Ugurol

Italy
Brand name Ugurol
Form tablets
Active substance / Dosage
TRANEXAMIC ACID
Prescription type Prescription only
ATC code
B02AA02
Registration number 021458
Manufacturer VIATRIS ITALIA S.R.L.
Ugurol tablets

Table of Contents

Package leaflet: Information for the patient

UGUROL 500 mg/5 ml injectable solution for intravenous use,

for oral and topical use
tranexamic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or nurse.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What UGUROL is and what it is used for

Ugurol contains tranexamic acid, which belongs to a group of medicines called antihemorrhagics,
antifibrinolytics, and amino acids.
Ugurol is used in adults and children from one year of age for the prevention and treatment of
bleeding due to a process that inhibits blood clotting called fibrinolysis.
The specific indications are:

  • heavy menstrual bleeding;
  • gastrointestinal bleeding;
  • hemorrhagic disorders of the urinary tract, following prostate surgery or surgical procedures on the urinary tract;
  • cardiac, abdominal, or gynecological surgery;
  • bleeding following treatment with other medicines used to dissolve blood clots.

2. What you should know before taking UGUROL

Do not take UGUROL:

  • if you are allergic to tranexamic acid or to any of the other ingredients of this medicine (listed in section 6);
  • if you have a disease that causes blood clots to form;
  • if you have a condition called "disseminated intravascular coagulation" (DIC), in which blood begins to clot in various parts of the body;
  • if you have kidney problems;
  • if you have had seizures in the past.

Due to the risk of cerebral edema and seizures, intrathecal, intraventricular, and intracerebral administration is not recommended.
If you think any of these points apply to you, or if you have any other doubts, speak with your doctor before taking Ugurol.

Warnings and precautions

Inform your doctor if any of the following apply to you, so they can determine whether Ugurol is suitable for you:

  • if you have noticed blood in your urine, which could be due to an obstruction in the urinary tract;
  • if you are at risk of developing blood clots;
  • if you have widespread blood clotting or bleeding (disseminated intravascular coagulation), Ugurol may not be suitable for you unless you have severe acute bleeding and blood tests have shown that fibrinolysis—the process that inhibits blood clotting—is activated;
  • if you have had seizures, Ugurol must not be administered. Your doctor should use the lowest possible dose to minimize the risk of seizures caused by treatment with Ugurol;
    • if you are undergoing prolonged treatment with Ugurol, possible disturbances in color vision should be monitored, and treatment should be discontinued if necessary. With long-term use of Ugurol injection solution, regular ophthalmological examinations (including visual acuity, color vision, fundoscopy, visual field testing, etc.) are recommended. In the event of pathological ophthalmological changes, especially retinal disorders, your doctor should consult a specialist before deciding whether prolonged use of Ugurol injection solution is appropriate in your case;
    • if you are being treated for postpartum hemorrhage: renal damage has been reported with doses exceeding 2 grams. Therefore, Ugurol should be used with caution at doses above 2 grams.

Other medicines and UGUROL

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, vitamins, minerals, herbal remedies, or dietary supplements.
In particular, inform your doctor if you are taking:

  • other medicines that promote blood clotting, known as antifibrinolytics;
  • medicines that prevent blood clotting, known as thrombolytics;
  • oral contraceptives.

Pregnancy and breastfeeding

Ask your doctor for advice if you are pregnant or breastfeeding before taking Ugurol.
Tranexamic acid is excreted in breast milk; therefore, the use of Ugurol is not recommended during breastfeeding.

Driving and using machines

No studies on the ability to drive vehicles or operate machinery have been conducted. Tranexamic acid may cause visual disturbances, including altered color vision, which may affect your ability to drive or operate machinery.

3. How to take UGUROL

Take this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor or nurse.

Use in adults by intravenous route
Ugurol solution is administered by slow intravenous injection. Your doctor will decide the appropriate dose for you and how long you should take it.

Use in adults by oral route

  • Prophylaxis: When taking the solution orally, dilute the contents of the vial with a small amount of sugared water. The daily dosage is 1½–2 vials of Ugurol 500 mg, starting at least 1 day before surgery and continuing treatment for no less than 3–4 days after the surgical procedure.
  • Therapy: When taking the solution orally, dilute the contents of the vial in a small amount of sugared water. The daily dosage is 1–2 vials of Ugurol 500 mg three times a day, or ½–1 vial of Ugurol 500 mg six times a day.

Oral administration is particularly indicated:

  • in hemorrhagic manifestations occurring in internal medicine, otorhinolaryngology, and dentistry;
  • for preparation prior to surgical procedures where bleeding due to plasmin activation is expected;
  • in menorrhagia;
  • in gynecological hemorrhages;
  • for maintaining therapy initiated intravenously, in order to prevent recurrence of bleeding.

