Microsoft word - a0006b94.doc

Core CMI for Tetracycline Antibiotics (text in italics is instructional)
Medicine Name(phonetic spelling if required)
Consumer Medicine Information
What is in this leaflet1
What Medicine Name is
Before you take
Medicine Name
Standard information as suggestedin Usability Guidelines When you must not take it
Do not take Medicine Name if:
1. you have ever had an allergic
reaction to :
medicines containing
(generic name)
 medicines containing other
tetracyclines
 any of the ingredients listed
at the end of this leaflet
viral infections such as colds or flu.
2. you are taking preparations
If you have any concerns about
containing vitamin A,
taking this medicine, ask your
isotretinoin or etretinate.
doctor or pharmacist.
3
Ask your doctor or
Keep this leaflet with the
pharmacist if you are not sure
medicine.
if you are taking any of these
medicines.
3. you are pregnant or
breastfeeding
As with many medicines,tetracyclines may harm thedeveloping or breastfeeding CMI, consider using a table of contents 3 Consider using addictive statement if
product is used for longterm therapy 2. you have or have had any
other health problems,
including:
Some medicines may interfere withthe absorption of Medicine Name.
If you are a woman of child-
bearing age, you should avoid
becoming pregnant while taking
3. you plan to become pregnant
Medicine Name.
or to breastfeed.
4. you are scheduled to have
surgery under general
anaesthetic.
If you are not sure whether you
If you have not told your doctor
should be taking Medicine
or pharmacist about any of the
Name, talk to your doctor.
above, tell them before you start
Medicine Name at least two hoursbefore or two hours after taking any taking Medicine Name.
Taking other medicines
Do not use Medicine Name if the
Tell your doctor if you are taking
packaging is torn or shows
any other medicines, including
signs of tampering.
medicines you buy without a
prescription from a pharmacy,
supermarket or health food
Do not take/use Medicine Name
after the expiry date (EXP)
printed on the pack has passed.
all, or worse, an unexpected effect.
An explanation which does not list Do not take/use Medicine Name
after the expiry date (EXP)
printed on the pack has passed.
Your doctor may advise you to
Do not give Medicine Name to
How to take Medicine
use an additional method of
children of eight years and
contraception while taking
under unless directed by the
Medicine Name.
child's doctor.
specific and consistent with the PI. The following order of information is suggested, but will depend upon Before you start to take it
subheadings are suggested butmay not be necessary in all cases. You must tell your doctor if:
These medicines may be affectedby Medicine Name or may affect Follow all directions given to
1. you are allergic to any other
you by your doctor and
medicines or other
pharmacist carefully.
substances such as foods,
dyes or preservatives.
When to take it
Include time with respect to food, dosing intervals, night-time dosing How much to take
dose of Medicine Name is . (as inPI) Take Medicine Name on an
If you are not sure how long you
empty stomach, either one hour
should be taking Medicine
before or two hours after any
Name, talk to your doctor.
Continue taking Medicine Name
until you finish the pack / bottle
or until your doctor
Take Medicine Name during or
recommends.
immediately after a meal, at
about the same time each day
If you forget to take it
(usually in the morning).
If it is almost time for your next
dose, skip the dose you missed
How long to take it
and take your next dose when
you are meant to. Otherwise,
Do not stop taking the
take it as soon as you
tablets/capsules because you
remember, then go back to
taking your tablets / capsules as
are feeling better.
you would normally.
How to take it
course prescribed by your doctor,all of the bacteria causing your Do not double a dose to make
up for the dose you have
throat irritation, if appropriate. Swallow Medicine Name with a
glass of water.
If you take too much
Keep taking this medicine for
(overdose)
the full time of treatment, even if
Swallow the tablets whole with a
you begin to feel better after a
Immediately telephone your
full glass of water or milk while
few days.
doctor or Poisons Information
sitting or standing upright.
Centre (telephone 13 11 26) for
Do not lie down immediately
advice, or go to casualty at your
after swallowing Medicine Name.
nearest hospital, if you think that
you or anyone else may have
taken too much Medicine Name.
Do this even if there are no
signs of discomfort or
poisoning. You may need
6 These two sentences are in reverse
4 Alternatively, place under While you
5 Alternatively, place under While you
are taking it/ Things you must not do. are taking it/ Things you must not do. Preferred location to be determined by 7 Consider including the relevant New
urgent medical attention.
make sure there is no problem
telephone numbers for these
with absorption.
places handy.
