Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 05

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 05/2015
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:VALACICLOVIR Tablets 500mg "PP"
Active ingredient:Valaciclovir hydrochloride
Dosage form:white to faint yellow tablet, major axis: 18.5 mm, minor axis: 7.5 mm,
thickness: 6.2 mm
Print on wrapping:(Face) VALACICLOVIR 500mg「PP」, VALACICLOVIR, 500mg
(Back) バラシクロビル錠 500mg「PP」, バラシクロビル錠, 抗ウイルス
化学療法剤, 500mg
Effects of this medicine
This medicine suppresses the growth of herpes simplex viruses and varicella/herpes zoster viruses by inhibiting DNA
synthesis of viruses.
It is usually used to treat herpes simplex, herpes zoster and varicella, to prevent onset of herpes simplex virus
infection (herpes simplex) caused by hematopoietic stem cell transplantation and recurrence of genital herpes.
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 disorder or decreased renal function.
・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))
・Herpes simplex: In general, for adults and children weighing more than 40 kg, take 1 tablet (500 mg of valaciclovir)
twice a day.
Onset of herpes simplex virus infection (herpes simplex) caused by hematopoietic stem cell transplantation: In
general, for adults and children weighing more than 40 kg, take 1 tablet (500 mg of valaciclovir) twice a day, starting
from 7 days before until 35 days after the hematopoietic stem cell transplantation enforcement.
Herpes zoster: In general, for adults and children weighing more than 40 kg, take 2 tablets (1,000 mg of valaciclovir)
3 times a day.
Varicella: In general, for adults and children weighing more than 40 kg, take 2 tablets (1,000 mg of valaciclovir) 3
times a day.
Recurrence of genital herpes: In general, for adults and children weighing more than 40 kg, take 1 tablet (500 mg of
valaciclovir) once a day. For HIV infection take 1 tablet (500 mg) twice a day.
In any case, strictly follow the instructions.
・Take this medicine after you received your dialysis, if you are on hemodialysis.
・This medicine may be started within 5 days from papule appearance on herpes zoster, within 2 days on varicella, as
a guide.
・This medicine may be switched to other treatment, if the symptoms do not have sign of improvement or get worse
after using for 5 days on herpes simplex, 7 days on herpes zoster, 5 to 7 days on adults varicella and 5 days on
children varicella. This medicine may be taken up to 10 days to avoid possibility of severe worsening of first type
genital herpes.
・The necessity of further medication is to be determined after take this medicine for full 1 year, in case of recurrence
of genital herpes.
・Take the tablet without crushing.
・If you miss a dose, take a dose as soon as possible when you noticed. If it is almost time for the next dose, skip the
missed dose and follow 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
・Use of condoms etc. are recommended to avoid infection risk to sexual partner, in case of recurrence of genital
herpes.
・Take appropriate amount of water during medication.
・This medicine may cause conscious disorder. Pay attention to operating dangerous machinery such as driving a car.
・Patients with renal disorder are more susceptible to conscious disorder, so avoid operating dangerous machinery
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such as driving a car.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, hives, itch, photosensitivity, nausea, dizziness and
urination difficulty. 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.
・respiratory distress, angioedema, palpitation [anaphylactic shock, anaphylaxis]
・headache, subcutaneous bleeding, sore throat [blood disorder such as pancytopenia, agranulocytosis etc.]
・decreased urine output, edema, headache [acute renal failure]
・conscious disorder (coma), hallucination, convulsions [neuropsychiatric symptoms]
・fever, bulbar conjunctival hyperemia, mucosal eruption with pain of oral mucosa etc. [Toxic Epidermal Necrolysis,
Stevens-Johnson syndrome]
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
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For further information, talk to your doctor or pharmacist.
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