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Chloral Hydrate 500mg/10mL

Consumer Medicine Information

What is in this leaflet?                   Chloral hydrate belongs to a group of    Before you take Chloral
                                           medicines called sedatives and           Hydrate Mixture
Please read this leaflet carefully         hypnotics. It is used short term to
before you take Chloral Hydrate            treat insomnia, a condition where
Mixture.                                   people have difficulty sleeping. In      Do not take if:
                                           patients with insomnia, Chloral
This leaflet answers some common                                                    You must not take Chloral
                                           Hydrate Mixture decreases the time it
questions about Chloral Hydrate                                                     Hydrate Mixture if you have an
                                           takes to fall asleep and increases the
Mixture. It does not contain all the                                                allergy to:
                                           length of time spent sleeping. Chloral
available information.                                                              • Chloral hydrate
                                           Hydrate Mixture is also used to calm
It does not take the place of talking to   patients down and make them sleepy       • Any of the ingredients listed at
your doctor or pharmacist.                 before surgery. If your child is to be     the end of this leaflet (See
All medicines have risks and               given chloral hydrate before a dental      "Ingredients")
benefits. Your doctor has weighed          or medical procedure, it should only     You must not take Chloral
the risks of you taking Chloral            be given at the health care facility     Hydrate Mixture if you have had
Hydrate Mixture against the benefits       where the procedure is to be done.       any of the following medical
they expect it will have for you.          This will allow the healthcare           conditions:
                                           professional to monitor your child.
If you have any concerns about                                                      • severe liver disease
taking this medicine, ask your             Chloral Hydrate mixture remains          • severe kidney disease
doctor or pharmacist.                      active in the body for many hours        • severe heart disease
                                           and may cause drowsiness the next
Keep this leaflet with the medicine.                                                • gastritis (inflammation of the
You may need to read it again.                                                        stomach)
                                           Your doctor may have prescribed          • oesophagitis (inflammation of the
                                           Chloral Hydrate Mixture for another        oesophagus)
                                           use. Ask your doctor if you have
                                                                                    • stomach ulcers
                                           any questions about why Chloral
What is Chloral Hydrate                                                             • inherited blood diseases known as
                                           Hydrate Mixture has been
Mixture used for?                          prescribed for you.
                                                                                    Do not give this medication to
The brand name of your medicine is         In general, sedatives and hypnotics
                                                                                    children unless advised by the
Chloral Hydrate Mixture. The active        such as Chloral Hydrate Mixture          child's doctor.
ingredient in Chloral Hydrate              should be taken for short periods
                                           only ( no more than 2 weeks).            Do not give Chloral Hydrate
Mixture is called chloral hydrate.
                                           Continuous long term use is not          Mixture to children who
                                           recommended unless advised by your       experience sleep apnoea, a
                                                                                    condition which leads to temporary
                                           doctor. The use of Chloral Hydrate
                                                                                    stops in breathing during sleep.
                                           Mixture may lead to dependence on
                                           the medicine.                            Do not take Chloral Hydrate
                                                                                    Mixture after the expiry date
                                           This medicine is only available with
                                                                                    (EXP) printed on the bottle.
                                           a doctor's prescription.

