TRANEX 250 mg Capsule

Зміст інструкції

1. TRANEX 250 mg capsule, 500 mg capsule
   1. What is TRANEX and what is it used for
   2. What you need to know before you take Tranex
   3. How to take Tranex
   4. Possible side effects
   5. How to store Tranex
   6. Contents of the pack and other information
2. TRANEX 500 mg/5 ml injectable solution
   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

TRANEX 250 mg capsule, 500 mg capsule

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.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is TRANEX and what is it used for

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

2. What you need to know before you take 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 leads to the formation of blood clots that prevent normal venous (at the level of the veins) or arterial (at the level of the arteries) circulation;
• you suffer from a condition called “consumption coagulopathy” in which the blood begins to form clots in various parts of the body;
• you have kidney problems (reduced function);
• you have had seizures in the past (violent and involuntary muscle contraction);
• you have endocavitary hemorrhages (bleeding from blood vessels into the internal cavities of the body).

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

• Tell your doctor if one of the following points applies to you: if you have a history of seizures, tranexamic acid should not be administered.
• if you have noticed blood in your urine, this may be due to an obstruction of the urinary tract (ureteral clot formation).
• if you suffer from renal insufficiency leading to a risk of accumulation, the dosage of tranexamic acid must be reduced based on the level of serum creatinine (a useful parameter for assessing kidney function).
• if you are at risk of developing blood clots;
• before using tranexamic acid, risk factors for thromboembolic disease must be examined.
• if you have excessive clots or bleeding throughout the body (disseminated intravascular coagulation), Tranex may not be suitable for you unless you have acute severe bleeding and blood tests have shown that the process inhibiting blood coagulation, called fibrinolysis, is activated.
• if you are undergoing prolonged treatment, attention should be paid to possible disturbances in color vision and, if necessary, treatment should be discontinued. In case of prolonged use of Tranex, regular eye examinations are recommended. If pathological ophthalmological changes occur, in particular retinal diseases, your doctor must decide, after consulting a specialist, on the need for prolonged use of Tranex Tranex must be used with caution in patients with heart and liver disease. Prophylactic treatment should begin 24 hours before the operation and continue for 3-4 days after it. The therapy of ongoing hemorrhages will be prolonged for at least 24 hours after the cessation of manifestations.

Other medicines and Tranex
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 inform your doctor if you are taking:

• other medicines that promote blood clotting called antifibrinolytics;
• medicines that prevent blood clotting called thrombolytics;
• oral contraceptives (medicines used to prevent pregnancy).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become
pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
It is advisable not to take TRANEX during established or suspected pregnancy.
Breastfeeding
Tranexamic acid is excreted in breast milk, so the use of Tranex is not recommended
during breastfeeding.

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

3. How to take Tranex

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

Adults:for prophylactic purposes, the recommended average daily doses, unless adjusted on a case-by-case basis, are 0.5-1 g orally.
For the treatment of ongoing bleeding, the recommended daily dose is 1 - 3 grams to be taken in multiple doses throughout the day orally. In cases of particular severity and urgency, treatment should be started with a vial of Tranex 500 mg/5 ml injectable solution injected slowly intravenously.

Use in children and adolescents
For prophylactic purposes, the recommended dose per kilogram (kg) of body weight may vary from 5 to 10 mg according to the doctor's assessment, to be taken in multiple doses throughout the day orally. For therapeutic purposes, 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
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 TRANEX than you should
If you take more Tranex than the recommended dose, you may experience dizziness (feeling of instability), headache, a transient drop in 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 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 everyone gets them.
The following side effects have been observed with Tranex:
Common (may affect up to 1 in 10 people)
Diarrhea, vomiting, nausea;
Uncommon (may affect up to 1 in 1000 people)
Skin rash;
Not known (frequency cannot be estimated based on available data)
Feeling unwell with hypotension (low blood pressure), blood clots, convulsions,
visual disturbances including altered color vision, allergic reactions, including anaphylaxis (severe
rapidly appearing allergic reaction involving the whole body).
In rare cases, fatigue, conjunctival irritation (of the
conjunctiva, the outer membrane of the eye), nasal congestion, itching, skin redness,
exanthems (skin rash, with the appearance of reddened areas of the skin) may also occur.
In case of hypersensitivity to tranexamic acid, avoid or discontinue
administration and institute appropriate therapy.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor, pharmacist or nurse. 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 Tranex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater 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 Tranex contains
The active ingredient 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; Other components are: dimethicone, precipitated silica. The capsules have the following composition: gelatin, red iron oxide E172, titanium dioxide E171.

Description of the appearance of Tranex and contents of the pack
Capsules of red color, opaque.
Blister 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).
Distributor for sales: Istituto Luso Farmaco D’Italia SpA - Milanofiori - Strada 6 -
Building 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

TRANEX 500 mg/5 ml injectable solution

tranexamic acid

Read this leaflet carefully before you start to use 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.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• 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 TRANEX is and what it is used for
• 2. What you need to know before you are given TRANEX
• 3. How to use 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
antihaemorrhagics, 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 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 ears, nose or throat;
• 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 TRANEX

Do not take TRANEX if:

• you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6);
• you have a disease that leads to the formation of blood clots;
• you have a condition called “consumption coagulopathy” in which the blood begins to form clots in different 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 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 TRANEX.

Warnings and precautions
Talk to your doctor or pharmacist before using TRANEX.
Tell your doctor if any of the following points apply to you, to help them decide if TRANEX 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), TRANEX 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, TRANEX should not be administered. The doctor will need to use the lowest possible dose to avoid seizures due to treatment with TRANEX;
• if you are undergoing prolonged treatment with TRANEX, attention should be paid to possible disturbances in color vision and, if necessary, treatment should be discontinued. In case of prolonged use of TRANEX injection solution, regular ophthalmological examinations (including visual acuity, color vision, fundus examination, visual field, etc.) are recommended. In case of pathological ophthalmological changes, in particular with retinal diseases, your doctor must decide, after consulting a specialist, on the need for prolonged use of TRANEX 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 Tranex at doses greater than 2 grams should be done with caution.

Other medicines and TRANEX
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 (medicines authorized for preventing pregnancy).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Tranexamic acid is excreted in breast milk, so the use of TRANEX is not recommended
during breastfeeding.

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

3. How to take TRANEX

Use in adults
TRANEX solution for injection will be administered to you 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 children
If TRANEX solution for injection is administered to a child starting 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
TRANEX must be administered slowly into a vein.
TRANEX must not be injected into a muscle.

If you are given more TRANEX than the recommended dose
If you are given more TRANEX than the recommended dose, you may experience a
transient drop in blood pressure. Inform your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Side effects reported with TRANEX are:
The following side effects have been observed with TRANEX
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)

• skin effects: rash.

Not known (frequency cannot be estimated based on available data)

• feeling unwell with hypotension (low blood pressure), especially 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 experience any side effects, including 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 TRANEX

This medicine does not require any particular storage conditions.
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 wastewater 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 TRANEX contains
The active ingredient is tranexamic acid. Each vial contains 500 mg of tranexamic acid.
The other components are :sterile water for injection q.s. to 5 ml.

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

Marketing Authorisation Holder
Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7 - Bagno a Ripoli (FI)
Distributor for sales: Istituto Luso Farmaco D’Italia SpA - Milanofiori - Strada 6 -
Building L - Rozzano (MI).

Manufacturer

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