UGUROL 250 mg Tabletka

Treść ulotki

1. UGUROL 500 mg/5 ml injectable solution for intravenous use,
   1. What is UGUROL and what is it 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
2. UGUROL 250 mg tablets
   1. What is UGUROL and what is it 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

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

for oral and local use
tranexamic acid

Read this leaflet carefully before taking this medicine as 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 any side effects occur, including those not listed in this leaflet, ask 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 you take 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 is UGUROL and what is it used for

Ugurol contains tranexamic acid, which belongs to a group of medicines called antihaemorrhagics,
antifibrinolytics, 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 coagulation called fibrinolysis.
The specific indications are:

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

2. What you need to know before taking UGUROL

Do not take UGUROL:

• if you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6);
• if you have a disease that leads to the formation of blood clots;
• if you have a condition called “disseminated intravascular coagulation” in which the blood begins to form clots in different 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 and intraventricular injection and
intracerebral application are not recommended.
If you think any of these points apply to you, or if you have any other doubts, talk to your doctor before
taking Ugurol.

Warnings and precautions
Tell your doctor if any of the following points apply to you, to help them decide if Ugurol is suitable for you:

• if you have noticed blood in your urine, this could be due to an obstruction of the urinary tract;
• if you are at risk of developing blood clots;
• if you have excessive clots or bleeding throughout the body (disseminated intravascular coagulation), Ugurol may not be suitable for you, unless you have acute severe bleeding and blood tests have shown that the process that inhibits blood clotting, called fibrinolysis, is activated;
• if you have had seizures, Ugurol should not be administered. The doctor will need to use the lowest possible dose to avoid seizures due to treatment with Ugurol;
• if you are undergoing prolonged treatment with Ugurol, attention should be paid to possible disturbances in color vision and, if necessary, treatment should be discontinued. In case of prolonged use of Ugurol injection solution, regular ophthalmological examinations (including visual acuity, color vision, fundus examination, visual field, etc.) are recommended. If pathological ophthalmological changes occur, particularly with retinal diseases, your doctor must decide, after consulting a specialist, on the need for prolonged use of Ugurol injection solution in your case;
• if you are being treated for postpartum hemorrhage: there have been reports of kidney damage with doses greater than 2 grams. Therefore, the use of Ugurol at doses greater than 2 grams should be done with caution.

Other medicines and UGUROL
Tell 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
food supplements.
In particular, you must tell your doctor if you are taking:

• other medicines that promote blood clotting called antifibrinolytics;
• medicines that prevent blood clotting called 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, so the use of Ugurol is not recommended during
breastfeeding.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and use machines. Tranexamic acid
can cause visual disturbances, including altered color vision, which may affect the ability to
drive and use machines.

3. How to take UGUROL

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

Use in adults by intravenous route
Ugurol solution is administered with a slow injection into a vein. The doctor will decide the appropriate dose for you and
for how long you will need to take it.

Use in adults by oral route

• Prophylaxis If you take the solution orally, diluting the contents of the vial with a little sugar water, the daily dosages are 1½-2 vials of Ugurol 500 mg, starting administration at least 1 day before surgery and continuing treatment for at least 3-4 days after the surgical procedure.
• Therapy If you take the solution orally, diluting the contents of the vial in a little sugar water, the daily dosages are 1-2 vials of Ugurol 500 mg 3 times a day or ½-1 vial of Ugurol 500 mg 6 times a day.

Oral administration is particularly indicated:

• in bleeding manifestations occurring in internal medicine, in otorhinolaryngology and in dentistry;
• for the preparation of surgical interventions in which bleeding due to plasmin activation is presumed to occur;
• in hypermenorrhea;
• in gemini in gynecology;
• for the maintenance of therapies started by intravenous route in order to prevent recurrence of bleeding.

Use in adults for local application
For the local application of Ugurol 500 mg/5ml solution, use the contents of 1 vial and pour it
directly onto the site of the bleeding or apply it using a gauze swab previously soaked.
Direct local application or by means of gauze swabs, previously soaked in solution, is particularly indicated
in bleeding at the oro-rhino-pharyngeal level where a rapid hemostasis is desired.

Use in children
If Ugurol 500 mg/5ml solution is administered to a child from one year of age, the dose will be calculated
based on the child's weight. The doctor will decide the appropriate dose for the child and for how long they will need
to take it.

Use in the elderly
It is not necessary to reduce the dose unless there is proven renal insufficiency.

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
It is not necessary to reduce the dose.

Method of administration
Ugurol 500 mg/5ml solution must be administered slowly into a vein.
Ugurol 500 mg/5ml solution must not be injected into a muscle.
For oral administration or local application of Ugurol 500 mg/5ml, see the paragraphs “Use in adults by oral route” and “Use in adults for local application”.

Instructions for opening the vial
The vials are equipped with a safety break and must be opened as follows:

• position the vial as shown in figure 1;
• apply pressure with your thumb placed above the COLORED POINT as shown in figure 2.

If you are given more UGUROL than the recommended dose
If you are given more Ugurol than the recommended dose, 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 a missed dose.
If you have any doubts 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.
The following side effects have been observed with Ugurol:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 1000 people)

• effects on the skin: rash.

