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					Core CMI for Paracetamol (text in italics is instructional for the CMI writer only)                   30 November 2005

[Medicine name]                                                  (If you want to include phonetic spelling, the Second
Edition of the Usability Guidelines suggests using the system outlined in the Webster’s International

Generic name

Consumer Medicine Information                       Date of Dispensing
This Core leaflet covers both prescription and non-prescription products containing paracetamol, and therefore
must be modified to suit the particular product being written about. Information in the CMI must be consistent
with the product’s Product Information (PI).

When writing about consumers seeking advice from health professionals, the schedule of the product should be
taken into consideration. Thus:
 S4 products should direct consumers to seek advice from their doctor or pharmacist, and
 S3 products should direct consumers to seek advice from their pharmacist or doctor.

                                                                                       the packaging is torn or shows signs
What is in this leaflet                      Ask your pharmacist or doctor if
                                                                                       of tampering.
                                             you have any questions about this
                                             medicine.                                 If it has expired or is damaged, return it
This leaflet answers some common
                                                                                       to your pharmacist for disposal.
questions about [Medicine name].             Your pharmacist or doctor may have
It does not contain all the available        given it for another reason.              If you are not sure whether you
information. It does not take the place                                                should start taking this medicine,
                                             Below are further statements that may
of talking to your pharmacist or doctor.                                               talk to your pharmacist or doctor (or
                                             be included in this section.
All medicines have risks and benefits.                                                 doctor or pharmacist).
                                             This medicine is not addictive.
Your pharmacist or doctor has weighed
the risks of you taking [Medicine            It is only available from your            Before you start to take it
name] against the benefits they expect       pharmacist.
it will have for you.                                                                  Tell your pharmacist or doctor if
                                             This medicine is only available on a
                                                                                       you have allergies to any other
If you have any concerns about               prescription from your doctor.
                                                                                       medicines, foods, preservatives or
taking this medicine, ask your                                                         dyes.
pharmacist or doctor.
                                                                                       Tell your pharmacist or doctor if
Keep this leaflet with the medicine.                                                   you have or have had any of the
You may need to read it again.               Before you take/give                      following medical conditions:
                                             [Medicine name]                            liver or kidney disease
                                                                                       Ask your pharmacist or doctor
                                                                                       about taking paracetamol if you are
What [Medicine name]                         When you must not take it                 pregnant or plan to become
                                                                                       pregnant, or breastfeeding.
is used for                                  Do not take [Medicine name] if you
                                                                                       Paracetamol may be used during
                                             have an allergy to:
                                                                                       pregnancy and if you are breastfeeding.
Paracetamol is used to (insert                any medicine containing
indication as specified in the ARTG, or         paracetamol                            If you have not told your pharmacist
for a non-validated grandfathered             any of the ingredients listed at the    or doctor about any of the above, tell
product, as specified on the product            end of this leaflet.                   him/her before you start taking
label).                                                                                [Medicine name].
                                             Some of the symptoms of an allergic
 List multiple indications in dot           reaction may include:
   points                                                                              Taking other medicines
                                              shortness of breath
Paracetamol works to stop the pain
                                              wheezing or difficulty breathing        Tell your pharmacist or doctor if
messages from getting through to the
brain. It also acts in the brain to reduce    swelling of the face, lips, tongue or   you are taking any other medicines,
fever.                                         other parts of the body                 including any that you get without a
                                              rash, itching or hives on the skin      prescription from your pharmacy,
                                                                                       supermarket or health food shop.
                                             Do not take this medicine/it after the
                                             expiry date printed on the pack or if

[Medicine name]                                                                                                  1
Core CMI for Paracetamol (text in italics is instructional for the CMI writer only)                 30 November 2005

