• Primary prevention of venous thromboembolic complications in adult patients who have undergone elective total hip replacement or total knee replacement.
• Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in adult patients with non-valvular atrial fibrillation and one or more risk factors such as stroke or transient ischemic attack, age ≥ 75 years, chronic heart failure (≥ II functional class according to NYHA classification), diabetes mellitus, hypertension, vascular disease (previous myocardial infarction, peripheral arterial disease, or atherosclerotic plaque in the aorta).
• Treatment and prevention of recurrence of acute deep vein thrombosis and/or pulmonary embolism and prevention of deaths caused by these diseases in adult patients.

Taking an excessively high dose of Axartoban® increases the risk of bleeding. If you accidentally take more of the drug than you should, consult your doctor immediately. Special treatment methods are available.

Like all medications, Axartoban® can cause undesirable reactions, but they do not occur in everyone.
It is important that you inform your doctor about any adverse reactions that occur so that he can take appropriate measures (for example, temporarily suspend or cancel treatment, change the dose and duration of treatment with the drug, and prescribe additional therapy).
Axartoban® affects blood clotting, so most adverse reactions are associated with symptoms such as bruising or bleeding.
Extensive or severe bleeding may occur, which is the most serious adverse reaction and, regardless of location, can cause disability, life-threatening, or even fatal. In some cases, such bleeding may be hidden.

Do not take Axartoban®.:

• if you are allergic to dabigatran etexylate or other components of this drug (listed in section 6 of the leaflet);
• if you have severe renal insufficiency;
• if you currently have bleeding or organ damage as a result of bleeding, including rupture of brain vessels and hemorrhage in brain tissue (hemorrhagic stroke) within 6 months before starting therapy;
• if you have a disease or condition with a high risk of extensive bleeding (for example, a stomach ulcer, a tumor with a high risk of bleeding, traumatic brain injury, spinal cord injury or intracranial hemorrhage, varicose veins of the esophagus or suspected varicose veins, vascular pathology of the brain and spinal cord, recently performed surgery brain surgery or ophthalmological surgery);
• if you have an increased tendency to develop bleeding. It may be congenital, caused by an unknown cause, or as a result of the simultaneous use of other medications;
if you are using medications to prevent thrombosis (for example, warfarin, rivaroxaban, apixaban, or heparin), except in cases of changing anticoagulant therapy or receiving unfractionated heparin therapy at doses necessary to ensure the functioning of a central venous or arterial catheter, or restoring heart rhythm through surgical treatment (catheter ablation) with non-valvular atrial fibrillation;
• if you have severe liver failure or liver disease
• liver, which can lead to death;
• if you are taking ketoconazole or itraconazole (drugs for the treatment of fungal infections);
• if you are taking cyclosporine (a drug used to prevent organ rejection after transplantation);
• if you are taking dronedarone (a drug for the treatment of cardiac arrhythmias);
• if you are taking tacrolimus (a drug for suppressing the immune system);
• if you are taking the combination drug glecaprevir + pibrentasvir (an antiviral drug for the treatment of viral hepatitis C);
if you have an artificial heart valve installed that requires constant anticoagulant therapy.

Before taking Axartoban®, be sure to inform your doctor if you are using any of the following medications:

• drugs to reduce blood clotting (for example, warfarin, acenocalol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid);
• drugs for the treatment of fungal infections (for example, ketoconazole, itraconazole), with the exception of those applied topically to the skin;
medications for the treatment of cardiac arrhythmias (for example, amiodarone, dronedarone, quinidine, verapamil). If you are taking medications containing amiodarone, quinidine, or verapamil, your doctor will advise you to take a reduced dose of Axartoban® (see also section 3 of the leaflet);
• drugs for the prevention of organ rejection after transplantation (for example, tacrolimus, cyclosporine);
• a combined drug containing glecaprevir and pibrentasvir (an antiviral drug for the treatment of viral hepatitis C);
• anti-inflammatory and painkillers (e.g. acetylsalicylic acid, ibuprofen, diclofenac);
• preparations of St. John's wort (a herbal remedy used to treat depression);
medications for the treatment of depression called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors (for example, sertraline, escitalopram, etc.);
• antibiotics (rifampicin or clarithromycin);
• antiviral drugs for the treatment of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) (e.g. ritonavir);
some drugs for the treatment of epilepsy (e.g. carbamazepine, phenytoin).

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

Store at temperatures below 25 °C. Store in the original packaging (pack/box).

Do not give the drug to children aged 0 to 18 years, as the safety and efficacy of the drug Axartoban® in children and adolescents have not been established. There is no data available.

The effect of dabigatran etexilate on the ability to drive vehicles and engage in other potentially dangerous activities requiring increased concentration and speed of psychomotor reactions has not been studied. Given that taking Axartoban® may be associated with an increased risk of bleeding, use caution when performing these types of activities.