Edoflusio is used in adults:
− to prevent blood clots from forming in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor, such as heart failure, previous stroke or high blood pressure;
− to treat blood clots formed in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and to prevent blood clots from recurring in the blood vessels of the legs and/or lungs.

Do not take Edoflusio:
− if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking Edoflusio.

Pregnancy and breastfeeding:
Pregnancy and breastfeeding
Do not take Edoflusio if you are pregnant or breast-feeding. If there is a chance you could become pregnant, use a reliable method of contraception while taking Edoflusio. If you become pregnant while taking Edoflusio, tell your doctor immediately, who will decide how you should be treated.

Driving and using machines:
Edoflusio has no or negligible influence on the ability to drive and use machines.

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

How much to take:
The recommended dose is one 60 mg tablet once a day.
− if you have impaired kidney function, the dose may be reduced by your doctor to one 30 mg tablet once a day;
− if you weigh 60 kg or less, the recommended dose is one tablet
− 30 mg once a day;
− If your doctor has prescribed medicines known as P-gp inhibitors: ciclosporin, dronedarone, erythromycin or ketoconazole, the recommended dose is one 30 mg tablet once a day.

How to take the tablet:
Swallow the tablet, preferably with water.
Edoflusio can be taken with or without food.
If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Edoflusio. The tablet can be crushed and mixed with a small amount of water or applesauce just before taking it. If necessary, your doctor may give you the crushed tablet through a nasogastric tube (nasogastric tube) or gastric feeding tubes (gastric tube).

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

- The active substance is edoxaban (as tosylate monohydrate).
Edoflusio15 film-coated tablets
Each tablet contains edoxaban 15 mg (as tosylate monohydrate).
Edoflusio30 film-coated tablets
Each tablet contains edoxaban 30 mg (as tosylate monohydrate).
Edoflusio60 film-coated tablets
Each tablet contains edoxaban 60 mg (as tosylate monohydrate).
- The other components are:
Edoflusio15 film-coated tablets
Tablet core: Hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460), croscarmellose sodium (E468)
Tablet film: Hypromellose type 2910, 6.0 mPas. (E464), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).
Edoflusio30 film-coated tablets
Tablet core: Hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460), croscarmellose sodium (E468)
Tablet film: Hypromellose type 2910, 6.0 mPas. (E464), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).
Edoflusio60 film-coated tablets
Tablet core: Hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460), croscarmellose sodium (E468)
Tablet film: Hypromellose type 2910, 6.0 mPas. (E464), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).

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

30 film-coated tablets