Tranexamic acid Sviss2care

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tranexamic acid Swiss2Care (Ugurol), 100 mg/ml (500 mg/5 ml), solution for injection

Tranexamic acid
Tranexamic acid Swiss2Care and Ugurol are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or nurse.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Tranexamic acid Swiss2Care and what is it 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. Package contents and other information

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

Tranexamic acid Swiss2Care contains tranexamic acid, which belongs to a group of medicines called antihemorrhagic 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, called fibrinolysis.
In particular, the indications for use include:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Hemorrhagic disorders of the urinary system after prostate surgery or surgical procedures in the urinary system
• Surgical procedures related to the ear, nose, and throat
• Surgical procedures related to the heart, abdominal cavity, or gynecological surgery
• Bleeding after the use of other medicines that dissolve blood clots.

2. Important information before using Tranexamic acid Swiss2Care

When not to use Tranexamic acid Swiss2Care

Warnings and precautions

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

Tranexamic acid Swiss2Care and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are 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 facilitate blood clotting, called antifibrinolytic agents
• medicines that prevent blood clotting, called thrombolytic agents
• oral contraceptives.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before using this medicine.
Tranexamic acid passes into human milk. Therefore, it is not recommended to use Tranexamic acid Swiss2Care during breastfeeding.

Driving and using machines

No studies have been conducted on the impact on the ability to drive and use machines.

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 on the appropriate dose for the patient and determine how long it should be used.
Use in children
If Tranexamic acid Swiss2Care in the form of a 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 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 Swiss2Care should be administered only as a slow intravenous injection.
Tranexamic acid Swiss2Care should not be administered intramuscularly.

Use of a higher than recommended dose of Tranexamic acid Swiss2Care

If the patient is given too high a dose of the medicine, they may experience dizziness, headache, transient decrease in blood pressure, and seizures. The patient should immediately contact 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 during the use of Tranexamic acid Swiss2Care

During the use of Tranexamic acid Swiss2Care, the following side effects have been observed:
Common (may affect up to 1 in 10 people):

• nausea, vomiting, diarrhea.

Uncommon (may affect up to 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;
• vision disturbances, including color vision disturbances;
• allergic reactions;
• fixed drug eruption.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 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 authorization holder or parallel importer.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tranexamic acid Swiss2Care

The medicine should be stored out of 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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tranexamic acid Swiss2Care contains

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

What Tranexamic acid Swiss2Care looks like and what the package contains

Ampoules made of colorless glass, in a cardboard box.
The package contains 5 ampoules of 5 ml each.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Italy, the country of export:

Rottapharm S.p.A.
Galleria Unione, 5 - 20122 Milan
Italy

Manufacturer:

Haupt Pharma Livron S.A.S
Rue Comté de Sinard 1
F-26250 Livron-sur-Drôme
France

Parallel importer:

Swiss2Care Sp. Z o.o. Sp. k.
ul. Mostowa 38/1
87-100 Toruń

Repackaged by:

CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Italian marketing authorization number: 021458029
021458031
Parallel import authorization number: 258/24

Date of leaflet approval: 26.06.2024