Do not take VARIXA
• If you are allergic (hypersensitive) to rivaroxaban or to any ingredients of VARIXA
• If you have a bleeding disorder that you have inherited or 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 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
VARIXA should not be used in children and adolescents, under 18 years of age.
Warnings and precautions
VARIXA should not be used in combination with certain other medicines which reduce blood clotting such as prasugrel or ticagrelor other than acetylsalicylic acid and clopidogrel/ticlopidine.
Take Special Care with VARIXA:
• If you suffer from moderate or severe kidney disease
• If you suffer from moderate liver disease
• If you have an increased risk of bleeding such as:
- bleeding disorders
- very high blood pressure, not controlled by medical treatment
- active ulcer or a recent ulcer of your stomach or bowel, 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
- a problem with the blood vessels in the back of your eyes (retinopathy)
- recent bleeding in your brain (intracranial bleeding)
- problems with your blood vessels in your brain or spinal column
- a recent operation on your brain, spinal column or eye
- a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung.
• If you have an artificial 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 you need to have an operation:
• it is very important to take VARIXA 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 VARIXA 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.
Other medicines and VARIXA
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines).
If you are taking:
- some medicine for fungal infections (e.g. ketoconazole, itraconazole, voriconazole), unless they are only applied to the skin
- some anti-retroviral medicines for HIV/AIDS (e.g. ritonavir)
- other medicines to reduce blood clotting (e.g. enoxaparin or clopidogrel or Vitamin K antagonists such as warfarin)
- anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
- some medicine for treatment of epilepsy (phenytoin, carbamazepine, phenobarbitone)
- St John’s Wort, a herbal product used for depression
- some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
- rifampicin, an antibiotic
- dronedarone, a medicine to treat abnormal heartbeat
