**Product Overview**Manufacturer: Tanabe Mitsubishi Pharma CorporationProduct Name: OkinaZole L600, 1 TabletDrug Classification: Prescription Drug Requiring GuidanceCategory: OTC (Over-the-Counter) MedicinePediatric Category: For Adults (Only dosage and usage for adults (15 years and older) available)Dosage Form: Tablet, Round Tablet, CapsuleContents: 1 TabletProduct Description:This is a one-day treatment medication for recurrent vaginal candidiasis, effective with a single dose (1 tablet) per use. It is recommended for busy women who "don't have time to visit a hospital" or "want a quick, hassle-free cure." It is effective not only against common Candida albicans but also against resistant strains such as Glabratra.
**Expiration Date**More than one year remaining at the time of shipment.JAN Code: 4987128174973Product Code: 050103982
**Initial and Revision Dates of the Package Insert**Initial Creation: March 2023Revisions: NoneDocument Version: 1-BB.8Please be sure to read this package insert before using this medication. Keep it in a safe place for reference when needed.
**Features**Vaginal candidiasis is an inflammation caused by a fungus (a type of mold) called Candida. When infected, symptoms include itching of the vulva, changes in the appearance and amount of vaginal discharge, and sometimes a sensation of heat, pain, or swelling in the vulva.The discharge is characteristic, resembling cottage cheese, white, and cloudy like sake lees.This medication is a treatment that improves the symptoms of vaginal candidiasis.
**Precautions Before Use**Use of this medication is limited to those who have previously been diagnosed and treated for vaginal candidiasis by a doctor.
**Things Not to Do**Failure to follow these precautions may worsen current symptoms or increase the risk of side effects.
1. Do not use if you:(1) Have never been diagnosed or treated for vaginal candidiasis by a doctor.(2) Have recurrent vaginal candidiasis (more than once within 2 months or twice within 6 months).(Repeated recurrences in a short period may indicate other conditions such as diabetes).(3) Are unsure if you have recurrent vaginal candidiasis (discharge not cottage cheese-like, white, cloudy, or with an unpleasant odor may suggest other conditions).(4) Have a fever or chills.(5) Experience nausea or vomiting.(6) Have lower abdominal pain.(7) Have back or shoulder pain.(8) Have irregular bleeding, abnormal bleeding, or blood-tinged discharge.(9) Have ulcers, blisters, or pain in the vagina or vulva.(10) Have painful urination or difficulty urinating.(11) Have been diagnosed with diabetes.(12) Are using anticoagulants such as warfarin.(13) Have had allergic reactions to this medication or its ingredients.(14) Are pregnant or suspect pregnancy.(15) Are under 15 years old or 60 years old and above.
2. Do not apply other medications to the vulva for 6 days after using this medication.(Other external skin medications besides antifungal treatments)
**Consultation**1. Before use, consult a doctor or pharmacist if you:(1) Are undergoing medical treatment.(2) Are breastfeeding.(3) Have had allergic reactions to medicines or other substances.
2. If any of the following symptoms appear after use, there may be side effects. Consult a doctor or pharmacist with this package insert:[Related area] Vaginal[Symptoms] Pain (throbbing), swelling, redness, sensation of heat, itching, heat sensation
3. If symptoms do not improve after 3 days or do not disappear after 6 days, consult a doctor with this package insert.
**Efficacy and Indications**Recurrent vaginal candidiasis (limited to those previously diagnosed and treated by a doctor).
