Tranexamic acid Accord

Package Leaflet: Information for the Patient

Tranexamic Acid Accord, 100 mg/ml, Solution for Injection

Tranexamic Acid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
• This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Tranexamic Acid Accord contains tranexamic acid, which belongs to a group of medicines called antifibrinolytics, anti-haemorrhagic agents.
Tranexamic Acid Accord is used in adults and children over 1 year of age to prevent and treat bleeding caused by a process that prevents blood clotting, called fibrinolysis.
The specific indications for use include:

• Heavy menstrual bleeding in women,
• Gastrointestinal bleeding,
• Haemorrhagic disorders of the urinary tract following prostate surgery or surgical procedures in the urinary tract,
• Surgical procedures involving the ear, nose, and throat,
• Surgical procedures involving the heart, abdomen, or gynaecological procedures,
• Bleeding after the use of other medicines that dissolve blood clots.

2. Important information before using Tranexamic Acid Accord

When not to use Tranexamic Acid Accord:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have a disease that leads to the formation of blood clots,
• if you have a condition called "consumption coagulopathy" that causes blood clotting throughout the body,
• if you have kidney problems,
• if you have had seizures.

Due to the risk of cerebral oedema and seizures, it is not recommended to perform intrathecal or intraventricular injections and intracerebral administration.
If any of the above applies to you, or if you are not sure whether the above text applies to you, you should talk to your doctor before taking Tranexamic Acid Accord.

Warnings and precautions

Tell your doctor if any of the following apply to you, to help him decide whether Tranexamic Acid Accord is suitable for you:

• If you have had blood in your urine, Tranexamic Acid Accord may lead to urinary tract obstruction.
• If you are at risk of blood clots.
• If you have excessive blood clotting or bleeding throughout the body (disseminated intravascular coagulation), Tranexamic Acid Accord may not be suitable for you, unless you have severe bleeding and blood tests have shown that the process that prevents blood clotting, called fibrinolysis, has been activated.
• If you have had seizures, you should not use Tranexamic Acid Accord. Your doctor will use the smallest possible dose to avoid seizures after using Tranexamic Acid Accord.
• If you are being treated with Tranexamic Acid Accord for a long time, you should be aware of possible vision disturbances and, if necessary, your doctor may recommend stopping treatment. During long-term use of tranexamic acid, regular ophthalmological examinations (eye examinations, including vision tests, colour vision, fundus examination, visual field, etc.) are recommended. In case of pathological eye changes, especially retinal diseases, your doctor will decide individually in each case whether long-term use of Tranexamic Acid Accord in the form of a solution for injection is necessary.

Tranexamic Acid Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken.
In particular, tell your doctor if you are taking:

• other medicines that help blood clotting, called antifibrinolytics,
• medicines that prevent blood clotting, called thrombolytics,
• oral contraceptives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Tranexamic acid passes into human milk. Therefore, Tranexamic Acid Accord should not be used during breastfeeding.

Driving and using machines

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

3. How to use Tranexamic Acid Accord

Use in adults

• Treatment of local fibrinolysis: The usual dose is 500 - 1000 mg (5-10 ml) two to three times a day.
• Treatment of generalised fibrinolysis: The usual dose is 1000 mg (10 ml) every 6 to 8 hours, equivalent to 15 mg/kg body weight.

Use in children

If Tranexamic Acid Accord in the form of a solution for injection is administered to children over 1 year of age, the dose will be calculated based on the child's body weight. Your 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 renal impairment is detected, the dose of tranexamic acid will be reduced according to the result of the blood test (serum creatinine concentration).

Use in patients with hepatic impairment

Dose reduction is not necessary.

Method of administration

Tranexamic Acid Accord should be administered only by slow intravenous injection.
Tranexamic Acid Accord must not be injected intramuscularly.

Overdose of Tranexamic Acid Accord

If you have been given too much of this medicine, you may experience dizziness, headache, transient hypotension. Contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects reported with Tranexamic Acid Accord:

Common side effects(may affect up to 1 in 10 people):

• gastrointestinal symptoms: nausea, vomiting, diarrhoea.

Uncommon side effects(may affect up to 1 in 100 people):

• skin symptoms: rash.

Frequency not known (cannot be estimated from the available data):

• malaise with hypotension (low blood pressure), with or without loss of consciousness, usually after too rapid intravenous injection,
• thrombosis,
• nervous system symptoms: seizures,
• eye symptoms: vision disturbances, including colour vision disturbances,
• immune system symptoms: allergic reactions.

