くすりのしおり

Internal
Revised: 12/2018

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 :
VALIXA Tablets 450mg
 Active ingredient:
Valganciclovir hydrochloride
 Dosage form:
pale red tablets, long diameter: 17.0 mm, short diameter: 8.0 mm, thickness: 7.0 mm
 Print on wrapping:

Effects of this medicine

This medicine exerts its antiviral activity by inhibiting DNA replication in human cytomegalovirus.
It is usually used to treat cytomegalovirus infection in acquired immune deficiency syndrome, organ transplant (including hemopoietic stem cell transplant) and malignant tumor. It is also used to inhibit cytomegalovirus infection in organ transplantation (except hematopoietic stem cell transplantation).

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 bone marrow depression.
  • If you are pregnant, possibly 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))
  • Cytomegalovirus infection:
    Initial treatment: In general, for adults, take 2 tablets (900 mg as valganciclovir) at a time after meal, twice a day.
    Maintenance treatment: In general, for adults, take 2 tablets (900 mg as valganciclovir) at a time after meal, once a day.
    Inhibition of cytomegalovirus infection in organ transplantation (except hematopoietic stem cell transplantation):
    In general, for adults, take 2 tablets (900 mg as valganciclovir) at a time after meal, once a day.
    In general, for children, take the amount determined by physician based on body surface area (calculated using height and body weight) and symptoms at a time after meal, once a day. The total daily dose should not exceed 2 tablets (900 mg as valganciclovir).
    In both cases, strictly follow the instructions.
  • Swallow down the medicine without breaking or crunching the tablets.
  • If you miss a dose, take the dose as soon as possible. If it is close to your 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

  • This medicine may cause convulsion, sedation, dizziness, ataxia and confusion. Avoid driving a car or operating dangerous machinery.
  • In animal experiments, teratogenicity (potential risk of fetal malformation) and genotoxicity have been reported for this medicine. Appropriate birth control should be used during treatment period for women of child-bearing potential, and during treatment as well as until 90 days after last dose for men.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, nausea, vomiting, oral candidiasis, abdominal pain, upper abdominal pain, stomach discomfort, fever, fatigue, malaise, headache, anemia, cough, insomnia, rash, dermatitis, nasopharyngitis, sinusitis and retinal detachment. 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.
  • anemic symptoms, fever, gum bleeding or nose bleeding [bone marrow depression, pancytopenia, aplastic anemia, leukopenia, neutropenia, anemia, decreased platelets]
  • abdominal pain, black stools, vomiting of blood [serious bleeding associated with decreased platelets (including gastrointestinal bleeding)]
  • decreased urine output, edema, loss of appetite [renal failure]
  • acute upper abdominal pain and low back pain, fever, nausea [pancreatitis]
  • acute high fever with shivering, joint pain, muscle pain [myelopathy such as sepsis and infection associated with immune system 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. Consult with your dispensing pharmacy or healthcare provider when you discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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