くすりのしおり

Internal
Published: 10/2016

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 :
HARVONI Combination Tablets
 Active ingredient:
Ledipasvir
Sofosbuvir
 Dosage form:
orange colored, diamond-shaped tablet, major axis: 20 mm, minor axis: 10 mm, thickness: 6.6 mm
 Print on wrapping:
(face) ハーボニー配合錠GSI 7985GILEAD
(back)HARVONIハーボニー配合錠抗ウイルス剤1日1回1錠
(printed on the bottle) ハーボニー配合錠

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 treat chronic hepatitis C with or without compensated cirrhosis.

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 antiarrhythmic agent.
    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))
  • In general, for adults, take 1 tablet at a time, once a day for 12 weeks. Strictly follow the instructions.
  • 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

  • Avoid taking any food containing St. John's wort, as it may decrease the blood level of this medicine and diminish medicinal effects.
  • If you take this medicine in combination with amiodarone which is antiarrhythmic agent, it may cause an arrhythmia including bradycardia. Receive an adequate explanation for full understanding.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include itch, nausea and stomatitis. 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.
  • 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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