Exacyl – composition, dosage, indications, contraindications. How does Exacyl work?

Proven content

Exacyl is a drug that belongs to the group of antihaemorrhagics. The active substance is tranexamic acid. Read how Exacyl works and how it should be dosed.

Exacyl — what kind of drug is it?

Exacyl is presented as film-coated tablets and contains the active substance tranexamic acid. Tranexamic acid belongs to the group of antihaemorrhagics. Tranexamic acid acts by inhibiting the fibrinolytic activity of plasmin. Exacyl is used for: 

1. vaginal bleeding: o caused by hormonal disorders, secondary to injuries, infections or degenerative changes of the uterus,
2. gastrointestinal bleeding,
3. hematuria from the lower urinary tract caused by: prostate adenoma, malignant neoplasms of the prostate and bladder, kidney stones, bleeding from the urinary tract after surgical procedures of the prostate and urinary system,
4. bleeding associated with ENT surgery (e.g. tonsillectomy).

Read: Bleeding from the upper gastrointestinal tract

Exacyl – composition and action

One tablet of Exacyl (500 mg) coated contains 500 mg of tranexamic acid (Acidum tranexamicum), 97,0 mg of wheat starch and 96,0 mg of sucrose.

The antihaemorrhagic effect of tranexamic acid is based on the inhibition of the fibrinolytic activity of plasmin. Tranexamic acid forms a complex with plasminogen and remains in this association even after plasminogen has been converted to plasmin. Plasmin bound to tranexamic acid has a reduced effect on fibrin compared to free plasmin.

After oral administration (20 mg / kg body weight), tranexamic acid is rapidly absorbed, reaching the maximum concentration in the serum 2-3 hours after dosing, no presence of the product in the serum after 6 hours.

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Exacyl – dosage

Exacyl is a film-coated tablet that is taken by mouth. Dosing of Exacyl is as follows.

adults:

1. 2 to 4 g daily in 2 or 3 divided doses (i.e. 4 to 8 tablets a day).

Kids:

1. according to the currently approved indications, the recommended dose for children is 20 mg / kg. per day. However, data on the efficacy, posology and safety of Exacyl in these indications are limited.

People with kidney problems:

1. In the event of renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level due to the risk of medicinal product accumulation.

If your serum creatinine level is:

1. 120 to 250 mol / l, the dose of tranexamic acid is 10 mg / kg. intravenously, 2 times a day,
2. 250 to 500 mol / l, the dose of tranexamic acid is 10 mg / kg. intravenously, once a day (every 24 hours),
3. over 500 mol / l, the dose of tranexamic acid is 5 mg / kg. intravenously, once a day (every 24 hours).  

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Exacyl – when should you not use this medicine?

Exacyl should not be taken if you have (s):

1. allergy to the active substance or any of the other ingredients of this medicine,
2. acute venous thrombosis (deep vein thrombosis, pulmonary embolism),
3. arterial thrombosis (angina, myocardial infarction, stroke),
4. fibrinolytic conditions secondary to coagulopathy from the use of clotting factors (these conditions cause blood to clot throughout the body),
5. in people with severe renal impairment (risk of medicinal product accumulation),
6. in people with a history of seizures.  

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Exacyl – warnings and precautions

Talk to your doctor or pharmacist before using Exacyl. In addition, special precautions should be taken if the patient has:

1. seizures occur. Your doctor will use the lowest dose possible to avoid seizures after taking Exacyl.
2. you experience visual disturbances including decreased vision, blurred vision, and color changes. Your doctor may decide to stop your treatment. In case of continuous, long-term use of Exacyl, regular ophthalmological examinations (eye examinations, including visual acuity, color vision, fundus, visual field, etc.) are indicated. In the case of pathological eye changes, especially retinal diseases, the doctor, after consulting a specialist, will decide on an individual basis whether it is necessary to use Exacyl for a long time,
3. you notice blood in your urine. Exacyl may lead to obstruction of the urinary tract,
4. have a history and / or a family history of thromboembolism. Your doctor will assess your risk factors for thromboembolism and decide if you can give this medicine.
5. the patient uses oral contraceptives. There is an increased risk of thrombosis,
6. have mild to moderate kidney problems. Your doctor will reduce the dose according to your serum creatinine levels.
7. develop a vein or arterial thromboembolism.

Tell your doctor immediately if you develop any of the following symptoms: unusual pain in the legs, weakness in the muscles of the limbs, chest pain, irregular pulse, sudden shortness of breath, loss of consciousness, confusion, sharp headache, dizziness, visual disturbances, slowed speech or loss of speech.

1 tablet of Exacyl contains 96,0 mg of sucrose and 97,0 mg of wheat starch. People with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Exacyl.

Exacyl also contains wheat starch. Wheat starch may only contain traces of gluten, so it is believed it can be used safely in people with celiac disease.

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Exacyl – pregnancy and breastfeeding

If a woman is pregnant or breastfeeding, thinks she may be pregnant or is planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Exacyl – side effects

Exacyl can cause certain side effects. The package leaflet distinguishes between common and uncommon side effects and those of an unknown frequency.

Common side effects (may affect up to 1 in 10 people):

1. nausea,
2. vomiting,
3. diarrhea.

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

1. skin allergic reactions.

Not known side effects (frequency cannot be estimated from the available data):

1. hypersensitivity reactions including anaphylaxis (severe and sudden allergic reaction)
2. seizures, especially in the presence of risk factors or a history of seizures or when the drug is used inappropriately
3. visual disturbances, including changes in color vision,
4. malaise with hypotension (low blood pressure), with or without loss of consciousness (usually after injection into a vein too quickly, exceptionally after oral administration),
5. thrombosis of veins or arteries in various parts of the body
6. permanent site drug rash. 

Exacyl – interactions with other drugs

Before taking Exacyl, tell your doctor about all medications you are currently taking (prescription and over-the-counter medications). In particular, tell your doctor if you are taking:

1. other medicines that help blood to clot, called antifibrinolytics (treatment should be under close medical supervision),
2. medicines that prevent blood clotting called thrombolytics
3. oral contraceptives.

You should also inform your doctor if you are taking:

1. Etamsylate (a medicine to stop bleeding)
2. Vitamin K1,
3. thiemonium methyl sulfate (an antispasmodic medicine).