LIXIANA TABLETS 30 mg [Class 1 Drugs]

The most commonly reported adverse reactions include anemia, nose bleeding, subcutaneous bleeding, bloody urine, contusion and wound haemorrhage. If any of these symptoms occur, consult with your doctor or pharmacist.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

• vomiting of blood, black/bloody stool, abdominal pain[gastrointestinal bleeding]
• sudden headache, nausea, motor paralysis, impaired consciousness[intracranial bleeding]
• defect in the visual field, reduced visual acuity, blurred vision, worsening of visual floaters[intraocular haemorrhage]
• general malaise, decreased urine output, edema, bloody urine[acute renal disorder]
• general malaise, loss of appetite, yellowing of the skin/white of eyes[liver dysfunction, jaundice]
• phlegm with blood, dry cough, shortness of breath, breathing difficulty, fever[interstitial lung disease]
• bleeding from nose/gums, increased menstrual bleeding, bruising on limbs[thrombocytopenia]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

• Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
• In general, for adults with body weight of 60 kg or less, take 30 mg of edoxaban at a time, once a day. For adults with body weight of more than 60 kg, take 60 mg of edoxaban at a time, once a day. The dosage may be decreased to 30 mg of edoxaban at a time, once a day according to your renal function and concomitant medications. This medicine contains 30 mg of edoxaban in a tablet. Strictly follow the instructions.
• If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. There should be 12 hours or more before the next scheduled dose. You should never take two doses at one time.
• If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
• Do not stop taking this medicine unless your doctor instructs you to do so.

• If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods.
  If you have: bleeding (intracranial bleeding, retroperitoneal bleeding or bleeding in other critical organs), bleeding tendency (bleeding disorders, gastrointestinal ulcers, diabetic retinopathy, cancer, anemia, etc.), acute bacterial endocarditis, renal failure, liver dysfunction or liver disease with coagulation disorder.
  If your body weight is less than 40 kg.
• If you are pregnant or breastfeeding.
• If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

• Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
• Discard the remainder. Do not store them. If you do not know how to discard the remainder, ask your pharmacist or medical institution. Do not give the medicine to anyone else.