Tranexamic acid accord

Package leaflet: Information for the patient

Tranexamic acid Accord, 100 mg/mL, solution for injection
Acidum tranexamicum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

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

Leaflet contents

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

Tranexamic acid Accord contains tranexamic acid, which belongs to a group of medicines known as
antifibrinolytic agents, antihemorrhagic agents, and amino acids.
Tranexamic acid Accord 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.
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 administration of other medicines that dissolve blood clots.

2. Information before using Tranexamic acid Accord

When not to use Tranexamic acid Accord:

• 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 causing blood clots,
• if the patient has a condition called "disseminated intravascular coagulation" (DIC), which causes blood clotting throughout the body,
• if the patient has had seizures.

Due to the risk of cerebral edema and seizures, tranexamic acid must not be administered into the
spinal canal, epidurally (around the spinal cord), or into the brain.
If any of the above apply to the patient, or if the patient is unsure whether the above applies to them,
they should speak to their doctor before taking Tranexamic acid Accord.
Warnings and precautions
This medicine must be administered INTRAVENOUSLY only, as an intravenous injection. The medicine must not be administered into the spinal canal, epidurally (around the spinal cord), or into the brain. Severe adverse reactions have been reported when the medicine was administered into the spinal canal (intrathecally). If the patient experiences any back or leg pain during or shortly after administration of the medicine, they must inform their doctor or nurse immediately.
The patient should inform their doctor if any of the following apply, to help them decide whether Tranexamic acid Accord is suitable:

• If the patient has blood in the urine, Tranexamic acid Accord may lead to obstruction of the urinary tract.
• If the patient is at risk of blood clots. The risk of developing blood clots may be higher in patients using hormonal contraceptives.
• If the patient has excessive blood clotting or bleeding throughout the body (disseminated intravascular coagulation), Tranexamic acid Accord may not be suitable for the patient, except in cases of acute severe bleeding when blood tests have shown that the process inhibiting blood clotting, called fibrinolysis, has been activated.
• If the patient has had seizures, Tranexamic acid Accord should not be used. The doctor will use the lowest possible dose to avoid the occurrence of seizures after administration of Tranexamic acid Accord.
• If the patient is receiving long-term treatment with Tranexamic acid Accord, possible disturbances in color vision should be monitored, and the doctor may recommend discontinuation of treatment if necessary. During long-term use of tranexamic acid, 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 Accord injection solution is necessary.

Tranexamic acid Accord with other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken.
In particular, the patient should inform their doctor if they are taking or using:

• other medicines that promote blood clotting, known as antifibrinolytic agents,
• medicines that prevent blood clotting, known as thrombolytic agents,
• hormonal contraceptives.

Pregnancy, breastfeeding and fertility
During pregnancy, while breastfeeding, if pregnancy is suspected, or when planning a pregnancy, the patient should consult their doctor or pharmacist before using this medicine.
Tranexamic acid passes into human milk. Therefore, the use of Tranexamic acid Accord is not recommended during breastfeeding.
If the patient is of reproductive age, she should consult her doctor or pharmacist and ensure the use of an effective method of contraception.

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

3. How to use Tranexamic acid Accord

Use in adults
Tranexamic acid is administered by a doctor, nurse, or other healthcare professional
exclusively by slow intravenous injection into one of the patient's veins. Tranexamic acid
must not be self-administered. The doctor will determine the appropriate dose and duration of
treatment. You must continue receiving tranexamic acid for as long as your doctor recommends.
If you have any questions about the use of tranexamic acid, consult your doctor.

Use in children
If Tranexamic acid Accord solution for intravenous injection is administered to children aged 1 year and older, the dose will be calculated based on the child's body weight. The doctor will decide the appropriate dose for the child and 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 impaired renal function, 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 Accord must be administered only by slow intravenous injection.
Tranexamic acid Accord must not be injected intramuscularly or into the spinal canal.

Use of a higher than recommended dose of Tranexamic acid Accord
If an excessive dose of Tranexamic acid Accord is administered, symptoms such as dizziness, headache, and transient lowering of blood pressure may occur. You should immediately contact a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported after administration of Tranexamic acid Accord:
Common adverse reactions (may occur in less than 1 in 10 people):

• gastrointestinal disorders: nausea, vomiting, diarrhoea.

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

• skin reactions: 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 disorders: convulsions,
• eye disorders: visual disturbances, including disturbances of colour vision,
• immune system disorders: allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can also 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tranexamic acid Accord

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
The doctor or nurse will check this information before administering the medicine.
Unopened ampoules do not require 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 injection solution contains 500 mg of tranexamic acid.
10 mL of injection solution contains 1000 mg of tranexamic acid.
The other ingredient is 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.
Type I glass ampoules are packed on trays or in blisters, within 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.
ul. Taśmowa 7
02-677 Warszawa
Tel: +48 22 577 28 00

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

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

| 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 |

Information intended exclusively for medical professionals:

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 must be discarded.
THERAPEUTIC INDICATIONS
Prevention and treatment of hemorrhage caused by generalized or local fibrinolysis in adults and children over 1 year of age, such as:

• Menstrual bleeding and uterine hemorrhage,
• Gastrointestinal bleeding,
• Hemorrhagic disorders of the urinary system following surgical procedures on the prostate gland or urological surgeries,
• Ear, nose, and throat surgical procedures,
• Gynecological surgeries or obstetric disorders,
• Thoracic and abdominal surgical procedures,
• Control of hemorrhage caused by administration of a fibrinolytic drug.

DOSAGE AND ADMINISTRATION
Tranexamic acid Accord, 100 mg/mL, solution for injection should be administered by slow intravenous injection according to the dosing regimen below.
THERAPEUTIC DOSE
Adults:

• Treatment of local fibrinolysis: The usual dose is 5–10 mL (500–1000 mg) administered by slow intravenous injection (1 mL/min), two to three times daily.
• Treatment of generalized fibrinolysis: The usual dose is 10 mL (1000 mg) administered by slow intravenous injection (1 mL/min) every 6 to 8 hours, equivalent to 15 mg/kg body weight.

Children:
In children from 1 year of age, for currently approved indications, the dosage range is 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 drug accumulation, the dosage of tranexamic acid should be reduced according to the table below:

Method of administration:
Tranexamic acid should be administered intravenously only. It must not be administered epidurally or intrathecally.
To reduce the risk of fatal medication errors due to incorrect route of administration of tranexamic acid, it is strongly recommended to label syringes containing tranexamic acid.
Administer only by slow intravenous injection.

Storage conditions of the medicinal product:
No special storage conditions apply for the medicinal product.
The product should be used immediately after first opening. Any unused portions or waste material should be disposed of in accordance with local regulations.

Shelf life:
Unopened vial: 24 months.