DOWNLOAD CMI DOCUMENT - CIRCADIN Prolonged Release Tablet

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					CIRCADIN® Prolonged Release Tablet
Melatonin
Consumer Medicine Information (CMI)


What is in this leaflet                    purpose.                               talk to your doctor.
                                           Ask your doctor or pharmacist
                                                                                  Before you start to take it
This leaflet contains answers to           if you have any questions
some common questions about                about why it has been                  Tell your doctor if:
CIRCADIN.                                  prescribed for you.                    1. you have any allergies to
It is particularly important that                                                      any other medicines or any
                                           This medicine is only available             other substances, such as
you read the sections "When
to take it" and "How to take it"           with a doctor’s prescription.               foods, preservatives or dyes.
before you take this medicine.                                                    2. you are pregnant or plan to
The leaflet does not contain all           Circadin is not addictive.                  become pregnant
the information that is known                                                     3. you are breast-feeding or
about Circadin.                            Before           you          take          planning to breast-feeding
It does not take the place of              CIRCADIN                               4. you have, or have had the
talking to your doctor or                  When you must not take it                   following medical conditions:
pharmacist.
                                           Do not take CIRCADIN if you are            •   suffer from liver
All medicines have risks and               allergic to it or any of the                   problems
benefits. Your doctor has                  ingredients listed at the end of           •   Suffer from kidney
weighed the risks of you taking            this leaflet.                                  problems
CIRCADIN against the benefits
                                           Symptoms of an allergic reaction           •   If you suffer from an
they expect it will have for you.
                                           may include shortness of breath,               autoimmune disease
If you have any concerns
                                           wheezing or difficulty breathing,          •   have a rare hereditary
about taking this medicine,
                                           swelling of the face, lips, tongue             problems of galactose
ask your doctor or pharmacist.
                                           or other parts of the body, or                 intolerance, the LAPP
Keep this     leaflet   with   the         rash, itching or hives on the skin.            lactase deficiency or
medicine.                                                                                 glucose-galactose
                                           Do not take CIRCADIN if you
                                                                                          malabsorption
You may need to read it again.             have been drinking alcohol or
                                           intend to drink alcohol or believe     Do not give CIRCADIN to a child
What CIRCADIN is used                      that you may have alcohol, in          or adolescent. There is no
for                                        your blood stream.                     experience with its use in
                                                                                  children or adolescents under 18
CIRCADIN is used to       improve          Do not take CIRCADIN if you are
                                                                                  years old.
sleep quality and         morning          pregnant    or  breast-feeding.
alertness in patients    over 55           CIRCADIN has not been studied          If you have not told your
years of age with poor   quality of        in pregnant or breast-feeding          doctor about any of the above,
sleep.                                     women.                                 tell him before you use
                                                                                  CIRCADIN.
                                           Do not take it after the expiry
The     active  substance       of         date printed on the pack.              Taking other medicines
CIRCADIN, melatonin (not of
plant or animal origin), belongs           If you take it after the expiry date   Tell your doctor if you are taking
to a group of naturally occurring          has passed, it may not work as         any other medicines, including
hormones produced in the body.             well. The expiry date refers to        any that you buy without a
                                           the last day of the month.             prescription from your pharmacy,
Melatonin works by controlling                                                    supermarket or health food shop.
the circadian rhythms and                  Do not take it if the packaging
                                                                                  Some medicines may affect the
increasing the propensity to               is torn or shows signs of
                                                                                  way other medicines work.
sleep.                                     tampering.
                                                                                  Some medicines and CIRCADIN
Your doctor, however, may                  If you are not sure whether you
                                                                                  may interfere with each other.
prescribe CIRCADIN for another             should start taking CIRCADIN
                                                                                  These include:

