Effects of this medicine

Before using this medicine, be sure to tell your doctor and pharmacist

• If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
  If you have: liver dysfunction, a history of thromboembolism and predisposition to thromboembolism or predisposition to bleeding.
  If you are under anticoagulative treatment.
  If you are scheduled to have surgical operation or have a history of surgery.

• If you are pregnant, possibly 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.)

Dosing schedule (How to take this medicine)

• Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))

• In general, for adults, take 150 mg of nintedanib at a time, twice daily, after breakfast and dinner. The dosage may be reduced to 1 capsule (100 mg of nintedanib) at a time, twice daily, according to the symptoms. This preparation contains 100 mg of nintedanib in a capsule. Strictly follow the instructions.
• Take capsules with a cup of water without chewing.

• If you miss a dose, skip the missed dose and follow your regular dosing schedule. Do not exceed the maximum daily dose of 3 capsules (300 mg). 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.

Precautions while taking this medicine

• Taking this medicine may be associated with liver dysfunction. Therefore patients will need to undergo liver function testing periodically. Patients with liver dysfunction will need to undergo more frequent liver function tests.
• Pay attention that St. John's wort (a kind of herb) may diminish medicinal effects.
• If you have a possibility of pregnancy, use adequate contraception while you are taking this medicine and for at least three months after the last dose of this medicine.
• Avoid breastfeeding while you are taking this medicine.

Possible adverse reactions to this medicine

• muddy or watery stool, sweating, nausea, severe abdominal pain [severe diarrhea]
• general malaise, loss of appetite, yellowing of the skin and the white of eyes, nausea, itching [liver dysfunction]
• pain or swelling of foot, chest pain, breathing difficulty, paralysis or numbness of limbs [thromboembolism]
• nose bleeding, gum bleeding, subcutaneous bleeding of limbs (bruise) [decreased platelets]
• severe abdominal pain, nausea, vomit [gastrointestinal perforation]
• dry cough, shortness of breath, fever (if you newly experience these symptoms or feel them getting worse) [interstitial pneumonia]

Storage conditions and other information

• Keep out of reach of children. Store below 25℃ and away from direct sunlight and moisture.
• Get out from a sheet just before taking this medicine since this medicine is susceptible to moisture.
• Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year