Tranexamic acid swiss2care

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Tranexamic acid Swiss2Care (Ugurol), 100 mg/ml (500 mg/5 ml), solution for injection
Acidum tranexamicum
Tranexamic acid Swiss2Care and Ugurol are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Tranexamic acid Swiss2Care is and what it is used for
2. Important information before using Tranexamic acid Swiss2Care
3. How to use Tranexamic acid Swiss2Care
4. Possible side effects
5. How to store Tranexamic acid Swiss2Care
6. Contents of the pack and other information

1. What Tranexamic acid Swiss2Care is and what it is used for

Tranexamic acid Swiss2Care contains tranexamic acid, which belongs to a group of medicines known as haemostatic agents, antifibrinolytic agents, and amino acids.
Tranexamic acid Swiss2Care 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 surgical procedures involving the urinary tract
• Surgical procedures involving the ear, nose, and throat
• Cardiac, abdominal, or gynaecological surgical procedures
• Bleeding following the use of other medicines that dissolve blood clots.

2. Important information before using Tranexamic acid Swiss2Care

When not to use Tranexamic acid Swiss2Care

• 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 "consumption coagulopathy", 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 applies to the patient, or if the patient is unsure whether the above information concerns them, they should consult their doctor before taking Tranexamic acid Swiss2Care.

Warnings and precautions
The patient should inform their doctor if any of the following apply, to help the doctor
decide whether Tranexamic acid Swiss2Care is suitable:

• If the patient has had blood in the urine, Tranexamic acid Swiss2Care 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 Swiss2Care may not be appropriate, except in cases of acute severe bleeding when blood tests have shown that fibrinolysis (a process that inhibits blood clotting) has been activated.
• If the patient has experienced seizures, Tranexamic acid Swiss2Care should not be used. The doctor will use the lowest possible dose to avoid the occurrence of seizures after administration of Tranexamic acid Swiss2Care.
• If the patient is being treated long-term with Tranexamic acid Swiss2Care, possible disturbances in color vision should be monitored, and the doctor may recommend discontinuation if necessary. During long-term treatment with Tranexamic acid Swiss2Care injection solution, regular ophthalmological examinations (eye examinations, including visual acuity, color vision, fundoscopy, visual field testing, etc.) are recommended. In case of pathological eye changes, especially retinal diseases, the doctor, after consultation with a specialist, will decide individually in each case whether long-term use of Tranexamic acid Swiss2Care injection solution is necessary.

Tranexamic acid Swiss2Care and other medicines
The patient should inform their doctor about all medicines currently being taken or
recently taken, as well as any medicines they plan to use, including those available
without a prescription, vitamins, minerals, herbal medicines, and dietary supplements.
In particular, the patient should inform their 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.

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 Swiss2Care is not recommended during breastfeeding.

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

3. How to use Tranexamic acid Swiss2Care

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 used.
Use in children
If Tranexamic acid Swiss2Care solution for 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 used.
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 Swiss2Care must be administered exclusively by slow intravenous injection.
Tranexamic acid Swiss2Care must not be administered intramuscularly.
Use of a higher than recommended dose of Tranexamic acid Swiss2Care
If an excessive dose of the medicine is administered to the patient, symptoms such as dizziness, headache, transient decrease in arterial blood pressure, and seizures may occur. You should immediately contact a doctor or nurse.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions reported during treatment with Tranexamic acid Swiss2Care

The following adverse reactions have been observed during treatment with Tranexamic acid Swiss2Care:
Common (may occur in less than 1 in 10 people):

• nausea, vomiting, diarrhoea.

Uncommon (may occur in less than 1 in 100 people):

• rash.

Frequency not known (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 colour vision disturbances;
• allergic reactions;
• fixed drug eruption.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring 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
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tranexamic acid Swiss2Care

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 should 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 Swiss2Care contains

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

What Tranexamic acid Swiss2Care looks like and contents of the packaging
Clear glass ampoules in a cardboard box.
The packaging contains 5 ampoules of 5 ml each.
For further detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Italy, the country of export:
Rottapharm S.p.A.
Galleria Unione, 5 - 20122 Milan
Italy
Manufacturer:
Haupt Pharma Livron S.A.S
1 Rue Comté de Sinard
F-26250 Livron-sur-Drôme
France
Parallel importer:
Swiss2Care Sp. z o.o. Sp. k.
ul. Mostowa 38/1
87-100 Toruń
Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Italian marketing authorisation number, country of export: 021458029
Parallel import licence number: 258/24