Tranexamic acid Zentiva 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Tranexamic acid Zentiva 500 mg film-coated tablets EFG

tranexamic acid

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet:

1. What tranexamic acid Zentiva is and what it is used for
2. What you need to know before taking tranexamic acid Zentiva
3. How to take tranexamic acid Zentiva
4. Possible side effects
5. How to store tranexamic acid Zentiva
6. Contents of the pack and other information

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

Tranexamic acid belongs to a group of medicines called "antifibrinolytic drugs". These medicines are used to stop or reduce bleeding. When bleeding occurs, the body forms clots to stop it. In some people, these clots break down, leading to excessive bleeding. Tranexamic acid prevents 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 various different conditions. You may have been prescribed this medicine for one of the following:

• After prostate surgery (post-prostatectomy).
• After bladder surgery.
• Heavy menstrual bleeding (menorrhagia).
• Severe nosebleeds (severe epistaxis).
• Surgery on the cervix (cervical conization).
• To prevent recurrent bleeding inside the eye (prevention of recurrent hemorrhage in traumatic hyphema).
• Dental extractions in haemophiliacs (people who bleed more easily than normal). If this applies to you, you will know.
• A hereditary condition called "hereditary angioedema" or "angioedema" (AE). Your doctor will inform you if you have this condition.

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

Do not take Tranexamic Acid Zentiva:

• If you are allergic to tranexamic acid or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney problems (renal failure).
• If you have or have ever 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 Tranexamic Acid Zentiva in the following cases:

• If you have had seizures.
• If you have visual impairment or blurred vision. Regular eye examinations may be necessary, especially in cases of retinal disease.
• If you have had blood in the urine, which may cause obstruction of the urinary tract.
• If you are at risk of developing blood clots. The risk of thrombotic events may increase in patients using oral contraceptives.
• If you have hereditary angioedema, a hereditary disorder causing swelling of the deeper layers of the skin due to fluid accumulation.
• If you have disseminated intravascular coagulation (DIC), a condition in which blood begins to clot throughout the body.
• If you are a woman with irregular menstrual periods.
• If you have any kidney disease.

Other medicines and Tranexamic Acid Zentiva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially the following:

• Fibrinolytic agents (used to help break down blood clots), such as streptokinase. This is because tranexamic acid would counteract the effect of these medicines.
• Oral contraceptives. They may increase the risk of blood clot formation.
• Any other medicines, including those not requiring a prescription.

Pregnancy, breastfeeding, and fertility

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

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

Tranexamic Acid Zentiva contains castor oil and sodium

Tranexamic Acid Zentiva contains castor oil. Castor oil may cause gastrointestinal discomfort and diarrhea.

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

3. How to take Tranexamic acid Zentiva

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Important:

Your doctor will choose the appropriate dose for you. Your dose will be clearly indicated on the doctor's prescription. Otherwise, or if you have any doubts, ask your doctor or pharmacist.

Remember: This medicine must 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 this medicine has been prescribed.
• Follow your doctor's instructions regarding how many tablets you should take, when to take them, and how long the treatment should last.

Use in children

Your doctor will tell you exactly what dose to give 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 adult dose.

If you take more Tranexamic acid Zentiva than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tranexamic acid Zentiva

Do not take a double dose to make up for a missed dose. Simply take the next dose as scheduled.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

Immediately inform your doctor if you experience any of the following:

• Hypersensitivity reactions, such as a severe and sudden allergic reaction causing difficulty breathing or dizziness (anaphylaxis)

Rare (affects 1 to 10 patients in 1,000)

• Visual disturbances, especially in color vision.
  • Blood clot formation in an eye. This may cause bleeding in the eye or vision loss.
  • Itching, redness, or swelling of the skin.

Very rare (affects fewer than 1 patient in 10,000)

• Blood clot formation in blood vessels (i.e., thrombosis).
• Allergic reactions that may cause difficulty breathing or dizziness.
• Nausea.
• Vomiting.
• Diarrhea.
• Seizures.
• 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; however, if they persist, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicinal Products: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tranexamic Acid Zentiva

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and other information

Composition of Tranexamic Acid Zentiva

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

The other components 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) of propylene glycol as a necessary component for the medicine to work properly.

Appearance of the product and contents of the pack

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

Tranexamic Acid Zentiva is supplied in:

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Manufacturer [1]

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 actually performing the release will be indicated on the marketed product.

For further information about this medicinal product, please contact 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 medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Tranexamsäure Tillomed 500 mg Filmtabletten
Germany: Tranexamsäure Tillomed 500 mg Filmtabletten
Spain: Ácido tranexámico Zentiva 500 mg comprimidos recubiertos con película EFG
Netherlands: Tranexaminezuur Tillomed 500 mg filmomhulde tabletten
Poland: Tranexamic Acid Tillomed

Date of the most recent approval of this package leaflet: September 2023.

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

[1]