Some medicines and paracetamol may         Children:                                  Things you must not do
interfere with each other. These           Only give paracetamol to children
include:                                   for up to 48 hours unless a doctor         Children:
 warfarin, a medicine used to             has told you to give it longer.            Do not give paracetamol for more
   prevent blood clots                                                                than 48 hours unless a doctor has
                                           If you forget to take it                   told you to.
 metoclopramide, a medicine used
   to control nausea and vomiting                                                     Adults:
                                           If it is less than ‘x’ hours before your
 medicines used to treat epilepsy or      next dose, skip the dose you missed
                                                                                      Do not take for more than a few days
   fits                                                                               at a time unless your doctor tells you
                                           and take your next dose when you
 chloramphenicol, an antibiotic used                                                 to.
                                           are meant to.
   to treat ear and eye infections                                                    Do not take more than the
                                           Otherwise, take it as soon as you
 alcohol                                                                             recommended dose unless your
                                           remember, and then go back to
Your doctor and pharmacist will have                                                  doctor tells you to.
                                           taking your medicine as you would
more information on these and other        normally.                                  Do not take [Medicine name] to treat
medicines to be careful with or avoid                                                 any other complaints unless your
while taking this medicine.                Do not take a double dose to make
                                                                                      pharmacist or doctor tells you to.
                                           up for the dose that you missed.
                                           This may increase the chance of you        Do not give your medicine to anyone
                                           getting an unwanted side effect.           else, even if they have the same
                                                                                      condition as you.
                                           If you are not sure what to do, ask
How to take [Medicine                      your pharmacist or doctor.
name]                                                                                 Things to be careful of
                                           If you have trouble remembering to
                                           take your medicine, ask your               Only drink small quantities of
Follow all directions given to you by      pharmacist for some hints.                 alcohol (beer, wine or spirits) while
your pharmacist or doctor carefully.
                                                                                      taking paracetamol.
They may differ from the information
                                           If you take too much                       Drinking large quantities of alcohol
contained in this leaflet.
                                                                                      while taking paracetamol may increase
If you do not understand the                                                          the risk of liver side effects.
instructions on the box/bottle, ask        Immediately telephone your doctor
your pharmacist or doctor for help.        or the Poisons Information Centre
                                           (telephone 13 11 26) for advice, or go
How much to take                           to Accident and Emergency at the
                                           nearest hospital, if you think that        Side effects
Include dosage ranges, usual doses for     you or anyone else may have taken
each indication or patient group etc .as   too much [Medicine name]. Do this          Tell your pharmacist or doctor as
specified on the product label.            even if there are no signs of              soon as possible if you do not feel
                                           discomfort or poisoning.                   well while you are taking [Medicine
Do not take more than the
                                           You may need urgent medical                name].
recommended dose.                                                                     This medicine helps most people with
                                                                                      (indication), but it may have unwanted
How to take it                                                                        side effects in a few people. All
Include specific instructions as                                                      medicines can have side effects.
specified on the product label.                                                       Sometimes they are serious, most of
                                           While you are using                        the time they are not. You may need
                                           [Medicine name]                            medical attention if you get some of
When to take it                                                                       the side effects.
Include specific instructions as                                                      Do not be alarmed by the following
specified on the product label.            Things you must do                         lists of side effects. You may not
                                           Talk to your pharmacist or doctor if       experience any of them.
How long to take it                        your symptoms do not improve.              Ask your pharmacist or doctor to
Include specific instructions as           Your pharmacist or doctor will assess      answer any questions you may have.
specified on the product label.            your condition and decide if you
                                                                                      Tell your pharmacist or doctor if
                                           should continue to take the medicine.
Adults:                                                                               you notice any of the following and
                                                                                      they worry you:
Only take paracetamol for a few
                                                                                       nausea or dyspepsia
days at a time unless your doctor
tells you to take it for longer.

[Medicine name]                                                                                               2
Core CMI for Paracetamol (text in italics is instructional for the CMI writer only)   30 November 2005

If any of the following happen, tell       Product description
your pharmacist or doctor
immediately or go to Accident and
Emergency at your nearest hospital:        What it looks like
 shortness of breath
 wheezing or difficulty breathing         Include identifying details as
                                           appropriate, such as dose form, colour
 swelling of the face, lips, tongue or    and markings of tablets, colour and
    other parts of the body                consistency of liquids, pack sizes, etc.
 rash, itching or hives on the skin
The above list includes very serious       Ingredients
side effects. You may need urgent
medical attention or hospitalisation.      [Medicine name] contains x mg of
These side effects are very rare for low   (generic name) as the active ingredient.
doses of this medicine and when used
                                           It also contains:
for a short period of time.
                                            list excipients in dot points
Tell your pharmacist or doctor if
                                           Where Australian Food Standard
you notice anything that is making
                                           codes exist, these could follow each
you feel unwell.
                                           Australian Approved name.
Other side effects not listed above may
also occur in some people.                 As appropriate, the CMI may include a
                                           negative list of ingredients. For
                                           example: This medicine does not
                                           contain lactose, sucrose, gluten,
                                           tartrazine or any other azo dyes.
After using [Medicine
name]                                      Manufacturer/Distributor/
                                           (use appropriate heading)
Keep your medicine in the original         [Medicine name] is
pack until it is time to take.             made/distributed/supplied in Australia
Keep your medicine in a cool dry           by:
place where the temperature stays          Include name and address of sponsor
below xC.
                                            = Registered Trademark or
Do not store [Medicine name] or any
                                            = Trademark (if appropriate)
other medicine in the bathroom or
near a sink. Do not leave it on a          This leaflet was prepared in
window sill or in the car.                 month/year.
Heat and dampness can destroy some         Include AUST R number(s)
                                           You may want to include a document
Keep it where children cannot reach        code and/or a reference to the
it.                                        approved PI.
A locked cupboard at least one-and-a-
half metres above the ground is a good
place to store medicines.

Ask your pharmacist what to do
with any medicine that is left over,
or if the expiry date has passed.

[Medicine name]                                                                              3

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