Use in adults for local application
For local application of Ugurol 500 mg/5 ml solution, use the contents of one vial and pour it directly onto the site of bleeding or apply it using a gauze swab previously soaked in the solution.
Direct local application or application via gauze swabs soaked in the solution is particularly indicated in oro-rhino-pharyngeal hemorrhages where rapid hemostasis is desired.

Use in children
If Ugurol 500 mg/5 ml solution is administered to a child aged one year or older, the dose will be calculated based on the child's body weight. The doctor will determine the appropriate dose and duration of treatment.

Use in elderly patients
Dose reduction is not necessary unless there is documented renal impairment.

Use in patients with kidney problems
If you have kidney problems, the dose of tranexamic acid will be reduced based on a blood test (serum creatinine level).

Use in patients with liver problems
Dose reduction is not necessary.

Method of administration
Ugurol 500 mg/5 ml solution must be administered slowly by intravenous injection.
Ugurol 500 mg/5 ml solution must not be injected intramuscularly.
For oral administration or local application of Ugurol 500 mg/5 ml solution, refer to the sections "Use in adults by oral route" and "Use in adults for local application".

Instructions for opening the ampoule
The ampoules are equipped with a safety break-ring and must be opened as follows:

  • position the ampoule as shown in Figure 1;
  • apply pressure with the thumb placed over the COLORED DOT as indicated in Figure 2.
Two black and white drawings showing hands handling a vial to precisely remove the cap or seal

If you are given more UGUROL than you should
If you are administered more Ugurol than recommended, you may experience a drop in blood pressure, dizziness, nausea, diarrhea, headache, convulsions, and, if predisposed, an increased risk of thrombosis. Inform your doctor or pharmacist immediately.

If you forget to take UGUROL
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with Ugurol:
Common (may affect up to 1 in 10 people)

  • effects on stomach and intestine: nausea, vomiting, diarrhoea.

Uncommon (may affect from 1 to 10 in 1,000 people)

  • effects on the skin: rash.

Not known (frequency cannot be estimated from the available data)

  • malaise with hypotension (low blood pressure), particularly if the injection was administered too rapidly;
  • blood clots;
  • effects on the nervous system: seizures;
  • effects on the eyes: visual disturbances including altered colour vision;
  • effects on the immune system: allergic reactions;
  • acute renal cortical necrosis (cases have been reported with the use of tranexamic acid at doses >2 g (total doses) in the treatment of postpartum haemorrhage).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store UGUROL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What UGUROL contains

  • The active substance is tranexamic acid. Each 5 ml vial contains 500 mg of tranexamic acid.
  • The other component is water for injectable preparations.

Description of the appearance of UGUROL and contents of the pack
Ugurol 500 mg/5 ml solution for injection for intravenous, oral and local use, pack of 5 vials
Ugurol 500 mg/5 ml solution for injection for intravenous, oral and local use, pack of 6 vials

Marketing Authorization Holder and Manufacturer
Rottapharm S.p.A. – Galleria Unione, 5 – 20122 Milan
Manufacturer
Haupt Pharma Livron S.A.S. – Rue Compte De Sinard, 1 -26250 Livron-Sur-Drôme (France)

Patient Information Leaflet

UGUROL 250 mg tablets

tranexamic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, nurse or pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What UGUROL is and what it is used for

Ugurol contains tranexamic acid, which belongs to a group of medicines called haemostatics, antifibrinolytics, and amino acids.
Ugurol is used in adults and children from one year of age for the prevention and treatment of bleeding due to a process that inhibits blood clotting called fibrinolysis.
The specific indications are:

  • heavy menstrual bleeding;
  • gastrointestinal bleeding;
  • haemorrhagic disorders of the urinary tract following prostate surgery or urinary tract surgical procedures;
  • cardiac, abdominal, or gynaecological surgery;
  • bleeding following treatment with other medicines used to dissolve blood clots.

2. What you should know before taking UGUROL

Do not take UGUROL:

  • if you are allergic to tranexamic acid or to any of the other ingredients of this medicine (listed in section 6);
  • if you have a disease that leads to blood clot formation;
  • if you have a condition called "consumption coagulopathy," in which blood starts forming clots in various parts of the body;
  • if you have kidney problems;
  • if you have had seizures in the past.

