くすりのしおり

Internal
Revised: 9/2019

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
OLUMIANT Tablets 2mg
 Active ingredient:
Baricitinib
 Dosage form:
light pink oblong tablet with dimple, major axis: approximately 9.0 mm, minor axis: approximately 7.5 mm, thickness: approximately 3.0 mm
 Print on wrapping:
(face)オルミエント錠2mg, 2mg, Lilly 2, オルミエント錠
(back)olumiant, オルミエント錠, 2mg

Effects of this medicine

This medicine affects the action of several substances associated with inflammation or expression of pain by inhibiting the activity of an enzyme called Janus Kinase (JAK), thereby showing improvement on symptoms of rheumatoid arthritis.
It is usually used for the treatment of patients with rheumatoid arthritis (including prevention of structural joint damage) who have not had shown enough efficacy with existing therapies. This medicine is used for the patients who have been treated with anti-rheumatoid arthritis medicines, such as methotrexate but still have rheumatoid arthritis symptoms.

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: serious infections (sepsis, etc.), active tuberculosis, renal dysfunction, neutropenia, lymphopenia, hemoglobin decreased, hepatitis B, or history of herpes zoster.
  • If you are pregnant, breastfeeding or possibly pregnant.
  • 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 a 4 mg tablet (4 mg of active ingredient) once a day. Depending on symptoms, the dosage may be reduced a 2 mg tablet (2 mg of active ingredient) once a day for patients. This medicine is 2 mg tablet. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. Then, continue your regular dosing schedule afterwards. 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

  • Beware of catching cold.
  • Periodic blood test will be performed to confirm blood counts such as white blood cell and clinical laboratory test results such as lipid level and hepatic function.
  • If you are planning to become pregnant, avoid the pregnancy while using this medicine and at least 1 menstrual cycle after the completion of the therapy with this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nasopharyngitis, upper respiratory tract infection, herpes zoster and nausea. The adverse reactions to be stopped taking this medicine, when any abnormalities occur, include infection, gastrointestinal perforation, interstitial pneumonia and venous thromboembolism. 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.
  • cold-like symptoms, malaise, fever, band-like skin rash with blisters [infection]
  • nausea, vomiting, severe abdominal pain [gastrointestinal perforation]
  • fever, sore throat, anemia [neutropenia, lymphopenia, hemoglobin decreased]
  • malaise, loss of appetite, yellowing of the skin or whites of the eyes [hepatic impairment, jaundice]
  • fever, dry cough, breathing difficulty [interstitial pneumonia]
  • swelling or redness of one calf, pain when pushing the calf, sudden feel of breath shortness or chest distress [venous thromboembolism]
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.

Storage conditions and other information

  • Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Seek advice of your pharmacist or healthcare provider about proper disposal of unused medicines.
  • Do not receive live vaccinations [for BCG, measles, rubella, measles-rubella, chickenpox and mumps] while using this medicine. Please consult with your doctor when you need a vaccination.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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