Exacil

Package Leaflet: Information for the Patient

EXACYL, 100 mg/ml, Solution for Injection

Tranexamic Acid

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Exacyl and what is it used for
• 2. Important information before using Exacyl
• 3. How to use Exacyl
• 4. Possible side effects
• 5. How to store Exacyl
• 6. Contents of the pack and other information

1. What is Exacyl and what is it used for

Exacyl contains tranexamic acid, which belongs to a group of medicines called antifibrinolytics, anti-haemorrhagics, and amino acids.
Exacyl is used in adults and children over 1 year of age to prevent and treat bleeding caused by a process that prevents blood clotting, called fibrinolysis.
Detailed indications for use include:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Haemorrhagic disorders of the urinary tract following prostate surgery or surgical procedures in the urinary tract
• Surgical procedures related to the ear, nose, and throat
• Surgical procedures related to the heart, abdominal cavity, or gynaecological surgery
• Bleeding after the use of other medicines that dissolve blood clots.

2. Important information before using Exacyl

When not to use Exacyl

• if you are allergic to the active substance 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 "consumption coagulopathy" that causes blood clotting throughout the body
• if you have kidney function disorders
• if you have had seizures.

Due to the risk of cerebral oedema and seizures, it is not recommended to perform intrathecal and intraventricular injections and intracranial administration.
If any of the above applies to you, or if you are not sure whether the above text applies to you, you should talk to your doctor before taking Exacyl.

Warnings and precautions

Tell your doctor if any of the following apply to you, so that he can help you decide whether Exacyl is suitable for you:

• If you have had blood in your urine, Exacyl may lead to urinary tract obstruction.
• If you are at risk of blood clots.
• If you have excessive blood clotting or bleeding throughout the body (disseminated intravascular coagulation), Exacyl may not be suitable for you, unless you have severe bleeding and blood tests have shown that the process that prevents blood clotting, called fibrinolysis, has been activated.
• If you have had seizures, do not use Exacyl. Your doctor will use the smallest possible dose to avoid seizures in you after using Exacyl.
• If you are being treated with Exacyl for a long time, you should be aware of possible vision disturbances and, if necessary, your doctor may recommend stopping treatment. During long-term use of Exacyl in the form of a solution for injection, regular ophthalmological examinations (eye examinations, including visual acuity, colour vision, fundus, visual field, etc.) are recommended. In the event of pathological changes in the eyes, especially retinal diseases, the doctor, after consulting a specialist, will decide individually in each case whether long-term use of Exacyl in the form of a solution for injection is necessary.

Exacyl and other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about medicines you plan to take, including those that are available without a prescription, vitamins, minerals, herbal medicines, and dietary supplements.
In particular, tell your doctor if you are taking:

• other medicines that facilitate blood clotting, called antifibrinolytics
• medicines that prevent blood clotting, called thrombolytics
• oral contraceptives.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Tranexamic acid passes into human milk. Therefore, it is not recommended to use Exacyl during breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

3. How to use Exacyl

This medicine is given as a slow intravenous injection into one of your veins.
Your doctor will decide on the appropriate dose for you and how long you should take it.

Use in children

If Exacyl in the form of a solution for intravenous injection is given to children from 1 year of age, the dose will be calculated based on the child's body weight. Your doctor will decide on the appropriate dose for the child and how long it should be taken.

Use in elderly patients

Dose reduction is not necessary, unless there is evidence of renal impairment.

Use in patients with renal impairment

If you have kidney function disorders, the dose of tranexamic acid will be reduced according to the results of a blood test (serum creatinine level).

Use in patients with hepatic impairment

Dose reduction is not necessary.

Method of administration

Exacyl should be administered only as a slow intravenous injection.
Exacyl must not be injected intramuscularly.

Overdose

If you have been given too much Exacyl, you may experience dizziness, headache, transient hypotension, and seizures. Contact your doctor or nurse immediately.

Side effects

Like all medicines, Exacyl can cause side effects, although not everybody gets them.

Side effects reported during the use of Exacyl

During the use of Exacyl, the following side effects have been observed:
Frequent(may affect up to 1 in 10 people):

• nausea, vomiting, diarrhoea.

Uncommon(may affect up to 1 in 100 people):

• rash.

Frequency not known(frequency cannot be estimated from the available data):

• malaise with hypotension (low blood pressure), usually after too rapid intravenous injection;
• blood clots in different parts of the body;
• seizures;
• vision disturbances, including colour vision disturbances;
• allergic reactions;
• fixed drug eruption.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, e-mail:
ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Exacyl

Keep this medicine out of the sight and reach of children.
There are no special storage requirements, protect from light.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Exacyl contains

• The active substance is tranexamic acid.
• The other ingredients are hydrochloric acid for pH adjustment, purified water.

What Exacyl looks like and contents of the pack

Colourless glass type I ampoules, placed in a cardboard box.
The pack contains 5 ampoules of 5 ml each.

Marketing authorisation holder

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer

Sanofi Winthrop Industrie
1, rue de la Vierge
33440 Ambarès, France
Delpharm Dijon
6, boulevard de l’Europe
21800 Quetigny, France

Date of last revision of the leaflet: