Tranexamic acid neupharm

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

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

Tranexamic acid Neupharm contains tranexamic acid, which belongs to a group of medicines known as haemostatic agents, antifibrinolytics, and amino acids.
Tranexamic acid Neupharm 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.
• 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 Neupharm

When not to use Tranexamic acid Neupharm

• 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 and intraventricular injections as well as intracerebral administration are not recommended.
If any of the above apply to the patient, or if the patient is unsure whether the above applies to them, they should speak with their doctor before taking Tranexamic acid Neupharm.
Warnings and precautions
Inform your doctor if any of the following apply to you, so they can decide whether Tranexamic acid Neupharm is suitable for you:

• If the patient has blood in the urine, Tranexamic acid Neupharm may lead to obstruction of the urinary tract.
• 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 Neupharm may not be appropriate, except in cases of acute severe bleeding when blood tests have confirmed activation of the process that inhibits blood clotting, known as fibrinolysis.
• If the patient has a history of seizures, Tranexamic acid Neupharm should not be used. The doctor will use the lowest possible dose to minimize the risk of seizures after administration of Tranexamic acid Neupharm.
• If the patient is receiving long-term treatment with Tranexamic acid Neupharm, possible disturbances in color vision should be monitored, and the doctor may recommend discontinuation of treatment if necessary. During prolonged use of Tranexamic acid Neupharm as an injection solution, regular ophthalmological examinations (eye examinations, including visual acuity, color vision, fundoscopy, visual fields, 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 Neupharm as an injection solution is necessary.

Tranexamic acid Neupharm 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 use, 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 baby, she should consult her doctor or pharmacist before using this medicine.
Tranexamic acid passes into human milk. Therefore, the use of Tranexamic acid Neupharm 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 Neupharm

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 Neupharm 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 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 Neupharm must be administered only as a slow intravenous injection.
Tranexamic acid Neupharm must not be administered by intramuscular injection.

Use of a higher than recommended dose of Tranexamic acid Neupharm
If an excessive dose of the medicine is administered to the patient, symptoms such as dizziness, headache, transient decrease in 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 Neupharm

The following adverse reactions have been observed during the use of Tranexamic acid Neupharm:

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 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 enables further collection of information on the safety of the medicine.

5. How to store Tranexamic acid Neupharm

Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Tranexamic acid Neupharm contains

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

What Tranexamic acid Neupharm looks like and contents of the pack
Ampoules made of colourless glass, packed 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, country of export:
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milan
Italy

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

Parallel importer:
Neupharm Sp. z o.o.
Ługowa 85
96-320 Mszczonów
Poland

Repackaged by:
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
Długosza 49
51-162 Wrocław
Poland

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

GP LABEL Ostrowski spółka jawna
Obywatelska 128/152 lok. 2B/C
94-104 Łódź
Poland

Marketing authorisation number in Italy, country of export: 021458031
Parallel import authorisation number: 42/26