TRANEXAMIC ACID APC INSTYTUT 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tranexamic Acid APC Instytut 500mg Film-Coated Tablets

tranexamic acid

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Tranexamic Acid APC Instytut and what is it used for
2. What you need to know before taking Tranexamic Acid APC Instytut
3. How to take Tranexamic Acid APC Instytut
4. Possible side effects
5. Storage of Tranexamic Acid APC Instytut
6. Package Contents and Additional Information

1. What is Tranexamic Acid APC Instytut and what is it used for

This medicine is used for heavy menstrual bleeding.

This medicine is a drug that reduces menstrual bleeding. It contains tranexamic acid, which prevents the action of the enzyme that dissolves blood clots. This results in less blood loss and faster relief of symptoms.

This medicine should only be used when your menstrual cycle is regular and you are over 15 years old.

2. What you need to know before taking Tranexamic Acid APC Instytut

This medicine should only be used if your periods are regular and heavy. To ensure this, you should always answer "yes" to the following questions:

1. Are your periods regular, i.e., your menstrual cycle lasts between 21 and 35 days?
2. Do you need to use double sanitary protection, such as pads and tampons or double pads, to prevent bleeding from seeping through, or do you need to change your sanitary protection very often?

Do not take Tranexamic AcidAPC Instytut:

• If you are allergic to tranexamic acid or any of the other ingredients of this medicine, which are listed in section 6.
• If you have or have ever had a blood clot in the blood vessels (i.e., thrombosis).
• If you have severe kidney problems (severe renal insufficiency).
• If you have a history of seizures.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take tranexamic acid if:

• You have irregular menstrual periods
• You or your family have a history of blood clots in the blood vessels (i.e., thrombosis).
• You have blood in your urine between menstrual periods.
• You are taking oral contraceptives (there is an increased risk of blood clot formation)

In rare cases, color vision disturbances and other visual disturbances have been experienced as a side effect of tranexamic acid. Normally, vision returns to normal after stopping the medicine. Stop taking tranexamic acid and inform your doctor immediately if you notice any change in your vision (e.g., changes in color vision).

Children and Adolescents

Consult your doctor before starting treatment if you are under 15 years old.

Other Medicines and Tranexamic Acid APC Instytut

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

• Fibrinolytic medicines (used to help break down blood clots), such as streptokinase. This is because tranexamic acid would counteract the effect of these medicines.
• Oral contraceptives.

Pregnancy, Breastfeeding, and Fertility

This medicine is indicated for regular menstrual bleeding and should not be used during pregnancy.

Tranexamic acid is excreted in breast milk, although in minimal amounts. If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and Using Machines

No studies have been conducted on the effects on the ability to drive and use machines. If you experience dizziness or drowsiness, do not drive or operate machinery.

3. How to Take Tranexamic Acid APC Instytut

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Treatment should be started when menstruation begins. Take 2 tablets 3 times a day for a maximum of 4 days.

Do not take more than 8 tablets per day.

Swallow the tablets with water.

If you take moreTranexamic AcidAPC Instytut than you should

If you have taken more medicine than you should, inform your doctor immediately or go to the emergency department of the nearest hospital.

If you take too much tranexamic acid, you may experience nausea or vomiting or feel dizzy or faint when standing up.

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.

If you forget to take Tranexamic Acid APC Instytut

Do not take a double dose to make up for a forgotten dose. Simply take the next dose as planned.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Common(may affect up to 1 in 10 patients): Nausea, vomiting, diarrhea, stomach pain, headache, dizziness. These side effects are usually mild and temporary.

Uncommon(may affect up to 1 in 100 patients): Skin allergic reactions.

Rare(frequency cannot be estimated from available data): Rare cases of blood clots, changes in color vision, and other visual disturbances, seizures.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tranexamic Acid APC Instytut

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

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofTranexamic Acid APC Instytut

• The active ingredient is tranexamic acid. Each tablet contains 500 mg of tranexamic acid.
• The other ingredients are:

Tablet core: microcrystalline cellulose, low-substituted hydroxypropylcellulose, povidone, anhydrous colloidal silica, talc, magnesium stearate.

Coating: consisting of poly(vinyl alcohol), titanium dioxide, macrogol, talc, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the Productand Package Contents

Tranexamic Acid APC Instytut tablets are pink, oval-shaped (approximately 17.4 mm long), biconvex, film-coated, and scored on one side. The tablet can be divided into two equal halves.

The tablets are packaged in blisters containing 20 or 30 tablets in cardboard boxes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Apc Instytut Sp. z o.o.

Aleje Jerozolimskie 146c

02-305 Warsaw

Poland

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

Date of the Last Revision of this Package Leaflet: May 2024

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/