Rivaroxaban 20 mg coated tablets
What is rivaroxaban and what are its uses?
- Rivaroxaban is used in adults for:
- Prevent blood clots in the brain (stroke) and other blood vessels in your body if you have a form of irregular heartbeat called non-valvular atrial fibrillation.
- Treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism).
- To prevent the recurrence of blood clots in the blood vessels of your legs and/or lungs.
Do not take rivaroxaban:
- If you are allergic to rivaroxaban or to any of the other ingredients of this medicine
- If you are bleeding heavily
- If you have a disease or medical condition in an organ that increases your risk of serious bleeding (such as a stomach ulcer, brain injury or bleeding, or recent brain or eye surgery).
- If you are taking medications to prevent blood clotting (such as warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant therapy or while receiving heparin via an intravenous or arterial line to keep it open.
- If you have liver disease, it increases your risk of bleeding.
- If you are pregnant or breastfeeding
Warnings and precautions:
- Pay special attention with rivaroxaban.
- If you have an increased risk of bleeding, as is the case in some situations (such as severe kidney disease, lung disease, if you have an artificial heart valve),
- If you are taking other medications to prevent blood clotting, in case of bleeding disorders or stomach or intestinal diseases)
- If you have an artificial heart valve
- If you know that you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots),
- Tell your doctor, who will decide if the treatment needs to be changed.
- If your doctor determines that your blood pressure is unstable, or if further treatment or surgery is planned to remove a blood clot from your lungs.
Possible side effects of rivaroxaban:
- These include a decrease in red blood cells which can make the skin pale and cause weakness or shortness of breath, bleeding in the stomach or intestines, bleeding in the genitourinary system, and nosebleeds.
- Bleeding gums, bleeding in the eye, bleeding in tissues or a body cavity (hematoma, bruise), coughing up blood, bleeding from the skin or under the skin, post-operative bleeding.
- Bleeding or fluid discharge from a surgical wound, swelling in the extremities, pain in the extremities, impaired kidney function (which can be seen in tests performed by your doctor), fever, stomach pain,
- Indigestion, feeling unwell or sick, constipation, diarrhea, low blood pressure, decreased general strength and energy (weakness, fatigue), headache, dizziness, skin rash, itchy skin.
Other medications and rivaroxaban:
- Tell your doctor if you are taking any of the following medications:
- Some medications for fungal infections (such as fluconazole, itraconazole, voriconazole, posaconazole), unless applied only to the skin.
- Ketoconazole tablets (used to treat Cushing's syndrome - when the body produces excess cortisol)
- Some medications for bacterial infections (such as clarithromycin and erythromycin)
- Some antiviral drugs for HIV/AIDS (such as ritonavir)
- Other medications to reduce blood clotting (such as enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol)
- Anti-inflammatory and pain-relieving medications (such as naproxen or acetylsalicylic acid)
- Dronedarone, a drug for treating abnormal heart rhythms
- Some medications for treating depression
- Some medications for treating epilepsy (phenytoin, carbamazepine, phenobarbital)
- St. John's wort, an herbal product used to treat depression
- Rifampicin, an antibiotic.
How to take rivaroxaban:
- To prevent blood clots in the brain (stroke) and other blood vessels in the body
- The recommended dose is one 20 mg rivaroxaban tablet once a day.
- If you have kidney problems, the dose can be reduced to one 15 mg rivaroxaban tablet once a day.
- If you need a procedure to treat blocked blood vessels in your heart, there is limited evidence to reduce the dose to one 15 mg rivaroxaban tablet once a day in addition to an antiplatelet drug such as clopidogrel.
- To treat blood clots in the veins of the legs and blood clots in the blood vessels of your lungs, and to prevent blood clots from recurring.
- The recommended dose is one 15 mg rivaroxaban tablet twice a day for 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg rivaroxaban tablet once a day.
- After at least 6 months of treatment for the blood clot, your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.
- If you have kidney problems and are taking one 20 mg rivaroxaban tablet once a day, your doctor may decide to reduce the dose for treatment after 3 weeks to one 15 mg rivaroxaban tablet once a day if the risk of bleeding is greater than the risk of developing another blood clot.
How to store rivaroxaban:
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date printed on the carton. The expiry date refers to the last day of that month.
- This medicine does not require any special storage conditions.
* The dosage form and method of administration of rivaroxaban 2.5 mg and 10 mg coated tablets should be prescribed according to the therapeutic indication and severity of the disease for each individual patient.
