Tranexamic acid Aurobindo

Package leaflet: Information for the user

Tranexamic Acid Aurobindo 100 mg/ml solution for injection

Read all of 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, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Acido Tranexamico Aurobindo is and what it is used for

Acido Tranexamico Aurobindo contains tranexamic acid, which belongs to a group of medicines called haemostatics, antifibrinolytics, amino acids.
This medicine 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.
Specific indications are:

• heavy menstrual bleeding in women;
• gastrointestinal bleeding;
• haemorrhagic 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 used to dissolve blood clots.

2. What you need to know before you are given Acido Tranexamico Aurobindo

Do not take Acido Tranexamico Aurobindo:

• 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” (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.

Due to the risk of cerebral edema and seizures, intrathecal, intraventricular, and intracerebral administration is not recommended.
If you think any of these conditions apply to you, or if you have any other doubts, please discuss them with your doctor before taking this medicine.

Warnings and precautions

Talk to your doctor or nurse before taking Acido Tranexamico Aurobindo if you have any of the following conditions. This will help them decide whether this medicine is suitable for you:

• if you have blood in your urine, which could lead to obstruction of 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), this medicine 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, this medicine should not be administered to you. Your doctor must use the lowest possible dose to avoid treatment-related seizures;
• if you are undergoing prolonged treatment with this medicine, possible disturbances in colour vision should be monitored, and treatment should be discontinued if necessary. Regular ophthalmological examinations (including visual acuity, colour vision, fundoscopy, visual fields, etc.) are recommended during long-term use. If pathological ophthalmological changes occur, particularly retinal disorders, your doctor should consult a specialist and decide whether continued long-term use of this medicine is appropriate in your case.

Other medicines and Acido Tranexamico Aurobindo

Tell your doctor, nurse, or pharmacist if you are taking or have recently taken any other medicines.
In particular, inform them if you are taking:

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

Pregnancy, breastfeeding and fertility

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

Driving and using machines

No studies on the ability to drive vehicles or operate machinery have been conducted.

3. How to use Tranexamic Acid Aurobindo

This medicine will be administered to you as a slow injection into a vein.
Your doctor will decide the appropriate dose and how long you should receive it.

Use in children
If this medicine is administered to a child from the age of one year, the dose will be calculated according to the child's body weight. The doctor will determine the appropriate dose and duration of treatment for the child.

Use in the elderly
Dose reduction is not necessary unless there is evidence of 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 impairment
Dose reduction is not necessary.

Method of administration
This medicine must be administered slowly into a vein.
It must not be injected into a muscle.

If you are given more Tranexamic Acid Aurobindo than the recommended dose
If you are given more tranexamic acid than the recommended dose, a transient drop in blood pressure may occur. Inform your doctor or pharmacist immediately.

If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

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

• gastrointestinal effects: nausea, vomiting, diarrhoea.

Uncommon: may affect up to 1 in 100 people

• skin effects: 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.

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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tranexamic Acid Aurobindo

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 and label after "Exp".
The expiry date refers to the last day of that month. The pharmacist will check the expiry date before the injection is administered.
This medicine does not require any special storage conditions.
After opening: Use immediately. Discard any unused portion.
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 Acido Tranexamico Aurobindo contains

• The active substance is tranexamic acid. Each ml of solution contains 100 mg of tranexamic acid. Each 5 ml vial of solution contains 500 mg of tranexamic acid. Each 10 ml vial of solution contains 1000 mg of tranexamic acid.
• The other ingredient is water for injections.

Description of the appearance of Acido Tranexamico Aurobindo and contents of the pack
Injection solution.
Clear type I glass vial containing 5 ml or 10 ml of solution for injection. To facilitate breaking, the vials may have a “single break point” or may be “scored”. The vials are contained in a printed carton.
Packs:
5 ml: 1, 5, 6, 10 and 100 vials in a carton.
10 ml: 5 and 10 vials in a carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta
Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD
United Kingdom
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Belgium: Tranexaminezuur AB 100 mg/ml oplossing voor injectie
Italy: Acido Tranexamico Aurobindo
Germany: Tranexamsäure PUREN 100 mg/ml Injektionslösung
Netherlands: Tranexaminezuur Aurobindo 100 mg/ml, oplossing voor injectie
Portugal: Ácido Tranexâmico Generis
Spain: Ácido Tranexámico Aurovitas 100 mg/ml solución inyectable EFG
United Kingdom: Tranexamic acid 100 mg/ml solution for injection

THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS:

Dosage in adults
Unless otherwise prescribed, the following doses are recommended:

1. standard treatment of local fibrinolysis: 0.5 g (1 vial of 5 ml) to 1 g (1 vial of 10 ml or 2 vials of 5 ml) of tranexamic acid by slow intravenous injection (= 1 ml/minute) two or three times daily.
2. standard treatment of generalized fibrinolysis:

1 g (1 vial of 10 ml or 2 vials of 5 ml) of tranexamic acid by slow intravenous injection (= 1 ml/minute) every 6–8 hours, corresponding to 15 mg/kg body weight.

Use in children
If Acido Tranexamico Aurobindo 100 mg/ml solution for injection is administered to children from one year of age, the dose will be based on the child's body weight. The physician will determine the correct dose for the child and the duration of treatment.
In children from one year of age, for the currently approved indications, the dosage is approximately 20 mg/kg/day.

Use in the elderly
Dose reduction is not required unless there is documented renal impairment.

Use in patients with renal impairment
In case of renal insufficiency that may pose a risk of accumulation, the use of tranexamic acid is contraindicated in patients with severe renal damage. For patients with mild to moderate renal insufficiency, the dose of tranexamic acid must be reduced according to the serum creatinine level.

Use in patients with hepatic impairment
Dose adjustment is not required.
Method of administration
Tranexamic Acid Aurobindo 100 mg/ml solution for injection must be administered by slow intravenous injection only (= 1 ml/minute).
Tranexamic Acid Aurobindo 100 mg/ml solution for injection must not be injected intramuscularly.