**Usage and Dosage**Adults (15 to less than 60 years): Insert 1 tablet deep into the vagina (preferably before sleep).If symptoms do not improve after 3 days or do not resolve after 6 days, see a doctor.
| Age | 15 years and older, less than 60 | Under 15 or 60 and over ||---|---|---|| Dose | 1 tablet (preferably before sleep) | Do not use |
- Strictly follow the usage and dosage instructions.- This medication is designed to be effective with a single use. The medication remains in the vagina and gradually works, so do not add additional vaginal antifungal tablets or suppositories.- Use only vaginally; do not swallow. If accidentally swallowed, seek medical attention immediately.- Do not use during menstruation. If menstruation occurs within 6 days after use, consult a doctor to confirm healing. (The medication's effect may be reduced during menstruation.)- If the tablet does not dissolve within 6 days and remains in the same shape and size as when inserted, do not insert another tablet on your own; consult a doctor or pharmacist.*Note: The medication remains in the vagina to exert its effect and is gradually expelled, so white clumps or paste-like matter may be discharged.*
**How to Use the Vaginal Tablet**＜Removing the Tablet＞Wash your hands thoroughly with soap. As shown in the diagram, press firmly on the protrusion of the PTP sheet containing the tablet with your fingertip to tear the foil on the back and remove the tablet.(Using the sheet directly may cause injury to the mucous membrane or other accidents.)
＜Insertion Method＞Spread your legs and squat. Insert the tablet into the deepest part of the vagina with your fingertip, as shown in the diagram. (Do not use applicators or other tools.)After insertion, wash your hands thoroughly.There is no specific orientation for inserting the tablet, but inserting from the thinner side is recommended for easier insertion.
The treatment for recurrent vaginal candidiasis ends here.However, since Candida bacteria remain in the vagina for 6 days after use, follow lifestyle precautions.- If no improvement after 3 days, see a doctor.- If symptoms do not disappear after 6 days, see a doctor.
**Ingredients and Amounts**Per tablet:Oxiconazole nitrate 600 mg
Excipients: crystalline cellulose, hydroxypropyl cellulose, hydrated citric acid, magnesium stearate
**Storage and Handling Precautions**1. Store in a cool, dry place away from direct sunlight.2. Keep out of reach of children.3. Do not transfer to other containers (may cause misuse or deterioration).4. Do not use after the expiration date.
**Additional Information in the Package Insert****Lifestyle Precautions**- If recurrent vaginal candidiasis occurs, inform your partner as they may be infected. If your partner experiences itching, redness, or other discomfort, seek medical attention promptly.- Avoid sexual activity for 6 days after using this medication to prevent infection transmission.- Do not use spermicidal agents during this period to avoid irritating the affected area.- Refrain from self-cleaning the vagina to maintain medication efficacy.- During bathing, avoid using soap on the vulva; rinse lightly with water only.- Candida can thrive in warm, humid conditions; keep the area dry as much as possible.- After bathing or swimming, dry the outside of the vagina thoroughly. Change wet clothes or swimsuits promptly.- Use sanitary products like panty liners and change them frequently.- Wear breathable cotton underwear.- Use clean underwear and towels daily; do not share towels with others to prevent infection.- Candida bacteria are also present in the intestines. After using the toilet, wipe from front to back to prevent intestinal infection.- Do not scratch the vulva even if itching occurs, as this can worsen irritation or spread infection.
**Contact Information**Tanabe Mitsubishi Pharma Corporation "Medicine Consultation Center"3-2-10 Doshomachi, Chuo-ku, OsakaToll-Free: 0120-54-7080Available on business days from 9:00 to 17:30
**Common Packaging (JAN code)**1 tablet: 4987128174973
**Manufacturer**Tanabe Mitsubishi Pharma Corporation
**Contents**1 tablet per package
**Suggested Retail Price**3,080 yen (tax included)
**Poisonous and Quasi-Drug Classification**Not classified as poison or quasi-drug
**Pesticide/Animal Drug Classification**Not classified as pesticide or animal drug
**Dosage Form Category**Tablet
**Pediatric Category**For adults only (dosage and usage for adults (15 years and older) only)
**Product Category**OTC (Over-the-Counter) Medicine
**Disclaimer**【Notice】- The product descriptions above, excluding pricing information, are provided by the manufacturer or the Self-Medication Database Center.- If you have any questions or concerns about using this medicine, consult a doctor or pharmacist.- We are not responsible for any health damages resulting from the use of medicines purchased through this service.
**Self-Medication Tax Deduction**Eligible for self-medication tax deduction.