Xarelto tablets are used for the following indications:
Active substance: rivaroxaban;
1 coated tablet contains 10 mg rivaroxaban;
Excipients: microcrystalline cellulose, sodium croscarmellose, hypromellose 5 cp, lactose, magnesium stearate, sodium lauryl sulfate, macrogol 3350, iron oxide red (E172), titanium dioxide (E 171).
Hypersensitivity to rivaroxaban or to any excipients of the preparation.
Clinically significant active bleeding.
Injury or conditions accompanied by a significant risk of bleeding, which include currently or recently diagnosed ulcers of the gastrointestinal tract, malignant tumors with a high risk of bleeding, recent brain or spinal cord injury, recent surgery on the main, spinal cord or eyes, recent intracranial hemorrhage, esophageal varices (detected or suspected), arteriovenous malformations, vascular aneurysms, or significant intraspinal or intracerebral vascular abnormalities.
Simultaneous use with any other anticoagulants, in particular unfractionated heparin, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexil and p. .), except for the specific circumstances of the transition to alternative anticoagulant therapy or cases when unfractionated heparin is prescribed in doses necessary for the functioning of an open catheter of the central veins or arteries.
Liver diseases associated with coagulopathy and a clinically significant risk of bleeding, including class B and C liver cirrhosis (according to the Child-Pugh classification).
The patient's age is up to 18 years.
During pregnancy and breastfeeding.
For oral administration.
Xarelto, 10 mg, can be taken with or without food.
For patients who are unable to swallow a whole tablet, it can be crushed and mixed with water or soft food, such as applesauce, just before ingestion.
Xarelto tablets in crushed form can be administered through a gastric tube. The correct position of the probe in the stomach should be checked before the introduction of Xarelto. Crushed tablets should be administered with a small amount of water through a gastric tube, after which the tube should be rinsed with water.
Pregnant
Contraindicated.
Children
Contraindicated.
Drivers
Carefully.
There have been rare cases of overdose (up to 600 mg) without complications such as bleeding or other adverse reactions. Due to limited absorption, when the preparation is administered at doses significantly higher than therapeutic doses (50 mg or higher), a satiety effect is expected without further increase in mean plasma level.
A specific neutralizing agent (andexanet alfa) that counteracts the pharmacological effects of rivaroxaban (see the Summary of Product Characteristics for andexanet alfa). In case of preparation overdose, activated charcoal can be used to reduce the absorption of rivaroxaban.
The most common reported adverse reactions in patients receiving rivaroxaban were bleeding. There were frequent reports of nosebleeds (4.5%) and bleeding from the gastrointestinal tract (3.8%).
Simultaneous use with any other anticoagulants, in particular unfractionated heparin, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexil and p. .), except for the specific circumstances of the transition to alternative anticoagulant therapy or cases when unfractionated heparin is prescribed in doses necessary for the functioning of an open catheter of the central veins or arteries.
Keep out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life is 3 years.
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