Prospecto: information for the patient

Amchafibrin 500 mg injectable solution

tranexamic acid

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospectus. See section 4.

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

2.What you need to know before starting to use Amchafibrin 500 mg injectable solution

3.How to use Amchafibrin 500 mg injectable solution

4.Possible adverse effects

5.Storage of Amchafibrin 500 mg injectable solution

6.Contents of the package and additional information

Amchafibrincontains tranexamic acid, which belongs toa group of medications called antihemorrhagics, antifibrinolytics, amino acids.

Amchafibrin is used in adults and children over one yearfor the prevention and treatment of bleeding losses due to a process that inhibits blood coagulation called fibrinolysis.

The specific indications include:

• Intense menstrual bleeding in women
• Gastrointestinal bleeding
• Urinary hemorrhagic disorders, after prostate surgery or surgical procedures affecting the urinary tract
• Surgery of the ear, nose, and throat
• Heart, abdominal, or gynecological surgery

- Bleeding after treatment with another medication to dissolve blood clots

No useAmchafibrin 500 mgif:

• He is allergic to tranexamic acid or any of the other components of this medication (listed in section 6).
• Currently suffers from a disease that causes blood clot formation.
• Suffers from a condition called 'consumption coagulopathy' in which the blood of the entire body begins to clot.
• Has kidney problems.
• Has a history of seizures.

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

If he thinks any of the above circumstances apply or has any doubts, inform his doctor before taking Amchafibrin 500 mg.

Warnings and precautions

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

• If he has blood in his urine, Amchafibrin 500 mg may cause obstruction of the urinary tract.
• If he has a risk of blood clot formation.
• If he suffers from excessive blood clotting or bleeding in the body (disseminated intravascular coagulation), Amchafibrin 500 mg may not be suitable for him, except if he has severe acute bleeding and blood tests show that the process that inhibits blood clotting called fibrinolysis has been activated.
• If he has had seizures, Amchafibrin 500 mg should not be administered. His doctor should use the lowest possible dose to avoid seizures after treatment with Amchafibrin 500 mg.
• If he is on long-term treatment with Amchafibrin 500 mg, he should pay attention to possible color vision disturbances, and if necessary, treatment should be suspended. With the continued long-term use of Amchafibrin 500 mg injectable solution, periodic ophthalmological examinations (eye exams such as visual acuity, color vision, fundus examination, visual field, etc.) are indicated. In the event of pathological ocular changes, especially retinal diseases, his doctor should decide, after consulting a specialist, whether the long-term use of Amchafibrin 500 mg injectable solution is necessary in his case.

Other medications and Amchafibrin 500 mg

Inform his doctor or pharmacist if he is using, has used recently any other medication, including those purchased without a prescription, vitamins, minerals, herbal products, or dietary supplements.

Specifically, he should inform his doctor if he takes:

• Other medications that help blood to clot, called antifibrinolytic medications.
• Medications that prevent blood clotting, called thrombolytic medications.
• Oral contraceptives. They may increase the risk of blood clots.

Pregnancy and lactation

If he is pregnant or breastfeeding, consult his doctor before using Amchafibrin 500 mg.

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

Driving and operating machines

No studies have been conducted on the ability to drive and operate machines.

Use in adults

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

Your doctor will decide on 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 old, the dose should be based on the child's weight. Your doctor will decide on 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 acid tranexamic should be reduced according to the results of a blood test (serum creatinine level).

Use in patients with liver disease

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

Administration form

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. Speak immediately with a doctor or pharmacist.

You can also contact the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount administered.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed withAmchafibrin 500 mg:

Frequent (may affect up to 1 in 10 patients)

• Gastrointestinal effects: nausea, vomiting, diarrhea

Rare(may affect up to 1 in 100 patients)

• Dermatological effects: rash

Unknown frequency (frequency cannot be estimated with available data)

• Discomfort with hypotension (low blood pressure), especially after a too rapid intravenous injection
• Blood clots
• Neurological effects: seizures
• Ocular effects: vision disturbances includingcolor vision loss
• Immunological effects: allergic reactions

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.Store in the original packaging.

Do not use Amchafibrin 500 mg injectable after the expiration date that appears on the carton after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Amchafibrin 500 mg injectable solution

• The active ingredient is tranexamic acid. Each ampoule contains 500 mg of tranexamic acid.
• The other components are: water for injection.

Appearance Amchafibrin 500 mg injectable solution and contents of the packaging

Injectable solution. Packaging containing 6 and 100 glass ampoules of 5 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Meda Pharma SL

C/General Aranaz, 86

28027 Madrid

Spain

Responsible for manufacturing

Biologici Italia Laboratories S.R.L

Via Filippo Serpero,

20060 Masate (MI)

Italy

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet: June 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/

The following information is intended solely for healthcare professionals:

The ampoules have an OPC (One Point Cut, single point of opening) system and must be broken according to the following instructions:

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

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