■When not to use the product
1. This product should not be taken in the following persons.
(1) Individuals suspected of infectious stomatitis (Consult your doctor, dentist, pharmacist or registered salesperson.)
●Individuals with extensive white patches which can be peeled off by scrubbing with gauze in the mouth (suspected of candidiasis)
●Individuals with yellow pus in the affected lesion (suspected of bacterial infection)
●Individuals with multiple vesicles (around 3 mm – 6 mm) in the mouth, blisters or rashes on the lip other than oral mucosa or skin (suspected of viral infection) .
●Individuals with systemic symptoms including fever, anorexia, general malaise, swollen lymph nodes (suspected of viral infection) .
(2) Individuals with infection in the mouth
(As there is a report that steroids are associated with worsening of infections, do not apply to the place where oral infection such as alveolar pyorrhea or gingivitis exists.)
(3) Individuals whose symptoms do not improve even after using for 5 days.
(4) Individuals whose symptoms worsen after using for one or two days only.
1. The following persons should contact a physician, dentist, pharmacist, or registered salesperson for a consultation before administration.
(1) Patients undergoing medical treatment from a physician or dentist.
(2) Patients who have experienced allergic symptoms associated with drugs, etc.
(3) Pregnant women or women suspected of being pregnant.
(4) Nursing women.
(5) Individuals with extensive affected area (The area cannot be covered by this product) .
(6) The elderly
2. If the following symptoms are observed after using this drug, these may be adverse reactions, so immediately discontinue the use, and show this document to your physician, pharmacist, or registered sales person for a consultation.
In the mouth: white patches (suspected of candidiasis) , yellow pus in the affected area (suspected of bacterial infection)
Other：allergic symptoms (e.g. asthma attack, edema)
3. If the following symptoms are observed after taking this drug, infectious stomatitis or stomatitis caused by other diseases is suspected. So, immediately discontinue the use of this drug, consult your doctor, dentist, pharmacist, or registered salesperson.
Fever, loss of appetite, systemic symptoms, swollen lymph nodes, blisters (other than oral cavity), rash/redness, itching, extensive affected lesion (the area cannot be covered by this product), eye pain, blurred vision and vulvar ulceration.
<Precautions of Dosage and Administration>
(1) Strictly follow the prescribed dosage and administration.
(2) The product naturally dissolves and disappears over time. Do not peel it off forcibly.
(3) Stop using if the pain is relieved (You do not need to peel off the product while in use.)
(4) When allowing children to take the medicine, a guardian must be present to watch and tell such them how to take it.
(5) Do not use in infants and small children aged less than 5 years.
(6) Be careful for children not to peel it off with their fingers after application.
(7) This product is an oral mucoadhesive drug. Do not take it orally. Taking orally does not work.
(8) If you swallow this product by mistake, apply a new one to the affected lesion again. Should your symptoms change or if you are worried, consult your doctor, dentist, pharmacist, or registered salesperson.
(9) This product may not be adhered to the area if you used it in the wrong way. Read the Patient Instructions for Use before use. There are places where this product does not adhere easily. If you cannot apply it well, consult your doctor, dentist, pharmacist, or registered salesperson.
(10) If you forget to wear a patch, put one on as soon as you can.
(11) If the white surface of this product gets wet with saliva, it will not adhere easily. In this case, apply tissue paper or gauze gently to the area where stomatitis occurs, wipe the saliva off and then apply a new patch to the area again.
(12) If your tongue vigorously touches the patch applied to the affected mucosal membrane, it may come off. Be careful.
(13) How to take the tablets out:
Press hard the protrusion of PTP sheet containing the tablets on the fingertips to break aluminum foil on the back. Then take the tablets and ingest.
<Precautions for storage and handling>
(1) Store in a cool, low humidity place away from direct sunlight.
(2) Take this medicine quickly after taking it out of the PTP sheet.
(3) Keep out of reach of children.
(4) Do not transfer the medicine to a different container.
(5) Do not use the product after its expiration date.
◇Dosage and administration◇
Use per affected lesion by applying the product to the involved mucosal membrane the following times.
Adults (15 years or over) / children(5 years or over) :
Use per affected lesion by applying the white surface of the product containing one dose once or twice daily to the involved mucosal membrane.
◇Ingredient and amount◇
In 1 tablet
Triamcinolone acetonide 0.025mg
◇Disclaimer on Multilingual OTC Product Information◇
・This product is a pharmaceutical product approved under a Japanese law, the Law for Ensuring the Quality, Efficacy and Safety of Drugs and Medical Devices, with a view to its sale and use in Japan.
・Multilingual product information is a translation of the product labeling written in Japanese and provided for your information only. It does not warrant that its contents and the product itself conforms to laws and regulations in countries other than Japan.
・Multilingual product information is a tentative translation by Our Company, and may be modified or altered without notice.
・Our Company assumes no responsibility for any occurred problem attributable to the contents of the multilingual product information.