くすりのしおり

Internal
Revised: 2/2016

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 :
Baraclude Tablets 0.5 mg
 Active ingredient:
Entecavir hydrate
 Dosage form:
white, triangular shaped film-coated tablet, perpendicular 8.4 mm, thickness 3.7 mm
 Print on wrapping:
(Face) Baraclude 0.5 mg, BMS 1611, (Back) バラクルード 0.5 mg

Effects of this medicine

This medicine may lower the ability of HBV to multiply infect new liver cell and lower the amount of HBV in the body.
It is usually used to treat chronic hepatitis B or hepatitis B with 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 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 one tablet (0.5 mg of entecavir) at a time, once daily on an empty stomach (avoid to take a medicine within 2 hours before and after meals). If other medicine (lamivudine) does not work well, the dosage may be adjusted to 2 tablets (1 mg) at a time, once daily. Strictly follow the instructions.
  • If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at the same time. Keep your regular dosing schedule. Ask your doctor or pharmacist when you are not sure what to do.
  • 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. In general, it is necessary to take this medicine for a long period of time. Strictly follow the instructions of your doctor or pharmacist, since your disease may worsen if you discontinue your medication by your own decision.

Precautions while taking this medicine

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, diarrhea, inflammation of nose and throat, back pain and sleeplessness. 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.
  • general malaise, nausea, vomiting, itching, yellow discoloration of the white of eyes/skin/urine [hepatic function disorder, exacerbation of hepatitis after discontinuation]
  • general malaise, rash, itching of skin, shortness of breath, breathlessness [anaphylactoid symptoms]
  • general malaise, feeling queasy, vomiting, abdominal pain, breathlessness [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 infants and children. Store at room temperature (1 to 30 degrees Celsius). Store away from light and moisture.
  • Discard the remainder. Do not store them. Ask your pharmacist or medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.