Rivaroxaban Dr. Reddy's 20 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

• 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 are breastfeeding.

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:
  • severe kidney disease for adults, and moderate or severe kidney disease for children and adolescents 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.

• 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 with a body weight below 30 kg. There is not enough information on its use in children and adolescents in the adult indications.

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 also known as aspirin)
• 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 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.

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 rivaroxaban 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 breastfeeding. 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 Tablets 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’.

Adults

• To prevent blood clots in brain (stroke) and other blood vessels in your body

The recommended dose is one 20 mg tablet once a day.

If you have kidney problems, the dose may be reduced to one 15 mg tablet once a day.

If you need a procedure to treat blocked blood vessels in your heart (called a percutaneous coronary intervention – PCI with an insertion of a stent), there is limited evidence to reduce the dose to one 15 mg tablet once a day (or to one 10 mg tablet once a day in case your kidneys are not working properly) in addition to an antiplatelet medicine such as clopidogrel.

• 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 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg tablet once a day.

After at least 6 months blood clot treatment your doctor may decide to continue treatment with either one 10 mg tablet once a day or one 20 mg tablet once a day.

If you have kidney problems, and take one 20 mg tablet once a day, your doctor may decide to reduce the dose for the treatment after 3 weeks to one 15 mg tablet once a day if the risk for bleeding is greater than the risk for having another blood clot.

Children and adolescents

The dose of rivaroxaban depends on the body weight, and will be calculated by the doctor.

• The recommended dose for children and adolescents with a body weight between 30 kg and less than 50 kg is one rivaroxaban 15 mg tablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kg or more is one rivaroxaban 20 mg tablet once a day.

Take each rivaroxaban dose with a drink (e.g. water or juice) during a meal. Take the tablets every day at approximately the same time. Consider setting an alarm to remind you. For parents or caregivers: please observe the child to ensure the full dose is taken.

As the rivaroxaban dose is based on body weight it is important to keep scheduled doctor’s visits because the dose may need to be adjusted as the weight changes.

Never adjust the dose of rivaroxaban by yourself. The doctor will adjust the dose if necessary.

Do not split the tablet in an attempt to provide a fraction of a tablet dose. If a lower dose is required please use the alternative presentation of rivaroxaban granules for oral suspension. For children and adolescents who are unable to swallow tablets whole, please use rivaroxaban granules for oral suspension.

If the oral suspension is not available, you may crush the rivaroxaban tablet and mix with water or apple puree immediately before taking. Take some food after taking this mixture. If necessary, your doctor may also give the crushed rivaroxaban tablet through a stomach tube.

• less than 30 minutes after you have taken rivaroxaban, take a new dose.
• more than 30 minutes after you have taken rivaroxaban, do not take a new dose. In this case, take the next rivaroxaban dose at the usual time.

Contact the doctor if you repeatedly spit up the dose or vomit after taking rivaroxaban.

Take the tablet(s) every day until your doctor tells you to stop.

Try to take the tablet(s) 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 brain (stroke) and other blood vessels in your body:

If your heart beat needs to be restored to normal by a procedure called cardioversion, take rivaroxaban at the times your doctor tells you.

Adults, children and adolescents

• 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.

Adults

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

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

Do not stop taking rivaroxaban without talking to your doctor first, because rivaroxaban treats and prevents serious conditions.

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)

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

• 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)

In general, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were primarily mild to moderate in severity.

Side effects that were observed more often in children and adolescents:

Very common (may affect more than 1 in 10 people)

• headache
• fever
• nose bleeding
• vomiting

Common (may affect up to 1 in 10 people)

• raised heartbeat
• blood tests may show an increase in bilirubin (bile pigment)
• thrombocytopenia (low number of platelets which are cells that help blood to clot)
• heavy menstrual bleeding

Uncommon (may affect up to 1 in 100 people)

• blood tests may show an increase in a subcategory of bilirubin (direct bilirubin, bile pigment)

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 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 15 mg or 20 mg of rivaroxaban.

The other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hypromellose, sodium laurilsulfate, magnesium stearate.See section 2 “Rivaroxaban contains lactose and sodium”

Tablet film coat: macrogol, hypromellose, titanium dioxide (E 171), iron oxide red (E 172).

For 20 mg: Talc

15 mg:

Red, round biconvex tablets (approx.6 mm diameter) marked with "15" on one side.

Pack sizes of 10, 14, 28, 42, 98 or 100 film-coated tablets.

20 mg:

Dark red, round biconvex tablets (approx.6 mm diameter) marked with "20" on one side.

Pack sizes of 10, 14, 28, 42, 98 or 100 film-coated tablets.

Not all pack sizes may be marketed.