くすりのしおり

Internal
Published: 4/2018

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 :
Tecfidera capsules 120mg
 Active ingredient:
Dimethyl fumarate
 Dosage form:
bright green/white capsule, major axis: 22 mm, minor axis: 7 mm
 Print on wrapping:
テクフィデラカプセル120mg

Effects of this medicine

This medicine reduces inflammation by suppressing cell activation which causes immune response. It also protects nerve cells from oxidant stress to suppress demyelination.
It is usually used for prevention of relapse and delay of progression of physical disability in multiple sclerosis.

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 decreased lymphocytes, renal disease or hepatic disease.
    If you have or are suspected of having infection.
    If you are susceptible to infection
  • 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.)

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, start with taking 120 mg of the active ingredient at a time, twice a day after breakfast and dinner. One week later, the dosage is increased to 240 mg of the active ingredient at a time, twice a day after breakfast and dinner. This preparation contains 120 mg of the active ingredient in a capsule. Strictly follow the instructions.
  • If you miss a dose after breakfast, take the missed dose after lunch. If you have already finished lunch, skip the missed dose and continue your regular dosing schedule. 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

  • Blood tests to count the number of lymphocytes should be carried out before and after the initial dose at least every 3 months. Keep all appointments/laboratory test schedules.
  • Periodic renal/hepatic examination should be carried out before and after the initial dose. Keep all appointments/laboratory test schedules.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include flushing, nausea, diarrhea, upper abdominal pain, itch, abdominal pain, hot flushes and rash. 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.
  • fever, sore throat [decreased lymphocytes, decreased white blood cells]
  • paralysis of limbs, impaired cognitive function, inability to recognize speech or describe in words. [progressive multifocal leukoencephalopathy]
  • decreased urine output, edema, headache [acute renal failure]
  • general malaise, loss of appetite [hepatic dysfunction]
  • respiratory distress, hives, redness with general itch [anaphylaxis]
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 light, heat and moisture.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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