Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 12/2015
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:MITICURE House Dust Mite Sublingual Tablets 10,000JAU
Active ingredient:Extract of dermatophagoides farinae, Extract of dermatophagoides
pteronyssius
Dosage form:white to faint brown, round freeze-dried tablet, diameter: 12.3 mm,
thickness: 3.3 mm
Print on wrapping:ミティキュアダニ舌下錠 10,000
Effects of this medicine
This medicine, made from extracts derived from mites, is used for hyposensitization therapy (allergen
immunotherapy) and started at a low dose to make your body accustomed to the mite antigens and gradually improve
the symptoms of allergic rhinitis caused by mites.
It is usually used to improve allergic rhinitis caused by mite antigens.
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 experienced shock by taking this medicine.
If you have bronchial asthma.
・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 and children 12 years old and above, take 3,300 JAU, once a day, for 1 week after starting this
medicine. From the 2nd week of administration and beyond, put 1 tablet (10,000 JAU of the active ingredient)
under the tongue at a time, keep it there for 1 minute, and then swallow, once a day. Do not gargle, eat or drink for
at least 5 minutes after swallowing the medicine. Strictly follow the instructions.
・Remove a tablet from the blister sheet with dry fingers just before use, since this medicine has hygroscopic
properties.
・When you remove a tablet from the blister sheet, peel the sheet on the back side and push the tablet out using the
ball of your finger, without using your fingernail. Since this medicine is softer than other tablets and may break up,
do not push out without peeling the sheet on the back side. Take the whole dose even if the tablet is chipped or
broken.
・This medicine gets dissolved by saliva when placed under the tongue. Do not swallow the saliva containing the
dissolved medicine immediately, but keep it there for 1 minute.
・It is recommended that you take the medicine in the presence of a family member or during daytime in case
anaphylaxis develops and treatment becomes necessary.
・If symptoms of bronchial asthma are severe during asthmatic attacks, ask your doctor whether you can take the
medicine.
・If you have acute infection or are not feeling well, ask your doctor whether you can take the medicine.
・Consult with your doctor before taking the medicine if you have received surgery or treatment for your mouth, such
as tooth extraction or if you have a wound or inflammation inside the mouth, such as stomatitis.
・If you miss a dose, take the missed dose as soon as you remember. Even if you cannot keep a tablet under your
tongue for 1 minute before swallowing, do not take another dose on the same day. Take it on the next day. You
should never take two doses at one time. If you are not sure if you have taken your dose, do not take the dose on
that day.
・If you accidentally take more than your prescribed dose, spit it out and gargle. Take it on the next day. If you notice
any abnormality, visit a medical institution immediately.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Make sure to consult with your doctor when you resume treatment with this medicine after a long interval.
Precautions while taking this medicine
・Avoid taking heavy exercise, drinking alcohol or taking a bath within 2 hours before and after taking this medicine.
Improved blood circulation in the body may promote the absorption of this medicine, leading to development of
adverse reactions.
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Possible adverse reactions to this medicine
The most commonly reported adverse reactions include oral edema, oral pruritus, throat irritation, throat discomfort,
oral discomfort, false feeling of the mouth and ear itching. 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.
・facial pallor, cold sweat, respiratory distress [shock, anaphylaxis]
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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