RAMELTEON Tablets 8mg "KYORIN" (ラメルテオン錠8mg「杏林」)

Country: Japan

Language: English

Source: すりの適正使用協議会 RAD-AR Council, Japan

Active ingredient:

Ramelteon

Available from:

Kyorin Rimedio Co.,Ltd.

INN (International Name):

Ramelteon

Pharmaceutical form:

pale orangish yellow tablets, diameter: 7.1 mm, thickness: 3.5 mm

Product summary:

Print on wrapping: (Face) ラメルテオン錠8mg「杏林」, ラメルテオン, 8mg, (Back) Ramelteon 8mg 「KYORIN」, ラメルテオン8mg「杏林」, 不眠症治療薬, 就寝前服用

Patient Information leaflet

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 12/2022
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:
RAMELTEON TABLETS 8MG "KYORIN"
ACTIVE INGREDIENT:
Ramelteon
DOSAGE FORM:
pale orangish yellow tablets, diameter: 7.1 mm, thickness:
3.5 mm
IMPRINT OR PRINT ON WRAPPING:
(Face) ラメルテオン錠 8mg「杏林」, ラメルテオ
ン, 8mg, (Back) Ramelteon 8mg 「KYORIN」, ラメルテオ
ン 8mg「杏林」, 不眠症治療薬, 就寝前服用
EFFECTS OF THIS MEDICINE
This medicine brings the brain and body into "a state of readily going
to sleep" by regularizing
the sleep-awake rhythm via its acting upon the receptor for
"melatonin," a hormone deeply
involved in the sleep mechanism.
It is usually used for treatment of insomnia.
THE FOLLOWING PATIENTS MAY NEED TO BE CAREFUL WHEN 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
or foods.
If you have liver disorder, sleep apnea syndrome, or brain 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 adults, take 1 tablet (8 mg of the active
ingredient) at a time, once a day,
before bedtime. Do not increase the prescribed dose at your own
discretion just beca