MELOTIN Prolonged Release Tablet
Melatonin
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains answers to
some common questions about
MELATONIN.
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
MELATONIN.
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
MELATONIN 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 MELATONIN IS USED FOR
MELATONIN 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
MELATONIN, 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 MELATONIN 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. MELATONIN is not addictive.
BEFORE YOU USE MELATONIN
When you must not use it
Do not take MELATONIN 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 MELATONIN 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 MELATONIN if you are
pregnant or breast-feeding.
MELATONIN has not been studied
in
pregnant or breast-feeding
women.
Do not take it after the expiry
date printed on the pack.
If you take it after the expiry date
has passed, it may not work as
well. The expiry date refers to the
last day of the month.
Do not take it if the packaging
is torn or shows signs of
tampering.
If you are not sure whether you
should start taking MELATONIN talk to your doctor.
Before you start to use it
Tell your doctor if:
1.
you have any allergies to any
other medicines or any other
substances, such as foods,
preservatives or dyes.
2.
you are pregnant or plan to
become pregnant
3.
you are breast-feeding or
planning to breast-feed
4.
you have, or have had the
following medical conditions:
•
suffer from liver
problems
•
suffer from kidney
problems
•
If you suffer from an
autoimmune disease
•
have a rare hereditary
problem of galactose
intolerance, the LAPP
lactase deficiency
or
glucose-galactose
malabsorption
Do not give MELATONIN to a child
or adolescent. There is no
experience with its use in children
or
adolescents under 18 years
old.
If you have not told your doctor
about any of the above, so
before you use MELATONIN.
Taking other medicines
Tell your doctor if you are taking
any other medicines, including
any that you buy without a
prescription from your pharmacy,
supermarket or health food shop.
Some medicines may affect
the
way other medicines work.
Some medicines and MELATONIN
may interfere with each other.
These include:
•
hypnotics and tranquilisers
(e.g. benzodiazepine),
•
fluvoxamine, thioridazine
and imipramine (used to
treat depression or
psychiatric problems),
•
oestrogen (contraceptives or
hormone replacement
therapy),
•
cimetidine and psoralens
(used to treat skin problems
e.g. psoriasis)
•
alcohol
•
caffeine
The effect of adding MELATONIN
to other medicines used to treat
insomnia has not been
examined. It is not known if
MELATONIN will increase or
decrease the effects of other
treatments
for insomnia.
Your doctor or pharmacist has
more information on medicines to
be careful with or avoid while
taking
MELATONIN.
HOW TO TAKE MELATONIN
How much to take
Take MELATONIN only when
prescribed by your doctor.
The standard dose of MELATONIN
is one tablet once a day.
There is no evidence that taking more than the recommended dose will increase the effect of
MELATONIN.
How to take it
Swallow your tablet whole with a
full glass of water.
Do not crush, chew or divide
your tablet.
Each MELATONIN tablet has been specially designed to release the right dose of medicine while you
sleep. If you crush, chew or divide the tablet they will not work properly
Follow all directions given to
you by your doctor carefully.
They may differ from the
information contained in this
leaflet.
If you do not understand the
instructions on the box, ask
your doctor or pharmacist for
help.
When to take it
After food, 1-2 hours before you
go to bed.
How long to take it
It is important that you continue taking MELATONIN for as long as your doctor prescribes.
MELATONIN may be continued for up to thirteen weeks.
If you forget to use it
If you forget to take your tablet,
take another as soon as you
remember, before going to bed or
wait
until it is time for your next
dose.
Do not take a double dose to
make up for a forgotten dose.
If you are not sure what to do,
talk to your doctor or
pharmacist.
If you have trouble remembering
to take your MELATONIN, ask your
pharmacist for some hints.
If you use too much (overdose)
Immediately
telephone your doctor or Poisons Information Centre (In Australia 13 11 26 and in New
Zealand 0800 POISON [0800 764 766]), or go to your nearest accident and emergency centre, if you
think that you or anyone else may have taken too much MELATONIN. Do this even if there are no
signs of discomfort or poisoning.
WHILE YOU ARE USING MELATONIN
If you are about to be started on
any new medicine tell your doctor and pharmacist that you are
taking MELATONIN.
Tell any other doctors, dentists
and pharmacists who treat you
that you are taking this medicine.
If you become pregnant while
taking MELATONIN, stop taking the
tablets and tell your doctor
immediately.
Things you must not do
Do not give MELATONIN to
anyone else, even if they have
the same condition as you.
Do not take more than the
recommended dose unless
your doctor tells you to.
Do not use this medicine to
treat any other complaints
unless your doctor tells you to.
