Rivaroxaban 2.5mg 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 an acute coronary syndrome and previously had a bleeding or a blood clot in your brain (stroke)
• have coronary artery disease or peripheral artery disease and previously had a bleeding in your brain (stroke) or where there was a blockage of the small arteries providing blood to the brain’s deep tissues (lacunar stroke) or if you had a blood clot in your brain (ischaemic, non-lacunar stroke) in the previous month
• 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.

Rivaroxaban 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 Rivaroxaban 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 the 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
  • you are older than 75 years
  • you weigh less than 60 kg
  • you have a coronary artery disease with severe symptomatic heart failure
• have a prosthetic heart valve
• 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 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.

• 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 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.

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, prasugrel and ticagrelor (see section “Warnings and Precautions”))
• 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 this medicine 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’.

The recommended dose is one 2.5 mg tablet twice a day. Take Rivaroxaban around the same time every day (for example, one tablet in the morning and one in the evening).

This medicine can be taken with or without food.

If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take this medicine. 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 tablet through a stomach tube.

Rivaroxaban will not be given to you on its own.

Your doctor will also tell you to take acetylsalicylic acid. If you get Rivaroxaban after an acute coronary syndrome, your doctor may tell you to also take clopidogrel or ticlopidine.

If you get Rivaroxaban after a procedure to open a narrowed or closed artery of your leg to restore blood flow, your doctor may also prescribe clopidogrel for you to take in addition to acetylsalicylic acid for a short while.

Your doctor will tell you how much of these to take (usually between 75 to 100 mg acetylsalicylic acid daily or a daily dose of 75 to 100 mg acetylsalicylic acid plus a daily dose of either 75 mg clopidogrel or a standard daily dose of ticlopidine).

Treatment with Rivaroxaban after an acute coronary syndrome should be started as soon as possible after stabilisation of the acute coronary syndrome, at the earliest 24 hours after admission to hospital and at the time when parenteral (via injection) anticoagulation therapy would normally be stopped.

Your doctor will tell you when to start treatment with Rivaroxaban if you have been diagnosed with coronary artery disease or peripheral artery disease.

Your doctor will decide how long you must continue treatment.

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

Do not take a double dose to make up for a missed dose. If you miss a dose, take your next dose at the usual time.

Take Rivaroxaban on a regular basis and for as long as your doctor keeps prescribing it.

Do not stop taking Rivaroxaban without talking to your doctor first. If you stop taking this medicine, it may increase your risk of having another heart attack or stroke or dying from a disease related to your heart or your blood vessels.

• bleeding into the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness. A serious medical emergency. Seek medical attention immediately!).
• long or excessive bleeding.
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris.

Your doctor may decide to keep you under closer observation or change the treatment.

• spreading intense skin rash, blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic illness (DRESS syndrome).

The frequency of these side effects is very rare (up to 1 in 10,000 people).

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; sudden drop in blood pressure.

The frequencies of severe allergic reactions are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people).

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 2.5 mg of rivaroxaban.
• The other ingredients are:
  Tablet core:
  lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, hypromellose, sodium laurilsulfate, magnesium stearate.
  Tablet coating (OPADRY YELLOW 03F520307): hypromellose, titanium dioxide (E-171), macrogol 3350, iron oxide yellow (E-172).

Rivaroxaban 2.5mg film-coated tablets are yellow coloured, round shaped, biconvex tablets (of approximate 5 mm diameter), embossed with “2.5” on one side and plain on other side.

Rivaroxaban is available in packs of 20, 28, 56, 100, 168 and 196 film-coated tablets.

Not all pack sizes may be marketed.

The Marketing Authorisation Holder:

The Manufacturer: