Myoroxa 10 mg Film-Coated Tablets

MYOROXA 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.

MYOROXA contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots in the veins after a hip or knee replacement operation.
• 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 MYOROXA:

• if you are allergic to rivaroxaban or any of the other ingredients of MYOROXA (listed in section 6)
• if you are bleeding excessively (e.g., brain or stomach bleeding)
• if you have a disease called triple positive antiphospholipid syndrome (a disorder in which the immune system mistakenly attacks normal proteins in the blood resulting in increased risk of blood clots)
• if you have a lesion or condition that increases the risk of serious bleeding (e.g., stomach ulcer, cancerous tumour at risk of bleeding, recent surgery of the brain or eyes); brain or spinal injury, enlarged veins in the tube running from the throat to the stomach, weak arteries that ruptures easily)
• Avoid using MYOROXA along with other blood-thinning medications like heparin, enoxaparin, dalteparin, fondaparinux, warfarin, dabigatran etexilate, apixaban, etc. There are some cases where switching between blood thinners might be necessary (see section 3), or if heparin needs to be used to keep a catheter open (see Other medicines and MYOROXA)
• if you have an inherited bleeding disorder
• if you have a liver disease with or without a bleeding disorder; or an increased risk of bleeding (cirrhotic patients with Child Pugh B and C)
• if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking MYOROXA. Take special care with MYOROXA:

• 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 MYOROXA 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 sections Do not take MYOROXA and Other medicines and MYOROXA)
• bleeding disorders
• very high blood pressure, not controlled by medical treatment
• 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 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 MYOROXA. Your doctor will decide, if you should be treated with MYOROXA and if you should be kept under closer observation.

If you need to have an operation:

• It is very important to take MYOROXA 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 MYOROXA 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 MYOROXA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose:

• to prevent blood clots in the veins after a hip or knee replacement operation, is one tablet MYOROXA 10 mg once a day. 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.
• to prevent blood clots in the brain (stroke) and other blood vessels in your body if you have non-valvular atrial fibrillation, is one tablet MYOROXA 20 mg once a day. If you have kidney problems, the dose may be reduced to one tablet MYOROXA 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, is one tablet MYOROXA 15 mg twice a day for the first 3 weeks, and then after 3 weeks the usual dose is one tablet MYOROXA 20 mg once a day.

MYOROXA 10 can be taken with or without food. MYOROXA 15 and MYOROXA 20 must be taken with food. Swallow the tablet preferably with water. If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take MYOROXA 15 mg or 20 mg. 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 MYOROXA 15 mg or 20 mg tablet through a stomach tube.

Try to take the tablet at the same time every day to help you to remember it. Take the tablet every day until your doctor tells you to stop. Your doctor will decide how long you must continue treatment.

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

If you take more MYOROXA than you should

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

If you forget to take MYOROXA

• If you are taking one MYOROXA 10 mg, or MYOROXA 15 mg, or MYOROXA 20 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 MYOROXA 15 mg tablet twice a day and have missed a dose, take it as soon as you remember. Do not take more than two MYOROXA 15 mg tablets in a single day. If you forget to take a dose you can take two MYOROXA 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 MYOROXA 15 mg tablet twice a day.

If you stop taking MYOROXA

Do not stop taking MYOROXA without talking to your doctor first, because MYOROXA prevents the development of a serious condition.

If you have any further questions on the use of MYOROXA, ask your doctor or pharmacist.

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

MYOROXA 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.

If any of the following happens, stop taking MYOROXA 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; sudden drop in blood pressure. These are all very serious side effects. If you have them, you may have had a severe allergic reaction to MYOROXA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if you experience any of the following side effects which may be a sign of bleeding:

• 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.

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

• 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).
• yellowing of the skin and eye (jaundice). These are all very serious side effects. You may need urgent medical attention.

The following side effects have been reported for MYOROXA:

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 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)
• 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
• 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
• bleeding into a muscle
• 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
• cholestasis (decreased bile flow), hepatitis incl. hepatocellular injury (inflamed liver incl. liver injury)
• fainting
• feeling unwell
• localised swelling
• faster heartbeat

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. 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 MYOROXA.

Store all medicines out of reach of children.

Store at or below 25 °C.

Keep in the original packaging until required for use.

Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).