Dayvigo 10mg Film coated tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Lemborexant

Boleh didapati daripada:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (Nama Antarabangsa):

Lemborexant

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

Eisai Manufacturing Limited

Risalah maklumat

DAYVIGO
® TABLET
Lemborexant 5mg and 10mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Dayvigo is used for
2.
How Dayvigo
works
3.
Before you use Dayvigo
4.
How to use Dayvigo
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Dayvigo
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT DAYVIGO
IS USED FOR
Dayvigo is intended for adults who have
trouble
falling
or
staying
asleep
(insomnia)
HOW DAYVIGO
WORKS
Dayvigo acts through blocking of orexin
receptors
(a
type
of
receptor
in
the
brain).
Orexin
transmitter
signaling
system
plays
a
role
in
wakefulness.
Blocking the binding of wake-promoting
transmitters orexin A and orexin B to its
receptors
is
thought
to
suppress
wake
drive.
BEFORE YOU USE DAYVIGO
-
_When you must not use it _
Do
not
take
Dayvigo
if
you
have
a
history
of
hypersensitivity
to
any
ingredients of Dayvigo.
_ _
Do not take Dayvigo if you fall asleep
often at unexpected times (narcolepsy).
_Pregnancy and lactation _
Do not take Dayvigo
if you are pregnant
or think you may be pregnant unless the
expected
therapeutic
benefits
are
evaluated to outweigh the possible risk
of treatment.
Do not take Dayvigo
if you are breast-
feeding or plan to breast-feed. Dayvigo
passes into your breastmilk. Consult your
doctor about the best way to feed your
baby during treatment with Dayvigo.
Dayvigo
_ _
is
not
recommended
for
children under the age of 18 years.
_ _
_ _
-
_Before you start use it _
Consult
your
doctor
before
using
Dayvigo if you have:
•
History of depression, mental
illness, or suicidal thoughts
•
History of drug or alcohol abuse or
addiction
•
History of a sudden onset of muscle
weakness (cataplexy)
•
History of daytime sleepiness
•
Lung problems or breathing
problems
•
Liver problems
-
_Taking other medicines _
Tell
your
doctor
if
you
are
taking
prescription
and
over-the-counter
medicines,
vitamins
and
herbal
supplements.
Taking
Dayvigo
with
certain
other
medicines can ca

Ciri produk

1.
PRODUCT NAME
DAYVIGO 5 mg Film-coated tablet
DAYVIGO 10 mg Film-coated tablet
2.
PRODUCT DESCRIPTION
Dayvigo 5mg: Film-coated tablet containing Lemborexant 5 mg, pale
yellow, round, biconvex, film-
coated tablets, and debossed with "5" on one side and "LЄM" on the
other side
Dayvigo 10mg: Film-coated tablet containing Lemborexant 10 mg, orange,
round, biconvex, film-coated
tablets, and debossed with "10" on one side and "LЄM" on the other
side
3.
INDICATIONS AND USAGE
DAYVIGO is indicated for the treatment of adult patients with
insomnia, characterized by difficulties
with sleep onset and/or sleep maintenance _[see Clinical Studies
(15.1)]_.
4.
DOSAGE AND ADMINISTRATION
4.1
DOSING INFORMATION
The recommended dosage of DAYVIGO is 5 mg taken no more than once per
night, immediately before
going to bed, with at least 7 hours remaining before the planned time
of awakening. The dose may be
increased to the maximum recommended dose of 10 mg based on clinical
response and tolerability. Time
to sleep onset may be delayed if taken with or soon after a meal _[see
Clinical Pharmacology (13.3)]. _
DAYVIGO should be used at the lowest dose and for the shortest
duration as clinically indicated.
4.2
DOSAGE RECOMMENDATIONS FOR CONCOMITANT USE WITH CYP3A INHIBITORS OR
CYP3A INDUCERS
Co-administration with Strong or Moderate CYP3A Inhibitors
Avoid concomitant use of DAYVIGO with strong or moderate CYP3A
inhibitors _[see Drug Interactions (8.1), _
_Clinical Pharmacology (13.3)]._
Co-administration with Weak CYP3A Inhibitors
The maximum recommended dosage of DAYVIGO is 5 mg no more than once
per night when co-
administered with weak CYP3A inhibitors _[see Drug Interactions (8.1),
Clinical Pharmacology (13.3)]._
Co-administration with Strong or Moderate CYP3A Inducers
Avoid concomitant use of DAYVIGO with strong or moderate CYP3A
inducers _[see Drug Interactions (8.1), _
_Clinical Pharmacology (13.3)]._
4.3
DOSAGE RECOMMENDATIONS FOR PATIENTS WITH HEPATIC IMPAIRMENT
The maximum recommended dose of DAYVIGO is 5 mg no more than on