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

Category 1 OTC medicine 

エンペシドL EMPECID L

Product features

● Empecid L is a therapeutic agent for recurrent vaginal candidiasis that contains imidazole antifungal component clotrimazole as an active ingredient.
● To be taken as 1 tablet once a day for 6 days, it is an effervescent vaginal suppository effective for recurrent vaginal candidiasis.

Indication

Recurrence of vaginal candidiasis (limited to those who have been diagnosed or treated by a physician in the past)

Dosage and administration

Insert the following amount deep into the vagina. Continue to use daily for 6 days.


Adults (15 to under 60 years old):1 tablet:1 time (preferably before bedtime)
Persons under 15 years of age or over 60 years of age:Do not use this drug.

If the symptoms do not improve after 3 days of use, or if the symptoms do not disappear after 6 days of use, please consult your physician with this document.

●How to use the vaginal suppository
・Before use, take a bath or clean the affected area with lukewarm water.
・Wash your hands and fingers thoroughly with soap and insert the vaginal suppository into the deepest part of the vagina with your fingertips as shown in the right figure.
・After insertion, wash fingers that have touched the affected area with soap.

Precautions of Dosage and Administration

(1)Strictly follow the prescribed dosage and administration.
(2)Use this drug only in the vagina and do not ingest it. If you accidentally ingest it, see a physician immediately.
(3) Do not use an applicator.
(4) Even if symptoms disappear during the use, please continue to use for 6 days from the start.
(5) Do not use during menstruation. Discontinue use if menstruation begins during use. In such a case, please consult a physician because it is necessary to confirm your cure, etc.

Ingredient and amount

In 1 tablets
Clotrimazole:100mg:It shows a strong antimycotic effect against candida, which is the causative microorganism of vaginal candidiasis.

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)Person who seems to have developed the condition for the first time. (The first time symptoms appear, they may be caused by another disease, in which case you need to see a physician.)
(2)Patients who have had an allergic symptom to this drug or its ingredients.(The use of this agent may cause allergic symptoms to arise again.)
(3)Person under 15 years of age or over 60 years of age. (Those younger than 15 years are likely to have developed the condition for the first time, and those over 60 years old need to consider the possibility of other diseases and the risk of multiple infections with other bacteria and fungi. Therefore, it is difficult to make self-judgment.)
(4)Pregnant women or women suspected of being pregnant.(Care should be taken when using this drug, and you should consult a specialist for instructions.)
(5)Persons with fever, chill, lower abdominal pain, back and shoulder pain, colored or bloody vaginal discharge, vaginal discharge with fishy smell, cessation of menstruation, irregular or abnormal bleeding from the vagina, ulcer in the vagina or vulva, edema or sores. (Since there is a possibility of other diseases, it is necessary to see a physician.)
(6)Persons diagnosed as having the following.
diabetes(It is likely that the disease will be repeated frequently, so you need to see a physician.)
(7)Persons who repeatedly experience this disease frequently. (Once every 1 to 2 months or more than 2 times within 6 months)
(8)Persons who do not know whether they are experiencing reoccurrence of vaginal candidiasis or not. (If you cannot judge yourself, you need to see a physician.)
2.The medicine should not be used on the following parts:   
Sites other than in the vagina. (This agent is effective only for intravaginal candida infection)
3.Do not use the following drugs on the vulva while using this drug.
 Dermatological drugs other than drugs for candidiasis treatment. (Symptoms may worsen or treatment may be delayed.)

■Consultation
1.The following persons should consult a physician or pharmacist before use.
(1)Patients undergoing medical treatment from a physician(Other drugs prescribed by your physician may be affected, or you may already be using the same medicine as this drug.)
(2)Patients who have experienced allergic symptoms associated with drugs, etc.(People who have allergies due to drugs, etc. may exprience allergic symptoms with this drug.)
(3)Nursing women.(Careful use of drugs is required.)
2.If any of the following symptoms persist, deteriorate or develop after using this drug, the symptoms may be side effects. Please stop using it immediately and consult your physician or pharmacist with this document.

Vaginal:local heat sensation, irritation, itching, redness, pain
Skin:rash
3.If the symptoms do not improve after 3 days of use, or if the symptoms do not disappear after 6 days of use, please consult your physician with this document. (There may be other diseases.)

Additive

Lactose, corn starch, pregelatinized starch, adipic acid, sodium hydrogen carbonate, magnesium stearate, stearic acid, polysorbate 80, silicic anhydride

Precautions for storage and handling

(1)Store in a cool, low humidity place away from direct sunlight.
(2)Keep out of reach of children.
(3)Do not transfer the medicine to a different container. (It may lead to misuse or alter the quality of the drug. )
(4)Do not take use the product after its expiration date.

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.