• 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 10 mg Tablets are and what they are used for
2. What you need to know before you take Rivaroxaban 10 mg Tablets
3. How to take Rivaroxaban 10 mg Tablets
4. Possible side effects
5. How to store Rivaroxaban 10 mg Tablets
6. Contents of the pack and other information

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

Do not take Rivaroxaban 10 mg Tablets and tell your doctor if any of these apply to you.

Talk to your doctor or pharmacist before taking rivaroxaban.

• if you have an increased risk of bleeding, as could be the case in situations such as:
  • if you have moderate or severe kidney disease, as 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 10 mg Tablets”)
  • if you have a bleeding disorder
  • if you have very high blood pressure, not controlled by medical treatment
  • if you have diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (food pipe), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the food pipe (oesophagus)) or tumours located in the stomach or bowels or genital tract or urinary tract
  • if you have a problem with the blood vessels in the back of your eyes (retinopathy)
  • if you have a lung disease where your air passages (bronchi) are widened and filled with pus (bronchiectasis), or you have had 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 finds 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.

• 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 will be needed.

Rivaroxaban 10 mg Tablets are not recommended for people under 18 years of age. There is not enough information on their use in children and adolescents.

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 any of the medicines below, tell your doctor before taking rivaroxaban, because the effect of rivaroxaban may be increased. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

• 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)
• medicines for bacterial infections (e.g. clarithromycin, erythromycin)
• 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 aspirin/acetylsalicylic acid)
• dronedarone, a medicine to treat abnormal heart beat
• medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))

If you are taking any of the medicines below, tell your doctor before taking rivaroxaban, because the effect of rivaroxaban may be reduced. Your doctor will decide if you should be treated with this medicine and if you should be kept under closer observation.

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

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

Do not take this medicine 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.

This medicine may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4 ”Possible side effects”). If you experience these side effects, do not drive, ride a bicycle or use any tools or machines.

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 and so is essentially “sodium-free”.

• To prevent blood clots in the veins after a hip or knee replacement operation
  The recommended dose is one 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 to prevent 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 once a day.

Swallow the tablet preferably with water. 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.

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 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 this medicine without talking to your doctor first, because rivaroxaban prevents the development of a serious condition.

Signs of bleeding

• bleeding into the brain or inside the skull (symptoms can include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and neck stiffness). This is a serious medical emergency. Seek medical attention immediately!)
• bleeding more and for longer
• exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain or angina pectoris (pain from not enough blood flowing to the heart).

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

Signs of severe skin reactions

• 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).

Signs of severe allergic reactions

• swelling of the face, lips, mouth, tongue or throat (angioedema and allergic oedema); difficulty swallowing; hives (red, itchy and swollen areas (welts) on the skin) and breathing difficulties (anaphylactic reactions); sudden drop in blood pressure (anaphylactic shock).

The frequency of anaphylactic reactions, including anaphylactic shock, is very rare (affecting up to 1 in 10,000 people). The frequency of angioedema and allergic oedema is uncommon (affecting up to 1 in 100 people).

Talk to your doctor or pharmacist if you get any of the following side effects or any side effects not listed.

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 after an operation
• oozing of blood or fluid from surgical wound
• swelling in the limbs
• pain in the limbs
• reduced kidney function (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
• low number of platelets, which are cells that help blood to clot (thrombocytopenia)
• allergic reactions, including allergic skin reactions and hives (see above sign of severe allergic reactions
• reduced liver function (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

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

• bleeding into a muscle
• cholestasis (decreased bile flow), inflamed liver including (hepatitis), liver injury (hepatocellular injury)
• yellowing of the skin and eyes (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)

Frequency not known (frequency cannot be estimated from the available data)

• kidney failure after 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 bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after 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 Yellow Card Scheme Website: 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 tablet contains 10 mg of rivaroxaban.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hypromellose, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, iron oxide red, titanium dioxide, macrogol.

Rivaroxaban 10 mg Tablets are light-red, round shaped, biconvex, film-coated tablets (approximately 6.1 mm in diameter), debossed with “C5” on one side and plain on other side.

They come in blisters of 5, 10, 14, 28, 30 or 98 film-coated tablets or in bottles of 30, 100 or 500 film-coated tablets.

Not all pack sizes may be marketed.

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