Rabovix 15 mg Film-Coated Tablets

RABOVIX contains the active substance rivaroxaban. Rivaroxaban belongs 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.

RABOVIX are used to:

• prevent blood clots in the 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 to prevent blood clots from re-occurring in the veins of your legs and/or lungs (pulmonary embolism)
• treat blood clots in the blood vessels of your lungs (pulmonary embolism) and to prevent blood clots re-occurring in the blood vessels of your lungs and/or legs (deep vein thrombosis).

Do not take RABOVIX:

• if you are hypersensitive (allergic) to rivaroxaban or any of the other ingredients of RABOVIX (listed in section 6).
• if you have an inherited bleeding disorder
• if you have a liver disease which leads to an increased risk of bleeding
• if you are pregnant or breastfeeding.

Warnings and precautions

Tell your doctor or healthcare professional before taking RABOVIX:

Take special care with RABOVIX:

• if you have moderate or severe kidney 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
• a problem with the blood vessels in the back of your eyes (retinopathy)
• recent bleeding in your brain (intracranial or intracerebral 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 have been diagnosed with persistent triple positive antiphospholipid syndrome (APS).

If you need to have an operation:

• it is very important to take RABOVIX before and after the operation exactly at the times you have been told by your doctor. Inform your doctor that you are taking RABOVIX.
• 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 RABOVIX 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

RABOVIX 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 RABOVIX

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Especially tell your doctor if you are taking:

• some medicines for fungal infections (e.g. ketoconazole, itraconazole, voriconazole, posaconazole).
• 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).

Tell your doctor before taking RABOVIX, because its effect may be increased. Your doctor will decide if you should be treated with RABOVIX and if you should be kept under closer observation. If your doctor thinks that you are at an increased risk to develop an ulcer of your stomach or bowel, he/she may also use a preventative ulcer treatment. Also tell your doctor if you are taking:

• some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital).
• St John's Wort, a herbal medicine used for depression.
• rifampicin, an antibiotic.

Tell your doctor before taking RABOVIX, because its effect may be reduced. Your doctor will decide if you should be treated with RABOVIX and if you should be kept under closer observation.

Do not share medicines prescribed for you with any other person. Always take RABOVIX exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

How much to take:

• To prevent blood clots in the brain (stroke) and other blood vessels in your body: The usual dose is one RABOVIX 20 mg tablet once a day. If your kidneys are not working properly, the dose may be reduced to one RABOVIX 15 mg tablet once a day.

• To treat blood clots in the veins of your legs and for preventing blood clots from re-occurring: The usual dose is one RABOVIX 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the usual dose is one RABOVIX 20 mg tablet once a day.

• To treat blood clots in the blood vessels of your lungs and for preventing blood clots from re-occurring: The usual dose is one RABOVIX 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks the usual dose is one RABOVIX 20 mg tablet once a day.

Swallow the tablet preferably with water. RABOVIX tablets have to be taken with food.

When to take RABOVIX:

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 for.

If you take more RABOVIX than you should

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

If you forget to take RABOVIX

• If you are taking one RABOVIX tablet once a day and have missed a dose, take it as soon as you remember. Do not take more than one tablet in a single day to make up for a forgotten dose. Take the next tablet on the following day and then carry on taking one tablet once a day.

• If you are taking one RABOVIX 15 mg tablet twice a day and have missed a dose, take it as soon as you remember. Do not take more than two RABOVIX 15 mg tablets in a single day. If you forget to take a dose you can take two RABOVIX 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day. On the following day you should carry on taking one RABOVIX 15 mg tablet twice a day.

If you stop taking RABOVIX Don't stop taking RABOVIX without talking to your doctor first, because RABOVIX treats and prevents serious conditions. If you have any further questions on the use of RABOVIX, ask your doctor or pharmacist.

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

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

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to RABOVIX. 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 (angina pectoris). These may be signs of bleeding.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent:

• bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleed, 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),
• bleeding following an operation,
• swelling in the limbs,
• pain in the limbs,
• fever,
• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness,
• stomach ache, indigestion, feeling or being sick, constipation,
• decreased general strength and energy (weakness, tiredness), headache, dizziness,
• blood tests may show an increase in some liver enzymes,
• impaired function of the kidneys,
• bleeding from the skin or under the skin,
• coughing up blood.

Less frequent

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

Frequency unknown:

• 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),
• kidney failure after a severe 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, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions & Quality Problem Reporting Form”, found online under SAHPRA’s publications: https://sahpra.org.za/wp-content/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pdf By reporting side effects, you can help provide more information on the safety of RABOVIX.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Keep the blister in the carton until required for use.
• Do not use after the expiry date stated on the carton or label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).