COMPOSITION:

Active substance:

1 tablet contains Tranexamic acid 500 mg;

Additional ingredients:

Microcrystalline cellulose, low substituted hydroxypropyl cellulose, povidone К30, сroscarmellose sodium, anhydrous colloidal silicon dioxide, talc, magnesium stearate,

Colorcoat FC4S white:

hydroxypropyl methylcellulose, diethylftalat, hydrogenated castor oil powder, stearic acid, talc, titanium dioxide (E 171).

INDICATIONS:

Hemorrhage or risk of hemorrhage in increased generalized fibrinolysis (bleeding during prostate surgery and in the postoperative period, hemorrhagic complications from fibrinolytic therapy) and local fibrinolysis (uterine bleeding, gastrointestinal hemorrhage, epistaxis, posttraumatic hyphema, bleeding after prostatectomy or bladder surgery, tonsillectomy, conization of the cervix, dental extraction in hemophiliacs).

Hereditary angioedema.

DOSAGE:

The drug is administered orally. The drug is administered without regard to meals.

Adult patients with normal renal function.

Follow these dosage instructions in adult patients with normal renal function with creatinine clearance of more than 50 ml/min:

Elderly.

If there are no disorders of renal excretory function no dose adjustment is required.

Children.

Use in children over 12 years old at a dose of 20-25 mg/kg. Treatment duration is usually 2-8 days.

Patients with renal failure.

Adjust the dose according to plasma creatinine level.

Children.

Do not use in children under 12 years old.

Clinical experience with tranexamic acid in menorrhagic children under 15 years of age is not available; therefore Vidanol® should not be administered in this population.

ADVERSE REACTIONS:

Immune system:

Hypersensitivity reactions, including anaphylaxis.

Digestive system:

nausea, vomiting, heartburn, diarrhea, abdominal pain, loss of appetite.

Skin and subcutaneous tissue:

Rash, itching, allergic skin reactions.

Nervous system:

Drowsiness, dizziness, seizures.

Visual organs:

Blurred vision, color-vision defect, retinal artery occlusion, congestive retinopathy.

Vascular effects:

Thromboembolic disorders, arterial or venous thrombosis of any location, arterial hypotension.

Renal effects:

Acute renal cortical necrosis.

Drug interactions:

Tranexamic acid is incompatible with urokinase, norepinephrine bitartrate, deoxyepinephrine hydrochloride, metaraminol bitartrate, dipyridamole, diazepam. Do not use highly active prothrombin complex and antifibrinolytic agents, anti-inhibitor coagulant complex simultaneously with tranexamic acid. Avoid combination of chlorpromazine with tranexamic acid in patients with subarachnoid hemorrhage; this can lead to cerebral vasospasm and cerebral ischemia and, probably, to reduction in cerebral blood flow; symptomatic properties of both drugs possibly promote the development of vasospasm and cerebral ischemia in such patients. Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.

Pregnancy and lactation:

Tranexamic acid passes through to the placenta and into breast milk. Safety studies on drug administration during pregnancy were not conducted, thus in such period the drug should be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus.

In case of necessity of drug administration it should be decided to terminate breastfeeding.

Children:

Do not use in children under 12 years old.

Clinical experience with tranexamic acid in menorrhagic children under 15 years of age is not available; therefore Vidanol® should not be administered in this population.

Special warnings and precautions for use

In renal failure (depending on elevation in serum creatinine level) the dose and number of administrations should be reduced.

In case of hematuria of renal origin (especially in hemophilia) there is a risk of mechanical anuria due to the formation of a blood clot in the urinary tract.

Cases of central retinal artery and central retinal vein obstruction have been reported. For patients who are to be treated continually for longer than several days, an ophthalmological examination, including visual acuity, color vision, eye-ground, visual fields and hepatic function examination are advised.

Treatment should be discontinued in patients with visual impairment.

The cause of menstrual disorders should be established before using Vidanol®. If menstrual bleeding is not adequately reduced by Vidanol® an alternative treatment should be considered.

Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis.

Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid. Patients with previous thromboembolic disorders and family history of thromboembolic disease (patients with thrombophilia) should use Vidanol® only if there is a strong medical indication and under strict medical supervision.

Tranexamic acid administration is not recommended in case of increased fibrinolysis due to disseminated intravascular clotting.

