Tranexamic Acid Eugia

Package Leaflet: Information for the User

Tranexamic Acid Eugia, 100 mg/mL, Solution for Injection

Tranexamic Acid

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

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult a doctor or nurse.
If the patient experiences any side effects, including those not listed in this package leaflet, inform a doctor or nurse. See section 4.

Package Leaflet Contents

• 1. What is Tranexamic Acid Eugia and what is it used for
• 2. Important information before using Tranexamic Acid Eugia
• 3. How to use Tranexamic Acid Eugia
• 4. Possible side effects
• 5. How to store Tranexamic Acid Eugia
• 6. Package contents and other information

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

Tranexamic Acid Eugia contains the active substance tranexamic acid, which belongs to a group of medicines called antifibrinolytics, anti-haemorrhagics, and amino acids.
This medicine is used in adults and children over 1 year of age to prevent and treat bleeding caused by a process that prevents blood clotting, called fibrinolysis.
The specific indications for use include:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Haemorrhagic disorders of the urinary tract following prostate surgery or surgical procedures in the urinary tract
• Surgical procedures related to the ear, nose, and throat
• Surgical procedures related to the heart, abdomen, or gynaecological surgery
• Bleeding after using other medicines that dissolve blood clots.

2. Important information before using Tranexamic Acid Eugia

When not to use Tranexamic Acid Eugia

• if the patient is allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
• if the patient currently has a disease that leads to the formation of blood clots
• if the patient has a condition called "consumption coagulopathy" that causes blood clotting throughout the body
• if the patient has kidney function disorders
• if the patient has a history of seizures.

Due to the risk of cerebral oedema and seizures, it is not recommended to administer intrathecal or intracerebral injections or intracerebral administration.
If any of the above applies to the patient, or in case of any doubts, inform a doctor before using this medicine.

Warnings and precautions:

Before starting treatment with tranexamic acid, discuss with a doctor or nurse if the patient has any of the following conditions. This will help them decide if this medicine is suitable for the patient:

• If the patient has had blood in the urine, it 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), this medicine may not be suitable for the patient, unless the patient has acute, severe bleeding and blood tests have shown that the process that prevents blood clotting, called fibrinolysis, has been activated.
• If the patient has had seizures, do not use this medicine. The doctor will use the smallest possible dose to avoid seizures in the patient after using this medicine.
• If the patient is being treated with this medicine for a long time, pay attention to possible colour vision disturbances and, if necessary, interrupt treatment. During long-term use of tranexamic acid, regular ophthalmological examinations (eye examinations, including visual acuity, colour vision, fundus, visual field, etc.) are recommended. In case of pathological ophthalmological changes, especially in case of retinal diseases, the doctor, after consulting a specialist, must decide whether long-term use of this medicine is necessary for the patient.

Tranexamic Acid Eugia and other medicines

Inform a doctor, nurse, or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
In particular, inform about the use of:

• 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, consult a doctor or pharmacist before using this medicine.
Tranexamic acid passes into human milk. Therefore, do not use this medicine during breastfeeding.

Driving and using machines

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

3. How to use Tranexamic Acid Eugia

This medicine is administered as a slow intravenous injection.
The doctor will decide on the appropriate dose and duration of treatment.

Use in children

If this medicine is administered to a child over 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 how long it should be used.

Use in the elderly

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 serum creatinine level.

Use in patients with hepatic impairment

Dose reduction is not necessary.

Method of administration

This medicine should be administered only as a slow intravenous injection.
This medicine must not be administered intramuscularly.

Overdose of Tranexamic Acid Eugia

If the patient is given too much tranexamic acid, it may cause a temporary decrease in blood pressure. Immediately consult a doctor or pharmacist.
In case of any further doubts about the use of this medicine, consult a doctor or nurse.

4. Possible side effects

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

Side effects reported with the use of this medicine:

The following side effects have been observed during treatment with this medicine
Common (may affect up to 1 in 10 people)

• gastrointestinal symptoms: nausea, vomiting, diarrhoea

Uncommon (may affect up to 1 in 100 people)

• skin symptoms: rash

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

• malaise with hypotension (low blood pressure), usually after too rapid intravenous injection
• blood clots
• nervous system symptoms: seizures
• eye symptoms: vision disturbances, including colour vision disturbances
• immune system symptoms: allergic reactions.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, inform a doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tranexamic Acid Eugia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label after EXP. The expiry date refers to the last day of the month.
No special precautions for storage are necessary.
After opening: use immediately. Discard any unused portion of the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tranexamic Acid Eugia contains

• The active substance is tranexamic acid. Each mL of solution contains 100 mg of tranexamic acid. Each 5 mL ampoule contains 500 mg of tranexamic acid. Each 10 mL ampoule contains 1000 mg of tranexamic acid.

The other ingredients are water for injections.

What Tranexamic Acid Eugia looks like and contents of the pack

Solution for injection.
Ampoule of transparent glass type I containing 5 mL or 10 mL of solution for injection. To facilitate breaking, ampoules may have a "one-point cut (OPC)" or may be "scored". Ampoules are packed in a carton with printing.
Pack sizes:
5 mL: 1, 5, 6, 10, and 100 ampoules in a carton.
10 mL: 5 and 10 ampoules in a carton.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Eugia Pharma (Malta) Limited
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus N 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium:
Tranexaminezuur AB 100 mg/ml oplossing voor injectie
Italy:
Acido tranexamico Aurobindo
Germany:
Tranexamsäure PUREN 100 mg/ml Injektionslösung
Portugal:
Ácido Tranexâmico Generis
Poland:
Tranexamic Acid Eugia

Date of last revision of the package leaflet:

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INFORMATION INTENDED FOR MEDICAL PROFESSIONALS ONLY:

Dosing in adults

Unless otherwise prescribed, the following doses are recommended:

• 1. Standard treatment of local fibrinolysis:

0.5 g (1 ampoule containing 5 mL) to 1 g (1 ampoule containing 10 mL or 2 ampoules containing 5 mL) of tranexamic acid in slow intravenous injection (= 1 mL/minute) two to three times a day.

• 2. Standard treatment of generalised fibrinolysis:

1 g (1 ampoule containing 10 mL or 2 ampoules containing 5 mL) of tranexamic acid in slow intravenous injection (= 1 mL/minute) every 6 to 8 hours, which corresponds to 15 mg/kg body weight.

Use in children

If Tranexamic Acid Eugia, 100 mg/mL, solution for injection is administered to a child over 1 year of age, the dose will be determined based on the child's body weight. The doctor will decide on the appropriate dose for the child and how long it should be used.
In children over 1 year of age, for currently approved indications, the dosage is approximately 20 mg/kg body weight per day.

Use in the elderly

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

Use in patients with renal impairment

In case of renal impairment leading to a risk of accumulation, the use of tranexamic acid is contraindicated in patients with severe renal impairment.
In patients with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level:

Use in patients with hepatic impairment

Dose reduction is not necessary.

Method of administration

Tranexamic Acid Eugia, 100 mg/mL, solution for injection should be administered only slowly (= 1 mL/minute) intravenously.
Tranexamic Acid Eugia, 100 mg/mL, solution for injection must not be administered intramuscularly.