Xerdoxo contains the active substance rivaroxaban. Xerdoxo is used in adults for:
- to prevent blood clots from forming in the brain (stroke) and other blood vessels in your body if you have an irregular heart rhythm called non-valvular atrial fibrillation.
- 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 the recurrence of blood clots in the blood vessels of the legs and/or lungs.
Xerdoxo is used in children and adolescents under 18 years of age with a body weight of 30 kg or more for:
- to treat blood clots and prevent blood clots from recurring in the veins or blood vessels of the lungs, after initial treatment of at least 5 days with injectable medicines used to treat blood clots.
Xerdoxo 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 use Xerdoxo:
- 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 Xerdoxo.

Pregnancy, lactation and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines:
Xerdoxo may cause dizziness (common side effect) or fainting (uncommon side effect). You should not drive, cycle or use tools or machines if you experience these symptoms.

Xerdoxo contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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

You should take Xerdoxo with meals.
Swallow the tablet(s), preferably with water.

If you have difficulty swallowing the tablet whole, ask your doctor about other ways to take Xerdoxo. 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 tablet
Crushed Xerdoxo, through a tube that reaches the stomach.

How much Xerdoxo you should use:
• Adults
- To prevent blood clots from forming in the brain (stroke) and other blood vessels in your body,
The recommended dose is one Xerdoxo 20 mg tablet once a day.
If you have kidney problems, the dose may be reduced to one Xerdoxo 15 mg tablet once a day.

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

- To treat blood clots formed 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 Xerdoxo 15 mg tablet twice a day for the first 3 weeks. For treatment after the 3 weeks, the recommended dose is one Xerdoxo 20 mg tablet 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 Xerdoxo 20 mg tablet once a day, your doctor may decide to reduce your treatment dose after 3 weeks to one Xerdoxo 15 mg tablet once a day if the risk of bleeding is greater than the risk of having another blood clot.

• Children and adolescents:
The dose of Xerdoxo depends on 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 Xerdoxo 15 mg tablet once a day.
- The recommended dose for children and adolescents weighing 50 kg or more is one Xerdoxo 20 mg tablet once a day.
Take each dose of Xerdoxo with a drink (e.g. water or juice) during a meal. Take the tablets at about the same time each day. Consider setting an alarm to remind you. For parents or caregivers: please supervise your child to make sure the entire dose is taken.

Since the dosage of Xerdoxo is based on body weight, it is important to attend scheduled doctor visits as the dosage may need to be adjusted as your weight changes.
Never adjust the dose of Xerdoxo yourself. Your doctor will adjust the dose if necessary.

Do not split the tablet in an attempt to deliver a fraction of the tablet dose. If a lower dose is required, please use the alternative dosage form of rivaroxaban granules for oral suspension. For children and adolescents who cannot swallow tablets whole, please use rivaroxaban granules for oral suspension.
If the oral suspension is not available, you can crush the Xerdoxo tablet and mix it with water or applesauce just before taking it. Eat food after taking this mixture. If necessary, your doctor may also give you the crushed Xerdoxo tablet through a stomach tube.

If you spit out the dose or vomit:
- less than 30 minutes after taking Xerdoxo, take a new dose.
- more than 30 minutes after taking Xerdoxo, do not take a new dose. In this case, take the next dose of Xerdoxo at the usual time.

Contact your doctor if you spit out the dose or have repeated vomiting after taking Xerdoxo.

When should you take Xerdoxo:
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 brought back to normal by a procedure called cardioversion, take Xerdoxo at the time your doctor tells you.

If you forget to take Xerdoxo:
- Adults, children and adolescents:
If you are taking a 20 mg tablet or a 15 mg tablet once a day and you miss a dose, take the tablet as soon as you remember. Do not take more than one tablet in one day to make up for the forgotten dose. Take the next tablet the following day and then continue taking one tablet per day as usual.

- Adults:
If you are taking one 15 mg tablet twice a day and you miss a dose, take it as soon as you remember. Do not take more than two 15 mg tablets in one day. If you forget to take a dose, you can take two 15 mg tablets at the same time to give a total of two tablets (30 mg) in one day. The next day you should continue to take one 15 mg tablet twice a day as usual.

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

- The active substance is rivaroxaban.
15mg:
Each film-coated tablet contains 15 mg rivaroxaban.
20mg:
Each film-coated tablet contains 20 mg rivaroxaban.
- The other ingredients are mannitol, microcrystalline cellulose, macrogol, micronised poloxamer, sodium lauryl sulphate, croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate in the tablet core, and hypromellose, macrogol, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172) - only for the 15 mg film-coated tablets - in the tablet coating.

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

98 film-coated tablets