Rivaroxaban Accord contains rivaroxaban as the active substance and is used in adults for:

• to prevent blood clots in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because you are at increased risk of blood clots after having surgery.
• to treat blood clots formed in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and to prevent blood clots from recurring in the blood vessels of the legs and/or lungs.

Rivaroxaban Accord belongs to a class of medicines called antithrombotic medicines. It works by blocking a clotting factor (factor Xa), thereby reducing the tendency of the blood to form clots.

Do not take Rivaroxaban Accord:
- if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking Rivaroxaban Accord.

Pregnancy and breastfeeding:
If you are pregnant or breast-feeding, do not take Rivaroxaban Accord. If there is a possibility that you could become pregnant, use effective contraception while taking Rivaroxaban Accord. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide on the right course of treatment.

Driving and using machines:
Rivaroxaban Accord 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 experience these symptoms.
Rivaroxaban Accord contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, please contact him before taking this medicine.

Always take this medicine exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure.

You should take Rivaroxaban Accord with food.
Swallow the tablet(s), preferably with water.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Rivaroxaban Accord. The tablet can be crushed and mixed with water or soft food, such as applesauce, just before taking it. This mixture should be followed immediately by food.

If necessary, your doctor may give you the crushed Rivaroxaban Accord tablet through a tube that goes into your stomach.

For enteral feeding, your doctor may crush the rivaroxaban tablets and prepare a suspension of them in 50 ml of water and administer them via a nasogastric tube or gastric feeding tube. After administration of a crushed rivaroxaban 15 mg or 20 mg tablet, enteral feeding should be carried out immediately.

Crushed rivaroxaban tablets are stable in water and applesauce for up to 4 hours.

How much should you use:
To prevent blood clots from forming in the brain (stroke) and other blood vessels in your body:
The recommended dose is one tablet of Rivaroxaban Accord 20 mg once a day.

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

If you need a procedure to treat blocked blood vessels in your heart (called percutaneous coronary angioplasty with stenting), there is limited evidence to reduce the dose to one Rivaroxaban Accord 15 mg tablet once a day (or one Rivaroxaban Accord 10 mg tablet once a day if you have kidney problems), in combination with an antiplatelet medicine such as clopidogrel.

To treat blood clots in the veins of the legs and blood clots in the blood vessels of the lungs and to prevent blood clots from recurring:
The recommended dose is one tablet of Rivaroxaban Accord 15 mg twice a day for the first 3 weeks.

For treatment beyond the 3 weeks, the recommended dose is one tablet of Rivaroxaban Accord 20 mg once a day.

After at least 6 months of treatment for blood clots, 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 are taking one Rivaroxaban Accord 20 mg tablet once a day, your doctor may decide to reduce the dose of treatment after 3 weeks to one Rivaroxaban Accord 15 mg tablet once a day if the risk of bleeding is greater than the risk of having another blood clot.

When should you take Rivaroxaban Accord:

Take the tablet(s) every day until your doctor tells you to stop.
Try to take your tablet(s) at the same time each day to help you remember.
Your doctor will decide how long you should continue treatment.

To prevent blood clots from forming in the brain (stroke) and other blood vessels in your body:

If your heartbeat needs to be restored to normal by a procedure called cardioversion, take Rivaroxaban Accord at the time your doctor tells you.

- The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
- The other components are:
Tablet core
Lactose monohydrate
Croscarmellose sodium (E468)
Sodium lauryl sulfate (E487)
Hypromellose 2910 (nominal viscosity 5.1 mPa.s) (E464)
Microcrystalline cellulose (E460)
Colloidal anhydrous silica (E551)
Magnesium stearate (E572)
The movie
Macrogol 4000 (E1521)
Hypromellose 2910 (nominal viscosity 5.1 mPa.s) (E464)
Titanium dioxide (E171)
Red iron oxide (E172)

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

98 film-coated tablets