems

If you have kidney problems, the dose of tranexamic acid should be reduced according to the results of a blood test (serum creatinine level).

Use in patients with liver failure

If you have liver problems, no dose reduction is necessary.

Method of administration

Amchafibrin should only be administered as a slow intravenous injection.

Amchafibrin should not be injected into a muscle.

If you receive more Amchafibrin 500 mg than you should

If you have received a higher dose of Amchafibrin than recommended, you may experience a temporary drop in blood pressure. Talk to a doctor or pharmacist immediately.

You can also contact the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount administered.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

The following side effects have been observed with Amchafibrin 500 mg:

Common (may affect up to 1 in 10 patients)

  • Gastrointestinal effects: nausea, vomiting, diarrhea

Uncommon (may affect up to 1 in 100 patients)

  • Skin effects: rash

Frequency not known (frequency cannot be estimated from the available data)

  • Discomfort with hypotension (low blood pressure), especially after a too rapid intravenous injection
  • Blood clots
  • Nervous system effects: seizures
  • Eye effects: vision disorders including color vision impairment
  • Immune system effects: allergic reactions

Reporting of side effects

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

5. Storage of Amchafibrin 500 mg

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

Do not store above 25°C. Store in the original package.

Do not use Amchafibrin 500 mg solution for injection after the expiry date which is stated on the carton after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition ofAmchafibrin 500 mgsolution for injection

  • The active substance is tranexamic acid. Each ampoule contains 500 mg of tranexamic acid.
  • The other ingredients are: water for injections.

AppearanceAmchafibrin 500 mgsolution for injectionand pack contents

Solution for injection. Pack containing 6 and 100 glass ampoules of 5 ml.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Biologici Italia Laboratories S.R.L

Via Filippo Serpero,

20060 Masate (MI)

Italy

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of last revision of this leaflet:June 2023

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

The following information is intended for healthcare professionals only:

The ampoules have a One Point Cut (OPC) opening system and should be broken according to the following instructions:

  • Hold the lower part of the ampoule with your hand, with your thumb pointing to the colored point, as shown below:

Hand holding a nasal applicator with the index finger pressing the upper plunger

  • Hold the upper part of the ampoule with your other hand, supporting your thumb on the colored point and applying pressure in the direction opposite to the colored point, as shown below:

Hand holding an applicator device with a button pressed on the skin of the finger

Online doctors for AMCHAFIBRIN 500 mg INJECTABLE SOLUTION

Discuss questions about AMCHAFIBRIN 500 mg INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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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
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • 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)
  • Prehospital Trauma Life Support (PHTLS)
  • 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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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:

  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
  • Chronic conditions and treatment adjustment.
  • Blood pressure issues, fatigue, metabolic concerns.
  • Preventive consultations and routine check-ups.
  • Interpretation of laboratory results and medical reports.
  • Medical advice for patients receiving care online.

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

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.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

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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€50
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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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€55
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Doctor

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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€60

Frequently Asked Questions

Is a prescription required for AMCHAFIBRIN 500 mg INJECTABLE SOLUTION?
AMCHAFIBRIN 500 mg INJECTABLE SOLUTION 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 AMCHAFIBRIN 500 mg INJECTABLE SOLUTION?
The active ingredient in AMCHAFIBRIN 500 mg INJECTABLE SOLUTION is tranexamic acid. This information helps identify medicines with the same composition but different brand names.
Who manufactures AMCHAFIBRIN 500 mg INJECTABLE SOLUTION?
AMCHAFIBRIN 500 mg INJECTABLE SOLUTION is manufactured by Viatris Healthcare Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of AMCHAFIBRIN 500 mg INJECTABLE SOLUTION 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 AMCHAFIBRIN 500 mg INJECTABLE SOLUTION 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 AMCHAFIBRIN 500 mg INJECTABLE SOLUTION?
Other medicines with the same active substance (tranexamic acid) include TRANEXAMIC ACID APC INSTYTUT 500 mg FILM-COATED TABLETS, TRANEXAMIC ACID BAXTER 100 mg/mL INJECTABLE SOLUTION, TRANEXAMIC ACID ZENTIVA 500 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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