Information for Children
Taking Melatobel® Granules
0.2% for Pediatricand Their Parents

Name of Medical institution
Supervisor

Dr. Kyoko Hoshino, President
Segawa Memorial Neurological Clinic for Children
Contact for inquiries about Melatobel ® Granules 0.2% for PediatricNobelpharma Co., Ltd. Customer Center: 0120-003-140
Service hours: 9:00–18:00(except Saturdays, Sundays, and national and company holidays)

Prepared: February 2024
MTB-07E-IFTB

Nobelpharma Co., Ltd.

Melatonin in the Body
Melatonin is a hormone that is mainly secreted by thepineal gland in the brain; its secretion increases at night.
In the body, melatonin works to “deepen your sleep;” italso “regulates your biological clock.” So, if melatoninsecretion is disrupted, you may experience difficulty infalling asleep at night or waking up in the morning.

Melatonin in the body

Table of Contents
Melatonin in the Body

1

Lifestyle for a Good Night’s Sleep

2

Neurodevelopmental Disorders and Sleep Disorders

4

Melatobel Granules 0.2% for Pediatric5

How to Take Melatobel® Granules 0.2% for Pediatric5

Precautions During the Use ofMelatobel® Granules 0.2% for Pediatric6®

Feel a naturalsleepiness

Normalize thedisrupted rhythms ofyour biological clock

Homeostaticcontrol system

Biologicalclock system

Arousal modulation
systemReduce your brain
activity as you gettired

Put your body in a
rest mode at night
and in an activemode during theday

Keep your brain
active to stay awake

Adverse Reactions to Melatobel® Granules 0.2% for
Pediatric

7Q&A

8Sleeping

AwakingLifestyle for a Good Night’s Sleep
As melatonin is released from the brain, you will feel sleepy. If
you are exposed to a lot of sunshine during the day, a lot of
melatonin is released at night, which helps you sleep well.
To normalize your biological clock, the following activities should
be included in your daily routine: get enough “sunlight in themorning,” eat “breakfast,” carry out “daytime activities,” and “dimthe light and go to bed early.”

Move your bodyduring the day
Physical activity makes you
feel comfortably tired andhelps you fall asleep fasterand deeper at night.
It also increases melatonin

Get enough sunlightin the morning

secretion at night.

Open the curtains when you wake up
in the morning.
The morning sunlight awakens andrefreshes your body and mind.
Activate your biological clock.

Dim the light andgo to bed early
Do not drink coffee or green tea containing

Eat breakfast
Breakfast is the source of energy
you need for study and exercise.
Eating breakfast increases yourbody temperature and allows
you to be more energetic andactive.
Also, chewing thoroughly
awakens your body and mind.

caffeine before bedtime as it may cause
difficulty in falling asleep.
Make the environment conducive for sleep, for example, by going
to bed at the same time every day as you take your drug.
Going to bed early will help you feel refreshed upon waking up in
the morning.
Also, too much time spent watching TV, playing video games,
and using smartphones at night will prevent you
from getting a good night’s sleep.
Set rules with your family for spending timeon them.

Neurodevelopmental Disorders and Sleep Disorders
It is known that children with neurodevelopmental disorders(developmental disorders) are more likely to develop sleep
disorders than those without, for example, “it takes too long forthem to fall asleep (difficulty in falling asleep),” “they wake up
more often in the middle of their sleep,” and “they have ashorter sleep time.”
Sleep disorders in children with neurodevelopmental disorders
are suggested to be caused by various factors, such as thecharacteristics of neurodevelopmental disorders, which include
hyperesthesia and undue concentration; problems with themechanism of biological clock that regulates the sleep–wakecycle; and psychological problems.
Of these disorders, “difficulty in falling asleep” has been
demonstrated to be improved by taking Melatobel® Granules
0.2% for Pediatric.
The occurrence of sleep disorders may worsen thecharacteristics of neurodevelopmental disorders during the dayand thus result in more frequent daytime problem behaviors. It isalso suggested to cause a vicious cycle of worsening sleep
disorders.

If a sleep disorderoccurs...

It worsens the characteristics ofneurodevelopmental disorders (morefrequent daytime problem behaviors!)

Interaction
Flickering

It causes
a sleep disorder!

