Tranexamic acid film-coated tablets 500 mg 20 pcs.

• active ingredient: tranexamic acid;
• 1 tablet contains tranexamic acid 500 mg;
• excipients: microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, magnesium stearate, crospovidone, dry mixture “Opadry white” containing titanium dioxide (E 171), hypromellose, triacetin.

Hypersensitivity to tranexamic acid or to other components of the drug, severe renal failure (due to the risk of cumulation), macroscopic hematuria, acute thromboembolic diseases, acute venous or arterial thrombosis, thrombophlebitis, history of arterial or venous thrombosis, high risk of thrombosis, myocardial infarction, subarachnoid hemorrhage, history of seizures; fibrinolytic states due to consumption coagulopathy, except for excessive activation of the fibrinolytic system in acute severe bleeding; impaired color perception.

Immune system disorders: hypersensitivity reactions, including anaphylaxis.

On the part of the digestive system: nausea, vomiting, heartburn, diarrhea, abdominal pain, decreased appetite.

Skin and subcutaneous tissue disorders: rash, itching, allergic skin reactions.

From the nervous system: drowsiness, dizziness, convulsions.

On the part of the organs of vision: visual impairment, color vision impairment, retinal artery occlusion, congestive retinopathy.

Vascular: thromboembolic complications, arterial or venous thrombosis of any location, arterial hypotension.

Renal: acute renal cortical necrosis.

The drug should be administered orally. Taking the drug does not depend on food intake.

Local fibrinolysis – 1–1.5 g 2–3 times for 3–15 days.

Prostatectomy – 1 g 3–4 times.

Menorrhagia – 1 g 3 times a day for 4 days. With prolonged menstrual bleeding, increase the dose, but not higher than the maximum dose (4 g per day).

It is not necessary to start treatment with the drug before the onset of menstrual bleeding.

Nosebleeds – 1 g 3 times 7 days. Use for periodic nosebleeds.

Conization of the cervix – 1.5 g 3 times for up to 12 days.

Hereditary angioedema 1–1.5 g 2–3 times Depending on the course of the disease.

Use during pregnancy or breastfeeding

Tranexamic acid crosses the placenta and enters breast milk. Studies on the safety of the drug during pregnancy have not been conducted, so the drug can be prescribed to pregnant women only if the expected benefit to the woman outweighs the potential risk to the fetus.

If necessary, the use of the drug should be considered for discontinuation of breastfeeding.

Children

Do not use in children under 12 years of age.

There is no clinical experience with the use of tranexamic acid in children under 15 years of age with menorrhagia, therefore this drug should not be used in this category of patients.

Ability to influence reaction speed when driving vehicles or other mechanisms

While using the drug, you should refrain from driving or working with complex mechanisms.

Symptoms: nausea, vomiting, abdominal pain, orthostatic hypotension, hypotension, dizziness, headache, seizures or increased manifestations of other adverse reactions, including the risk of thrombosis.

Treatment: induce vomiting, gastric lavage, take activated charcoal. It is necessary to drink plenty of fluids to promote renal excretion. Apply symptomatic treatment and, if necessary, anticoagulant therapy.

Tranexamic acid is incompatible with urokinase, norepinephrine bitartrate, desoxyepinephrine hydrochloride, metarmin bitartrate, dipyridamole, diazepam. Highly active prothrombin complexes and antifibrinolytic agents, antiinhibitory coagulation complexes should not be used simultaneously with tranexamic acid. The combination of chlorpromazine and tranexamic acid should be avoided in patients with subarachnoid hemorrhage; this may lead to cerebral vasospasm and cerebral ischemia and, possibly, to a decrease in cerebral blood flow; the symptomatic properties of both drugs may contribute to the development of vasospasm and cerebral ischemia in these patients. Tranexamic acid should be used with caution in patients taking oral contraceptives, since the risk of thrombosis is increased.

Store in the original packaging at a temperature not exceeding 25 ºС.

Keep out of reach of children.