CHLORAL HYDRATE MIXTURE                                              Published by MIMS/myDr August 2004                1
Do not take Chloral Hydrate             Taking other medicines:                  Read the directions label of your
Mixture if the bottle is damaged or                                              Chloral Hydrate Mixture carefully.
shows signs of tampering. Do not        Tell your doctor of pharmacist if        If you have any concerns about
take Chloral Hydrate Mixture            you are taking any other                 how to take Chloral Hydrate
which has not been properly             medicines, including medicines you       Mixture, talk to your doctor or
stored.                                 buy without a prescription from          pharmacist.
If the bottle of Chloral Hydrate        your pharmacy, supermarket or
Mixture has expired or is damaged,      health food shop.
                                                                                 How much to take:
return it to your pharmacist for        In particular, tell your doctor if you
disposal.                               are taking any of the following:         The usual adult dose is 10 -20mL
                                        • Any medicines used to prevent          taken 15 - 30 minutes before
If you are not sure whether you
                                          clotting of the blood (e.g.            bedtime.
should start taking Chloral
Hydrate Mixture, talk to your             Coumadin®, Marevan®)                   You should not take more than
doctor or pharmacist.                   • Benzodiazepines and other              40mL a day.
                                          medicines used to treat anxiety or     If you have kidney or liver disease,
Tell your doctor if:                      to help you sleep                      or are elderly, your doctor may start
                                        • Strong pain killers e.g. morphine      you on a lower dose to prevent
You must tell your doctor if:                                                    untoward side effects.
                                        • Medicines used to control
• you have had an allergic reaction       depression or mood swings              Your doctor or pharmacist will tell
  to any other medicines, foods,        • Antipsychotic medicines, used to       you how much Chloral Hydrate
  dyes or preservatives                   treat mental illnesses                 Mixture you will need to take each
• you have a history of or have a       • Medicines used to treat hay fever,     day.
  current drug or alcohol addiction       coughs and colds                       Smaller doses are used in children. If
• you are pregnant or intend to         • Alcohol                                Chloral Hydrate Mixture has been
  become pregnant.
                                        • Frusemide, a medicine to treat         prescribed for a child, your doctor or
   Your doctor will discuss with you      high blood pressure and other          pharmacist will tell you what the
   the possible risks and benefits of     heart conditions                       dose for your child is. It is important
   using Chloral Hydrate Mixture                                                 that you give your child the correct
                                        Some medicines may affect the way
   during pregnancy.                                                             dose.
                                        other medicines work. They may
• you are breast feeding, or wish to    also react with Chloral Hydrate
  breastfeed.                           Mixture resulting in untoward or         How to take it:
   This medicine may pass into the      sometimes dangerous side effects.
                                        Your doctor or pharmacist will be        Shake the bottle well and
   breast milk and there is a                                                    accurately measure the dose with a
                                        able to tell you which medicines
   possibility that your baby may be                                             medicine measure.
                                        are safe to take with Chloral
   affected. Your doctor will discuss   Hydrate Mixture.                         Shaking the bottle and using a
   with you the possible risks and                                               medicine measure will make sure
                                        This list is not exhaustive. Your
   benefits of using Chloral Hydrate    doctor or pharmacist has more            that you get the correct dose. You
   Mixture during breastfeeding.                                                 can buy a medicine measure from
                                        information on medicines to be
• you have any other medical            careful with or to avoid while taking    your pharmacist.
  conditions, especially the            Chloral Hydrate Mixture.                 Mix the dose with water, ginger
                                        In future, before you start to take      ale, or fruit juice before you take
   - kidney problems                    any other medicines, tell your           it. Mixing with a drink can help
   - liver diseases                     doctor or pharmacist that you are        reduce the risk of stomach upset.
   - stomach ulcers                     taking Chloral Hydrate Mixture.
   - breathing difficulties (e.g.
   - sleep apnoea in children, a
   condition which leads to             How do I take Chloral
   temporary stops in breathing
                                        Hydrate Mixture?
   during sleep
• you drink alcohol.                    Follow your doctor's instructions
   Alcohol may increase the effects     about how to take Chloral Hydrate
   of Chloral Hydrate Mixture.          Mixture.