Consumer Medicine Information_eBS_040111
•   hypnotics and tranquilisers            They may differ from the              and pharmacist that you are
    (e.g. benzodiazepines),                information contained in this         taking CIRCADIN.
•   fluvoxamine, thioridazine              leaflet.
                                                                                 Tell any other doctors, dentists
    and imipramine (used to                If you do not understand the          and pharmacists who treat you
    treat depression or                    instructions on the box, ask          that you are taking this medicine.
    psychiatric problems),                 your doctor or pharmacist for
                                           help.                                 If you become pregnant while
•   oestrogen (contraceptives or                                                 taking CIRCADIN, stop taking
    hormone replacement                    When to take it                       the tablets and tell your doctor
    therapy),                                                                    immediately.
                                           After food, 1-2 hours before you
•   cimetidine and psoralens               go to bed.                            Things you must not do
    (used to treat skin problems
    e.g. psoriasis)                        How long to take it                   Do not give CIRCADIN to
•   Alcohol                                It is important that you continue     anyone else, even if they have
                                           taking CIRCADIN for as long as        the same condition as you.
• Caffeine
                                           your        doctor     prescribes.    Do not take more than the
The effect of adding CIRCADIN              CIRCADIN may be continued for
to other medicines used to treat                                                 recommended dose unless
                                           up to thirteen weeks.                 your doctor tells you to.
insomnia has not been
examined. It is not known if               If you forget to take it              Do not use this medicine to
CIRCADIN will increase or                                                        treat any other complaints
                                           If you forget to take your tablet,
decrease the effects of other                                                    unless your doctor tells you
                                           take another as soon as you
treatments for insomnia.                                                         to.
                                           remember, before going to bed or
Your doctor or pharmacist has              wait until it is time for your next   Do not drink alcohol before or
more information on medicines              dose.                                 after taking this medicine
to be careful with or avoid while
                                           Do not take a double dose to          Things to be careful of
taking CIRCADIN.
                                           make up for a forgotten dose.
                                                                                 CIRCADIN         rarely    causes
                                           If you are not sure what to do,       drowsiness, nevertheless it is
How to take CIRCADIN                       talk to     your doctor or            not recommended to drive or
                                           pharmacist.                           operate machinery for 8 hours
How much to take
                                           If you have trouble remembering       after you take it. Circadin does
Take CIRCADIN only when                                                          not impair morning alertness,
                                           to take your CIRCADIN, ask your
prescribed by your doctor.                                                       but if you suffer from drowsiness
                                           pharmacist for some hints.
The standard dose of CIRCADIN                                                    during the day you should
is one tablet once a day.                  If  you    take      too    much      consult your doctor.
There is no evidence that taking           (overdose)
more than the recommended                  Immediately telephone your
dose will increase the effect of           doctor or Poisons Information         Side Effects
CIRCADIN.                                  Centre (In Australia 13 11 26
                                           and in New Zealand 0800 764           Tell your doctor or pharmacist
                                           766), or go to accident and           as soon as possible if you do
How to take it                             emergency at your nearest             not feel well while you are
                                           hospital, if you think that you       taking CIRCADIN
Swallow your tablet whole with a
full glass of water.                       or anyone else may have taken         CIRCADIN has been shown to
                                           too much CIRCADIN. Do this            improve the sleep of most
Do not crush, chew or divide
                                           even if there are no signs of         people aged over 55 years, but it
your tablet.
                                           discomfort or poisoning.              may have unwanted side effects
Each CIRCADIN tablet has been
                                                                                 in a few people. All medicines
specially designed to release the
                                                                                 can      have   side    effects.
right dose of medicine while you
sleep. If you crush, chew or               While you          are     using      Sometimes they are serious, but
                                           CIRCADIN                              most of the time they are not.
divide the tablet they will not
                                                                                 You may need medical treatment
work properly
                                           Things you must do                    if you get some of the side
Follow all directions given to                                                   effects.
you by your doctor carefully.              If you are about to be started on
                                           any new medicine tell your doctor


