CIRCADIN™ PROLONGED RELEASE TABLETS 2MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MELATONIN

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

N05CH01

Dosage:

2 mg

Pharmaceutical form:

TABLET, EXTENDED RELEASE

Composition:

MELATONIN 2 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SWISSCO SERVICES AG

Authorization status:

ACTIVE

Authorization date:

2011-05-04

Patient Information leaflet

NAME OF THE MEDICINE
Melatonin 2mg
Chemical name: N-[2-(5-Methoxyindol-3-yl)
ethyl]acetamide. Melatonin is a slightly off-white,
odourless crystalline powder.
Structural formula:
Molecular formula: C
13
H
16
N
2
O
2
Molecular weight: 232.27
CAS number: 73-31-4
pKa: 12.3 – 12.7
DESCRIPTION
The active ingredient in Circadin prolonged
release tablets is melatonin. Circadin prolonged
release tablets also contain the excipients:
Ammonio methacrylate copolymer, calcium
hydrogen phosphate, lactose, colloidal anhydrous
silica, purified talc and magnesium stearate.
Melatonin is very slightly soluble in water and in
dilute hydrochloric acid.
PHARMACOLOGY
Pharmacotherapeutic group: Melatonin Receptor
Agonists, ATC code: N05CH01
PHARMACOLOGICAL ACTIONS:
Melatonin is a naturally occurring hormone
produced by the pineal gland and is structurally
related to serotonin. Physiologically, melatonin
secretion increases soon after the onset of
darkness, peaks at 2-4 am and diminishes
during the second half of the night. Melatonin is
associated with the control of circadian rhythms
and entrainment to the light-dark cycle. It is also
associated with a hypnotic effect and increased
propensity for sleep.
_Mechanism of action _
The activity of melatonin at the MT1 MT2 and
MT3 receptors is believed to contribute to its
sleep-promoting properties, as these receptors
(mainly MT1 and MT2) are involved in the
regulation of circadian rhythms and sleep
regulation.
_Rationale for use_
Because of the role of melatonin in sleep and
circadian rhythm regulation, and the age related
decrease in endogenous melatonin production,
melatonin may effectively improve sleep quality
particularly in patients who are over 55 with
primary insomnia.
PHARMACOKINETICS:
_Absorption_
The absorption of orally ingested melatonin is
complete in adults and may be decreased by up
to 50% in the elderly. The kinetics of melatonin
are linear over the range of 2-8 mg.
Bioavailability is in the order of 15%.
There is a significant first pass effect with an
estimated first pas

Summary of Product characteristics

1/12
PRODUCT INFORMATION
CIRCADIN
® 2MG PROLONGED RELEASE TABLETS
_NAME OF THE MEDICINE _
Melatonin 2mg
Chemical name: N-[2-(5-Methoxyindol-3-yl)ethyl]acetamide. Melatonin is
a slightly
off-white, odourless crystalline powder.
Structural formula:
Molecular formula: C
13
H
16
N
2
O
2
Molecular weight: 232.27
CAS number: 73-31-4
pKa: 12.3 – 12.7
_DESCRIPTION _
The active ingredient in Circadin prolonged release tablets is
melatonin. Circadin
prolonged
release
tablets
also
contain
the
excipients:
Ammonio
methacrylate
copolymer, calcium hydrogen phosphate, lactose, colloidal anhydrous
silica, purified
talc and magnesium stearate. Melatonin is very slightly soluble in
water and in dilute
hydrochloric acid.
_PHARMACOLOGY _
Pharmacotherapeutic group: Melatonin Receptor Agonists, ATC code:
N05CH01
PHARMACOLOGICAL ACTIONS:
Melatonin is a naturally occurring hormone produced by the pineal
gland and is
structurally related to serotonin. Physiologically, melatonin
secretion increases soon
after the onset of darkness, peaks at 2-4 am and diminishes during the
second half of
the night. Melatonin is associated with the control of circadian
rhythms and
2/12
entrainment to the light-dark cycle. It is also associated with a
hypnotic effect and
increased propensity for sleep.
_Mechanism of action _
The activity of melatonin at the MT1 MT2 and MT3 receptors is believed
to contribute to its
sleep-promoting properties, as these receptors (mainly MT1 and MT2)
are involved in the
regulation of circadian rhythms and sleep regulation.
_Rationale for use _
Because of the role of melatonin in sleep and circadian rhythm
regulation, and the age
related decrease in endogenous melatonin production, melatonin may
effectively
improve sleep quality particularly in patients who are over 55 with
primary insomnia.
PHARMACOKINETICS:
_Absorption _
The absorption of orally ingested melatonin is complete in adults and
may be decreased by up
to 50% in the elderly. The kinetics of melatonin are linear over the
range of 2-8 mg.
Bioavailability is in the