Tranexamic acid delfarma

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Tranexamic acid Delfarma (Medsamic), 100 mg/ml, solution for injection
Acidum tranexamicum
Tranexamic acid Delfarma and Medsamic are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse immediately. See section 4.

Table of contents

1. What Tranexamic acid Delfarma is and what it is used for
2. Important information before using Tranexamic acid Delfarma
3. How to use Tranexamic acid Delfarma
4. Possible side effects
5. How to store Tranexamic acid Delfarma
6. Contents of the pack and other information

1. What Tranexamic acid Delfarma is and what it is used for

Tranexamic acid Delfarma contains the active substance tranexamic acid, which belongs to a group of medicines known as haemostatic agents, antifibrinolytic agents, and amino acids.
Tranexamic acid Delfarma is used in adults and children over 1 year of age to prevent and treat bleeding caused by a process that inhibits blood clotting, 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
• Ear, nose, and throat surgical procedures
• Cardiac, abdominal, or gynaecological surgical procedures
• Bleeding following administration of other medicines that dissolve blood clots

2. Important information before using Tranexamic acid Delfarma

When not to use Tranexamic acid Delfarma

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has a disease that leads to blood clots
• 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 experienced seizures.

Due to the risk of cerebral edema and seizures, intrathecal, intraventricular, and intracerebral injections are not recommended.
If any of the above apply to the patient, or if the patient is unsure whether the above statements apply to them, they should speak with their doctor before taking Tranexamic acid Delfarma.

Warnings and precautions
Inform your doctor if any of the following apply to you, so they can decide whether Tranexamic acid Delfarma is suitable for you:

• If the patient has blood in the urine, Tranexamic acid Delfarma may cause 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 Delfarma may not be appropriate, except in cases of acute severe bleeding when blood tests have confirmed activation of the process inhibiting blood clot breakdown, known as fibrinolysis.
• If the patient has had seizures, Tranexamic acid Delfarma should not be used. The doctor will administer the lowest possible dose to minimize the risk of seizures following treatment with Tranexamic acid Delfarma.
• If the patient is undergoing long-term treatment with Tranexamic acid Delfarma, possible disturbances in color vision should be monitored, and the doctor may recommend discontinuation if necessary. During prolonged use of Tranexamic acid Delfarma as an injection solution, regular ophthalmological examinations (eye examinations, including visual acuity, color vision, fundoscopy, visual fields, etc.) are recommended. In the event of pathological eye changes, especially retinal diseases, the doctor, after consultation with a specialist, will decide on an individual basis whether continued long-term use of Tranexamic acid Delfarma as an injection solution is justified.

Tranexamic acid Delfarma and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines, vitamins, minerals, herbal remedies, and dietary supplements.
In particular, inform your doctor if the patient is taking:

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Tranexamic acid passes into human milk. Therefore, the use of Tranexamic acid Delfarma is not recommended during breastfeeding.

Driving and operating machinery
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery.

3. How to use Tranexamic acid Delfarma

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

Use in children
If Tranexamic acid Delfarma solution for intravenous injection 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 the appropriate dose for the child and determine how long it should be administered.

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 renal function, the dose of tranexamic acid will be reduced according to the results of blood tests (serum creatinine concentration).

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

Method of administration
Tranexamic acid Delfarma must be administered only as a slow intravenous injection.
Tranexamic acid Delfarma must not be administered by intramuscular injection.

Overdose of Tranexamic acid Delfarma
If an excessive dose of Tranexamic acid Delfarma is administered, symptoms such as dizziness, headache, transient lowering of blood pressure, and seizures may occur. Immediate contact with a doctor or nurse is required.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions reported during the use of Tranexamic acid Delfarma
The following adverse reactions have been observed during the use of Tranexamic acid Delfarma:

Common (may occur in up to 1 in 10 people):

• nausea, vomiting, diarrhoea.

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

• rash.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

5. How to store Tranexamic acid Delfarma

Keep the medicine out of the sight and reach of children.
Protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tranexamic acid Delfarma contains

• The active substance is tranexamic acid.
• The other component is water for injections.

What Tranexamic acid Delfarma looks like and contents of the pack
Ampoules placed in a cardboard box.
The pack contains 5 ampoules of 5 ml each.
For additional information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Cyprus, country of export:
Medochemie Ltd
Constantinoupoleos 1-10, 3011 Limassol, Cyprus
Manufacturer:
Medochemie Ltd Ampoule Injectable Facility
48 Iapetou Street, Agios Athanassios Industrial Area
4101 Agios Athanassios, Limassol, Cyprus
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Relabelled and repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Cyprus, country of export: 021959
Parallel import licence number: 305/25
Date of revision of the leaflet: 10.09.2025