If you think any of these apply to you, or if you have any other doubts, talk to your doctor before taking UGUROL.
Warnings and precautions
Inform your doctor if any of the following apply to you, so they can determine whether UGUROL is suitable for you:

  • if you have noticed blood in your urine, which could be due to an obstruction in the urinary tract;
  • if you are at risk of developing blood clots;
  • if you have widespread blood clotting or bleeding (disseminated intravascular coagulation), UGUROL may not be suitable for you unless you have severe acute bleeding and blood tests have shown that the process inhibiting blood clotting, called fibrinolysis, is activated;
  • if you have had seizures, UGUROL must not be administered. Your doctor should use the lowest possible dose to avoid seizures caused by treatment with UGUROL;
  • if you are undergoing prolonged treatment with UGUROL, possible disturbances in color vision should be monitored, and treatment should be discontinued if necessary. During long-term use of UGUROL, regular ophthalmological examinations (including visual acuity, color vision, fundoscopy, visual field testing, etc.) are recommended. In case of pathological ophthalmological changes, especially in retinal diseases, your doctor should consult a specialist before deciding whether prolonged use of UGUROL is appropriate in your case.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.
This medicine contains E 110 (erythrosine lake), which may cause allergic reactions.
Other medicines and UGUROL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, vitamins, minerals, herbal medicines, or dietary supplements.
In particular, inform your doctor if you are taking:

  • other medicines that promote blood clotting, known as antifibrinolytics;
  • medicines that prevent blood clotting, known as thrombolytics;
  • oral contraceptives.

Pregnancy and breastfeeding
Consult your doctor if you are pregnant or breastfeeding before taking UGUROL.
Tranexamic acid is excreted in breast milk; therefore, the use of UGUROL is not recommended during breastfeeding.
Driving and using machines
No studies have been conducted on the ability to drive vehicles or operate machinery. Tranexamic acid may cause visual disturbances, including altered color vision, which could affect your ability to drive or operate machinery.

3. How to take UGUROL

Take this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor, nurse, or pharmacist.

Use in adults

  • Prophylaxis: The recommended daily dosage is 3–4 tablets of Ugurol 250 mg, starting administration at least 1 day before surgery and continuing treatment for no less than 3–4 days after the surgical procedure.
  • Treatment: Depending on the clinical condition, administer 2–4 tablets of Ugurol 250 mg three times daily, or 1–2 tablets of Ugurol 250 mg six times daily. This treatment should be continued until complete cessation of bleeding. Oral administration is particularly indicated:
    • in hemorrhagic manifestations occurring in internal medicine, otorhinolaryngology, and dentistry;
    • for preparation prior to surgical procedures where bleeding due to plasmin activation is expected;
    • in menorrhagia;
    • in gynecological hemorrhages;
    • to maintain therapy initiated by intravenous route, aimed at preventing recurrence of bleeding.

Use in children
If Ugurol is administered to a child, the dose will be calculated based on the child's body weight. The doctor will determine the appropriate dose and duration of treatment.
In younger children, from one year of age, the formulation "Ugurol 500 mg solution for injection for intravenous, oral, and local use" is recommended.
The use of "Ugurol 250 mg tablets" is instead possible in older children with normal swallowing ability.

Use in elderly patients
Dose reduction is not necessary unless renal insufficiency is documented.

Use in patients with kidney problems
If you have kidney problems, the dose of tranexamic acid will be adjusted based on a blood test (serum creatinine level).

Use in patients with liver problems
Dose reduction is not necessary.

If you take more UGUROL than the recommended dose
If you take more Ugurol than the recommended dose, you may experience a drop in blood pressure, dizziness, nausea, diarrhea, headache, seizures, and, in predisposed individuals, an increased risk of thrombosis.
Inform your doctor or pharmacist immediately.

If you forget to take UGUROL
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with Ugurol:
Common (may affect up to 1 in 10 people)

  • effects on the stomach and intestine: nausea, vomiting, diarrhoea.

Uncommon (may affect from 1 to 10 in 1,000 people)

  • effects on the skin: rash.

Not known (frequency cannot be estimated from the available data)

  • malaise with hypotension (low blood pressure), particularly if the injection was administered too rapidly;
  • blood clots;
  • effects on the nervous system: seizures;
  • effects on the eyes: visual disturbances including altered colour vision;
  • effects on the immune system: allergic reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store UGUROL

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What UGUROL contains

  • The active substance is tranexamic acid. Each tablet contains 250 mg of tranexamic acid.
  • The other components are microcrystalline cellulose, calcium phosphate dibasic, talc, maize starch, methylcellulose, polyvinylpyrrolidone, sodium lauryl sulfate, magnesium stearate, gelatin. The coating contains: hydroxypropylmethylcellulose, polyethylene glycol 4000, E110 lake.

Description of the appearance of UGUROL and contents of the pack
UGUROL 250 mg tablets, box of 20 tablets
Marketing Authorisation Holder and Manufacturer
Rottapharm S.p.A. – Galleria Unione, 5 – 20122 Milan
Manufacturer
FAMAR ITALIA S.p.A. – Via Zambelletti, 25 – 20021 Baranzate (MI)