If any of the side effects gets serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tranexamic Acid Accord

Keep this medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Your doctor or nurse will check this information before administering the medicine.
Unopened ampoules do not require any special storage conditions.

6. Contents of the pack and other information

What Tranexamic Acid Accord contains

The active substance is tranexamic acid.
5 ml of the solution for injection contains 500 mg of tranexamic acid.
10 ml of the solution for injection contains 1000 mg of tranexamic acid.
The other ingredients are water for injections.

What Tranexamic Acid Accord looks like and contents of the pack

Tranexamic Acid Accord, solution for injection is a clear, colourless solution, free from visible particles.
Ampoules made of type I glass are packed on trays or in blisters, in a cardboard box.
Pack sizes: 1 ampoule of 5 ml, 5 ampoules of 5 ml, 10 ampoules of 5 ml, 1 ampoule of 10 ml, 5 ampoules of 10 ml, 10 ampoules of 10 ml.
Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Tel: + 48 22 577 28 00

Manufacturer/Importer

Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Country

Member State

Medicinal product name

Austria
Tranexamsäure Accord 100 mg/ml Injektionslösung
Belgium
Tranexamic acid Accord 100 mg/ml oplossing voor injectie /
solution injectable / injektionslösung
Czech Republic
Tranexamic acid Accord 100 mg/ml injekční roztok
Cyprus
Tranexamic acid Accord 100 mg/ml solution for injection
Denmark
Tranexamsyre Accord
Estonia
Tranexamic acid Accord
Finland
Tranexamic acid Accord 100 mg/ml injektioneste, liuos
Spain
Tranexamic acid Accord 100 mg/ml, solución inyectable
Netherlands
Tranexaminezuur Accord 100 mg/ml oplossing voor injectie
Ireland
Tranexamic acid 100 mg/ml Solution for Injection
Iceland
Tranexamic acid Accord 100 mg/ml, stungulyf, lausn
Malta
Tranexamic acid 100 mg/ml Solution for Injection
Germany
Tranexamsäure Accord 100 mg/ml Injektionslösung
Norway
Traneksamsyre Accord
Poland
Tranexamic acid Accord
Portugal
Tranexamic acid Accord
Sweden
Tranexamic acid Accord 100 mg/ml Injektionsvätska, lösning
United Kingdom
(Northern Ireland)
Tranexamic acid 100 mg/ml Solution for Injection
Italy
Acido Tranexamico Accord

Date of last revision of the package leaflet: May 2024

Information intended for healthcare professionals only:

Tranexamic Acid Accord, 100 mg/ml, Solution for Injection

GENERAL INFORMATION

Tranexamic Acid Accord, 100 mg/ml, Solution for Injection is intended for single use only. Any unused portion of the solution should be discarded.

THERAPEUTIC INDICATIONS

Prevention and treatment of bleeding caused by generalised or local fibrinolysis in adults and children over 1 year of age, such as:

• Menstrual bleeding and uterine bleeding,
• Gastrointestinal bleeding,
• Haemorrhagic disorders of the urinary tract following prostate surgery or surgical procedures in the urinary tract,
• Surgical procedures involving the ear, nose, and throat,
• Gynaecological surgical procedures or obstetric complications,
• Surgical procedures in the thorax or abdomen,
• Control of bleeding caused by the administration of a fibrinolytic agent.

DOSAGE AND ADMINISTRATION

Tranexamic Acid Accord, 100 mg/ml, Solution for Injection should be administered by slow intravenous injection according to the dosing schedule below.

THERAPEUTIC DOSE

Adults:

• Treatment of local fibrinolysis: The usual dose is 5-10 ml (500 - 1000 mg) in slow intravenous injection (1 ml/min) two to three times a day
• Treatment of generalised fibrinolysis: The usual dose is 10 ml (1000 mg) in slow intravenous injection (1 ml/min) every 6 to 8 hours, equivalent to 15 mg/kg body weight.

Children:

In children over 1 year of age, for currently approved indications, the dosage is within the range of 20 mg/kg body weight/day.

Elderly patients:

Dose reduction is not necessary, unless there is evidence of renal impairment.

Renal impairment:

Due to the risk of accumulation of the medicinal product, the dose of tranexamic acid should be reduced according to the following table:

Method of administration:

Administration by slow intravenous injection only.

Special precautions for storage:

No special precautions for storage are necessary.
The product should be used immediately after opening. Any unused product or waste material should be disposed of in accordance with local requirements.

Shelf life:

Unopened ampoule: 24 months.