Rivaroxaban 10 mg Film-Coated Tablets

RIVAROXABAN 10 mg SHANUR belongs to a group of medicines called antithrombotic medicines. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.

RIVAROXABAN 10 mg SHANUR contains the active substance rivaroxaban and is used in adults to prevent blood clots in the veins (deep vein thrombosis) in patients undergoing an operation of the lower limbs, because after an operation you are at an increased risk of getting blood clots.

Do not take RIVAROXABAN 10 mg SHANUR

• if you are hypersensitive (allergic) to rivaroxaban or any of the other ingredients of RIVAROXABAN 10 mg SHANUR (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 have a disease called antiphospholipid syndrome (APS) as you are at an increased risk of recurrent arterial blood clots (thrombotic events).
• if you are pregnant or breast-feeding.

Do not take RIVAROXABAN 10 mg SHANUR and tell your doctor if any of these apply to you.

Warnings and precautions

Take special care with RIVAROXABAN 10 mg SHANUR:

• 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.

Do not share medicines prescribed for you with any other person. Always take RIVAROXABAN 10 mg SHANUR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

• One tablet RIVAROXABAN 10 mg SHANUR once a day.

Swallow the tablet preferably with water. RIVAROXABAN 10 mg SHANUR can be taken with or without food. If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take RIVAROXABAN 10 mg SHANUR. The tablet may be crushed and mixed with water or apple puree immediately before you take it. If necessary, your doctor may also give you the crushed RIVAROXABAN 10 mg SHANUR tablet through a stomach tube. Your doctor will tell you how long your treatment with RIVAROXABAN 10 mg SHANUR will last. If you have the impression that the effect of RIVAROXABAN 10 mg SHANUR is too strong or too weak, tell your doctor or pharmacist.

When to take RIVAROXABAN 10 mg SHANUR

Take the 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. Your doctor will decide how long you must continue treatment. To prevent blood clots in the veins after a hip or knee replacement operation: Take the first tablet 6 - 10 hours after your operation. 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.

RIVAROXABAN 10 mg SHANUR can have side effects. Not all side effects reported for RIVAROXABAN 10 mg SHANUR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RIVAROXABAN 10 mg SHANUR, please consult your health care provider for advice.

RIVAROXABAN 10 mg SHANUR may cause bleeding which may potentially be life threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). In some cases, the bleeding may not be obvious.

Possible side effects which may be a sign of bleeding

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, 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 skin reaction

Tell your doctor immediately if you experience skin reactions such as:

• Less frequent: spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens - Johnson syndrome/toxic epidermal necrolysis)
• Less frequent: a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome).

Possible side effects which may be a sign of a severe allergic reaction

Tell your doctor immediately if you experience any of the following side effects:

• Less frequent: swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.

These are very serious side effects. If you have them, you may have had a serious reaction to RIVAROXABAN 10 mg SHANUR. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleeds, bleeding in the gum
• bleeding into the eye (including bleeding from the whites of the eyes)
• bleeding into tissue or a cavity of the body (haematoma, 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 pain, indigestion, feeling or being sick, constipation, diarrhoea
• low blood pressure (symptoms may be feeling dizzy or fainting when standing up)
• decreased general strength and energy (weakness, tiredness), headache, dizziness
• rash, itchy skin
• blood tests may show an increase in some liver enzymes.

Less frequent side effects:

• bleeding into the brain or inside the skull
• bleeding into a joint causing pain and swelling
• thrombocytopenia (low number of platelets, which are cells that help blood to clot)
• allergic reactions, including allergic skin reactions
• 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
• fainting
• feeling unwell
• faster heartbeat
• dry mouth
• hives
• bleeding into a muscle
• cholestasis (decreased bile flow), hepatitis incl. hepatocellular injury (inflamed liver incl. liver injury)
• yellowing of the skin and eye (jaundice)
• localised swelling
• collection of blood (haematoma) in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery (pseudoaneurysm).

Frequency unknown:

• kidney failure after a severe bleeding
• increased pressure within muscles of the legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after a bleeding).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. 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 RIVAROXABAN 10 mg SHANUR. Suspected side effects can also be reported directly to the Holder of the Certificate of Registration via [email protected]

• Store all medicines out of reach of children.
• Store at or below 30 °C.
• Store in the original package.
• Do not use after the expiry date stated on the carton.
• 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 reach and sight of children.