Xarelto contains the active substance rivaroxaban.
Xarelto 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.
Xarelto is used in children and adolescents below 18 years and with a body weight of 30 kg or more to:
treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs, following initial treatment of at least 5 days with injectable medicines used to treat blood clots.
Xarelto belongs to a group of medicines called antithrombotic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.
2. What you need to know before you take Xarelto
Do not take Xarelto
if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
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 are breast-feeding
Do not take Xarelto and tell your doctor if any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Xarelto.
Take special care with Xarelto
if you have an increased risk of bleeding, as could be the case in situations such as:
severe kidney disease for adults, and moderate or severe kidney disease for children and adolescents, since your kidney function may affect the amount of medicine that works in your body
if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see section “Other medicines and Xarelto”)
bleeding disorders
very high blood pressure, not controlled by medical treatment
diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus) or tumours located in the stomach or bowels or genital tract or urinary tract
a problem with the blood vessels in the back of your eyes (retinopathy)
a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung
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
If any of the above apply to you, tell your doctor before you take Xarelto. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.
If you need to have an operation
it is very important to take Xarelto before and after the operation exactly at the times you have been told by your doctor.
If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):
it is very important to take Xarelto before and after the injection or removal of the catheter exactly at the times you have been told by your doctor
tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.
Children and adolescents
Xarelto tablets are not recommended for children with a body weight below 30 kg.
There is not enough information on the use of Xarelto in children and adolescents in the adult indications.
Other medicines and Xarelto
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
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))
If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of Xarelto may be increased. Your doctor will decide, if you should be treated with this medicine and if you should be kept under closer observation.
If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.
If you are taking
some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital)
St John’s Wort (Hypericum perforatum), a herbal product used for depression
rifampicin, an antibiotic
If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of Xarelto may be reduced. Your doctor will decide, if you should be treated with Xarelto and if you should be kept under closer observation.
Pregnancy and breast-feeding
Do not take Xarelto if you are pregnant or breast-feeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Xarelto. If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.
Driving and using machines
Xarelto may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, “Possible side effects”). You should not drive, ride a bicycle or use any tools or machines if you are affected by these symptoms.
Xarelto contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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