Xaroban 10 mg/15 mg/20 mg Film-Coated Tablets

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.

XAROBAN 10 mg is indicated for:

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

XAROBAN 15 and 20 mg is indicated to:

• prevent blood clots in 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 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.

Do not take XAROBAN:

• if you are hypersensitive (allergic) to rivaroxaban, or to any of the ingredients of XAROBAN (see section 5)
• if you are currently bleeding excessively or have an inherited bleeding disorder
• 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 have a liver disease which leads to an increased risk of bleeding
• if you are pregnant or breast-feeding your baby

Warnings and precautions

Take special care with XAROBAN:

• if you have a prosthetic heart valve
• if you have an increased risk of bleeding, as could be the case in situations such as:
• 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 XAROBAN)
• 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 kidney disease.
• If you are taking certain antifungal medicines (e.g. ketoconazole, itraconazole, voriconazole and posaconazole) or HIV treatment (e.g. ritonavir).
• If you are taking non-steroidal anti-inflammatory medicines (NSAIDs) for pain or other medicines to prevent blood clots.
• 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 are an elderly patient, you may be at higher risk of bleeding so your doctor may want to monitor you more closely.
• If you experience any form of severe skin rash (e.g. spreading, intense and/or blistering) or hypersensitivity symptoms.

If any of the above apply to you, tell your doctor before you take XAROBAN. 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 XAROBAN 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 XAROBAN 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 use XAROBAN exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure.

Adults:

• XAROBAN 10 mg: To prevent blood clots in the veins after a hip or knee replacement operation: The recommended dose is one tablet XAROBAN 10 mg once a day.
• XAROBAN 15 mg and 20 mg: To prevent blood clots in brain (stroke) and other blood vessels in your body: The recommended dose is one tablet XAROBAN 20 mg once a day. If you have kidney problems, the dose may be reduced to one tablet XAROBAN 15 mg once a day.
• To treat blood clots in the veins of your legs and blood clots in the blood vessels of your lungs, and for preventing blood clots from re-occurring: The recommended dose is one tablet XAROBAN 15 mg twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one tablet XAROBAN 20 mg once a day. Your doctor may decide to continue treatment with one 20 mg tablet once a day for as long as required.

Children: XAROBAN is not recommended for use in children (see Do not take XAROBAN. Your doctor will tell you how long your treatment with XAROBAN will last. Do not stop treatment early because symptoms may return.

If you have the impression that the effect of XAROBAN is too strong or too weak, tell your doctor or pharmacist.

If you take more XAROBAN than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include:

• Increased bleeding.

If you forget to take XAROBAN: If you are taking one 20 mg tablet or one 15 mg 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 10 mg tablet and 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 XAROBAN: Do not stop taking XAROBAN without talking to your doctor first, because XAROBAN treats and prevents serious conditions.

Not all side effects reported for XAROBAN are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using XAROBAN, please consult your healthcare provider for advice.

XAROBAN may cause bleedings which may potentially be life threatening. Excessive bleeding may lead to sudden drop in blood pressure (shock). In some cases, the bleeding may not be obvious.

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

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting
• long or excessive bleeding
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain (angina pectoris). These may be signs of bleeding (haemorrhage).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to XAROBAN. 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:

• bleeding into the brain or inside the skull (symptoms such as sudden weakness, tingling, or paralysis of face, arm or leg, change in vision, severe headache, nausea or vomiting)
• irregular or fast heartbeat (tachycardia)
• kidney failure after a severe bleeding
• yellowing of the skin and eyes caused by liver or blood problems (jaundice)
• hepatitis (inflammation of the liver with symptoms such as nausea, mild fever, abdominal pain), abnormal liver function (clay coloured stool, dark urine, itching, loss of appetite)
• Stevens-Johnson syndrome or other serious skin disorder (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters), Toxic epidermal necrolysis (TEN) (a life-threatening skin disorder with symptoms such as a painful red area that spreads quickly, skin peeling without blisters, raw areas of skin)
• 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 (anaemia)
• dizziness, headache
• bleeding into the eye (including bleeding from the whites of the eyes)
• low blood pressure (symptoms may be feeling dizzy or fainting when standing up), bleeding into tissue or a cavity of the body (haematoma, bruising), oozing of blood or fluid from surgical wound
• nosebleed, coughing up blood
• bleeding in the stomach or bowel, bleeding gums, stomach ache, indigestion, nausea, vomiting, constipation, diarrhoea
• severe itching of the skin (pruritus), rash, bruising, bleeding from the skin or under the skin
• painful legs/arms
• urogenital bleeding (including blood in the urine and heavy menstrual bleeding), impaired function of the kidneys (may be seen in tests performed by your doctor)
• fever, swollen lower legs or hands, decreased general strength and energy (weakness, tiredness)
• blood tests may show an increase in some liver enzymes
• bleeding following an operation

Less frequent side effects:

• high platelet count in the blood (thrombocytosis) seen in blood test results
• bleeding into the tissues and slow blood clotting after injury (thrombocytopenia)
• dry mouth
• cholestasis (decreased bile flow)
• skin rash, rash of round, red welts on the skin that itch intensely, sometimes with dangerous swelling (urticaria)
• bleeding into a joint causing pain and swelling, bleeding into the muscle
• general feeling of discomfort, illness, or unease, swelling due to excessive fluid accumulation
• blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets

The following side effects have been reported but the frequency for them to occur is not known:

• 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. 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 Reporting Form”, found on SAHPRA’s website: www.sahpra.org.za under “online services”. By reporting side effects, you can help provide more information on the safety of XAROBAN.

Store all medicines out of reach of children.

Store at or below 25 °C, protect from light and moisture.

Keep blisters in carton until required for use.

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).