Product Information for the User

Amchafibrin 500 mg Film-Coated Tablets

Tranexamic Acid

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again. If you have any doubts, consult yourdoctor orpharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist evenifthey are not listed in this product information. See section 4.

1.What Amchafibrin is and for what it is used

2.What you need to knowbeforestarting totake Amchafibrin

3.How to takeAmchafibrin

4.Possible side effects

5Storage of Amchafibrin

6.Contents of the pack and additional information

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

This medicineis indicated for the treatment and prevention of blood loss associated with excessive abnormal bleeding, such as:

• any type of operation on the prostate or bladder,
• abnormally heavy and prolonged menstrual bleeding,
• patients with a predisposition to abnormal bleeding (hemophiliacs) undergoing dental surgery (extractions),
• localized swelling affecting the mouth and upper respiratory tract (hereditary angioneurotic edema).

Do not take Amchafibrin:

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

Consult your doctor or pharmacist if you are unsure.

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 blood clot may form in the urethra preventing urine from being passed.
• If you are taking oral contraceptives, due to an increased risk of thrombosis.

Other medications and Amchafibrin

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

It is essential 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 the acid tranexamic would neutralize the effect of these medications.
• Oral contraceptives.

Consult your doctor or pharmacist if you are unsure.

Pregnancy and breastfeeding

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

The acid tranexamic is excreted in breast milk, although in a minimal amount. If you are breastfeeding, consult your doctor or pharmacist before taking this medication.

Children

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

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. If you experience dizziness or somnolence, it is not recommended to drive vehicles or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.If in 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 you have been prescribed this medication.Follow your doctor's instructions about how many tablets you should take, when you should take them, and the duration of treatment.

Dose in some particular cases:

-Total or partial prostatectomy: during the first 3 days after the operation, take 2 tablets, 3 to 4 times a day, until there is no blood in the urine.

-Prolonged and excessive menstrual bleeding (metrorrhagia): take 2 tablets, 3 times a day, for 3 or 4 days. Do not exceed a total daily dose of 4 g (8 tablets). Treatment with Amchafibrin should not be initiated until menstrual bleeding has started.

Use in the elderly

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 tell you exactly how much to give to the child. Your doctor will calculate the dose based on the child's weight.

If in 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, induce vomiting, perform gastric lavage, and initiate treatment with activated charcoal. Maintain a high fluid intake to promote renal elimination.

If you have taken too much, consult your doctor or pharmacist immediately, or call the Toxicology Information Service. Phone. 91 562 04 20. Bring this leaflet with you.

If you forget to takeAmchafibrin

Do not take a double dose to make up for the missed doses, but instead continue taking this medication in the usual manner.

If you interrupt treatment with Amchafibrin

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

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

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

Inform your doctor immediately if you experience any of the following situations:

• If you experience a rash or allergic reaction such as itching, swelling of the lips/lips or wheezing/difficulty breathing. In this case, stop taking the tablets immediately and inform your doctor right away.
• If you experience blood clots in the veins (a rare adverse 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 (affects 1 to 10 patients per 1,000)

– Visual disturbances, especially color vision.

– Formation of a blood clot in an eye. This can cause bleeding in the eye or loss of vision.

– Itching, redness, or swelling in the skin.

Very rare (affects fewer than 1 patient per 10,000)

– Formation of a blood clot in 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 generally mild and disappear very quickly; but if they continue, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 30 °C.

Do not usethis medicationafter the expiration date that appears onthe packagingafter “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.Deposit the packaging and medicines that you no longer need at the SIGREpoint of the pharmacy. In case of doubtask your pharmacisthow to dispose ofthepackaging and themedicines that you no longerneed.By doing so, you will help protect the environment.

Composition of Amchafibrin

• The active principle 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,basic butyl methacrylate copolymer, titanium dioxide (E 171), macrogol, and vanillin.

Appearance of the product and contents of the packaging

White film-coated tablets with an oval shape and a notch on one of the faces.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Meda Pharma S.L.

C/General Aranaz, 86

28027 Madrid

Spain

Responsible for manufacturing

Madaus GmbH

Lütticher Str. 5

53842 Troisdorf,

Germany

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:November 2022

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