AMCHAFIBRIN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amchafibrin 500 mg Film-Coated Tablets

tranexamic acid

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Amchafibrin is and what it is used for
2. What you need to know before taking Amchafibrin
3. How to take Amchafibrin
4. Possible side effects

5 Conservation of Amchafibrin

1. Contents of the pack and further information

1. What Amchafibrin is and what it is used for

Amchafibrin contains the active ingredient tranexamic acid, which belongs to a group of medications called antifibrinolytics.

This medication is indicated for the treatment and prevention of excessive bleeding associated with abnormal bleeding, such as:

• any type of prostate or bladder surgery,
• abnormally heavy and prolonged menstrual bleeding,
• patients with a tendency to bleed abnormally (hemophiliacs) who undergo dental surgery (extractions),
• localized swelling that affects the mouth and upper respiratory tract (hereditary angioedema).

2. What you need to know before taking Amchafibrin

Do not take Amchafibrin:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have a tendency to form blood clots (thrombi).
• If you are at risk of excessive bleeding due to a coagulation disorder called consumption coagulopathy.
• If you have severe kidney problems (severe renal insufficiency).
• If you have a history of seizures.

In case of doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amchafibrin:

• If you have impaired renal function.
• If you have hematuria (blood in the urine) of renal origin, as a clot may form in the urethra that prevents urine from coming out.
• If you are taking oral contraceptives, due to the increased risk of thrombosis.

Other medications and Amchafibrin

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

It is important to inform your doctor if you are taking any of the following medications:

• Fibrinolytic medications (used to help break down blood clots). This is because tranexamic acid would cancel the effect of these medications.
• Oral contraceptives.

In case of doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding

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

Tranexamic acid is excreted in breast milk, although in minimal amounts. If you are breastfeeding, consult your doctor or pharmacist before taking this medication.

Children

The primary use of tranexamic acid in children is for dental extraction. Use with caution. The dose of this medication in children and adolescents should be calculated based on body weight.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. In case of dizziness or drowsiness, it is not recommended to drive vehicles or operate machinery.

3. How to take Amchafibrin

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults:

Usual dose

Take 2 to 3 tablets, 2-3 times a day.

The exact dose for you depends on the reason why this medication has been prescribed to you. Follow your doctor's instructions regarding how many tablets to take, when to take them, and the duration of treatment.

Dose in certain specific cases:

• Total or partial prostate removal (prostatectomy): during the first 3 days after surgery, take 2 tablets, 3 to 4 times a day, until there is no blood in the urine.
• Abnormally heavy and prolonged menstrual bleeding (metrorrhagia): take 2 tablets, 3 times a day, for 3 or 4 days. Do not exceed a total dose of 4 g per day (8 tablets). Treatment with Amchafibrin should not be started until menstrual bleeding has begun.

Use in advanced age

No dose reduction is necessary unless there is renal insufficiency.

Renal insufficiency

This medication may accumulate in patients with renal insufficiency, so the dose should be reduced in these cases.

Use in children and adolescents

Your doctor will indicate the exact dose to be given to the child. Your doctor will calculate the dose based on the child's weight.

In case of doubt, ask your doctor or pharmacist.

If you take more Amchafibrin than you should

If you take more Amchafibrin than you should, you may experience nausea, vomiting, orthostatic symptoms, and/or hypotension. In this case, vomiting should be induced, gastric lavage should be performed, and treatment with activated charcoal should be started. Maintain high fluid intake to favor renal elimination.

In case of overdose, consult your doctor or pharmacist immediately, or call the Toxicology Information Service. Tel. 91 562 04 20. Bring this package leaflet with you.

If you forget to take Amchafibrin

Do not take a double dose to make up for forgotten doses, but continue taking this medication as usual.

If you interrupt treatment with Amchafibrin

Do not interrupt treatment with this medication without consulting your doctor.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Immediately inform your doctor of any of the following situations:

• If you experience a rash or allergic reaction such as itching, swelling of the lips/tongue, or wheezing/difficulty breathing. In such cases, stop taking the tablets immediately and inform your doctor as soon as possible.
• If you experience blood clots in the veins (a rare side effect that may affect up to 1 in 1,000 people), especially in the legs (symptoms are swelling, pain, and redness in the legs), which can move through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

Rare (affect 1 to 10 patients in every 1,000)

• Visual disturbances, especially in color vision.
• Formation of a blood clot in an eye. This can cause bleeding in the eye or vision loss.
• Itching, redness, or swelling of the skin.

Very rare (affect less than 1 patient in every 10,000)

• Formation of a blood clot in the blood vessels (i.e., thrombosis).
• Allergic reactions that can cause difficulty breathing or dizziness.
• Nausea.
• Vomiting.
• Diarrhea.
• Seizures or convulsions.
• General feeling of discomfort (malaise) and low blood pressure (hypotension), with or without loss of consciousness.

Nausea, vomiting, and diarrhea are usually mild and disappear quickly; however, if they persist, inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Amchafibrin

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

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging after "CAD" or "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Amchafibrin

• The active ingredient is tranexamic acid. Each film-coated tablet contains 500 mg of tranexamic acid.
• The other components are: microcrystalline cellulose, low-substituted hydroxypropylcellulose, talc, magnesium stearate, povidone, anhydrous colloidal silica, butyl methacrylate basic copolymer, titanium dioxide (E 171), macrogol, and vanillin.

Appearance of the product and contents of the pack

White, oval, film-coated tablets with a score on one side.

The tablets are presented in PVC/PVDC-Aluminum blisters, and the available pack size is 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Madaus GmbH

Lütticher Str. 5

53842 Troisdorf,

Germany

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

Viatris Pharmaceuticals, S.L.

C/General Aranaz, 86

28027 Madrid

Spain

Date of the last revision of this package leaflet:November 2022

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