Drug Information Sheet("Kusuri-no-Shiori")
External
Published: 08/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails 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:DIOCTYL SODIUM SULFOSUCCINATE OTIC SOLUTION 5%"CEO"
Active ingredient:DIOCTYL SODIUM SULFOSUCCINATE
Dosage form:slightly white, turbid, aqueous ear drops
Print on wrapping:ジオクチルソジウムスルホサクシネート耳科用液 5％「CEO」
Effects of this medicine
This medicine shows surface-active effects and promotes penetration of the medicinal solution and softening bydirectly acting on earwax on the surface of the skin of the external ear canal.
It is usually used to remove earwax.
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 tympanic membrane perforation.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects. 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, apply this medicine into the external ear with a cotton swab. When it is difficult to remove earwax, washthe external ear with lukewarm water (37 degrees Celsius) 5 to 20 minutes later after applying a few ear drops inyour ear. If you have severe cerumen impaction, wash the external ear with lukewarm water (37 degrees Celsius)
after applying the ear drops, 3 times a day for 1 day or 2 consecutive days. Strictly follow the instructions.
・Warm the ear drops as close to body temperature as possible by holding the container in your hand before use. You
may experience dizziness if the temperature of the medicinal liquid is low on application. Lie down with the ear to
be treated facing up when applying the ear drops, and pay attention that the tip of the container does not touch
your ear directly. After washing your ear, cover your ear with a clean gauze, get up and then wipe off any excess
liquid.
・Use this medicine only for ear dropping・If you miss a dose, apply the missed dose as soon as possible.
・If you accidentally using more than your prescribed dose, consult with your doctor or pharmacist.
・Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include itch, redness of ear canal, pain, dermatitis, rash and skinirritation.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor 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. Store at a room temperature.
Discard the remainder. Do not store them.
・Do not replace this medicine in other containers (misuse and changes in quality may occur otherwise).
Do not place anything other than this medicine in the container and use it.
For healthcare professional use only//

For further information, talk to your doctor or pharmacist.

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