TRANEXAMIC ACID BAXTER 100 mg/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Tranexamic Acid Baxter 100 mg/ml Solution for Injection and Infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tranexamic Acid Baxter and what is it used for
2. What you need to know before you use Tranexamic Acid Baxter
3. How to use Tranexamic Acid Baxter
4. Possible side effects
5. Storage of Tranexamic Acid Baxter
6. Contents of the pack and further information

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

Tranexamic Acid Baxter solution for injection and infusion contains tranexamic acid, which belongs to a group of medicines called antihemorrhagics, antifibrinolytics, amino acids.

This medicine is used in adults and children over one year of age to prevent and treat bleeding due to a process that inhibits blood coagulation called fibrinolysis.

The specific indications include the following:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Hemorrhagic disorders of the urinary tract, after prostate surgery or surgical procedures that affect the urinary tract
• Ear, nose, or throat surgery
• Cardiac, abdominal, or gynecological surgery
• Bleeding after treatment with another medicine to dissolve blood clots.

2. What you need to know before you use Tranexamic Acid Baxter

Do not useTranexamic Acid Baxter:

• If you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
• If you currently have a disease that leads to blood clots
• If you have a condition called "consumption coagulopathy" where the blood throughout the body begins to clot
• If you have kidney problems
• If you have a history of seizures.

Due to the risk of cerebral edema and seizures, intrathecal and intraventricular injection and intracerebral application are not recommended.

If you think any of these situations apply to you, or if you have any doubts, talk to your doctor before using this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse if any of these circumstances apply to you. This will help them decide if this medicine is suitable for you.

• If you have had blood in your urine, this could lead to obstruction of the urinary tract.
• If you are at risk of forming blood clots.
• If you suffer from excessive clotting or bleeding in the body (disseminated intravascular coagulation), this medicine may not be suitable for you, unless you have acute severe bleeding and blood tests show that the process that inhibits blood coagulation called fibrinolysis has been activated.
• If you have had seizures, tranexamic acid should not be administered. Your doctor should use the lowest possible dose to avoid seizures after treatment with this medicine.
• If you are on long-term treatment with this medicine, attention should be paid to possible alterations in color vision, and if necessary, treatment should be suspended. With long-term continuous use of this medicine, periodic ophthalmological examinations (eye exams, such as visual acuity, color vision, fundus examination, visual field, etc.) are indicated. In the event of pathological ophthalmic changes, especially retinal diseases, your doctor should decide, after consulting with a specialist, on the need for long-term use of this medicine in your case.

UsingTranexamic Acid Baxterwith other medicines

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.

Specifically, you should inform them if you use:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Tranexamic acid is excreted in breast milk, therefore, the use of this medicine is not recommended during breastfeeding.

Driving and using machines

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

3. How to use Tranexamic Acid Baxter

Tranexamic Acid solution for injection and infusion will be administered to you by slow injection or infusion into a vein.

Your doctor will decide the correct dose for you and for how long you should receive it.

Use in children

If this medicine is given to a child over one year of age, the dose should be based on the child's weight.

Your doctor will decide the correct dose for the child and for how long they should receive it.

Use in elderly patients

No dose reduction is necessary unless there are signs of renal insufficiency.

Use in patients with kidney problems

If you have kidney problems, the dose of tranexamic acid will be reduced according to the results of a blood test (serum creatinine level).

Use in patients with liver failure

No dose reduction is necessary.

Method of administration

This medicine should only be administered slowly into a vein.

This medicine should not be injected into a muscle.

If you use moreTranexamic Acid Baxterthan the recommended dose

If you have received a higher dose of tranexamic acid than recommended, you may experience a temporary drop in blood pressure. Talk to your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

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

The side effects reported withtranexamic acidare as follows:

The following side effects have been reported with tranexamic acid

Common: may affect up to 1 in 10 people

• Gastrointestinal disorders: nausea, vomiting, diarrhea.

Uncommon: may affect up to 1 in 100 people

• Skin disorders: rash.

Frequency not known: cannot be estimated from the available data

• Disorders with hypotension (low blood pressure), with or without loss of consciousness, especially after too rapid intravenous injection
• Blood clots
• Nervous system disorders: seizures
• Eye disorders: vision disturbances including color vision impairment
• Immune system disorders: allergic reactions.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tranexamic Acid Baxter

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date is the last day of the month shown.

Do not freeze.

After first opening: the solution for injection and infusion is for single use only. The unused solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Chemical and physical stability have been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless the dilution has been made in controlled and validated aseptic conditions.

6. Contents of the pack and further information

Composition ofTranexamic Acid Baxter

The active substance is tranexamic acid.

Each ml contains 100 mg of tranexamic acid.

Each 5 ml vial contains 500 mg of tranexamic acid.

Each 10 ml vial contains 1000 mg of tranexamic acid.

The other ingredient is water for injections.

Appearance and packaging

Tranexamic Acid Baxter is a solution for injection and infusion.

Clear, colorless, and essentially free from visible particles.

6 ml glass type I vial filled with 5 ml, in blister and cardboard box.

10 ml glass type I vial filled with 10 ml, in blister and cardboard box.

Pack sizes

5 vials of 5 ml,

10 vials of 5 ml,

5 vials of 10 ml,

10 vials of 10 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Baxter Holding B.V.

Kobaltweg 49,

3542CE Utrecht, Netherlands

Manufacturer

Bieffe Medital S.p.A.,

Via Nuova Provinciale, 23034 Grossotto (SO) Italy.

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

Baxter S.L.

Pouet de Camilo, 2. 46394 Ribarroja del Turia (Valencia)

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Tranexamic acid Baxter 100 mg/ml Solution for injection/infusion

Belgium Tranexamic acid Baxter 100 mg/ml solution for injection/infusion

Denmark Tranexamic acid Baxter 100 mg/ml injection/infusion solution

Estonia Tranexamic acid Baxter

Finland Tranexamic acid Baxter 100 mg/ml solution for injection/infusion

Greece Tranexamic acid Baxter 100 mg/ml solution for injection/infusion

Germany Tranexamic acid Baxter 100 mg/ml Solution for injection/infusion

Hungary Tranexamic acid Baxter 100 mg/ml oldatos injekció

Ireland Tranexamic acid 100 mg/ml solution for injection/infusion

Italy Acido Tranexamico Baxter 100 mg/ml soluzione iniettabile/infusione

Latvia Tranexamic acid Baxter 100 mg/ml šķīstums injekcijām/infūzijām

Lithuania Tranexamic acid Baxter 100mg/ml injekcinis tirpalas

Netherlands Tranexaminezuur Baxter 100 mg/ml, oplossing voor injectie/infusie

Norway Tranexamic acid Baxter

Poland Tranexamic acid Baxter

Portugal Ácido Tranexâmico Baxter

Slovakia Tranexamic acid Baxter 100 mg/ml injekčný roztok

Spain Ácido tranexámico Baxter 100 mg/ml solución inyectable y para perfusión EFG

Sweden Tranexamic acid Baxter 100 mg/ml solution for injection/infusion

United Kingdom Tranexamic acid 100 mg/ml solution for injection/infusion

Date of last revision of this leaflet:April 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/