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

• feeling unwell with hypotension (low blood pressure), particularly if the injection was given too quickly;
• blood clots;
• effects on the nervous system: convulsions;
• effects on the eyes: visual disturbances including altered colour vision;
• effects on the immune system: allergic reactions;
• acute cortical renal 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What UGUROL contains

• The active ingredient is tranexamic acid. Each 5 ml vial contains 500 mg of tranexamic acid.
• The other component is water for injections.

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

Marketing Authorisation Holder and Manufacturer
Rottapharm S.p.A. – Galleria Unione, 5 – 20122 Milano

Manufacturer
Haupt Pharma Livron S.A.S. – Rue Compte De Sinard, 1 -26250 Livron-Sur-Drôme (France)

UGUROL 250 mg tablets

tranexamic acid

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse
• If you get any side effects, even 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 you take 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 is UGUROL and what is it used for

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

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

2. What you need to know before taking UGUROL

Do not take UGUROL:

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

If you think any of these points apply to you, or if you have any other doubts, talk to your doctor before
taking Ugurol.

Warnings and precautions
Tell your doctor if any of the following points apply to you, to help them decide if Ugurol is suitable for you:

• if you have noticed blood in your urine, this may be due to an obstruction of the urinary tract;
• if you are at risk of developing blood clots;
• if you have excessive clots or bleeding throughout the body (disseminated intravascular coagulation), Ugurol may not be suitable for you, unless you have severe acute bleeding and blood tests

have shown that the process that inhibits blood clotting,
called fibrinolysis, is activated;

• if you have had seizures, Ugurol should not be administered. The doctor will have to use the lowest possible dose to avoid seizures due to treatment with Ugurol;
• if you are undergoing prolonged treatment with Ugurol, attention should be paid to possible disturbances of color vision and, if necessary, treatment should be discontinued. In case of prolonged use of Ugurol, regular ophthalmological visits (including visual acuity, color vision, fundus examination, visual field, etc.) are recommended. In case of pathological ophthalmological changes, particularly with retinal diseases, your doctor must decide, after consulting a specialist, on the need for prolonged use of Ugurol in your case.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.
This medicine contains lacquer E 110 which may cause allergic reactions.

Other medicines and UGUROL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription, vitamins, minerals, herbal medicines or
food supplements.
In particular, you should tell your doctor if you are taking:

• other medicines that promote blood clotting called antifibrinolytics;
• medicines that prevent blood clotting called 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, so the use of Ugurol is not recommended during
breastfeeding.

Driving and using machines
No studies have been performed on the ability to drive vehicles and use machines. Tranexamic acid
can cause visual disturbances, including altered color vision, which may affect the ability to
drive and use machines.

3. How to take UGUROL

Take this medicine following exactly the instructions of your doctor.
If you have any doubts, consult your doctor, nurse or pharmacist.

Use in adults

• Prophylaxis The recommended average daily dosage is 3-4 Ugurol 250 mg tablets, starting administration at least 1 day before surgery and continuing treatment for a period of no less than 3-4 days after the surgical procedure.
• Therapy Administer, depending on the clinical picture, 2-4 Ugurol 250 mg tablets 3 times a day or 1-2 Ugurol 250 mg tablets 6 times a day. This treatment should be continued until the complete cessation of bleeding. Oral administration is particularly indicated:
• in hemorrhagic manifestations occurring in internal medicine, in otorhinolaryngology and in dentistry;
• for the preparation of surgical interventions in which bleeding due to plasmin activation is presumed to occur;
• in hypermenorrhea;
• in postpartum hemorrhage in gynecology;
• for the maintenance of therapies started intravenously in order to prevent recurrence of bleeding.

Use in children
If Ugurol is administered to a child, the dose will be calculated based on the child's weight. The doctor
will decide the appropriate dose for the child and for how long it should be taken.
In younger children, from one year of age, it is recommended to use the Ugurol “500 mg
injectable solution for intravenous, oral and local use”.
The use of Ugurol “250 mg tablets” is instead possible in older children, with normal swallowing abilities.

Use in the elderly
It is not necessary to reduce the dose unless there is proven renal insufficiency.

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
It is not necessary to reduce the dose.

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, 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 a missed dose.
If you have any doubts 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.
The following side effects have been observed with Ugurol:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 1000 people)

• effects on the skin: rash.

Not known(frequency cannot be estimated from available data)

• feeling unwell with hypotension (low blood pressure), particularly if the injection was given too quickly;
• blood clots;
• effects on the nervous system: convulsions;
• effects on the eyes: visual disturbances including altered colour vision;
• effects on the immune system: allergic reactions.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What UGUROL contains

• The active ingredient is tranexamic acid. Each tablet contains 250 mg of tranexamic acid.
• The other ingredients are microcrystalline cellulose, dibasic calcium phosphate, talc, corn starch, casein methylene, polyvinylpyrrolidone, sodium lauryl sulfate, magnesium stearate, gelatin. The film coating contains: hydroxypropylmethylcellulose, polyethylene glycol 4000, lacquer E110.

Description of the appearance of UGUROL and contents of the pack
UGUROL 250 mg tablets, pack of 20 tablets

Marketing Authorisation Holder and Manufacturer
Rottapharm S.p.A. – Galleria Unione, 5 – 20122 Milano

Manufacturer
FAMAR ITALIA S.p.A. – Via Zambelletti, 25 – 20021 Baranzate (MI)