くすりのしおり

Internal
Published: 7/2019

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 :
SYMTUZA Combination Tablets
 Active ingredient:
Darunavir ethanolate
Cobicistat
Emtricitabine
Tenofovir alafenamide fumarate
 Dosage form:
yellow to yellowish brown tablet, major axis: 22 mm, minor axis: 10 mm, thickness: 8 mm
 Print on wrapping:
(bottle label) シムツーザ配合錠

Effects of this medicine

This medicine suppresses growth of human immunodeficiency virus (HIV) by inhibiting activities of HIV type-1 (HIV-1) protease and reverse transcriptase, thereby slowing disease progression.
It is usually used to treat HIV-1 infection in patients who have never been treated with anti-HIV medicines or to treat HIV-1 infection not resistant to darunavir in patients who have previously been treated with anti-HIV medicines.

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 renal disorder, liver disorder, hemophilia or bleeding tendency.
  • 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 40 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.
  • This medicine may cause dizziness. Pay attention when driving a car or operating dangerous machinery.
  • 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, headache, rash, nausea, fatigue, abdominal pain and vomiting. 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.
  • high fever (38 degrees Celsius or higher), bloodshot eyes, erosions of the mouth or lips, red rash [toxic epidermal necrolysis, mucocutaneous ocular syndrome, erythema multiforme, acute generalized exanthematous pustulosis]
  • general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [liver dysfunction, jaundice]
  • severe upper abdominal pain, low back pain, nausea [acute pancreatitis]
  • edema, decreased urine output, general malaise [renal failure or severe renal dysfunction]
  • 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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