Circadin

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Melatonin 2mg;  ;  

Disponible des:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Designació comuna internacional (DCI):

Melatonin 2 mg

Dosis:

2 mg

formulario farmacéutico:

Modified release tablet

Composición:

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

Unidades en paquete:

Blister pack, PVC/PVdC/Al, 7 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Carbogen Amcis AG

indicaciones terapéuticas:

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.

Resumen del producto:

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 - Blister pack, PVC/PVdC/Al - 42 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Data d'autorització:

2009-12-17

Informació per a l'usuari

Consumer Medicine Information
_CIRCADIN_
_®_
_ PROLONGED RELEASE TABLET _
_Melatonin_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
CIRCADIN.
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 CIRCADIN.
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
CIRCADIN 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 CIRCADIN IS USED
FOR
CIRCADIN
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
CIRCADIN,
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 CIRCADIN 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
.
CIRCADIN is not addictive.
BEFORE YOU TAKE
CIRCADIN
_WHEN YOU MUST NOT TAKE IT_
Do not take CIRCADIN 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
CIRCADIN
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 CIRCADIN if you are
pregnant
or
breast-feeding.
CIRCADIN has not been studied
in
pr

Fitxa tècnica

New Zealand Data sheet
Page 1 of 14
1
CIRCADIN
®
Melatonin 2 mg Prolonged Release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in CIRCADIN 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
CIRCADIN 2 mg prolonged release tablets: White to off-white, round,
biconvex tablets.
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 _
CIRCADIN 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 CIRCADIN 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, CIRCADIN is not recommended for use in patients with
hepatic impairment.
New Zealand Data sheet
Page 2 of 14
4.3
CONTRAINDICATIONS
CIRCADIN 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 _
CIRCADIN may cause drowsiness. Therefore the product should be used
with caution
if the effects of drowsiness are likely to be associated