Inbaxa 10 mg

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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.

What is in this leaflet :

  • What Rivaroxaban is and what it is used for
  • What you need to know before you take Rivaroxaban
  • How to take Rivaroxaban
  • Possible side effects
  • How to store Rivaroxaban
  • Contents of the pack and other information
  • What Rivaroxaban is and what it is used for Rivaroxaban contains the active substance rivaroxaban and is used in adults to:

      • 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.

    Rivaroxaban belongs to a group of medicines called antithrombic agents. It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.

  • What you need to know before you take Rivaroxaban

    • DO NOT take Rivaroxaban if you: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 and tell your doctor if any of these apply to you.

    • Warnings and precautions Talk to your doctor or pharmacist before taking Rivaroxaban

    • Take special care with Rivaroxaban

      • if you have and 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 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)

        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 lun

    • 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 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 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.

    • Children and adolescents

      • Rivaroxaban is not recommended for people under 18 years of age.There is not enough information on its use in children and adolescents.

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

      • If you are taking:

        • some medicines for fungal infections (e.g. ketoconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin

        • 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

    • 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 withthis 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 preventive 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 observation.

    • Pregnancy and breast feeding 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.

    • Driving and using machines Rivaroxaban may cause dizziness (common side effect) or fainting (uncommon side effect) (see section 4, ‘Possible side effects’). You should not drive or use machines if you are affected by these symptoms.

  • How to take Rivaroxaban Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

    • How much to take Prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery

      The recommended dose is 10 mg rivaroxaban taken orally once daily. The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established. The duration of treatment depends on the Individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery.

    • For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended.

    • For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.

    Swallow the tablet(s) preferably with

    Take Rivaroxaban together with a meal.

    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. This mixture should be immediately followed by food.

    If necessary, your doctor may also give you the crushed Rivaroxaban tablet through a stomach tube.

    • When to take 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.

      • If you take more Rivaroxaban than you should Contact your doctor immediately if you have taken too many Rivaroxaban tablets. Taking too much Rivaroxaban increases the risk of bleeding.

      • If you forget to take Rivaroxaban If a dose is missed the patient should take rivaroxaban immediately and then continue the following day with once daily intake as before.

      • If you stop taking Rivaroxaban Do not stop taking Rivaroxaban without talking to your doctor first, because Rivaroxaban treats and prevents serious conditions.

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

  • Possible side effects Like all medicines, Rivaroxaban can cause side effects, although not everybody gets them.
    Like other similar medicines (antithrombotic agents), Rivaroxaban 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.

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

      • 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.

    • Overall list of possible side effects:Common (may affect up to 1 in 10 people):

      • 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

      • fever

      • reduction in red blood cells which can make the skin pale and cause weakness or breathlessness

      • 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

      • impaired function of the kidneys (may be seen in tests performed by your doctor)

      • 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

      • bleeding into a joint causing pain and swelling

      • fainting

      • feeling unwell

      • dry mouth

      • faster heartbeat

      • allergic reactions, including allergic skin reactions

      • hives

      • 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

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

      • bleeding into a muscle

      • localised swelling

      • yellowing of the skin and eye (jaundice)

      • 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):

        • 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)

        • kidney failure after a severe bleeding

      The following side effects have been reported since authorisation:

      • Angioedema and allergic oedema (swelling of the face, lips, mouth, tongue or throat)

      • Cholestasis (decreased bile flow), Hepatitits incl. hepatocellular injury (inflamed liver incl. liver injury)

      • Thrombocytopenia (low number of platelets, which are cells that help blood to clot).

      • Reporting of side effects 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. By reporting side effects you can help provide
        more information on the safety of this medicine.

  • How to store Rivaroxaban Keep this medicine out of the sight and reach of children.

    Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of the month.
    This medicine does not require any special storage conditions.
    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  • Contents of the pack and other information

    • What Rivaroxaban contains

      • The active substance is rivaroxaban. Each tablet contains 10 mg

      • The other ingredients are:
        Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate,
        hypromellose, sodium laurilsulfate, magnesium stearate.
        Tablet film coat: macrogol, hypromellose, titanium dioxide (E 171), iron oxide red (E 172).

    • What Rivaroxaban looks like and contents of the pack Rivaroxaban 10 mg Film-coated Tablets
      Red, round, biconvex film-coated tablets having “A2” debossed on one side and plain on the other side
      OPNAI/PVC/AI blister or Alu/PVC/PVdC blister:
      Blister packs containing 10, 14, 28, 42, 98 or 100 film-coated tablets
      HOPE bottle:
      HOPE bottle containing 30 or 100 tablets with child resistant or continuous thread closure with induction sealing wad.
      Each bottle contains a dessicant 1 Silica gel canister.
      Not all pack sizes may be marketed