Things you must not do
Do not stop taking your tablets /
capsules because you are
Be careful driving or operating
feeling better, unless advised by
machinery until you know how
your doctor.
Medicine Name affects you.
While you are taking
Medicine Name
bacteria may continue to grow andmultiply so that your infection may Things you must do
Side effects
If you are taking Medicine Name
for an infection and your
Do not give Medicine Name to
statements will be consistent in this symptoms do not improve within
anyone else, even if they have
a few days, or if they become
the same condition as you.
product specific and consistent with worse, tell your doctor.
Do not use Medicine Name to
If you get severe diarrhoea, tell
treat any other medical
Tell your doctor or pharmacist
your doctor or pharmacist
complaints unless your doctor
as soon as possible if you do
immediately. Do this even if it
tells you to.
not feel well while you are taking
occurs several weeks after
Medicine Name.
Medicine Name has been
Things to be careful of
stopped.
Protect your skin when you are
in the sun, especially between
10 am and 3 pm.
If you become pregnant while
taking Medicine Name, tell your
doctor immediately.
If outdoors, wear protective
If you are about to start taking
clothing and use a 15+
any new medicines, tell your
sunscreen. If your skin does
doctor or pharmacist that you
appear to be burning, stop
are taking Medicine Name.
taking Medicine Name and tell
Check with your doctor as soon
your doctor.
as possible if you have any
Tell all doctors, dentists and
problems while taking Medicine
pharmacists who are treating
If you get thrush (a fungal
Name, even if you do not think
you that you are taking Medicine
infection which can affect the
the problems are connected with
mouth and / or vagina) or any
the medicine or are not listed in
other infection while taking, or
this leaflet.
If you are taking iron
soon after stopping Medicine
preparations, including vitamin
Name, tell your doctor.
preparations containing iron, or
antacids, you must take them at
9 You may wish to include an additional
least two hours before or two
caution about iron preparations and hours after Medicine Name to
antacids here. The need for an extrastatement should be determined bytesting Ask your doctor or pharmacist
10 The Usability Guidelines recommend
to answer any questions you
including this statement and the one may have.
8 The reference to casualty and urgent
medical attention could be left out, consider including them here under Tell your doctor if you notice
bathroom or near a sink. Do not
any of the following and they
leave them in the car or on
worry you:
window sills.
Keep Medicine Name where
children cannot reach it.
These side effects are usually mild.
Disposal
Do not take any medicine for
this diarrhoea without first
If your doctor tells you to stop
checking with your doctor.
taking Medicine Name, or the
tablets / capsules have passed
Tell your doctor immediately if
their expiry date, ask your
you notice any of the following:
pharmacist what to do with any
tablets /capsules left over.
effects. Medicine Name canchange bacteria, which are Product description
specific. The Usability Guidelines If any of the following happen,
stop taking Medicine Name and
tell your doctor immediately or
Do not take any diarrhoea
What it looks like
go to casualty at your nearest
medicine without first checking
hospital:
with your doctor.
Ingredients
Ask your doctor or pharmacist if
in this list.
effects. You may need urgentmedical attention or hospitalisation.
Manufacturer / Distributor /
Supplier
Other side effects not listed
above may also occur in some
After using Medicine
patients. Tell your doctor if you
notice anything else that is
making you feel unwell.
The statements in this core
specific. See general statements inUsability Guidelines, including: document are optional.
Some people may get other side
Some may not be
effects while taking/using
Storage
appropriate for a given
Medicine Name.
product. In order to
Keep your tablets / capsules in
achieve consistency,
After finishing it
the (blister) pack/bottle until it is
time to take them.
however, CMI writers are
Tell your doctor immediately if
encouraged to use these
you notice any of the following
statements and follow the
side effects, particularly if they
Usability Guidelines
occur several weeks after
wherever possible.
Keep Medicine Name in a cool,
stopping treatment with
dry place where the temperature
Medicine Name:
stays below 30°C. Do not store
it, or any other medicine, in a

Source: http://www.asmi.com.au/industry/CMI_Tetracycline%20antibiotics.pdf