TRANEXAMIC ACID ZENTIVA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Zentiva Tranexamic Acid 500mg Film-Coated Tablets EFG

tranexamic acid

Read all of this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Tranexamic acid belongs to a group of medicines called anti-fibrinolytic agents. These medicines are used to stop or reduce bleeding. In the event of bleeding, the body forms clots to stop it. In some people, these clots are broken down, which can cause excessive bleeding. Tranexamic acid stops the breakdown of these clots and thus reduces bleeding.

This medicine is used to prevent or reduce bleeding for a short period of time in many different conditions. You may have been prescribed it for one of the following:

• After prostate surgery (post-prostatectomy).
• After bladder surgery.
• Heavy menstrual bleeding (menorrhagia).
• Severe nosebleeds (severe epistaxis).
• Cervical surgery (conization of the cervix).
• To prevent repeated bleeding inside the eye (prevention of recurrent hemorrhage in traumatic hyphema).
• Dental extraction in hemophiliacs (people who bleed more easily than normal). If this applies to you, you will know.
• A hereditary disease called hereditary angioedema (HAE). Your doctor will inform you if you have this disease.

2. What you need to know before you take Zentiva Tranexamic Acid

Do not take Zentiva Tranexamic Acid:

• If you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney problems (renal insufficiency).
• If you have or have had a blood clot in the blood vessels (i.e., thrombosis).
• If you have a history of seizures.
• If you are at risk of excessive bleeding due to a coagulation disorder called consumption coagulopathy.

If you are in any of the above situations, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zentiva Tranexamic Acid in the following cases:

• If you have had seizures.
• If you have visual impairment or blurred vision. Regular eye exams may be necessary, especially in the case of retinal diseases.
• If you have had blood in your urine, which can cause a blockage of the urinary tract.
• If you are at risk of having blood clots. The risk of blood clotting events may increase in patients using oral contraceptives.
• If you have hereditary angioedema, a hereditary disorder that causes inflammation of the deeper layers of the skin due to fluid accumulation.
• If you have disseminated intravascular coagulation (DIC), a disease in which the blood begins to clot throughout the body.
• If you are a woman with irregular periods.
• If you have any kidney disease.

Other medicines and Zentiva Tranexamic Acid

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, in particular the following:

• Fibrinolytic medicines (used to help break down blood clots), such as streptokinase. This is because Zentiva Tranexamic Acid would counteract the effect of these medicines.
• Oral contraceptives. They may increase the risk of blood clot formation.
• Any other medicine, including those that do not require a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Zentiva Tranexamic Acid.

Tranexamic acid is excreted in breast milk, although in a minimal amount. If you are breastfeeding, consult your doctor or pharmacist before taking Zentiva Tranexamic Acid.

Zentiva Tranexamic Acid contains castor oil and sodium

Zentiva Tranexamic Acid contains castor oil. Castor oil may cause stomach upset and diarrhea.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Zentiva Tranexamic Acid

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Important:

Your doctor will choose the right dose for you. Your dose will be clearly stated on the doctor's prescription. If not, or if you have any doubts, ask your doctor or pharmacist.

Remember: This medicine should always be taken with a glass of water. The tablets should be swallowed whole. Do not crush or chew them.

Use in adults and elderly patients

• The usual dose is 2 or 3 tablets 2 to 3 times a day.
• The exact dose for you depends on the reason why you have been prescribed this medicine.
• Follow your doctor's instructions about how many tablets you should take, when you should take them, and the duration of treatment.

Use in children

Your doctor will tell you exactly what dose to give to the child. Your doctor will calculate the dose based on the child's weight.

Patients with kidney problems

Your doctor will tell you what dose to take. The dose you take may be lower than the usual dose for adults.

If you take more Zentiva Tranexamic Acid than you should

If you take too much Zentiva Tranexamic Acid, you may feel nauseous or vomit 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 taken.

If you forget to take Zentiva Tranexamic Acid

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

If you have any further questions on 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 everybody gets them.

Tell your doctor immediately if you experience any of the following:

• hypersensitivity reactions, such as a severe and sudden allergic reaction that causes difficulty breathing or dizziness (anaphylaxis)

Rare (affect 1 to 10 people in every 1,000)

• Visual disturbances, especially in color vision.
  • Formation of a blood clot in an eye. This can cause bleeding in the eye or vision loss.
  • Itching, redness, or swelling of the skin.

Very rare (affect less than 1 person in every 10,000)

• Formation of a blood clot in the blood vessels (i.e., thrombosis).
• Allergic reactions that can cause difficulty breathing or dizziness.
• Nausea.
• Vomiting.
• Diarrhea.
• Seizures or convulsions.
• General feeling of discomfort (malaise) and low blood pressure (hypotension), with or without loss of consciousness.

Nausea, vomiting, and diarrhea are usually mild and disappear quickly; but if they continue, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the national reporting system included in the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zentiva Tranexamic Acid

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 packaging. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

It should be used within 25 days after first opening the plastic bottle (HDPE).

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.

6. Contents of the pack and further information

Composition of Zentiva Tranexamic Acid

The active substance is tranexamic acid. Each tablet contains 500 mg of tranexamic acid.

The other ingredients are microcrystalline cellulose, pregelatinized corn starch, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, povidone, talc, hydrogenated castor oil, magnesium stearate, hypromellose, titanium dioxide, macrogol, propylene glycol, and sodium lauryl sulfate.

This medicine contains 5.50% (w/w) propylene glycol as a necessary component for the medicine to work properly.

Appearance of the product and pack contents

Zentiva Tranexamic Acid tablets are white to pale yellow in color, oval in shape, and film-coated, smooth on both sides, for oral use.

Zentiva Tranexamic Acid is available in:

Blister packs (OPA/Alu/PVC) containing 10, 20, 30, 50, 60, and 100 tablets.

High-density polyethylene (HDPE) bottles containing 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Manufacturer[1]

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road

Portmarnock, Co. Dublin

Ireland

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

SGS Pharma Magyarorszag Kft.

Derkovits Gyula Utca 53,

Budapest XIX,1193,

Hungary

[1] Only the site that actually performs the release will be indicated on the marketed product.

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

Zentiva Spain S.L.U.,

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

Austria Tranexamsäure Tillomed 500 mg Filmtabletten

Germany Tranexamsäure Tillomed 500 mg Filmtabletten

Spain Ácido tranexámico Zentiva 500 mg film-coated tablets EFG

Netherlands Tranexaminezuur Tillomed 500 mg filmomhulde tabletten

Poland Tranexamic Acid Tillomed

Date of last approval of this leaflet: September 2023.

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

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