Patient Information Leaflet: Product Characteristics

Tranexamic Acid Zentiva 500 mg Film-Coated Tablets

tranexamic acid

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Tranexamic acid belongs to a group of medications called «antifibrinolytic drugs». These drugs are used to stop or reduce bleeding. When bleeding occurs, the body forms clots to stop it. In some people, these clots break down, causing excessive bleeding. Tranexamic acid stops the breakdown of these clots and, therefore, reduces bleeding.

This medicationis used to prevent or reduce bleeding for a short period of time in many different disorders. It may have been prescribed for one of the following cases:

Do not take Zentiva Tranexamic Acid:

Consult your doctor or pharmacist if you are in any of the above situations.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeTranexamic Acidin the following cases:

Other medications andTranexamic Acid Zentiva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, particularly the following:

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before usingTranexamic Acid.

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

Tranexamic Acid Zentiva contains ricin oil and sodium

Tranexamic Acid Zentiva contains ricin oil. Ricin oil may cause stomach discomfort and diarrhea.

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

Follow exactly the administration instructions for this medication as indicated 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. If not, or if you have any doubts, ask your doctor or pharmacist.

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

Use in adults and elderly patients

Use in children

Your doctor will indicate exactly the dose that you should give to the child. Your doctor will calculate the dose based on the child's weight.

Patients with kidney problems

Your doctor will indicate the dose that you should take. The dose that you take may be lower than the usual dose for adults.

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 disoriented when standing up.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Inform your doctor immediately if you experience any of the following situations:

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

Rare (affect 1 to 10 patients per 1,000)

– Visual disturbances, especially color vision.

• Formation of a blood clot in an eye. This may cause bleeding in the eye or loss of vision.
• Itching, redness, or swelling of the skin.

Very rare (affect less than 1 patient per 10,000)

– Formation of a blood clot in blood vessels (i.e., thrombosis).

– Allergic reactions that may cause difficulty breathing or dizziness.

– Nausea.

– Vomiting.

– Diarrhea.

– Seizures or convulsions.

–General feeling of discomfort (indisposition)and low blood pressure (hypotension), with or without loss of consciousness.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.esBy reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGREpoint at the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition ofTranexamic Acid Zentiva

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

The other components aremicrocrystalline cellulose, pregelatinized maize starch, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, povidone, talc, hydrogenated ricin oil, magnesium stearate, hypromellose, titanium dioxide, macrogol, propylene glycol, and sodium lauryl sulfate.

This medicine contains a 5.50% (p/p) of propylene glycol as a necessary component for the medicine to work correctly.

Appearance of the productand contents of the package

Tranexamic Acid Zentiva tablets have awhite to pale yellow color, oval shape, and film-coated, 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 package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Responsible for manufacturing[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,

SanGwann, SGN 3000, Malta

SGS Pharma Magyarorszag Kft.

Derkovits Gyula Utca 53,

Budapest XIX,1193,

Hungary

[1]Only the actual release site will be indicated in the marketed product.

You can request more information about this medicine by contacting 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 European Economic Area member states with the following names:

AustriaTranexamsäure Tillomed500mg Filmtabletten

GermanyTranexamsäure Tillomed500mg Filmtabletten

SpainTranexamic Acid Zentiva 500mg film-coated tablets EFG

NetherlandsTranexaminezuur Tillomed 500mg film-coated tablets

PolandTranexamic Acid Tillomed

Last approval date of this leaflet: September 2023.

More detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/