Patients with disseminated intravascular coagulation who require treatment with tranexamic acid must be under the strict supervision of a physician experienced in treating this disorder.

Clinical experience with tranexamic acid in menorrhagic children under 15 years of age is not available; therefore Vidanol® should not be administered in this group of patients.

Tranexamic acid should not be administered concomitantly with Factor IX complex or anti-inhibitor coagulant complex, as the risk of thrombosis may be increased.

Tranexamic acid has been detected in semen in fibrinolytic concentration but does not influence sperm migration. There are no clinical data supporting the impact on fertility.

It has been reported about cases of seizures in administration of tranexamic acid. Most of these cases have been reported after intravenous administration of tranexamic acid in high doses during coronary artery bypass graft (CABG). When using the recommended low doses of tranexamic acid, the incidence of seizures after surgery is the same as in patients who did not receive tranexamic acid.

Effects on ability to drive and use machines

People taking the drug should refrain from driving or operating complex machines.

Overdose:

Symptoms:

Mental confusion, dizziness, impairment of consciousness and convulsive attacks, nausea, tunica mucous erosion, QT-interval lengthening.

Treatment:

The therapy is symptomatic. In cases of overdose it is necessary to examine properly a patient, including ECG. In cases of evident overdose gastric lavage is administered. Antacids are used for mucous coat of stomach protection.

Hemodialysis, including peritoneal dialysis or CAPD, is non-effective for Levofloxacin excretion from the organism. There are no any specific antidotes.

Contraindications

– Hypersensitivity to tranexamic acid or any of the other ingredients.

– Severe renal impairment (because of risk of accumulation).

– Macroscopic hematuria.

– Acute thromboembolic disease.

– Acute venous or arterial thrombosis.

– Thrombophlebitis.

– History of venous or arterial thrombosis.

– High risk of thrombosis.

– Myocardial infarction.

– Subarachnoid hemorrhage.

– History of convulsions.

– Fibrinolytic conditions following consumption coagulopathy, except for the excessive activation of the fibrinolytic system in severe acute bleeding.

– Defective color vision.

PHARMACOLOGICAL PROPERTIES:

Pharmacotherapeutic groups: Fibrinolysis inhibitors. Code ATC B02A A02.

Pharmacodynamic properties

Antifibrinolytic. Tranexamic acid specifically inhibits activation of profibrinolysin (plasminogen) and its conversion to fibrinolysin (plasmin). It has local and systemic homeostatic effect on hemorrhages connected with increased fibrinolysis (platelet pathology, menorrhagia). Also tranexamic acid stimulates the production of kinin and other active peptides that play role in allergic and inflammatory reactions and makes an anti-allergic and anti-inflammatory action.

Pharmacokinetic properties

Absorption in oral use is within the limits of 0.5-2 g – 30-50 %. ТСmax in oral administration is 0.5 g, 1 g and 2 g – 3 hours, Сmax – 5, 8 and 15 μg/ml, respectively. Plasma protein binding (profibrinolysin) is NLT 3%.

Distribution in tissues is quite homogeneous (except for the cerebrospinal fluid, where the concentration is 1/10 of plasma); it passes through the placenta barrier into breast milk (around 1% from mother plasma concentration). Has been detected in semen where it inhibits fibrinolytic activity but does not influence sperm migration. The initial volume of distribution is 9 to 12 liters. Antifibrinolytic concentration remains in different tissues for about 17 hours, in plasma up to 7-8 hours.

A small part is metabolized. AUC has a three-phase form with Т1/2 in final phase – 3 hours. Overall renal clearance is equal to overall plasma clearance (7 L/h). Urinary excretion (the main route is glomerular filtration) is around 95% in unchanged form during first 12 hours.

Two tranexamic acid metabolites are identified: N-acetyl and deamidated derivatives. In renal insufficiency there is a risk of tranexamic acid accumulation.

PHARMACEUTICAL CHARACTERISTICS:

General physico-chemical properties:

Coated tablets.

White, circular, biconvex coated tablets, plain on both sides.

Shelf-life:

3 years.

Storage:

Store at a temperature NMT 25°С.

Keep out of the reach of children.

Package:

10 tablets are in blister; 3 or 6 blisters are in a carton pack.

Conditions of supply:

By prescription.