Rivaroxaban 10 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet See section 4.

1. What Rivaroxaban is and what it is used for
2. What you need to know before you take Rivaroxaban
3. How to take Rivaroxaban
4. Possible side effects
5. How to store Rivaroxaban
6. Contents of the pack and other information

• are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6)
• are bleeding excessively
• 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)
• 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
• have a liver disease which leads to an increased risk of bleeding
• are pregnant or breast-feeding.

Do not take Rivaroxaban and tell your doctor if any of these apply to you.

Talk to your doctor or pharmacist before taking Rivaroxaban.

Take special care with Rivaroxaban:

• 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
  • 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 Rivaroxaban”)
  • 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) or tumours located in the stomach or bowels or genital tract or urinary tract
  • 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 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 any of the above apply to you, tell your doctor before you take Rivaroxaban. 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 Rivaroxaban 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 Rivaroxaban 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.

Rivaroxaban is not recommended for children and adolescents under 18 years of age. There is not enough information in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you are taking:

• some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin
• ketoconazole tablets (used to treat Cushing’s syndrome - when the body produces an excess of cortisol)
• some medicines for bacterial infections (e.g. clarithromycin, erythromycin)
• some anti-viral medicines for HIV / AIDS (e.g. ritonavir)
• other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol)
• anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine to treat abnormal heart beat
• some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)).

If any of the above apply to you, tell your doctor before taking Rivaroxaban, because the effect of this medicine may be increased. Your doctor will decide, if you should be treated with Rivaroxaban and if you should be kept under closer observation.

If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.

If you are taking:

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

If any of the above apply to you, tell your doctor before taking Rivaroxaban, because the effect of this medicine may be reduced. Your doctor will decide, if you should be treated with Rivaroxaban and if you should be kept under closer observation.

Do not take Rivaroxaban if you are pregnant or breast-feeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Rivaroxaban. If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.

Rivaroxaban may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ‘Possible side effects’). You should not drive, ride a bicycle or use any tools or machines if you are affected by these symptoms.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

• To prevent blood clots in the veins after a hip or knee replacement operation
  The recommended dose is one Rivaroxaban 10 mg tablet 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
  After at least 6 months blood clot treatment, the recommended dose is either one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed you Rivaroxaban 10 mg tablet once a day.

Swallow the tablet preferably with water.

Rivaroxaban 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. 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 tablet through a stomach tube.

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

Contact your doctor immediately if you have taken too many Rivaroxaban tablets. Taking too much Rivaroxaban increases the risk of bleeding.

If you 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.

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

Common (may affect up to 1 in 10 people)

• 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.

Uncommon (may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above ,signs of bleeding)
• 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.

Rare (may affect up to 1 in 1,000 people)

• 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).

Very rare (may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granulocytic blood cells that cause inflammation in the lung (eosinophilic pneumonia).

Not known (frequency cannot be estimated from the available data)

• kidney failure after a severe bleeding
• bleeding in the kidney sometimes with presence of blood in urine leading to inability of the kidneys to work properly (anticoagulant-related nephropathy)
• 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 get any 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 directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core:
  lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hypromellose, sodium laurilsulfate, magnesium stearate.
  Tablet coating (OPADRY PINK 03F540128):
  hypromellose, titanium dioxide (E-171), macrogol 3350, iron oxide red (E-172).

Rivaroxaban 10 mg film-coated tablets are pink coloured, round shaped, biconvex tablets (of approximate 8.4 mm diameter), embossed with “10” on one side and plain on other side.

Rivaroxaban is available in packs of 10, 15, 20, 30, 98 and 100 film-coated tablets.

Not all pack sizes may be marketed.

The Marketing Authorisation Holder:

The Manufacturer: