Exacyl

Package leaflet: Information for the user

EXACYL, 500 mg, coated tablets
Acidum tranexamicum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur in the patient, including side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Exacyl is and what it is 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 Exacyl is and what it is used for

Exacyl contains the active substance tranexamic acid. Tranexamic acid belongs to a group of medicines known as antifibrinolytic agents. Tranexamic acid works by inhibiting the fibrinolytic activity of plasmin.

Exacyl is used in:

• Bleeding from the genital tract:
  • caused by hormonal disorders
  • secondary to injuries, infections, or degenerative changes of the uterus
• Gastrointestinal bleeding
• Haematuria from the lower urinary tract caused by:
  • benign prostatic hyperplasia
  • malignant tumours of the prostate gland and urinary bladder
  • kidney stones
  • bleeding from the urinary tract following surgical procedures on the prostate gland and urinary system
• Bleeding associated with otolaryngological surgical procedures (e.g. tonsillectomy)

2. Important information before using Exacyl

When not to use Exacyl

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has acute venous thrombosis (deep vein thrombosis, pulmonary embolism)
• if the patient has arterial thrombosis (angina pectoris, myocardial infarction, stroke)
• if the patient has fibrinolytic states secondary to coagulopathy due to consumption of clotting factors (these conditions cause blood clotting throughout the body)
• in patients with severe renal impairment (risk of drug accumulation)
• in patients with a history of seizures. Warnings and precautions Before starting treatment with Exacyl, discuss this with your doctor or pharmacist:
• if the patient experiences seizures. The doctor will use the lowest possible dose to avoid seizures after administration of Exacyl.
• if the patient experiences visual disturbances, including blurred vision, unclear vision, or color vision disturbances. The doctor may decide that treatment should be discontinued. In case of continuous, long-term use of Exacyl, regular ophthalmological examinations are recommended (eye examinations, including visual acuity, color vision, fundoscopy, visual fields, etc.). In case of pathological eye changes, especially retinal diseases, the doctor, after consultation with a specialist, will decide individually in each case whether long-term use of Exacyl is necessary.
• if the patient notices blood in the urine. Exacyl may lead to urinary tract obstruction.
• if the patient has a personal and/or family history of thromboembolic disease. The doctor will assess the risk factors for thromboembolic disease and decide whether administration of this medicine is possible.
• if the patient is using oral contraceptives. There is an increased risk of thrombosis.
• if the patient has mild to moderate renal function impairment. The doctor will reduce the dose according to serum creatinine levels (see section 3).
• if the patient develops venous or arterial thromboembolic disorders. The doctor should be informed immediately if any of the following symptoms occur: unusual leg pain, muscle weakness in limbs, chest pain, irregular pulse, sudden shortness of breath, loss of consciousness, disorientation, sudden severe headache, dizziness, visual disturbances, slurred speech, or loss of speech. Exacyl and other medicines Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use, including those available without a prescription. In particular, inform the doctor if the patient is taking:
• other medicines that promote blood clotting, known as antifibrinolytic agents (treatment should be conducted under strict medical supervision)
• medicines that prevent blood clotting, known as thrombolytic agents
• oral contraceptives. Also inform the doctor if the patient is using:
• Etamsylate (a haemostatic agent)
• Vitamin K1 and thymoiodate methylsulfate (an antispasmodic) Exacyl with food and drink Exacyl can be taken independently of meals. Pregnancy, breastfeeding and fertility If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. This medicine should be avoided in pregnant women. Tranexamic acid passes into breast milk. Breastfeeding is not recommended during treatment with this medicine. Driving and operating machinery

Dizziness and malaise may occur during treatment with Exacyl. If such symptoms occur,
the patient should not drive or operate machinery.
Exacyl contains sucrose and wheat starch
This medicine is suitable for patients with coeliac disease.
This medicine should not be used by patients allergic to wheat (other than coeliac disease).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.

3. How to use Exacyl

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dosage:
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.
Patients with renal function impairment
In patients with impaired renal function, due to the risk of drug accumulation, tranexamic acid dosage should be adjusted according to serum creatinine concentration.
If serum creatinine concentration is:
between 120 and 250 μmol/L, the dose of tranexamic acid is 10 mg/kg body weight intravenously, twice daily;
between 250 and 500 μmol/L, the dose of tranexamic acid is 10 mg/kg body weight intravenously, once daily (every 24 hours);
above 500 μmol/L, the dose of tranexamic acid is 5 mg/kg body weight intravenously, once daily (every 24 hours).
Use of a higher than recommended dose of Exacyl
Overdose may result in central nervous system dizziness, headache, hypotension, and seizures. Seizures tend to occur more frequently with increasing dose. If a higher than recommended dose has been taken, consult a doctor or pharmacist immediately.
Missed dose of Exacyl
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose.
Do not take a double dose to make up for a missed dose.
Stopping Exacyl
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects reported during use of Exacyl
The following side effects have been observed during treatment with Exacyl:
Common (may affect up to 1 in 10 people):

• nausea, vomiting, diarrhoea.
  Uncommon (may affect up to 1 in 100 people):
• skin allergic reactions.
  Frequency not known (frequency cannot be estimated from available data):
• hypersensitivity reactions, including anaphylaxis (a severe and sudden allergic reaction); if such side effects occur, inform a doctor immediately or go to the nearest emergency department;
• seizures, especially in patients with risk factors or history of seizures, or in cases of improper use of the medicine (see section 2);
• visual disturbances, including colour vision disturbances;
• malaise with hypotension (low blood pressure), with or without loss of consciousness (usually after too rapid intravenous injection, rarely after oral administration);
• venous or arterial thrombosis in various parts of the body;
• an allergic reaction which usually recurs at the same site(s) upon re-administration of the drug and may present as round or oval red, swollen skin lesions, blisters and itching (fixed drug eruption). After healing, skin pigmentation at the site of lesions may persist for some time;
• sudden onset of kidney-related symptoms caused by tissue death in the outer part of the kidney (acute tubular necrosis).

Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Phone: +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. Reporting side effects helps to 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 below 25°C and 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Exacyl contains

• The active substance is tranexamic acid. Each coated tablet contains 500 mg of tranexamic acid.
• Other components: wheat starch, magnesium stearate, sucrose; coating: acrylic resin, Carnauba wax.

What Exacyl looks like and contents of the pack
Tablets packed in blisters, placed in a cardboard box. The pack contains 20 coated tablets.

Marketing Authorisation 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
ul. Lubelska 52
35-233 Rzeszów
Poland