Kvas traneksamovi Tillomed

Package Leaflet: Information for the User

Tranexamic Acid Tillomed, 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.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

1.

What is Tranexamic Acid Tillomed and what is it used for

2.

Important information before using Tranexamic Acid Tillomed

3.

How to use Tranexamic Acid Tillomed

4.

Possible side effects

5.

How to store Tranexamic Acid Tillomed

6.

Contents of the package and other information

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

Tranexamic Acid Tillomed contains tranexamic acid, which belongs to a group of medicines called antifibrinolytics, anti-haemorrhagics, and amino acids.
Tranexamic Acid Tillomed 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
• Bleeding from the gastrointestinal tract
• Bleeding disorders of the urinary system after prostate surgery or surgical procedures in the urinary system
• Surgical procedures in the ear, nose, and throat
• Surgical procedures in the heart, abdominal cavity, or gynaecological surgery
• Bleeding after the use of other medicines that dissolve blood clots.

2. Important information before using Tranexamic Acid Tillomed

When not to use Tranexamic Acid Tillomed

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

Due to the risk of cerebral oedema and seizures, it is not recommended to administer the medicine into the spine, epidurally (around the spinal cord), or into the brain.
If any of the above applies to the patient, or if the patient is unsure whether the above text applies to them, they should consult their doctor before using Tranexamic Acid Tillomed.

Warnings and precautions

This medicine can only be administered intravenously in an intravenous infusion (iv) or intravenous injection (iv injection). This medicine must not be administered into the spine, epidurally (around the spinal cord), or into the brain. Serious consequences have been reported after administration of this medicine into the spine (intrathecal administration). If back pain or leg pain occurs during or shortly after administration of the medicine, the patient should immediately inform their doctor or nurse.
The patient should inform their doctor if any of the following situations apply to them, to help the doctor decide whether Tranexamic Acid Tillomed is suitable for the patient:

• If the patient has had blood in their urine, Tranexamic Acid Tillomed may cause urinary tract obstruction.
• If the patient is at risk of blood clots. The risk of thrombotic events may be higher in patients taking oral contraceptives.
• If the patient has excessive blood clotting or bleeding throughout the body (disseminated intravascular coagulation), Tranexamic Acid Tillomed 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 is being treated for postpartum haemorrhage: cases of acute kidney injury have been reported after administration of doses greater than 2 g. Therefore, caution should be exercised when using Tranexamic Acid Tillomed in doses greater than 2 g.
• If the patient has had seizures, they should not use Tranexamic Acid Tillomed. The doctor will use the smallest possible dose to avoid seizures in the patient after administration of Tranexamic Acid Tillomed.
• If the patient is being treated with Tranexamic Acid Tillomed for a long time, they should be aware of possible vision disturbances and, if necessary, the doctor may recommend discontinuing treatment. During long-term use of tranexamic acid, regular ophthalmological examinations (eye examinations, including visual acuity, colour vision, fundus examination, visual field examination, etc.) are recommended. In case of pathological ophthalmological changes, especially in case of retinal diseases, the doctor, after consulting a specialist, must decide whether it is necessary to continue long-term treatment with Tranexamic Acid Tillomed in the patient.

Tranexamic Acid Tillomed and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking:

• other medicines that promote blood clotting, called antifibrinolytics
• medicines that prevent blood clotting, called thrombolytics
• oral contraceptives containing oestrogens

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.
Tranexamic acid passes into human milk. Therefore, Tranexamic Acid Tillomed should not be used 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 Tillomed

Tranexamic Acid Tillomed in the form of a solution for injection will be administered to the patient by slow intravenous injection and should not be administered by any other route.
The doctor will decide on the appropriate dose and how long it should be taken.

Use in children

If Tranexamic Acid Tillomed in the form of a solution for injection is administered to children 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 determine how long it should be used.

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 the blood test (serum creatinine level).

Use in patients with hepatic impairment

Dose reduction is not necessary.

Method of administration

Tranexamic Acid Tillomed should be administered by slow intravenous injection only.
Tranexamic Acid Tillomed must not be injected intramuscularly or into the spine.

Use of a higher than recommended dose of Tranexamic Acid Tillomed

If the patient is given too much of the medicine, they may experience a temporary decrease in blood pressure. The patient should immediately contact their doctor or pharmacist.
If the patient has any further questions about the use of this medicine, they should ask their 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 Tranexamic Acid Tillomed:

During treatment with Tranexamic Acid Tillomed, the following side effects have been observed:
Common side effects (may affect up to 1 in 10 people)

• gastrointestinal symptoms: nausea, vomiting, diarrhoea

Uncommon side effects (may affect up to 1 in 100 people)

• skin symptoms: rash

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

• malaise with hypotension (low blood pressure), with or without loss of consciousness, especially if the injection is given too quickly
• thrombosis
• neurological symptoms: seizures
• eye symptoms: vision disturbances, including colour vision disturbances
• sudden onset of kidney function disorders
• immune system symptoms: allergic reactions.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should tell their doctor or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: +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.
By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Tranexamic Acid Tillomed

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
After first opening: the solution for injection is intended for single use only. Any unused solution for injection should be discarded.
The chemical and physical stability of the product has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Tranexamic Acid Tillomed contains

• The active substance is tranexamic acid.
• Each 5 mL solution for injection contains 500 mg tranexamic acid.
• Each 10 mL solution for injection contains 1000 mg tranexamic acid.
• The other ingredient is water for injections.

What Tranexamic Acid Tillomed looks like and contents of the package

Tranexamic Acid Tillomed, solution for injection is a clear, colourless solution.
Packages containing 1, 5 or 10 glass ampoules of type I, 5 mL, in a cardboard box, each ampoule contains 500 mg tranexamic acid.
Packages containing 1, 5 or 10 glass vials of type I, 10 mL, in a cardboard box, each vial contains 1000 mg tranexamic acid.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Tillomed Pharma GmbH
Mittelstraße 5/5a
12529 Schönefeld
Germany
Phone: +48 509 368 531
Email: [email protected]

Importer

MIAS Pharma Limited
Suite 2, Stafford House
Strand Road, Portmarnock
Co. Dublin
Ireland
Tillomed Malta Limited
Malta Life Sciences Park
LS2.01.06 Industrial Estate, San Gwann, SGN 3000
Malta

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State Name of the medicine

Austria
Tranexamsäure Tillomed 100 mg/ml Injektionslösung
Bulgaria
Транексамова киселина Тиломед 100 mg/ml
инжекционен разтвор
Denmark
Tranexamic acid Tillomed
Finland
Tranexamic acid Tillomed
France
ACIDE TRANEXAMIQUE TILLOMED
Netherlands
Tranexaminezuur Tillomed 100 mg/ml oplossing voor
injectie
Germany
Tranexamsäure Tillomed 100 mg/ml Injektionslösung
Norway
Tranexamic acid Tillomed
Poland
Kwas traneksamowy Tillomed
Sweden
Tranexamic acid Tillomed
Date of last revision of the package leaflet:March 2024