Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 03/2020
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:Melatobel granules 0.2% for pediatricActive ingredient:Melatonin
Dosage form:white granules
Imprint or print on wrapping:
Effects of this medicine
This medicine improves difficulty in onset of sleep by acting on Melatonin receptor.
It is usually used to improve difficulty in onset of sleep associated with neurodevelopmental disease (developmentaldisorder) in childhood.
The following patients may need to be careful when using this medicine.Be sure to tell your doctor andpharmacist.
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods. If you haverenal or liver disorder.
・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))
・In general, for children, take 0.5 g of this medicine (1 mg of melatonin) once a day before bedtime. However, thedosage will be adjusted by the doctor's judgement, according to the symptoms. The maximum daily dose should
not exceed 2 g (4 mg) once a day. The dosage will be decided by the doctor according to the symptoms. Strictly
follow the instructions.
・Take this medicine right before bedtime after getting ready for going to bed.
・Do not take this medicine with or right after meal as it may possibly diminish the effects.
・If you need to wake up in a short time after sleeping to do something, do not take this medicine.
・If you notice that you miss a dose, you do not have to carry over the missed dose for the next day. Take a dose
before bedtime on the next day. You should never take two doses at one time.
・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・This medicine may cause sleepiness or dizziness. Pay attention when playing or acting such as climbing up heights,
or driving vehicles such as bicycle. Especially for older children (at older ages), pay attention not to operate
dangerous electric tools.
・Refrain from excessively drinking coffee or tea containing much caffeine as they may affect this medicine.
・Make sure to inform that you are taking this medicine by bringing medication notebook with you when consultingwith other doctor or purchasing other medicine or supplement at pharmacy.

Possible adverse reactions to this medicine
The most commonly reported adverse reactions include somnolence (in a state with a feeling of strong sleepiness atdaytime or with half dozing due to sleepiness) and headache. If any of these symptoms occur, consult with yourdoctor or pharmacist.
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 at a room temperature (1 to 30 degrees Celcius) away from light, heat andmoisture.

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・Discard the remainder. Do not store them.
・[To family members] Family members should pay close attention to the patient conditions when the administration isdiscontinued. It may cause the worsening of the symptoms associated with neurodevelopmental disease(developmental disorder), such as irritability (a mere stimulation may cause emotional or physical changes) or
hyperactivity (restlessness), or have trouble falling a sleep.
For healthcare professional use only//For further information, talk to your doctor or pharmacist.

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