Tranexamic Acid Polpharma

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language.

Tranexamic Acid Polpharma (ACIDO TRANEXAMICO Bioindustria L.I.M.), 100 mg/ml
injection solution
Acidum tranexamicum
Tranexamic Acid Polpharma and ACIDO TRANEXAMICO Bioindustria L.I.M. are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Tranexamic Acid Polpharma and what is it used for
• 2. Important information before taking Tranexamic Acid Polpharma
• 3. How to take Tranexamic Acid Polpharma
• 4. Possible side effects
• 5. How to store Tranexamic Acid Polpharma
• 6. Contents of the packaging and other information

1. What is Tranexamic Acid Polpharma and what is it used for

Tranexamic Acid Polpharma contains tranexamic acid, which belongs to a group of medicines called antifibrinolytics, antihemorrhagics, and amino acids.
Tranexamic Acid Polpharma is used in adults and children over 1 year of age to prevent and treat bleeding caused by a process that inhibits blood clotting, called fibrinolysis. The detailed indications for use include:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Hemorrhagic disorders of the urinary system after prostate surgery or surgical procedures in the urinary system
• Surgical procedures related to the ear, nose, and throat
• Surgical procedures related to the heart, abdomen, or gynecological surgery
• Bleeding after taking other medicines that dissolve blood clots.

2. Important information before taking Tranexamic Acid Polpharma

When not to take Tranexamic Acid Polpharma

Due to the risk of cerebral edema and seizures, intrathecal and intraventricular injections, as well as intracerebral administration, are not recommended.
If any of the above applies to the patient, or if the patient is not sure if the above text applies to them, they should consult a doctor before taking Tranexamic Acid Polpharma.

Warnings and precautions

The patient should inform their doctor if any of the following apply to them, so that the doctor can decide whether Tranexamic Acid Polpharma is suitable for the patient:

• If the patient has had blood in their urine, Tranexamic Acid Polpharma may lead to urinary tract obstruction.
• If the patient is at risk of blood clots.
• If the patient has excessive blood clotting or bleeding throughout the body (disseminated intravascular coagulation), Tranexamic Acid Polpharma may not be suitable for the patient, unless the patient has severe bleeding and blood tests have shown that the process inhibiting blood clotting, called fibrinolysis, has been activated.
• If the patient has had seizures, they should not take Tranexamic Acid Polpharma. The doctor will use the smallest possible dose to avoid seizures in the patient after taking Tranexamic Acid Polpharma.
• If the patient is taking Tranexamic Acid Polpharma for a long time, they should be aware of possible vision disturbances and, if necessary, the doctor may recommend stopping the treatment. During long-term use of Tranexamic Acid Polpharma in the form of an injection solution, regular ophthalmological examinations (eye examinations, including vision tests, color vision, fundus, visual field, etc.) are recommended. In the case of pathological eye changes, especially retinal diseases, the doctor, after consulting a specialist, will decide individually in each case whether long-term use of Tranexamic Acid Polpharma in the form of an injection solution is necessary.

Tranexamic Acid Polpharma and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription, vitamins, minerals, herbal medicines, and dietary supplements.
In particular, the patient should inform their doctor if they are taking:

• other medicines that facilitate blood clotting, called antifibrinolytics
• medicines that prevent blood clotting, called thrombolytics
• oral contraceptives.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Tranexamic acid passes into human milk. Therefore, Tranexamic Acid Polpharma should not be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effects of Tranexamic Acid Polpharma on the ability to drive and use machines.

3. How to take Tranexamic Acid Polpharma

This medicine is administered as a slow intravenous injection into one of the patient's veins.
The doctor will decide on the appropriate dose for the patient and determine how long it should be taken.

Use in children

If Tranexamic Acid Polpharma in the form of an intravenous injection solution is administered to children from 1 year of age, the dose will be calculated based on the child's body weight. The doctor will decide on the appropriate dose for the child and determine how long it should be taken.

Use in elderly patients

Dose reduction is not necessary, unless there is evidence of renal impairment.

Use in patients with renal impairment

If the patient has renal impairment, the dose of tranexamic acid will be reduced according to the results of a blood test (serum creatinine level).

Use in patients with hepatic impairment

Dose reduction is not necessary.

Method of administration

Tranexamic Acid Polpharma should be administered only as a slow intravenous injection. Tranexamic Acid Polpharma should not be injected intramuscularly.

Overdose of Tranexamic Acid Polpharma

If the patient is given too much of the medicine, they may experience dizziness, headache, transient decrease in blood pressure, and seizures. The patient should contact their doctor or nurse immediately.

4. Possible side effects

Like all medicines, Tranexamic Acid Polpharma can cause side effects, although not everybody gets them.

Side effects reported during the use of Tranexamic Acid Polpharma

During the use of Tranexamic Acid Polpharma, the following side effects have been observed:
Common(may affect up to 1 in 10 people):

• nausea, vomiting, diarrhea.

Uncommon(may affect up to 1 in 100 people):

• rash.

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

• malaise with hypotension (low blood pressure), usually after too rapid intravenous injection;
• blood clots in different parts of the body;
• seizures;
• vision disturbances, including color vision disturbances;
• allergic reactions;
• fixed drug eruption.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49-21-301,
fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl .
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tranexamic Acid Polpharma

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tranexamic Acid Polpharma contains

• The active substance is tranexamic acid. 1 ml of the injection solution contains 100 mg of tranexamic acid. One ampoule (5 ml) contains 500 mg of tranexamic acid.
• The other ingredients are: water for injections.

What Tranexamic Acid Polpharma looks like and what the pack contains

Ampoules made of colorless glass, placed in a cardboard box.
The packaging contains 5 ampoules of 5 ml each.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Italy, the country of export:

Bioindustria Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis 2, 15067 Novi Ligure (Al), Italy

Manufacturer:

Bioindustria Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis 2, 15067 Novi Ligure (Al), Italy

Parallel importer:

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49
51-162 Wrocław

Marketing authorization number in Italy, the country of export: 035748019

Parallel import authorization number: 208/25

Date of leaflet approval: 20.06.2025

[logo of the parallel importer]