Tranexamic acid polpharma

Package leaflet: Information for the patient

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
brand names of the same medicinal product.
Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Tranexamic Acid Polpharma contains tranexamic acid, which belongs to a group of medicines known as haemostatic agents, antifibrinolytics, 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, known as fibrinolysis. Specific indications include:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Haemorrhagic disorders of the urinary system 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. Information before using Tranexamic Acid Polpharma

When not to use Tranexamic Acid Polpharma

• 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 had 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 text applies to them, they should speak with their doctor before taking Tranexamic Acid Polpharma.
Warnings and precautions
Inform your doctor if any of the following apply to you, so they can decide whether Tranexamic Acid Polpharma is appropriate for you:

• If the patient has had blood in the 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, except in cases of acute severe bleeding when blood tests have confirmed activation of the clot-dissolving process known as fibrinolysis.
• If the patient has had seizures, Tranexamic Acid Polpharma should not be used. The doctor will use the lowest possible dose to minimize the risk of seizures after administration of Tranexamic Acid Polpharma.
• If the patient is receiving long-term treatment with Tranexamic Acid Polpharma, possible disturbances in color vision should be monitored, and the doctor may recommend discontinuation of treatment if necessary. During prolonged use of Tranexamic Acid Polpharma injection solution, regular ophthalmological examinations (eye examinations, including visual acuity, color vision, fundoscopy, visual field testing, etc.) are recommended. In the event of pathological eye changes, especially retinal diseases, the doctor, after consultation with a specialist, will decide individually in each case whether prolonged use of Tranexamic Acid Polpharma injection solution is necessary.

Tranexamic Acid Polpharma and other medicines
Tell 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 medicines, 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 might 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 Polpharma is not recommended during breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect of this medicine on the ability to drive or operate machinery.

3. How to use Tranexamic Acid Polpharma

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 given.

Use in children
If Tranexamic Acid Polpharma 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 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 renal function disorders, 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 Polpharma must be administered only as a slow intravenous injection. Tranexamic Acid Polpharma must not be administered by intramuscular injection.

Overdose of Tranexamic Acid Polpharma
If an excessive dose of the medicine is administered to the patient, symptoms such as dizziness, headache, transient lowering of arterial 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 will experience them.
Adverse reactions reported during the use of Tranexamic Acid Polpharma

The following adverse reactions have been observed during the use of Tranexamic Acid Polpharma:

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

• nausea, vomiting, diarrhoea.

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

• 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 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 181C,
02-222 Warsaw,
tel.: +48 22 49-21-301,
fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl .
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Tranexamic Acid Polpharma

Keep the medicine out of the sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the carton. 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 no longer required. 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 injection solution contains 100 mg of tranexamic acid. One ampoule (5 ml) contains 500 mg of tranexamic acid.
• The other component is: water for injections.

What Tranexamic Acid Polpharma looks like and contents of the pack
Ampoules made of colourless glass, placed in a cardboard box.
The pack contains 5 ampoules of 5 ml each.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49
51-162 Wrocław
Marketing authorisation number in Italy, the country of export: 035748019
Parallel import licence number: 208/25
[parallel importer's logo]