Tranexamic Acid Tillomed

Leaflet accompanying the packaging: patient information

Tranexamic Acid Tillomed, 500 mg, coated tablets

Tranexamic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tranexamic Acid Tillomed and what is it used for
• 2. Important information before taking Tranexamic Acid Tillomed
• 3. How to take Tranexamic Acid Tillomed
• 4. Possible side effects
• 5. How to store Tranexamic Acid Tillomed
• 6. Contents of the pack and other information

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

Tranexamic acid belongs to a group of medicines called anti-fibrinolytic agents. They are used to prevent or reduce unwanted bleeding. During bleeding, the body produces clots to stop the bleeding. In some people, these clots dissolve, causing excessive bleeding. Tranexamic acid prevents the dissolution of clots and thus reduces unwanted bleeding.
Tranexamic Acid Tillomed is used to prevent or reduce bleeding for a short period in many different disease states. This medicine may have been prescribed for one of the following reasons:

• After prostate surgery (after prostatectomy);
• After bladder surgery;
• Heavy menstrual bleeding;
• Severe nosebleeds;
• Cervical surgery (cervical conization);
• Bleeding inside the eye (prevention of recurrent bleeding in case of traumatic bleeding in the anterior chamber of the eye);
• Removal (extraction) of teeth in people with hemophilia (people more prone to bleeding). The patient is informed if this situation applies to them;
• A hereditary disease called hereditary angioedema (HANO). The doctor will inform the patient if they have this disease.

2. Important information before taking Tranexamic Acid Tillomed

When not to take Tranexamic Acid Tillomed

• 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 disease (risk of accumulation of the medicine in the body),
• if you have ever had a blood clot in the blood vessels (a disease called thrombosis),
• if you have a history of seizures,
• if you are at risk of excessive bleeding due to a bleeding disorder called consumption coagulopathy.

If you have any of the above conditions, you should talk to your doctor or pharmacist.

Warnings and precautions

Before starting to take Tranexamic Acid Tillomed, you should discuss it with your doctor or pharmacist:

• if you have had seizures;
• if you have vision disturbances or blurred vision. Regular eye exams may be necessary, especially in cases of retinal diseases;
• if you have blood in your urine, which can lead to blockage of the urinary tract;
• if you are at risk of blood clots. The risk of thrombotic events may be increased in women taking oral contraceptives;
• if you have hereditary angioedema, a hereditary disorder that causes swelling of the deeper layers of the skin due to fluid accumulation;
• if you have disseminated intravascular coagulation (DIC), a disease in which blood clots form in the body;
• if you have irregular menstrual periods;
• if you have kidney disease.

Children and adolescents
There is no clinical experience with the use of tranexamic acid in children under 15 years of age with heavy menstrual bleeding.

Tranexamic Acid Tillomed and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take (including those available without a prescription). In particular, tell them about:

• Other medicines that help dissolve blood clots, called fibrinolytic agents.
• Medicines that prevent blood clotting, called antithrombotic agents.
• Oral contraceptives. They may increase the risk of blood clots.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no sufficient clinical data on the use of tranexamic acid in pregnant women. As a precautionary measure, tranexamic acid should not be used during the first trimester of pregnancy. Tranexamic acid can be used throughout pregnancy only if the expected benefit outweighs the potential risk.
Breastfeeding
Tranexamic acid passes into human milk. Since there is no experience with treatment lasting several days in breastfeeding women and their children, the doctor should prescribe Tranexamic Acid Tillomed 500 mg coated tablets only after careful evaluation of the benefits and risks.

Tranexamic Acid Tillomed, coated tablets, contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Tranexamic Acid Tillomed

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Important:

The correct dose of the medicine will be determined by your doctor. The dose will be clearly marked on the packaging of the medicine.

Otherwise, consult your doctor or pharmacist.

Note: the medicine should always be taken with a glass of water. Swallow the tablets whole. Do not crush or chew the tablets.

