The drug Rivaroxaban, 10 mg is intended for patients over 18 years of age for:

• prevention of venous thromboembolism (VTE) in patients undergoing major orthopedic surgery on the lower extremities;
prevention of recurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) after at least 6 months of DVT or PE treatment.

If you accidentally take Rivaroxaban more than you should, consult your doctor immediately. Taking a large dose of Rivaroxaban increases the risk of bleeding.

Like all medications, Rivaroxaban can cause undesirable reactions, but they do not occur in everyone. Like other similar antithrombotic drugs, Rivaroxaban can cause life-threatening bleeding. The risk of bleeding may increase if you have high blood pressure or are taking medications that affect blood clotting.
Stop taking the drug and seek medical help immediately
if any of the following symptoms occur, which can be very dangerous:
• severe bleeding;
• weakness, rapid pulse, shortness of breath, decreased blood pressure, anxiety, cold sweat (may be signs of a life-threatening allergic (anaphylactic) reaction); • weakness, marked decrease in blood pressure, rapid pulse, pallor, shortness of breath, dizziness, fainting, low hemoglobin (anemia), black feces, red urine (may be signs of latent bleeding); • headache, muscle weakness on one side of the body, vomiting, convulsions, impaired consciousness and tension of the muscles of the occiput (may be signs of intracerebral or intracranial hemorrhage); • hemorrhage in the eye, hemoptysis, blood in the stool or urine;
• extensive bruising, subcutaneous hemorrhages (hematomas), swelling of tissues or joints, pain (may be the result of hemorrhage); • heart pain, low urine volume (may be the result of bleeding);

(For more information about all possible adverse reactions, see the leaflet)

Do not take the drug Rivaroxaban:
• if you are allergic to rivaroxaban or any other components of the drug listed in section 6 of the leaflet;
• if you have significant active bleeding (for example, intracranial bleeding, gastrointestinal bleeding); • if you have an injury or pathological condition associated with an increased risk of major bleeding (for example, an existing or recently suffered gastrointestinal ulcer, the presence of malignant neoplasms with a high risk of bleeding, recent injuries to the brain or spinal cord, recent surgical interventions on the brain, spinal cord or eyes, recent intracranial hemorrhage, diagnosed or suspected varicose veins of the esophagus, arteriovenous malformations, vascular aneurysms or vascular pathologies of the brain or spinal cord); • if you are receiving concomitant treatment with any other anticoagulants, for example, unfractionated heparin (NPH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.), except in cases of switching from or to rivaroxaban or when the use of unfractionated heparin in doses necessary to ensure the functioning of a central venous or arterial catheter;
• if you have liver diseases that occur with blood clotting disorders;
• if you have severe renal impairment (creatinine clearance <15 ml/min) (there are no clinical data on the use of rivaroxaban in this category of patients).

  If any of these statements apply to you, be sure to inform your doctor.

Before using Rivaroxaban, be sure to tell your doctor if you are taking any of the following medications, as the effect of Rivaroxaban may increase.:
• some drugs for the treatment of fungal infections (for example, fluconazole, itraconazole, voriconazole, posaconazole), except those applied topically to the skin; • ketoconazole in tablets (for the treatment of Itsenko-Cushing syndrome, when an excessive amount of the hormone cortisol is formed in the body); • some drugs for the treatment of bacterial infections (e.g. clarithromycin, erythromycin); • Some antiviral drugs for the treatment of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) infection (e.g. ritonavir); • other drugs to reduce blood clotting (for example, enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol); • Anti-inflammatory and painkillers (e.g. naproxen or acetylsalicylic acid); • dronedarone (a drug for the treatment of cardiac arrhythmias);
• Some medications for the treatment of depression (selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors).

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
Organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., 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

Keep the drug out of the reach of the child so that the child cannot see it. Do not use the drug after the expiration date (shelf life) indicated on the carton after "Good before". The expiration date is the last day of the given month. Store at temperatures below 30 C. Store in the original packaging (pack).

Rivaroxaban is not intended for use in children and adolescents under 18 years of age.