CHLORAL HYDRATE MIXTURE                                            Published by MIMS/myDr August 2004                2
How long to take it for:              What do I do if I take                  Visit your doctor regularly.
                                      too much? (Overdose)                    Your doctor needs to check your
Do not take Chloral Hydrate                                                   progress and see whether you need to
Mixture for longer then your
                                      Immediately telephone your doctor       keep taking Chloral Hydrate Mixture.
doctor says.
Usually, Chloral Hydrate Mixture      or the Poisons Information Centre
                                      (telephone 13 11 26) for advice, or     Things you must not do:
should be taken for short periods
                                      go to Accident and Emergency at
only (no more than 2 weeks).                                                  Do not take Chloral Hydrate
                                      your nearest hospital, if you think
Continuous long-term use is not       that you or anyone else may have        Mixture for a longer time than
recommended unless advised by your    taken too much Chloral Hydrate          your doctor has prescribed.
doctor. The use of Chloral Hydrate    Mixture. Do this, even if there are     Chloral Hydrate Mixture should only
Mixture may lead to dependence on     no signs of discomfort or               be taken for short periods (no more
the medicine within two weeks of      poisoning. You may need urgent          than 2 weeks) unless otherwise
use. If you are concerned that you    medical attention.                      advised by your doctor.
may be dependent talk to your         If you are not sure what to do,
doctor.                               contact your doctor or pharmacist.      Do not suddenly stop taking
                                                                              Chloral Hydrate Mixture or lower
Continue to take Chloral Hydrate      Keep telephone numbers for these        the dose without first checking
Mixture until your doctor tells you   places handy.                           with your doctor.
to stop.                                                                      Stopping this medicine suddenly may
                                      Signs of overdose include feeling
                                      dizzy or feeling faint, drowsiness,     cause some unwanted side effects.
If you forget to take it:             confusion, breathing difficulties,      Your doctor will explain how you
                                      irregular heart beats and coma.         should slowly reduce your dose of
If it is almost time for your next                                            Chloral Hydrate Mixture before you
dose, skip the dose you missed and                                            can stop taking it completely.
take your next dose when you are
meant to.                                                                     Do not let yourself run out of

Otherwise, take it as soon as you
                                      While you are taking                    medicine over the weekend or on
                                      Chloral Hydrate Mixture                 holidays.
remember, and then go back to
taking your medicine as you would                                             Do not give this medicine to anyone
normally.                                                                     else, even if his or her symptoms
                                      Things you must do:                     seem similar to yours.
Do not try and make up for the
dose that you missed by taking        Tell your doctor if, for any reason,    Do not use Chloral Hydrate
more than one dose at a time. This    you have not taken your medicine        Mixture to treat any other
may increase the chance of you        exactly as directed.                    complaints unless your doctor says
getting an unwanted side effect.      Otherwise, your doctor may think        to.
If you are not sure what to do, ask   that it was not working as it should
your doctor or pharmacist.            and change your treatment               Things to be careful of:
If you have trouble remembering                                               Be careful driving or operating
to take you medicine, ask your        Tell your doctor if you feel the        machinery until you know how
pharmacist for some hints.            mixture is not helping your             Chloral Hydrate Mixture affects
                                      condition.                              you.
                                      Tell your doctor immediately if         As with other sedatives and hypnotic
                                      you become pregnant while taking        medicines, Chloral Hydrate Mixture
                                      Chloral Hydrate Mixture.                may cause drowsiness in some
                                                                              people. Make sure you know how
                                      Tell any other doctors, dentists,
                                                                              you react to Chloral Hydrate Mixture
                                      and pharmacists who are treating
                                      you that you are taking Chloral         before you drive a car, operate
                                      Hydrate Mixture.                        machinery, or do anything else that
                                      If you are about to be started on any   could be dangerous.
                                      new medicines, remind you doctor,
                                      dentist or pharmacist that you are
                                      taking Chloral Hydrate Mixture.

