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Introduction
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.
1. What is Zentiva Tranexamic Acid and how is it used
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:
- After prostate surgery (post-prostatectomy).
- After bladder surgery.
- Heavy menstrual bleeding (menorrhagia).
- Severe nasal bleeding (epistaxis).
- Cervical surgery (conization of the cervix).
- To prevent repeated bleeding inside the eye (prevention of recurrent hemorrhage intraumatic hyphema).
- Extraction of dental pieces in hemophiliacs (people who bleed more easily than normal). If this applies to you, you will know.
- A hereditary disease called «angioneurotic edema» or «angioedema» (AE). The doctor will inform you if you have this disease.
2. What you need to know before starting to take Tranexamic Acid Zentiva
Do not take Zentiva Tranexamic Acid:
- If you are allergic to tranexamic acid or any of the other components of this medication (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 (trombosis).
- If you have a history of seizures.
- If you are at risk of excessive bleeding due to a condition called "consumption coagulopathy."
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:
- If you have had seizures.
- If you have visual impairment or blurred vision. Regular eye exams may be necessary, especially in cases of retinal disease.
- If you have blood in your urine, which may cause urinary tract obstruction.
- If you are at risk of blood clots. The risk of blood clotting events may increase in patients using oral contraceptives.
- If you have hereditary angioedema, a genetic disorder that causes inflammation of the skin's deeper layers 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 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:
- Fibrinolytic medications (used to help break down blood clots), such as streptokinase. This is because Tranexamic Acid would neutralize the effect of these medications.
- Oral contraceptives. They may increase the risk of blood clot formation.
- Any other medication, including over-the-counter medications.
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."
3. How to take Tranexamic Acid Zentiva
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
- The usual dose is 2 or 3 tablets 2 to 3 times a day.
- The exact dose for you will depend on the reason for which you have been prescribed this medication.
- Follow your doctor's instructions regarding how many tablets you should take, when you should take them, and the duration of treatment.
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.
4. Possible Adverse Effects
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.
5. Conservation of Tranexamic Acid Zentiva
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.
6. Contents of the packaging and additional information
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
Zentiva, k.s., U kabelovny 130, Prague 10 – Dolní Mecholupy, 102 37 Czech Republic |
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/
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