Xarelto Film-Coated Tablets

Xarelto 10 is used to prevent blood clots in your veins after a major operation on your legs. For example this could be an operation on your hip or knee. Your doctor has prescribed Xarelto 10 for you because after an operation you are at an increased risk of getting blood clots. Xarelto 10 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. The active substance rivaroxaban 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.

Do not take XARELTO 10 - 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 breast-feeding Do not take XARELTO 10 and tell your doctor if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking XARELTO 10. XARELTO 10 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 Xarelto - if you have an increased risk of bleeding, as could be the case in situations such as:

• moderate or severe kidney disease, 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)
• 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 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 10 is not recommended for people under 18 years of age. There is not enough information on its use in children and adolescents.

Other medicines and XARELTO 10

Always tell your health care provider if you are taking any other medicines. This includes complementary or traditional medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not share medicines prescribed for you with others. Always take Xarelto 10 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take:

The usual dose is one Xarelto 10 tablet (10 mg) once a day. Swallow the tablet preferably with water. Xarelto 10 tablet can be taken with or without food. If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Xarelto. The tablet may be crushed and mixed with water or a soft food such as apple puree immediately before you take it. If necessary, your doctor may give you the crushed Xarelto tablet through a stomach tube.

When to take Xarelto 10:

Take the first tablet 6 - 10 hours after your operation. Then take a tablet every day until your doctor tells you to stop. Try to take the tablet at the same time every day to help you to remember it. If you have had a major hip operation you will usually take the tablets for 5 weeks. If you have had a major knee operation you will usually take the tablets for 2 weeks.

Children and adolescents up to 18 years of age:

Don’t give Xarelto 10 tablets to people under 18 years of age. There is not enough information on its use in children and adolescents.

If you take more Xarelto 10 than you should:

Contact your doctor immediately if you have taken too many Xarelto 10 tablets. Taking too much Xarelto 10 increases the risk of bleeding. Please consult your doctor or pharmacist in the case of accidental overdose. If neither is available, rush the patient to the nearest hospital or poison control center.

If you forget to take Xarelto 10:

If you have missed a dose, take it as soon as you remember. Take the next tablet on the following day and then carry on taking a tablet once a day as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Xarelto 10:

Don’t stop taking Xarelto 10 without talking to your doctor first, because Xarelto 10 prevents the development of a serious condition. If you have any further questions on the use of Xarelto 10, ask your doctor or pharmacist.

Xarelto 10 can have side effects Not all side - effects reported for Xarelto 10 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Xarelto 10, please consult your doctor, pharmacist or other healthcare professional for advice. Like other similar medicines (antithrombotic agents), Xarelto 10 may cause bleedings which may potentially be life threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases these bleedings may not be obvious. Tell your doctor, if you experience any of the following side - effects:

• long or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, or unexplained swelling, breathlessness, chest pain or angina pectoris, which may be signs of bleeding.

Your doctor may decide to keep you under closer observation or change how you should be treated. Possible side effects which may be a sign of severe allergic reactions Tell your doctor immediately if you experience any of the following side effects:

• long or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, unexplained shock and chest pain (angina pectoris)

The following side - effects have been reported for Xarelto 10:

• Frequent bleeding in the stomach or bowel, blood in the urine (urogenital bleeding), heavy periods (menstrual bleeding), nose bleeds, bleeding of the gum
• bleeding in the eye (including bleeding from the whites of the eyes)
• bleeding in tissue (bruising) or deep in (a cavity of) the body (hematoma)
• bleeding following an operation
• swelling in the limbs
• pain in the limbs
• increase in body temperature (fever)
• pale skin, weakness and breathlessness due to a reduction in red blood cells (anemia)
• stomachache, indigestion, feeling or being sick, constipation, diarrhoea
• impaired function of the kidneys (may be seen in tests performed by your doctor)
• low blood pressure (symptoms may be feeling dizzy or fainting when standing up (hypotension))
• weakness, tiredness, headache, dizziness
• rash, itchy skin
• blood tests may show an increase in some liver enzymes
• coughing up blood

Less frequent

• bleeding in the brain or inside the skull
• bleeding in a joint causing pain and swelling
• oozing of blood or fluid from surgical wound
• feeling unwell
• dry mouth
• allergic reactions, including allergic skin reactions
• itchy, raised rash (hives)
• impaired function of the liver (may be seen in tests performed by your doctor)
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets
• raised heartbeat
• fainting
• bleeding in the muscle
• collection of blood (hematoma) following complication in a cardiac procedure where a catheter is inserted to treat narrowed coronary arteries (pseudoaneurysm)
• swelling in a particular area
• yellowing of the skin and eyes (jaundice)

Not known: frequency cannot be estimated from the available data

• increased pressure within muscles of the legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome)
• decrease in urine, swelling in limbs, shortness of breath and fatigue after a severe bleeding (kidney failure)

The following side effects have been reported since authorisation:

• allergic reaction causing swelling of the face, lips, mouth, tongue or throat (angioedema and allergic edema)
• diarrhoea, trapped gas, stomach cramp, weight loss caused by blocked bile flow (choloestasis), swollen or tender in right side of abdomen, inflamed liver including liver injury (hepatitis)
• low number of platelets, which are cells that help blood to clot (thrombocytopenia)

Reporting of side effects If you get side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NIMOTOP 30mg.

Store at or below 30  C. Keep blister strips in the original carton until use. Do not use Xarelto 10 after the expiry date which is stated on the carton and on each blister. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Store all medicines out of the reach and sight of children.