くすりのしおり

Internal
Revised: 3/2017

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 :
SOVALDI Tablets 400mg
 Active ingredient:
Sofosbuvir
 Dosage form:
yellow capsule-shaped tablet, major axis: 20 mm, minor axis: 9 mm, thickness: 7 mm
 Print on wrapping:
(face)ソバルディ錠400mgGSI 7977GILEAD
(back)SOVALDIソバルディ錠400mg抗ウイルス剤1日1回1錠
(printed on the bottle) ソバルディ錠400mg

Effects of this medicine

This medicine inhibits protein (NS5B RNA polymerase) involved in hepatitis C virus replication, and suppresses the proliferation of hepatitis C virus (antiviral effects). This medicine is used concomitantly with ribavirin.
With or without compensated cirrhosis, this medicine is usually used to suppress viremia in serogroup 2 (genotype 2) chronic hepatitis C patients or in chronic hepatitis C patients without both serogroup 1 (genotype 1) and serogroup 2 (genotype 2) chronic hepatitis C virus 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 renal dysfunction.
    If you have ever diagnosed as Hepatitis B.
  • 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))
  • Patients with serogroup 2 (genotype 2): In general, for adults, take 1 tablet (400 mg of the active ingredient) at a time, once a day for 12 weeks. Strictly follow the instructions.
    Patients with neither serogroup 1 (genotype 1) nor serogroup 2 (genotype 2): In general, for adults, take 1 tablet (400 mg of the active ingredient) at a time, once a day for 24 weeks.
    In any case, strictly follow the instructions.
  • This medicine is used concomitantly with ribavirin. Follow the instruction about ribavirin.
  • If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, 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

  • For ribavirin used concomitantly with this medicine, teratogenic action (possibility to cause fetal malformation) has been reported in animal experiments. If you/your partner have/has a possibility of pregnancy, avoid pregnancy while you are taking ribavirin and for 6 months after you discontinue it. Also, you/your partner need to have a pregnancy test once a month in order to confirm that you/your partner do/does not become pregnant.
  • Avoid taking any food containing St. John's wort, as it may decrease the blood level of this medicine and diminish medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include anaemia, headache, dull, nausea, itch, fatigue, insomnia, and asthenia. 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.
  • palpitation and shortness of breath when going upstairs or uphill, headache, dizziness [anaemia]
  • headache, dull headache, dizziness, stiff shoulder, palpitation [blood pressure rising]
  • headache, nausea, vomiting, temporary conscious disorder, paralyzation on either side of the limbs, speech disorder [cerebrovascular disorder]
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.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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