Tranexamic acid Bioindustria L.I.M.

Package leaflet: Information for the patient

TRANEXAMIC ACID Bioindustria L.I.M.

500 mg/5 ml injectable solution for intravenous, oral and topical use
tranexamic acid
Generic medicine
Please read this leaflet carefully before you are given 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 get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What ACIDO TRANEXAMICO Bioindustria L.I.M. is and what it is used for

ACIDO TRANEXAMICO Bioindustria L.I.M. contains tranexamic acid, which belongs to a group of
medicinal products known as haemostatics, antifibrinolytics, and amino acids.
ACIDO TRANEXAMICO Bioindustria L.I.M. is used in adults and children from one year of age for the prevention and treatment of bleeding caused by a process that inhibits blood coagulation called fibrinolysis.
Specific indications include:

• heavy menstrual bleeding;
• gastrointestinal bleeding;
• haemorrhagic disorders of the urinary tract, following surgery on the prostate or urinary tract procedures;
• surgery on the ears, nose, or throat;
• cardiac, abdominal, or gynaecological surgery;
• bleeding following treatment with other medicinal products used to dissolve blood clots.

2. What you should know before being administered ACIDO TRANEXAMICO Bioindustria L.I.M.

Do not take ACIDO TRANEXAMICO Bioindustria L.I.M. if you:

• are allergic to tranexamic acid or to any of the other ingredients of this medicine (listed in section 6);
• have a disease that leads to the formation of blood clots;
• have a condition called "consumption coagulopathy" in which blood starts forming clots in various parts of the body;
• have kidney problems;
• 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, speak with your doctor before
taking ACIDO TRANEXAMICO Bioindustria L.I.M.
Warnings and precautions
Inform your doctor if any of the following apply to you, to help them decide whether ACIDO TRANEXAMICO
Bioindustria L.I.M. is suitable for you:

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

Other medicines and ACIDO TRANEXAMICO Bioindustria L.I.M.
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, you must inform 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 ACIDO
TRANEXAMICO Bioindustria L.I.M.
Tranexamic acid is excreted in breast milk; therefore, the use of ACIDO TRANEXAMICO Bioindustria L.I.M.
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 ACIDO TRANEXAMICO Bioindustria L.I.M.

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

Administration in adults by intravenous route
ACIDO TRANEXAMICO Bioindustria L.I.M. solution for injection is administered by slow intravenous injection into a vein. Your doctor will determine the appropriate dose for you and how long you should continue treatment.

Administration in adults by oral route

• Prophylaxis When taking the solution orally, dilute the contents of the vial in a small amount of sweetened water. The daily dosage is 1½–2 vials of ACIDO TRANEXAMICO Bioindustria L.I.M. 500 mg, starting at least one 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 sweetened water. The daily dosage is 1–2 vials of ACIDO TRANEXAMICO Bioindustria L.I.M. 500 mg three times a day, or ½–1 vial of ACIDO TRANEXAMICO Bioindustria L.I.M. 500 mg six times a day.

Oral administration is particularly indicated:

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

Administration in adults by local application
For local application of ACIDO TRANEXAMICO Bioindustria L.I.M., use the contents of one vial and pour it directly onto the site of bleeding or apply it using a gauze pad previously soaked in the solution.
Direct local application or application via gauze pads soaked in the solution is particularly indicated for hemorrhages at the oronasopharyngeal level where rapid hemostasis is desired.

Use in children
If ACIDO TRANEXAMICO Bioindustria L.I.M. solution for injection 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 determine the appropriate dose and duration of treatment.

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.

Method of administration
ACIDO TRANEXAMICO Bioindustria L.I.M. must be administered slowly into a vein.
ACIDO TRANEXAMICO Bioindustria L.I.M. must not be injected into a muscle.
For oral administration or local application of ACIDO TRANEXAMICO Bioindustria L.I.M. 500 mg/5 ml, refer to the sections “Administration in adults by oral route” and “Administration in adults by local application”.

If you are given more ACIDO TRANEXAMICO Bioindustria L.I.M. than the recommended dose
If you are given more ACIDO TRANEXAMICO Bioindustria L.I.M. than the recommended dose, you may experience low blood pressure, dizziness, nausea, diarrhea, headache, seizures, and, if predisposed, an increased risk of thrombosis. Inform your doctor or pharmacist immediately.

If you forget to take ACIDO TRANEXAMICO Bioindustria L.I.M.
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this one may cause adverse effects, although not everyone experiences them.
The following adverse effects have been observed with ACIDO TRANEXAMICO Bioindustria L.I.M.:

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

5. How to store TRANEXAMIC ACID Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label 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 ACIDO TRANEXAMICO Bioindustria L.I.M. contains

• The active substance 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 ACIDO TRANEXAMICO Bioindustria L.I.M. and contents of the pack
Pack containing 5 vials of 5 ml of injectable solution for intravenous, oral and topical use.
Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
(Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis 2, 15067 Novi Ligure (AL) – Italy