CHLORAL HYDRATE MIXTURE                                          Published by MIMS/myDr August 2004            3
Be careful when drinking alcohol        • excitement                             Disposal:
while taking Chloral Hydrate            • confusion, lack of concentration
Mixture.                                                                         If your doctor tells you to stop taking
                                        • hallucinations or delusions            Chloral Hydrate Mixture, ask you
Combining Chloral Hydrate Mixture
                                        • paranoid behaviour                     pharmacist what to do with any
and alcohol can make you more
sleepy, dizzy or lightheaded. Your      These may be serious side effects.       mixture that is left over.
doctor may suggest that you avoid       You may need urgent medical
alcohol or reduce the amount of         attention. Serious side effects are
alcohol you drink while you are         rare.
taking Chloral Hydrate Mixture.         Your doctor or pharmacist will have      Product Description
                                        more information. Your doctor or
                                        pharmacist should discuss the
                                        possible side effects of Chloral
                                                                                 What it looks like:
What are the side                       Hydrate Mixture with you.                Chloral Hydrate Mixture
effects?                                This is not a complete list of all       500mg/10mL is a turbid, pale pink
                                        possible side effects. Others may        syrupy liquid. It comes in 500mL
Tell your doctor or pharmacist as       occur in some people and there may       bottles.
soon as possible if you do not feel     be some side effects not yet known.
well while you are taking Chloral
                                        Do not be alarmed by this list of
Hydrate Mixture, even if the
problem is not listed below.            possible side effects. You may not       Active Ingredient:
Like other medicines, Chloral           experience any of them.
Hydrate Mixture can sometimes                                                    Chloral Hydrate 50mg per mL
cause unwanted side effects.                                                     Inactive Ingredients:
Sometimes they are serious, most of
                                                                                 • Sucrose
the time they are not. You may need     How do I store Chloral                   • Citric acid - anhydrous
medical treatment if you get some of    Hydrate Mixture?                         • Saccharin sodium
the side effects. If you get any
unwanted side effects, tell your                                                 • Glycerol
doctor or pharmacist.                   Storage:                                 • Methyl hydroxybenzoate
Tell your doctor if you notice any                                               • Ethanol
                                        Chloral Hydrate Mixture should
of the following that are               be stored in a safe place where          • Propylene glycol
troublesome or ongoing, and they        children cannot reach it                 • Anise Oil
worry you:
                                        A locked cupboard at least 1½ meters     • Imitation Raspberry Flavour
• nausea, vomiting                      above the ground is a good place to        DC11104
• diarrhoea, flatulence                 store medicines.                         • Water - purified
• unpleasant taste in the mouth         Keep you Chloral Hydrate Mixture
• drowsiness, tiredness (sometimes      in its bottle until it is time to take
  lasting the next morning)             it.
• dizziness, lightheadedness            Chloral Hydrate Mixture should be        What other information
• unsteadiness                          stored below 25°C and kept away          should I know?
• headache, hangover feeling            from light.
                                                                                 If you have diabetes and use urine
• unpleasant dreams                     Do not leave Chloral Hydrate             test strips to test your sugar levels,
• sweet smelling urine                  Mixture in the car or on                 speak to your doctor or pharmacist
                                        windowsills. Do not store                about which test strips to use.
Tell your doctor immediately or go
                                        medicines in the bathroom or near        Chloral Hydrate Mixture may
to Accident and Emergency at
                                        a sink.                                  interfere with urine test strips which
your nearest hospital if you notice
any of the following:                   Heat and dampness can destroy some       use copper sulphate. This may lead to
                                        medicines.                               false results with some urine test
• sudden signs of allergy such as a
  rash, itching or hives on the skin;                                            strips.
  swelling of the face, lips, tongue
  or other parts of the body;
  wheezing or troubled breathing
• breathing difficulty

CHLORAL HYDRATE MIXTURE                                            Published by MIMS/myDr August 2004               4
Speak to your doctor or
pharmacist if you are not sure
which test to use.

Where to go to for
further information
Pharmaceutical companies are not in
a position to give people an
individual diagnosis or medical
advice. Your doctor or pharmacist is
the best person to give you advice on
the treatment of your condition.

Chloral Hydrate Mixture is supplied
in Australia by:
ORION Laboratories Pty Ltd
85 Briggs St
Welshpool WA 6106
Australian Registration Number:
AUST R 42849
This leaflet was prepared in
September 2003

CHLORAL HYDRATE MIXTURE                 Published by MIMS/myDr August 2004   5

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