Tranex

Package leaflet: Information for the patient

TRANEX 250 mg capsules, 500 mg capsules

tranexamic acid
Please read all of 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TRANEX is and what it is used for

Tranex contains the active substance tranexamic acid, which belongs to a group of medicines
called antihemorrhagics, antifibrinolytics, amino acid drugs that prevent or stop
bleeding from blood vessels.
TRANEX is used in adults and children for the prophylaxis (prevention) and treatment
of bleeding.

2. What you should know before taking Tranex

Do not take Tranex if:

• you are allergic to tranexamic acid or to any of the other ingredients of this medicine (listed in section 6);
• you have a disease that causes blood clots to form, impairing normal venous (in the veins) or arterial (in the arteries) circulation;
• you have a condition called "consumption coagulopathy" in which blood begins to form clots in various parts of the body;
• you have kidney problems (reduced kidney function);
• you have had seizures in the past (violent, involuntary muscle contractions);
• you have intracavitary bleeding (bleeding from blood vessels into internal body cavities).

Warnings and precautions
Talk to your doctor or pharmacist before taking TRANEX.

• Inform your doctor if any of the following apply to you: if you have a history of seizures, tranexamic acid should not be administered.
• if you notice blood in your urine, this could be due to obstruction of the urinary tract (ureteral clot formation).
• if you have renal insufficiency leading to a risk of accumulation, the dosage of tranexamic acid must be adjusted according to serum creatinine levels (a parameter useful for assessing kidney function).
• if you are at risk of developing blood clots;
• before using tranexamic acid, risk factors for thromboembolic disease should be evaluated.
• if you have widespread excessive clotting or bleeding (disseminated intravascular coagulation), Tranex may not be suitable for you, unless you have acute severe bleeding and blood tests have shown that fibrinolysis—the process that inhibits blood clotting—is activated.
• if you are undergoing prolonged treatment, possible disturbances in color vision should be carefully monitored, and if necessary, treatment should be discontinued. Regular ophthalmological examinations are recommended during prolonged use of Tranex. If pathological ophthalmological changes occur, particularly retinal diseases, your doctor, after consulting a specialist, must decide on the need for prolonged use of Tranex. Tranex must be used with caution in patients with cardiac or hepatic disease. Prophylactic treatment should begin 24 hours before surgery and continue for 3–4 days afterwards. Treatment of ongoing bleeding should continue for at least 24 hours after cessation of bleeding symptoms.

Other medicines and Tranex
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, you must 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 (medicines used to prevent pregnancy).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is advisable not to take TRANEX during confirmed or suspected pregnancy.
Breastfeeding
Tranexamic acid is excreted in breast milk; therefore, the use of Tranex 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 the ability to drive and operate machinery.

3. How to take Tranex

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults: for prophylactic use, the recommended average daily doses, unless otherwise adjusted on a case-by-case basis, are 0.5–1 g orally.
For the treatment of active bleeding, the recommended daily dose is 1–3 grams, taken orally in divided doses throughout the day. In cases of particular severity and urgency, treatment should be initiated with one vial of Tranex 500 mg/5 ml injectable solution, administered slowly intravenously.
Use in children and adolescents
For prophylactic use, the recommended dose per kilogram (kg) of body weight may range from 5 to 10 mg, as assessed by the physician, to be taken orally in divided doses throughout the day. For therapeutic use, the recommended oral dose is double (10 to 20 mg/kg). However, data on efficacy, dosage, and safety for these indications are limited. The efficacy and safety of tranexamic acid in children undergoing heart surgery have not been fully established.
Use in the elderly
Dose reduction is not necessary unless there is proven renal impairment.
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 TRANEX than you should
If you take more Tranex than the recommended dose, you may experience dizziness (sensation of unsteadiness), headache, or transient low blood pressure. Inform your doctor or pharmacist immediately.
If you forget to take Tranex
Do not take a double dose to make up for a 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 Tranex:

Common (may affect up to 1 in 10 people)
Diarrhoea, vomiting, nausea;

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

Not known (frequency cannot be estimated from the available data)
Malaise with hypotension (low blood pressure), blood clots, seizures, visual disturbances including altered colour vision, allergic reactions, including anaphylaxis (severe, rapidly developing allergic reaction affecting the whole body).

In rare cases, fatigue, conjunctival irritation (of the conjunctiva, the eye's outer membrane), nasal obstruction, itching, skin redness, and skin rashes (skin eruption with appearance of reddened areas of the skin) may also occur.

In case of hypersensitivity to tranexamic acid, avoid or discontinue administration and initiate appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
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 Tranex

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 carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Tranex contains
The active substance is tranexamic acid.

• Tranex 250 mg capsules: each capsule contains 250 mg of tranexamic acid;
• Tranex 500 mg capsules: each capsule contains 500 mg of tranexamic acid.
  The other components are: dimethicone, precipitated silica. The capsule shell contains the following: gelatin, red iron oxide E172, titanium dioxide E171.

Description of the appearance of Tranex and contents of the pack
Red, opaque capsules.
Blister pack made of PVC/aluminum containing 30 capsules.

MARKETING AUTHORISATION HOLDER
Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7 - Bagno a Ripoli (FI).
Selling concessionaire: Istituto Luso Farmaco D’Italia SpA - Milanofiori - Strada 6 -
Edificio L - Rozzano (MI).

MANUFACTURER
A. Menarini Manufacturing Logistics and Services s.r.l., via Campo di Pile - L’Aquila
Laboratorios Menarini SA – C/Alfonso XII, 587 – Badalona (Barcelona), Spain

Patient information leaflet

TRANEX 500 mg/5 ml solution for injection

tranexamic acid
Please read this leaflet carefully before using 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What TRANEX is and what it is used for

TRANEX contains tranexamic acid, which belongs to a group of medicines called
antihemorrhagics, antifibrinolytics, amino acids.
TRANEX 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 surgery on the prostate or urinary tract procedures;
• surgery on the ears, nose, or throat;
• surgery on the heart, abdomen, or gynecological surgery;
• bleeding following treatment with other medicines used to dissolve blood clots.

2. What you need to know before taking TRANEX

Do not take TRANEX if:

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

Warnings and precautions

Talk to your doctor or pharmacist before using TRANEX.
Inform your doctor if any of the following apply to you, to help them determine whether TRANEX is suitable for you:

• if you have noticed blood in your urine, this could be due to a blockage in the urinary tract;
• if you are at risk of developing blood clots;
• if you have widespread clotting or bleeding throughout the body (disseminated intravascular coagulation), TRANEX may not be suitable for you unless you have severe acute bleeding and blood tests have shown that the process that inhibits blood clot breakdown, called fibrinolysis, is activated;
• if you have had seizures, TRANEX must not be administered. Your doctor should use the lowest possible dose to avoid treatment-related seizures;
• if you are undergoing prolonged treatment with TRANEX, possible disturbances in color vision should be monitored, and if necessary, treatment should be discontinued. With prolonged use of TRANEX injection solution, regular ophthalmological examinations (including visual acuity, color vision, fundoscopy, visual field testing, etc.) are recommended. In case of pathological ophthalmological changes, especially involving retinal diseases, your doctor should decide, after consulting a specialist, whether prolonged use of TRANEX injection solution is appropriate in your case;
• if you are being treated for postpartum hemorrhage: cases of kidney damage have been reported with doses exceeding 2 grams. Therefore, use of TRANEX at doses higher than 2 grams should be done with caution.

Other medicines and TRANEX

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 (medicines approved for pregnancy prevention).

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Tranexamic acid is excreted in breast milk; therefore, the use of TRANEX is not recommended during breastfeeding.

Driving and use of 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 TRANEX

Use in adults
TRANEX injection solution will be administered to you as a slow intravenous injection.
Your doctor will decide the appropriate dose and how long you should take it.

Use in children
If TRANEX injection solution is administered to a child aged one year or older, the dose will be calculated based on the child's body weight. Your doctor will decide the appropriate dose and how long the child should take it.

Use in elderly
Dose reduction is not necessary unless there is proven 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
TRANEX must be administered slowly intravenously.
TRANEX must not be injected intramuscularly.

If you are given more TRANEX than the recommended dose
If you are given more TRANEX than the recommended dose, you may experience transient hypotension. Inform your doctor or pharmacist immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions reported with TRANEX are:
The following adverse reactions have been observed with TRANEX:
Common (may affect up to 1 in 10 people)

• gastrointestinal effects: nausea, vomiting, diarrhoea.

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

• skin reactions: 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;
• nervous system effects: convulsions;
• eye effects: visual disturbances including altered colour vision;
• immune system effects: 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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet,
please contact your doctor or pharmacist. You can also report adverse reactions directly
via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on
the safety of this medicine.

5. How to store TRANEX

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 TRANEX contains
The active substance is tranexamic acid. Each vial contains 500 mg of tranexamic acid.
The other components are: sterile bidistilled water q.s. to 5 ml.

Description of the appearance of TRANEX and contents of the pack
Tranex 500 mg/5 ml solution for injection, 6 vials of 5 ml.
Each vial contains a clear, colourless solution.

Marketing Authorization Holder
Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7 - Bagno a Ripoli (FI)
Selling Licensee: Istituto Luso Farmaco D’Italia SpA - Milanofiori - Strada 6 -
Edificio L - Rozzano (MI).

Manufacturer
A. Menarini Manufacturing Logistics and Services s.r.l. - Via Sette Santi 3, Firenze.
Alfasigma SpA – Via Enrico Fermi, 1 – 65020 Alanno (PE).
Biologici Italia Laboratories s.r.l. - Via Filippo Serpero 2 – Masate, Milano