Exacil

Package Leaflet: Information for the User

EXACYL, 500 mg, Film-Coated Tablets

Tranexamic Acid

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Exacyl and what is it used for
• 2. Important information before taking Exacyl
• 3. How to take 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 the active substance tranexamic acid. Tranexamic acid belongs to a group of
medicines called antifibrinolytics. The action of tranexamic acid is to inhibit the fibrinolytic activity of plasmin.
Exacyl is used for:

• bleeding from the genital tract: caused by hormonal disorders or occurring secondary to injuries, infections, or degenerative changes in the uterus;
• bleeding from the gastrointestinal tract;
• hematuria from the lower urinary tract caused by: benign prostatic hyperplasia, malignant tumors of the prostate and bladder, kidney stones, or bleeding from the urinary tract after surgical procedures on the prostate and urinary system;
• bleeding associated with otolaryngological surgical procedures (e.g., tonsillectomy).

2. Important information before taking Exacyl

When Not to Take 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 acute venous thrombosis (deep vein thrombosis, pulmonary embolism)
• if you have arterial thrombosis (angina pectoris, myocardial infarction, stroke)
• if you have fibrinolytic states secondary to consumption coagulopathy (these conditions cause blood clotting throughout the body)
• in patients with severe renal impairment (risk of accumulation of the medicinal product)
• in patients with a history of seizures.

Warnings and Precautions

Before starting Exacyl, discuss with your doctor or pharmacist:

• if you have had seizures. The doctor will use the smallest possible dose to avoid seizures in the patient after taking Exacyl.
• if you have visual disturbances, including blurred vision, impaired vision, color vision disturbances. The doctor may decide to discontinue treatment. In the case of prolonged, long-term use of Exacyl, regular ophthalmological examinations are recommended (eye exams, including vision acuity, color vision, fundus, visual field, etc.). In the case of pathological eye changes, especially retinal diseases, the doctor, after consulting a specialist, will decide individually in each case whether long-term use of Exacyl is necessary.
• if you notice blood in your urine. Exacyl may lead to urinary tract obstruction.
• If you have a history of thromboembolic disease and (or) family history. The doctor will assess the risk factors for thromboembolic disease and decide whether it is possible to administer this medicine.
• if you are taking oral contraceptives. There is an increased risk of thrombosis.
• if you have mild to moderate renal impairment. The doctor will reduce the dose according to the serum creatinine level (see section 3).
• If you experience thromboembolic disorders of the veins or arteries.

You should immediately inform your doctor if you experience any of the following symptoms:
unusual leg pain, muscle weakness, chest pain, irregular pulse, sudden shortness of breath, loss of consciousness, disorientation, severe headache, dizziness, visual disturbances, slurred speech, or loss of speech.

Exacyl and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
In particular, inform your doctor if you are taking:

• other medicines that facilitate blood clotting, called antifibrinolytic agents (treatment should be carried out under close medical supervision)
• medicines that prevent blood clotting, called thrombolytic agents
• oral contraceptives.

You should also inform your doctor if you are taking:

• Etamsylate (a medication that stops bleeding)
• Vitamin K1 and tiemonium methylsulfate (an antispasmodic medication)

Exacyl with Food and Drink

Exacyl can be taken with or without food.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should avoid taking this medicine if you are pregnant.
Tranexamic acid passes into breast milk. Breast-feeding is not recommended during treatment with this medicine.

Driving and Using Machines

During treatment with Exacyl, dizziness and malaise may occur. If you experience such symptoms, do not drive or operate machinery.

Exacyl Contains Sucrose and Wheat Starch

The medicine is suitable for patients with celiac disease.
Patients with wheat allergy (other than celiac disease) should not take this medicine.
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to Take Exacyl

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended dose is:
Adults
2 to 4 g per day in 2 or 3 divided doses (i.e., 4 to 8 tablets per day).
Children
20 mg/kg body weight per day.
Tablets should be taken orally.
Patient with Renal Impairment
In case of renal impairment, due to the risk of accumulation of the medicinal product, the dosing of tranexamic acid should be reduced according to the serum creatinine level.
If the serum creatinine level is:
between 120 and 250 μmol/l, the dose of tranexamic acid is 10 mg/kg body weight intravenously, twice a day;
between 250 and 500 μmol/l, the dose of tranexamic acid is 10 mg/kg body weight intravenously, once a day (every 24 hours);
above 500 μmol/l, the dose of tranexamic acid is 5 mg/kg body weight intravenously, once a day (every 24 hours).

Taking More Than the Recommended Dose of Exacyl

As a result of overdose, the following may occur: dizziness of central origin, headache, hypotension, and seizures. Seizures tend to occur more frequently with increasing dose. If you have taken more than the recommended dose of the medicine, seek medical advice immediately.

Missing a Dose of Exacyl

If you miss a dose, take it as soon as possible, unless it is almost time for your next dose.
Do not take a double dose to make up for a forgotten dose.

Stopping Treatment with Exacyl

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

Possible Side Effects

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

Side Effects Reported During Treatment with Exacyl.

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

• nausea, vomiting, diarrhea.

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

• allergic skin reactions.

Frequency Not Known(frequency cannot be estimated from the available data):

• hypersensitivity reactions, including anaphylaxis (severe and sudden allergic reaction); in case of such side effects, seek medical attention immediately.
• seizures, especially in cases with risk factors or a history of seizures, or also in cases of improper use of the medicine (see section 2);
• visual disturbances, including color vision disturbances;
• malaise with hypotension (low blood pressure), with or without loss of consciousness (usually after too rapid intravenous injection, exceptionally after oral administration);
• venous or arterial thrombosis in various parts of the body;
• fixed drug eruption;
• sudden renal impairment.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Exacyl

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, 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. Each film-coated tablet contains 500 mg of tranexamic acid.
• The other ingredients are: wheat starch, magnesium stearate, sucrose; coating: acrylic resin, carnauba wax.

What Exacyl Looks Like and Contents of the Pack

Tablets are packaged in blisters, placed in a cardboard box.
The pack contains 20 film-coated tablets.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer

Fidelio Healthcare Limburg GmbH
Mundipharmastrasse 2
65549 Limburg
Germany
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
Lubelska Street 52
35-233 Rzeszów

Date of Last Revision of the Package Leaflet: May 2023