Do not drink alcohol before or
after taking this medicine
Thing to be careful of
MELATONIN rarely causes
drowsiness, nevertheless it is not
recommended to drive or operate
machinery for 8 hours after you
take it. Melatonin does not impair
morning alertness, but if you
suffer from drowsiness during the
day you should consult your
doctor.
SIDE EFFECTS
Tell your doctor or pharmacist
as soon as possible if you do
not feel well while you are
taking
MELATONIN.
MELATONIN has been shown to
improve the sleep of most people
aged over 55 years, but it may
have unwanted side effects in a
few people. All medicines can have side effects. Sometimes they are
serious, but most of the time they are not. You may need medical treatment if you get some of the
side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you.
These are considered to be
uncommon side effects (i.e.,
likely to occur in fewer than 1 in
100
patients):
Irritability, nervousness,
restlessness insomnia, abnormal
dreams, anxiety, nightmares,
migraine,
lethargy, psychomotor
hyperactivity (restlessness
associated with increased
activity), dizziness,
somnolence
(tiredness), headache, high blood
pressure, (upper) abdominal
pain, indigestion,
mouth
ulceration, dry mouth, nausea,
hyperbilirubinaemia (changes in
the composition of your
blood
which could cause yellowing of
the skin or eyes (jaundice),
inflammation of the skin
(dermatitis), night sweats, pruritis
(itching), rash, dry skin, pain in
extremities, menopausal
symptoms, asthenia (feeling of
weakness), chest pain, excretion
of glucose in urine, excess
proteins
in the urine, abnormal
liver function and weight
increase.
The following events are
considered to be rare (i.e., likely
to occur in fewer than 1 in 1,000
patients):
Shingles, reduced number of
white blood cells in the blood,
decreased number of platelets in
the
blood, high level of fatty
molecules in the blood, severe
chest pain due to angina, feeling
your
heartbeat (palpitations). low
serum calcium levels in the blood,
low sodium levels in the blood,
altered mood, aggression,
agitation, crying, stress
symptoms, disorientation, early
morning
awakening, increased
sex drive, depressed mood,
depression, loss of
consciousness or fainting,
memory impairment, disturbance
in attention, dreamy state,
restless legs syndrome, poor quality
sleep, ‘pins and needles’
feeling (paresthesia) reduced
visual acuity (visual impairment),
blurred
vision, watery eyes,
dizziness when standing or sitting,
vertigo, hot flushes, gastro-
oesophageal
reflux,
gastrointestinal disorder, blistering
in the mouth, tongue ulceration,
gastrointestinal upset,
vomiting,
abnormal bowel sounds,
flatulence (wind), salivary
hypersecretion (excess saliva
production), halitosis (bad breath),
abdominal discomfort, gastric
disorder, inflammation of the
stomach lining, eczema, erythema
(skin rash), hand dermatitis,
psoriasis, pruritic rash (itchy rash),
nail disorder, arthritis, muscle
spasms, neck pain, night cramps,
increased duration of erection,
inflammation of the prostate
gland, tiredness, pain, thirst,
passing large volumes or urine,
presence
of red blood cells in the
urine, urination during the night,
increased liver enzymes,
abnormal blood
electrolytes and
abnormal laboratory tests.
Other side effects not listed above
may also occur in some patients.
Tell your doctor if you notice
any
other effects.
Do not be alarmed by this list of
possible side effects. You may not
experience any of them
AFTER USING MELATONIN
Storage
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack they may not keep well.
Keep MELATONIN away from sunlight.
Keep the medicine in a cool dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.
Do not leave it in the car.
Heat and damp can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one- and-a-half metres above the ground is a good place to store
medicines.
Disposal
If your doctor tells you to stop taking the tablets or the tablets have passed their expiry date, ask
your pharmacist what to do with any that are left over.
Return any unused medicine to your pharmacist.
PRODUCT DESCRIPTION
What it looks like
MELOTIN 2 mg tablets are white
to off-white round bi-convex
shaped tablets
MELOTIN tablets are available
in pack sizes* of 7, 15, 21, 30, 42, 60, 90 tablets.
Ingredients
Active ingredient
Each MELATONIN 2 mg tablet
contains 2 mg melatonin as the
active ingredient
Inactive ingredients:
•
Ammonio methacrylate
copolymer type B,
•
calcium hydrogen
phosphate,
•
lactose monohydrate,
•
colloidal anhydrous silica,
•
purified talc
•
magnesium stearate.
*Some of these pack sizes are not marketed
SPONSOR
Arrotex Pharmaceuticals (NZ) Limited
C/o Quigg Partners
Level 7, The Bayleys Building
36 Brandon Street
Wellington 6011, New Zealand
This leaflet was prepared in:
November 2021
