くすりのしおり

Internal
Published: 2/2019

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 :
EPCLUSA Combination Tablets
 Active ingredient:
Sofosbuvir
Velpatasvir
 Dosage form:
pink colored, diamond-shaped tablet, major axis: 20 mm, minor axis: 10 mm, thickness: 6.6 mm
 Print on wrapping:
(face) エプクルーサ配合錠 GSI 7916 GILEAD
(back) EPCLUSA エプクルーサ配合錠 抗ウイルス剤1日1回1錠

Effects of this medicine

This medicine inhibits protein (NS5A replication complex and NS5B_RNA polymerase) involved in hepatitis C virus replication and suppresses the proliferation of hepatitis C virus (antiviral effects).
It is usually used to improve viremia associated with chronic hepatitis C and compensated cirrhosis type C with a history of prior treatment and viremia associated with decompensated cirrhosis type C.

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 previously taken amiodarone which is an antiarrhythmic agent.
  • If you have ever been diagnosed with 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))
  • For improvement of viremia associated with chronic hepatitis C and compensated cirrhosis type C with a history of prior treatment: In general, for adults, take 1 tablet at a time once a day for 24 weeks in combination with ribavirin. Receive an adequate explanation on ribavirin.
    For improvement of viremia associated with decompensated cirrhosis type C: In general, for adults, take 1 tablet at a time once a day for 12 weeks.
    In any case, strictly follow the instructions.
  • If you miss a dose, take the missed dose when you remember. 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

  • If you take this medicine in combination with amiodarone which is an antiarrhythmic agent, it may cause arrhythmia including bradycardia. Receive an adequate explanation for full understanding.
  • Avoid taking any food containing St. John's wort, as it may decrease the blood level of this medicine and diminish medicinal effects.
  • When taken concomitantly with ribavirin, teratogenic action (possibility to cause fetal malformation) has been reported on ribavirin in animal experiments. Follow the instruction on contraception and pregnancy test by the doctor. If you/your partner have/has a possibility of pregnancy, avoid pregnancy while you are taking the medicine and for 6 months after you discontinue it. Also, you/your partner need to receive a pregnancy test once a month in order to confirm that you/your partner do/does not become pregnant.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include anemia, malaise, itching, rash 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.
  • palpitation or shortness of breath when going up stairs or a slope, headache, dizziness [anemia]
  • headache, dull headache, dizziness, shoulder stiffness, palpitation [hypertension]
  • headache, nausea, vomiting, transient consciousness disorder, hemiplesia of 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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