Uncontrollableemotions

If the characteristics ofneurodevelopmental
disorders worsened...

Melatobel® Granules 0.2% for Pediatric
Melatobel® Granules 0.2% for Pediatric contains 2mg ofmelatonin per gram. It is used to treat difficulty in falling
asleep which is associated with pediatricneurodevelopmental disorders.
If difficulty in falling asleep persists despite the improved
lifestyle, the time from bedtime to sleep onset can bepotentially shortened by taking Melatobel® Granules 0.2%for Pediatric.

How to Take Melatobel® Granules 0.2% for PediatricTake the drug once daily immediately before going tobed.
Do not take the drug during or immediately after meal.
Make the environment
conducive for sleep, forexample, by going to bed at
the same time every day as
you take your drug.
Please continue following
the advices given in“Lifestyle for a Good Night’sSleep” (p. 2-3) while taking
the drug.

Precautions During the Use ofMelatobel® Granules 0.2% for PediatricSomnolence (i.e., difficulty in waking up in themorning or feeling sleepy during the day) is one of theadverse reactions to this drug.

Adverse Reactions toMelatobel® Granules 0.2% for Pediatric
You may experience the following adverse reactions toMelatobel® Granules 0.2% for Pediatric.

Take the drug immediately before going to bed, but
do not take it if you need to get up temporarily to dosomething after bedtime.
While taking the drug, exercise caution when doing
your activities, such as climbing heights and riding abicycle or other vehicles. Especially, older children
must be advised not to operate machines such as
hazardous power tools.

Consult your doctor if you have any of the following
symptoms or wishes:

When your sleep status does not improveAfter checking your sleep status, the dose of yourmedication will be increased at an interval of at least 1week.

Somnolence

Headache

Abnormal liverfunction test values

A state of feeling very sleepy
or feeling sluggish due todrowsiness during the day

Please consult your doctor if you experience any of these
symptoms or feel something unusual.

When you want to discontinue your medication
If you suddenly discontinue your medication, you may
experience daytime problem behaviors or worsening
sleep disorders.

Do not take other melatonin-containing products (e.g.,medicines or supplements privately imported overseas)
while taking this drug.

How to store the drug
Store this drug in a lightproof container or in a darkplace as it is easily decomposed by light.

You cannot take this drug withsome antidepressants (e.g.,fluvoxamine maleate). Also, theeffects of this drug may appear
strongly if taken with quinolones
or caffeine. If you are currently
taking any other drug, please be
sure to consult your doctor or
pharmacist with your medication
record.

Q&AQ

Do I get sleepy immediately after takingMelatobel® Granules 0.2% for Pediatric?

AQ

This drug is intended to improve your sleep onset(shorten the time to fall asleep) after going to bed,
not to make you sleepy right away. So you need totake the drug at a specified time (e.g., 9:00 p.m. for anelementary school student or 10:00 p.m. for a juniorhigh school student) and then go to bed and turn off
the lights at the same time every day, wheneverpossible, to establish a quiet sleeping environment.

Can I take an additional dose if I do notfeel sleepy after taking a dose ofMelatobel® Granules 0.2% for Pediatric, orif I wake up in the middle of my sleep?

AAn additional dose can not be taken. Melatobel®
Granules 0.2% for Pediatric should be taken once daily
at the dose prescribed by your doctor. Do not take an
additional dose even if you wake up in the middle ofyour sleep after bedtime. Consult your doctor if yoursleep status does not improve. When you consult yourdoctor, it is important to specifically explain yourproblems with your sleep, for example, “very resistantto going to bed and get out of bed before falling
asleep,” or “wake up in the middle of sleep andcannot fall asleep again.”

QCan I take Melatobel® Granules 0.2% for
Pediatric immediately after meal?

AQ

The efficacy of this drug may be influenced by meal.
Do not take the drug during or immediately aftermeal; instead, take the drug immediately before
bedtime.

Can I discontinue taking Melatobel®
Granules 0.2% for Pediatric if I can alreadysleep at night and get up in the morning
easily?

AIf you suddenly discontinue your medication, you
may experience worsened daytime problem
behaviors. Please be sure to consult your doctor if
you want to stop taking this drug.