Caution: The following texts are translated from the Japanese original. We cannot take responsibility for ambiguity in the translation.

Designated Category 2 OTC medicine

アフタッチA AFTACH A

Product features

Stomatitis medication that you “stick on”. Protects stomatitis well and slowly releases medicine components on the affected area.
This medication becomes jelly-like in a short while after application and dissolves naturally.

Indication

Stomatitis aphthosa

Dosage and administration

Use per affected lesion by applying the product to the involved mucosal membrane the following times.

(Age: Doses Per Day)
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.

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 use the medicine, a guardian must be present to watch and tell such them how to use 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 remove tablets from the package
Push the convex part of the PTP sheet containing the tablets with your fingertips to break the aluminum foil on the back, take it out and take.
(If accidentally swallowed without removing the package, it will lead to unexpected accidents such as piercing the esophageal mucosa.)

Ingredient and amount

In 1tablets
Triamcinolone acetonide : 0.025mg: Relieves inflammation in the affected area and improves stomatitis.

Precautions

■When not to use the product
(If you do not follow these instructions, the current symptoms may worsen or adverse reactions are more likely to occur.)
1.This product should not be used by 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.

■Consultation
1.The following persons should contact a physician, dentist, pharmacist, or registered salesperson for a consultation before use.
(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, dentist, 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.

Additive

Hydroxypropyl cellulose, carboxyvinyl polymer, magnesium stearate, lactose, carmellose calcium (CMC-Ca), talc, magnesium aluminometasilicate, yellow no. 5

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. (It may lead to misuse or alter the quality of the drug. )
(5)Do not use this product past its expiration date.

Other

<How to use of AFTACH_A >
1、Aphthous stomatitis, which this medication targets, is a collective term for one to several small, painful, whitish circular ulcers (less than 10 mm in diameter) with shallow concave centers surrounded by redness, found on the tongue and the inside of cheeks and lips as shown on the diagram on the left.
2、Gently wipe off saliva (medication may not adhere properly if the area where it is applied is wet due to saliva) using tissue paper or gauze on the area where stomatitis has occurred.
3、Apply a small quantity of saliva to your fingertip, gently press your fingertip to the orange side of the medication, and apply the medication.
4、While looking in the mirror, adhere the white side (containing active ingredients) carefully so as to cover the part affected with stomatitis. If the white side gets wet with saliva, adhesion to the affected area will deteriorate, and if it does not adhere properly, reapply a new medication.
5、The following, are especially difficult to apply areas, where a cotton swab or similar may be used instead of fingertip to apply. If medication will not adhere to uneven surfaces such as the back of the tongue, the gums or similar, please consult a doctor, dentist, pharmacist, or registered seller.
6、Once you have adhered the medication to the stomatitis, press for a few seconds, confirm that it has adhered properly and only then remove your finger. For medication to attach properly, be careful not to touch the medication with your tongue for a while. After a while, the medication will turn into jelly and gradually dissolve.

Disclaimer on Multilingual 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.