Lixiana®

Lixiana<sup>®</sup>

Lixiana®

Edoxaban

Lixiana®

15, 30, 60 mg edoxaban (as tosilate).

Film-coated Tablet for Oral Use

 

Product leaflet summary

Therapeutic Indications

– Prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.

– Treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels in the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels in the legs and/or lungs.

 

Dosage and Administration

How much to take the recommended dose is one 60 mg tablet once daily.

– If you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor.

– If your body weight is 60 kg or lower, the recommended dose is one 30 mg tablet once daily.

– 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 daily.

 

Contraindications

– If you are allergic to edoxaban or any of the other ingredients of this medicine.

– If you are actively bleeding

– If you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, or recent surgery of the brain or eyes)

– If you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, 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 have uncontrolled high blood pressure

– If you are pregnant or breast-feeding Warnings and precautions talk to your doctor or pharmacist before taking Lixiana, – If you have an increased risk of bleeding, as could be the case if you have any of the following conditions:

  • end-stage kidney disease or if you are on dialysis
  • severe liver disease
  • bleeding disorders
  • a problem with the blood vessels in the back of your eyes (retinopathy)
  • recent bleeding in your brain (intracranial or intracerebral bleeding)
  • problems with the blood vessels in your brain or spinal column

-if you have a mechanical heart valve Lixiana 15 mg is only to be used when changing from Lixiana 30 mg to a vitamin K antagonist (e.g. warfarin) If you need to have an operation: It is very important to take Lixiana before and after the operation exactly at the times you have been told by your doctor. If possible, Lixiana should be stopped at least 24 hours before an operation. Your doctor will determine when to restart Lixiana.

 

Pregnancy and Lactation

Do not take Lixiana 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 Lixiana. If you become pregnant while you are taking Lixiana, immediately tell your doctor, who will decide how you should be treated.

 

Ability to Drive and Use Machinery

Lixiana has no or negligible effects on your ability to drive or use machines.

 

Package Presentation:

Lixiana 15 mg is available in pack of 14 film-coated tablets

Lixiana 30 mg is available in pack of 28 film-coated tablets

Lixiana 60 mg is available in pack of 28 film-coated tablets