くすりのしおり

Internal
Revised: 3/2018

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 :
Tivicay Tablets 50mg
 Active ingredient:
Dolutegravir sodium
 Dosage form:
yellow tablet, diameter: approximately 9.1 mm, thickness: approximately 4.7 mm
 Print on wrapping:

Effects of this medicine

This medicine suppresses the integrase of human immunodeficiency virus (HIV) to exert the antiviral effect.
It is usually used to treat HIV 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 or C.
  • 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))
  • For patients taking an anti-HIV drug for the first time or have ever taken an anti-HIV drug other than integrase inhibitors: In general, for adults, take 1 tablet (50 mg of dolutegravir) at a time, once a day. In general, for children above 12 years old weighing 40 kg or more, take 1 tablet (50 mg of dolutegravir) at a time, once a day.
    For patients who have resistance to integrase inhibitors: In general, for adults, take 1 tablet (50 mg of dolutegravir) at a time, twice a day.
    In any case, this medicine should be used in combination with other anti-HIV drugs. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, 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 used for radical cure of HIV infection. The disease may progress even if you are taking this medicine. Inform your doctor of any change of your physical condition.
  • Pay attention that St. John's wort may decrease the blood level of this medicine.
  • Iron preparations, supplements containing calcium, etc. inhibit the absorption of this medicine. If you are taking iron preparations, supplements containing calcium, etc. other than from meals, take this medicine 2 hours before or 6 hours after taking supplements, etc.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, diarrhea and headache. 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.
  • rash, fever, swollen lymph nodes [drug hypersensitivity syndrome]
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 reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Seek advise of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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