Consumer Medicine Information_eBS_040111
Ask your doctor or pharmacist to           memory impairment, disturbance              Keep CIRCADIN away from
answer any questions you may               in attention, dreamy state,                 sunlight.
have.                                      restless legs syndrome,             poor
                                                                                       Keep the medicine in a cool
                                           quality sleep, ‘pins and needles’
Tell your doctor if you notice                                                         dry    place    where     the
                                           feeling       (paresthesia)reduced                                    °
any of the following and they                                                          temperature stays below 25 C.
                                           visual acuity (visual impairment),
worry you.                                                                             Do not store it or any other
                                           blurred      vision,watery         eyes,
These are considered to be                 dizziness when standing or                  medicine in the bathroom,
uncommon side effect (i.e., likely         sitting, vertigo, hot flushes,              near a sink, or on a window-
to occur in fewer than 1 in 100            gastro-oesophageal                reflux,   sill.
patients):                                 gastrointestinal               disorder,
                                                                                       Do not leave it in the car.
                                           blistering in the mouth, tongue
Irritability,           nervousness,       luceration, gastrointestinal upset,         Heat and damp can destroy
restlessness insomnia, abnormal            vomiting,       abnormal          bowel     some medicines.
dreams,        anxiety,      migraine,
                                           sounds, flatulence (wind), salivary         Keep it where children cannot
lethargy,                psychomotor
                                           hypersecretion (excess saliva               reach it.
hyperactivity           (restlessness
                                           production),         halitosis      (bad    A locked cupboard at least one-
associated         with     increased
                                           breath), abdominal discomfort,              and-a-half metres above the
activity), dizziness, somnolence           gastric disorder, inflammation of
(tiredness),high blood pressure,                                                       ground is a good place to store
                                           the stomach lining, , eczema,
(upper)         abdominal        pain,                                                 medicines.
                                           erythema (skin rash), hand
indigestion, mouth ulceration, dry
                                           dermatitis, psoriasis, pruritic rash        Disposal
mouth,           hyperbilirubinaemia
                                           (itchy     rash),     nail     disorder,
(changes in the composition of             arthritis, ,muscle spasms, , neck           If your doctor tells you to stop
your blood which could cause               pain, night cramps, increased               taking the tablets or the tablets
yellowing of the skin or eyes (                                                        have passed their expiry date,
                                           duration of erection,inflammation
jaundice), inflammation of the                                                         ask your pharmacist what to do
                                           of      the       prostate        gland,
skin (dermatitis, night sweats,                                                        with any that are left over.
                                           tiredness,pain, thirst, passing
pruritis (itching), rash, dry skin,
                                           large volumes or urine, presence            Return any unused medicine to
pain in extremities, menopausal            of red blood cells in the urine,
symptoms, asthenia (feeling of                                                         your pharmacist.
                                           urination     during       the     night,
weakness), chest pain, excretion
                                           increased         liver       enzymes,
of glucose in urine, excess
                                           abnormal blood electrolytes and
proteins in the urine, abnormal
                                           abnormal laboratory tests.
                                                                                       Product description
liver      function     and    weight
increase                                   Other side effects not listed               What CIRCADIN looks like
                                           above may also occur in some                CIRCADIN 2 mg tablets are
                                           patients. Tell your doctor if you           white to off-white round bi-
The     following   events      are
                                           notice any other effects.                   convex shaped tablets
considered to be rare (i.e., likely
to occur in fewer than 1 in 1,000          Do not be alarmed by this list of           CIRCADIN tablets are available
patients):                                 possible side effects. You may              in packs of 21 tablets.
                                           not experience any of them
Shingles, reduced number of                                                            Ingredients
                                           CIRCADIN is not addictive.
white blood cells in the blood,                                                        Active ingredient
decreased number of platelets in           After using CIRCADIN                        Each CIRCADIN 2 mg tablet
the blood, high level of fatty                                                         contains 2 mg melatonin as the
molecules in the blood, severe             Storage
                                                                                       active ingredient
chest pain due to angina, feeling          Keep your tablets in the blister
your heartbeat (palpitations). low         pack until it is time to take               Inactive ingredients:
serum calcium levels in the                them.                                       • Ammonio methacrylate
blood, low sodium levels in the            If you take the tablets out of the              copolymer type B,
blood, altered mood, aggression,           blister pack they may not keep              • calcium hydrogen
agitation,     crying,      stress                                                         phosphate,
                                           well.
symptoms, disorientation, early                                                        • lactose,
morning awakening, increased                                                           • colloidal anhydrous silica,
sex drive, depressed mood,                                                             • purified talc
depression,         loss         of                                                    • magnesium stearate.
consciousness       or    fainting,


Consumer Medicine Information_eBS_040111
Sponsor
RAD Data Australia Pty Ltd
Level 7, Suite 2
100 Walker St
North Sydney
NSW 2060


Distributed in Australia by:
Sigma Pharmaceuticals
(Australia) Pty Ltd
96 Merrindale Drive
Croydon VIC 3136
Tel: 1300 656 755


This leaflet was         prepared
December 2010
Australian Registration Number:
AUST R: 153959

CIRCADIN is a           registered
trademark       of         Neurim
Pharmaceuticals.




Consumer Medicine Information_eBS_040111

				
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