Download Drug Information Sheet("Kusuri-no-Shiori") External Published: 01

Drug Information Sheet("Kusuri-no-Shiori")
External
Published: 01/2016
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:ORA-BLISS Gargle Gran. 11%
Active ingredient:Sodium fluoride
Dosage form:pale red easily soluble granules
Print on wrapping:オラブリス洗口用顆粒 11％
Effects of this medicine
This medicine enhances tolerance of dental enamel to acid, promotes remineralization and strengthens tooth
structure. It also suppresses metabolic activity of plaque bacteria.
It is usually used to prevent tooth decay.
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 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>>
・Daily use: In general, dissolve 1 packet (1.5 g) in 300 mL or 167 mL of water (0.055% [approximately 250 ppm as
fluoride] or 0.099% [approximately 450 ppm as fluoride] of the active ingredient). Gargle with 5 to 10 mL of the
solution at a time, once a day, after meal or before bedtime.
Weekly use: In general, dissolve 1 packet (1.5 g) in 83 mL of water (0.199% [approximately 900 ppm as fluoride]) of
the active ingredient]. Gargle with 5 to 10 mL of the solution at a time, once a week, after meal or before bedtime.
In any case, strictly follow the instructions.
・Before rinsing your mouth, brush your teeth or gargle with water.
・For young children, make sure that they can rinse their mouth correctly before using this medicine.
・When rinsing your mouth, do not place the amount of solution for a single dose in two divided doses into your
mouth.
・Do not gargle, eat or drink for at least 30 minutes after rinsing your mouth.
・When gargling with this medicine, slightly tilt your head down and swish to prevent accidental swallowing.
・If you accidently swallow this medicine and acute toxic symptoms such as vomiting, abdominal pain and diarrhea
occur, drink milk or take a calcium preparation, such as calcium gluconate, as first aid measures, and visit your
doctor.
・If you miss a dose, use the missed dose as soon as possible.
・If you accidentally use 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
・When gargling at home, daily use is recommended. When gargling in groups such as at schools/facilities, daily use is
recommended for children of preschool age and younger, and either weekly or daily use for school children and
older. Follow the dentist's instructions regarding usage.
・If a child under 6 years old, in the period of tooth formation, repeatedly swallows this medicine by accident,
symptoms such as white spots or pigmentation of the teeth may develop due to fluoride overdose.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hypersensitivity. If any of these symptoms occur, 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.
No pertinent entries.
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 out of the reach of children. Store away from direct sunlight, heat and moisture.
・Close the lid of the container immediately after use so that children do not swallow the solution by mistake.
・Store the solution in the refrigerator.
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・If the appearance of the solution has changed, discard the solution and prepare a new solution in a thoroughly
washed container.
・Fluoride has corrosive effects on glass. Use plastic containers to prepare/store the solution.
・Discard the remainder. Do not store them. Ask your pharmacy or medical institution on how to discard the
remainder.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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