Varixa Film-Coated Tablets

• VARIXA 10 belong to a group of medicines called antithrombotic medicines. It works by blocking a blood clotting factor (Factor Xa) and thus reduces the tendency of the blood to clot.

• VARIXA 10 prevents blood clots in the veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots.

Do not take VARIXA 10

• If you are allergic (hypersensitive) to rivaroxaban or to any ingredients of VARIXA 10, (listed in section 6)
• 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 10 should not be used in children and adolescents, under 18 years of age.

Warnings and precautions

VARIXA 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 VARIXA 10:

• 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 10 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 10 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.

Do not share medicines prescribed for you with any other person.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

To prevent blood clots in the veins after a hip or knee replacement operation the recommended dose is one tablet VARIXA 10 mg once a day. Your doctor has prescribed you VARIXA 10 mg once a day.

When to take VARIXA 10

Take the tablet(s) every day until your doctor tells you to stop. Try to take the tablet(s) 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.

If you take more VARIXA 10 than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison center. Taking too much VARIXA 10 increases the risk of bleeding.

If you forget to take VARIXA 10

Do not take a double dose to make up for forgotten individual doses. 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.

If you stop taking VARIXA 10

Do not stop taking VARIXA 10 without talking to your doctor first, because VARIXA 10 treats and prevents serious conditions. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

VARIXA 10 can have side-effects. Not all side effects reported for VARIXA 10 are included in this leaflet. Should your health worsen or if you experience any untoward effects while taking VARIXA 10, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking VARIXA 10 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties(angioedema); sudden drop in blood pressure.
• anaphylactic reactions, including anaphylactic shock
• allergic oedema

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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• long or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris, which may be signs of bleeding.
• spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).

• a medicine reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome). These are all serious side effects. You may need urgent medical attention.

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), nosebleed, 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-ache, 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

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 not known:

• 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 VARIXA 10

KEEP OUT OF REACH OF CHILDREN

Any unused medicine or waste material should be returned to the pharmacy for destruction. Do not dispose of unused medicine in drains or sewerage systems (e.g toilets).

Store at or below 30 °C. Keep well closed. Protect from moisture and light.

Do not remove blister card from the carton until required for use.