Tranexamic acid tillomed

Package leaflet: Information for the user

Tranexamic acid Tillomed, 100 mg/mL, solution for injection
Acidum tranexamicum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. See section 4.

Contents of the leaflet

1. What Kwas traneksamowy Tillomed is and what it is used for
2. What you need to know before using Kwas traneksamowy Tillomed
3. How to use Kwas traneksamowy Tillomed
4. Possible side effects
5. How to store Kwas traneksamowy Tillomed
6. Contents of the pack and other information

1. What Kwas traneksamowy Tillomed is and what it is used for

Kwas traneksamowy Tillomed contains tranexamic acid, which belongs to a group of medicines called antifibrinolytic agents, haemostatics, and amino acids.
Kwas traneksamowy Tillomed is used in adults and children over 1 year of age to prevent and treat bleeding caused by a process that breaks down blood clots, known as fibrinolysis.
Specific indications include:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Haemorrhagic disorders of the urinary tract following prostate surgery or other urological surgical procedures
• Surgical procedures involving the ear, nose, and throat
• Cardiac, abdominal, or gynaecological surgical procedures
• Bleeding following administration of other medicines that dissolve blood clots.

2. Important information before using Kwas traneksamowy Tillomed

When not to use Kwas traneksamowy 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 blood clots formation
• if the patient has a condition called "disseminated intravascular coagulation" (DIC), which causes blood clotting throughout the body
• if the patient has kidney function disorders
• if the patient has ever experienced seizures

Due to the risk of cerebral edema and seizures, administration of the drug into the spine,
epidurally (around the spinal cord), or intracerebrally (into the brain) is not recommended.
If any of the above apply to the patient, or if the patient is unsure whether the above applies,
they should consult their doctor before using Kwas traneksamowy Tillomed.

Warnings and precautions

This medicine must be administered ONLY intravenously via 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 adverse events have been reported following intrathecal administration (spinal administration) of this medicine. If back or leg pain occurs during or shortly after administration of the medicine, the patient must immediately inform the doctor or nurse.

The patient should inform the doctor if any of the following situations apply, to help the doctor decide whether Kwas traneksamowy Tillomed is appropriate:

• If the patient has had blood in the urine, Kwas traneksamowy Tillomed may lead to urinary tract obstruction.
• If the patient is at risk of developing blood clots. The risk of thromboembolic events may be higher in patients taking oral contraceptives.
• If the patient has excessive blood clotting or bleeding throughout the body (disseminated intravascular coagulation, DIC), Kwas traneksamowy Tillomed may not be suitable, except in cases of acute, severe bleeding when blood tests have confirmed activation of the fibrinolytic process (the process that normally breaks down clots).
• If the patient is being treated for postpartum hemorrhage: cases of acute kidney injury have been reported following doses exceeding 2 g. Therefore, caution is advised when administering Kwas traneksamowy Tillomed in doses exceeding 2 g.
• If the patient has a history of seizures, Kwas traneksamowy Tillomed should not be used. The doctor will use the lowest possible dose to minimize the risk of seizures following administration of Kwas traneksamowy Tillomed.
• If the patient is receiving long-term treatment with Kwas traneksamowy Tillomed, possible disturbances in color vision should be monitored, and if necessary, the doctor may recommend discontinuation of treatment. During prolonged use of tranexamic acid, regular ophthalmological examinations (eye examinations, including visual acuity, color vision, fundoscopy, visual fields, etc.) are recommended. In case of pathological ophthalmological findings, especially retinal disorders, the doctor must, after consultation with a specialist, decide whether continued long-term treatment with Kwas traneksamowy Tillomed is necessary.

Kwas traneksamowy Tillomed and other medicines

The patient should inform the doctor or nurse about all medicines currently taken or recently used, as well as any medicines planned for future use.

In particular, the patient should inform the doctor if they are taking:

• other medicines that promote blood clotting, known as antifibrinolytic agents
• medicines that prevent blood clotting, known as thrombolytic agents
• oral contraceptives containing estrogens

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Tranexamic acid passes into human milk. Therefore, the use of Kwas traneksamowy Tillomed during breastfeeding is not recommended.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive vehicles or operate machinery.

3. How to use Kwas traneksamowy Tillomed

Kwas traneksamowy Tillomed solution for injection will be administered to the patient as a slow intravenous injection and should not be given by any other route.
The doctor will decide the correct dose and how long it should be administered.

Use in children
If Kwas traneksamowy Tillomed solution for intravenous injection is administered to children aged 1 year and older, the dose will be calculated based on the child's body weight.
The doctor will determine the appropriate dose for the child and decide how long it should be given.

Use in elderly patients
Dose reduction is not necessary unless there is evidence of renal impairment.

Use in patients with renal function disorders
If the patient has impaired kidney function, the dose of tranexamic acid will be reduced according to the results of blood tests (serum creatinine concentration).

Use in patients with liver function disorders
Dose reduction is not necessary.

Method of administration
Kwas traneksamowy Tillomed must be administered only as a slow intravenous injection.
Kwas traneksamowy Tillomed must not be injected intramuscularly or into the spinal canal.

Use of a higher than recommended dose of Kwas traneksamowy Tillomed
If an overdose of the medicine is administered to the patient, transient hypotension (low blood pressure) may occur. Immediate contact with a doctor or pharmacist is required.

If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions reported after administration of Kwas traneksamowy Tillomed:
The following adverse reactions have been observed during the use of Kwas traneksamowy Tillomed:

Frequent adverse reactions (may occur in up to 1 in 10 people)

• Gastrointestinal symptoms: nausea, vomiting, diarrhoea

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Skin reactions: rash

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

• Malaise with hypotension (low blood pressure), with or without loss of consciousness, especially if the injection is administered too rapidly
• Thrombosis
• Nervous system disorders: seizures
• Eye disorders: visual disturbances, including colour vision disturbances
• Sudden onset of renal dysfunction
• Immune system disorders: allergic reactions

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the medicine's safety and helps to gather more information on its benefit-risk profile.

5. How to store Kwas traneksamowy Tillomed

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and label following: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
After first opening: the injection solution is intended for single use only. Any unused injection solution must be discarded.
Chemical and physical stability of the product has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the user is responsible for the duration and conditions of storage prior to use.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Kwas traneksamowy Tillomed contains

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

What Kwas traneksamowy Tillomed looks like and contents of the pack
Kwas traneksamowy Tillomed, solution for injection is a clear, colourless solution.
Packaging containing 1, 5 or 10 ampoules made of type I glass with a capacity of 5 mL in a cardboard box, each ampoule containing 500 mg of tranexamic acid.
Packaging containing 1, 5 or 10 vials made of type I glass with a capacity of 10 mL in a cardboard box, each vial containing 1000 mg of 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
Tel: +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 medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

| Member State | Medicinal Product Name | |------------------|----------------------------| | 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 |