くすりのしおり

Internal
Published: 8/2018

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 :
ODEFSEY Combination Tablets
 Active ingredient:
Rilpivirine hydrochloride
Tenofovir alafenamide fumarate
Emtricitabine
 Dosage form:
gray tablet, major axis: 15 mm, minor axis: 7 mm, thickness: 6 mm
 Print on wrapping:

Effects of this medicine

This medicine is an antiviral medicine that suppresses growth of human immunodeficiency virus type-1 (HIV-1) by inhibiting activities of reverse transcriptase of the virus.
It is usually used to treat HIV-1 infection.

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 hepatitis B and/or C virus infection.
    If you are likely to have arrhythmia.
  • 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 and children 12 years old or over and weighing 35 kg or over, take 1 tablet at a time, once a day with or right after a meal. Strictly follow the instructions.
  • It is important that you do not miss a dose, because missing a dose may lead to loss of efficacy of this medicine. If you notice that you have missed a dose within 12 hours after the scheduled time, take the missed dose immediately with a meal, and follow your regular dosing schedule from the next day. However, if more than 12 hours have passed, skip the missed dose and follow 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

  • This medicine is not intended for radical treatment of HIV infection. The disease may progress even though you are taking it. Therefore, inform your doctor of all changes in your physical condition.
  • Kidney function may be checked before and while taking this medicine.
  • Avoid taking any food containing St. John's wort, since it may decrease the blood level of the medicine and diminish medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, nausea, headache, flatulence, insomnia and abnormal dreams. 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.
  • edema, decreased urine output, general malaise [severe renal dysfunction such as renal failure]
  • hyperventilation, consciousness disorder, shivering of limbs [lactic acidosis]
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. Ask your pharmacy or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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