Use in adults and the elderly

• The usual recommended dose is 2 or 3 tablets 2 to 3 times a day.
• The appropriate dose will depend on the reason why the medicine was prescribed.
• Follow the doctor's instructions regarding the number of tablets to take, the time of day, and the duration of treatment.

Use in children and adolescents

The doctor will inform you about the dose of the medicine to be given to the child. The doctor will determine the dose based on the child's body weight.

Patients with renal impairment

The doctor will inform you about the correct dose. The dose may be lower than that usually taken by adults.

Taking a higher dose of Tranexamic Acid Tillomed than recommended

If you take too much of the medicine, tell your doctor or go to the nearest hospital emergency department immediately.
Taking too much of the medicine Tranexamic Acid Tillomed can cause nausea, vomiting, diarrhea, headache, or dizziness, feeling dizzy when standing up and/or low blood pressure, muscle weakness, or can cause seizures (seizures are more likely to occur with higher doses of tranexamic acid). Some patients are at risk of blood clots.
Treatment of overdose:
There is no specific antidote. Consider treatment with anticoagulant medicines. In case of ingestion of large doses of tranexamic acid in tablets, the following actions may be helpful: inducing vomiting, gastric lavage, treatment with activated charcoal.

Missing a dose of Tranexamic Acid Tillomed

Do not take a double dose to make up for a missed dose. 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 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 symptoms:

• if you have an allergic reaction, such as sudden, severe allergic reactions causing difficulty breathing or dizziness (anaphylaxis).

Common side effects (may affect up to 1 in 10 people)

• headache
• dizziness
• nausea or vomiting. Usually mild and passes very quickly, but if it persists, tell your doctor or pharmacist
• diarrhea. Usually mild and passes very quickly, but if it persists, tell your doctor or pharmacist.

Uncommon side effects (may affect up to 1 in 100 people)

• itching, redness, or swelling of the skin (skin allergic reactions).

Rare side effects (may affect up to 1 in 1,000 people)

• vision disturbances, especially those related to color vision
• blood clots in the blood vessels (a disease called thrombosis).

Very rare side effects (may affect up to 1 in 10,000 people)

• arterial or venous thrombosis
• decreased platelet count (thrombocytopenia), prolonged bleeding time
• general malaise with low blood pressure, with or without loss of consciousness.

Frequency not known (frequency cannot be estimated from the available data)

• seizures, especially in case of improper use of the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tranexamic Acid Tillomed

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for the storage of the medicinal product.
After opening the HDPE bottle, the medicine should be used within 25 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tranexamic Acid Tillomed contains

The active substance is tranexamic acid. One tablet contains 500 mg of tranexamic acid.
The other ingredients are: microcrystalline cellulose PH 102, cornstarch, hydroxypropylcellulose (LH11), colloidal silica, povidone (PVP K-30), talc, hydrogenated castor oil, magnesium stearate.
Opadry White OY-IN-58910 coating: hypromellose 6 mPas, hypromellose 15 mPas, titanium dioxide (E 171), macrogol, propylene glycol, sodium lauryl sulfate.

What Tranexamic Acid Tillomed looks like and contents of the pack

Tranexamic Acid Tillomed 500 mg coated tablets are white to light yellow, oval, coated tablets, smooth on both sides.
Tranexamic Acid Tillomed 500 mg coated tablets are available in:
Blister packs (OPA/Aluminum/PVC/Aluminum) containing 10, 20, 30, 50, 60, and 100 tablets, in a cardboard box.
HDPE bottles containing 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Tillomed Spain S.L.U.
Calle Marcelo Spinola 8, planta 1,
Puerta F, 28016, Madrid,
Spain
Tel: +48 509 368 531
Email: [email protected]

Manufacturer/Importer

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

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
Acido tranexamico Tillomed 500 mg comprimidos recubiertos con pelicula
EFG
Netherlands
Tranexaminezuur Tillomed 500 mg filmomhulde tabletten
Poland
Tranexamic Acid Tillomed
Northern Ireland
Tranexamic Acid 500 mg film-coated tablets
(United Kingdom)
Date of last revision of the leaflet:09.2023