Vigisom

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Melatonin 2mg;  ;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dosage:

2 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Melatonin 2mg     Excipient: Ammonio methacrylate copolymer Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Purified talc

Prescription type:

Prescription

Therapeutic indications:

Monotherapy for the short term treatment (up to 13 weeks) of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 7 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 21 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2020-09-08

Patient Information leaflet

Consumer Medicine Information
_VIGISOM_
_®_
_ PROLONGED RELEASE TABLET _
_Melatonin_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
VIGISOM.
IT IS PARTICULARLY IMPORTANT THAT
YOU READ THE SECTIONS "WHEN TO
TAKE IT" AND "HOW TO TAKE IT"
BEFORE YOU TAKE THIS MEDICINE.
The leaflet does not contain all
the
information
that
is
known
about VIGISOM.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
VIGISOM
against
the
benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT VIGISOM IS USED FOR
VIGISOM
is
used
to
improve
sleep
quality
and
morning
alertness
in
patients
over
55
years of age with poor quality of
sleep.
_ _
The
active
substance
of
VIGISOM, melatonin (not of plant
or animal origin), belongs to a
group
of
naturally
occurring
hormones produced in the body.
Melatonin
works
by
controlling
the
circadian
rhythms
and
increasing
the
propensity
to
sleep.
Your
doctor,
however,
may
prescribe VIGISOM for another
purpose.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY QUESTIONS ABOUT
WHY IT HAS BEEN PRESCRIBED FOR
YOU.
This medicine is only available
with a doctor’s prescription
.
VIGISOM is not addictive.
BEFORE YOU TAKE VIGISOM
_WHEN YOU MUST NOT TAKE IT_
Do not take VIGISOM if you are
allergic
to
it
or
any
of
the
ingredients listed at the end of this
leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue
or other parts of the body, or rash,
itching or hives on the skin.
Do not take VIGISOM if you have
been drinking alcohol or intend to
drink alcohol or believe that you
may have alcohol, in your blood
stream.
Do not take VIGISOM if you are
pregnant
or
breast-feeding.
VIGISOM has not been studied in
pregnant
or
brea

Summary of Product characteristics

New Zealand Data sheet
Page 1 of 14
1
VIGISOM
®
Melatonin 2 mg Prolonged Release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in VIGISOM prolonged release tablets is a
melatonin NOT of
plant or animal origin.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
VIGISOM 2 mg prolonged release tablets: White to off-white, round,
biconvex tablets
in blister packs of 21 and 30.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Monotherapy for the short term treatment of primary insomnia
characterized by poor
quality of sleep in patients who are aged 55 or over.
4.2
DOSE AND METHOD OF ADMINISTRATION
Oral use. Tablets should be swallowed whole.
The recommended dose is 2 mg once daily, 1 - 2 hours before bedtime
and after food.
This dosage may be continued for up to thirteen weeks.
_PAEDIATRIC USE _
VIGISOM is not recommended for use in children and adolescents below
18 years of
age due to insufficient data on safety and efficacy.
_RENAL INSUFFICIENCY _
The effect of any stage of renal insufficiency on melatonin
pharmacokinetics has not
been studied. Caution should be used when melatonin is administered to
such
patients.
_HEPATIC IMPAIRMENT _
There is no experience of the use of VIGISOM in patients with liver
impairment.
Published data demonstrates markedly elevated endogenous melatonin
levels during
daytime hours due to decreased clearance in patients with hepatic
impairment.
Therefore, VIGISOM is not recommended for use in patients with hepatic
impairment.
New Zealand Data sheet
Page 2 of 14
4.3
CONTRAINDICATIONS
VIGISOM prolonged release tablets are contraindicated in patients with
a known
hypersensitivity to any ingredient of the product (see section 2
QUALITATIVE AND
QUANTITATIVE COMPOSITION and section 6.1 List of excipients).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_DROWSINESS _
VIGISOM may cause drowsiness. Therefore the product should be used
with caution
if the effects of drowsiness are li