くすりのしおり

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Revised: 8/2020

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details 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 :
Sanbetason ophthalmic and otorhinologic solution 0.1%
 Active ingredient:
Betamethasone sodium phosphate
 Dosage form:
colorless to faint yellow, limpid, ophthalmic/nasal/otic solution, 5mL, (bottle) clear and colorless, (cap) bright yellow green
 Print on wrapping:

Effects of this medicine

This medicine is a synthetic adrenocortical hormone (steroid) preparation and suppresses inflammation/allergic symptoms of eye/ear/nose by anti-inflammatory and anti-allergic effect.
It is usually used to treat eye inflammatory disease such as blepharitis, conjunctivitis, and keratitis, or to treat ear/upper respiratory tract inflammatory/allergic disease such as otitis externa, otitis media, and allergic rhinitis.

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: corneal epithelial abrasion, corneal ulcer, viral conjunctival/corneal disease, tuberculous/fungal/suppurative eye disease, tuberculous/viral disease in an ear/a nose, or diabetes.
    If you wear contact lenses.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. 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))
  • For ophthalmology: In general, apply 1 to 2 drops at a time, 3 to 4 times a day.
    For otorhinology: In general, apply an appropriate amount of the medicine, 1 to several times a day by ear dripping, nasal dripping, ear instillation, use of a nebulizer or a tampon, or applying into the affected parts.
    In any case, the dosage may be adjusted according to your symptoms. Strictly follow the instructions.
  • If you are a child patient (especially less than 2 years old), you should especially follow your doctor's instructions.
  • For ophthalmology: Before applying, wash your hands thoroughly with soap and running water. Pull down your lower eyelid lightly and apply the medicine. Be careful such that the dropper tip does not touch your eyelid, eyelashes, or eye.
    After applying, keep your eyes closed without blinking for a while(1 to 5 minutes). Wipe off any excess liquid gently with clean gauze or a tissue. If you need to apply other eye drops at the same time, wait more than 5 minutes.
    For nasal disease: Before applying, blow your nose gently. Wash your hands thoroughly with soap and running water. Tilt your head back or lie on your back to make your nose turn up, apply the medicine so the dropper tip dose not touch nose or anything else. After applying, keep still for a while and let the medicine spread inside. If you use a nebulizer or a tampon, strictly follow the instruction.
    For otology: Before applying, warm the medicine dropper using your palm. Lie down with the ear on the affected side up and pull the earlobe backward so that the dropper tip dose not touch ear canal and apply the medicine. After applying, keep still for a while and let the medicine spread inside. Sit up with covering the ear with a clean gauze or tissue and wipe off any excess liquid oozing out.
  • If you miss a dose, apply the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should not apply two doses at one time.
  • If you accidentally apply more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop applying 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 irritation and delayed healing of wound. If any of these symptoms occurs, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • (continued use) eye pain, headache, focus disorder [glaucoma]
  • eye pain, lacrimation, focus disorder [corneal herpes, keratomycosis, pseudomonas aeruginosa infection, corneal perforation]
  • (long-term use) focus disorder [posterior subcapsular cataract]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep of reach of children. Store in a shading bag away from heat.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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