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Rivaroxaban 15 mg film-coated tablets What Rivaroxaban is used for: Rivaroxaban is used in adults to: Prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm 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), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs. Do not take Rivaroxaban: If you are allergic to rivaroxaban or any of the other ingredients of this medicine If you are bleeding excessively If you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) If you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open. If you have a liver disease which leads to an increased risk of bleeding If you are pregnant or breastfeeding Warnings & Precautions: Take special care with Rivaroxaban If you have an increased risk of bleeding, as could be the case in some situations (such as severe kidney disease, a lung disease, if you have a prosthetic heart valve, if you are taking other medicines to prevent blood clotting, in case of bleeding disorders or diseases of your stomach or bowel) If you have a prosthetic heart valve If you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed. If your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned Possible Side Effects of Rivaroxaban: These include reduction in red blood cells which can make the skin pale and cause weakness or breathlessness, bleeding in the stomach or bowel, urogenital bleeding, nose bleed, bleeding in the gum, bleeding into the eye, bleeding into tissue or a cavity of the body (hematoma, bruising), coughing up blood, bleeding from the skin or under the skin, bleeding following an operation, oozing of blood or fluid from surgical wound, swelling in the limbs, pain in the limbs, impaired function of the kidneys (may be seen in tests performed by your doctor), fever, stomach ache, indigestion, feeling or being sick, constipation, diarrhea, low blood pressure, decreased general strength and energy (weakness, tiredness), headache, dizziness, rash, itchy skin. Other medicines and Rivaroxaban: Tell your doctor or pharmacist if you are taking: some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin ketoconazole tablets (used to treat Cushing’s syndrome - when the body produces an excess of cortisol) some medicines for bacterial infections (e.g. clarithromycin, erythromycin) some anti-viral medicines for HIV / AIDS (e.g. ritonavir) other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol) anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid) dronedarone, a medicine to treat abnormal heart beat some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)) some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital) St John’s Wort (Hypericum perforatum), a herbal product used for depression rifampicin, an antibiotic. How to take Rivaroxaban: You must take Rivaroxaban every day together with a meal. To prevent blood clots in brain (stroke) and other blood vessels in your body The recommended dose is one tablet Rivaroxaban 20 mg once a day. If you have kidney problems, the dose may be reduced to one tablet Rivaroxaban 15 mg once a day. If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention - PCI with an insertion of a stent), there is limited evidence to reduce the dose to one tablet Rivaroxaban 15 mg once a day in addition to an antiplatelet medicinal product such as clopidogrel. To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring. The recommended dose is one tablet Rivaroxaban 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet Rivaroxaban 20 mg once a day. After at least 6 months blood clot treatment 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 take one tablet Rivaroxaban 20 mg once a day, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Rivaroxaban 15 mg once a day if the risk for bleeding is greater than the risk for having 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 which is stated on the carton and on each blister or bottle after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. * Dosage form and route of administration of Rivaroxaban 2.5mg & 10mg film-coated tablets should be prescribed according to therapeutic indication and disease severity of each individual patient. A valid prescription should be available upon delivery
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