Medicine name if phonetic spelling is required the Second asthma

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Medicine name if phonetic spelling is required the Second  asthma Powered By Docstoc
					                                                                                                         October, 1997
Core CMI for Oral Asthma Drugs (text in italics is instructional)

[Medicine name]                                             (if phonetic spelling is required, the Second Edition
of the Usability Guidelines suggests using the system outlined in the Webster’s International Dictionary).

Generic name

Consumer Medicine Information                                                                Date of Dispensing

Consumer Name                                                                                Pharmacist Name
Consumer Address                                                                             Pharmacist Address
Consumer Address                                                                             Pharmacist Address

                                                                                  This medicine is available only with
What is in this leaflet1                  What [Medicine name]                    a doctor’s prescription.
                                          is used for
This leaflet answers some common                                                  Use in children statement :

questions about [Medicine name].
                                          Include information on the expected
                                          effects of using [Medicine name],       [Medicine name] is not
It does not contain all the available                                             recommended for use in children
                                          the therapeutic indications (that is,
information.                                                                      (under the age of x), as there have
                                          what it is used for), the pharmaco-
                                          therapeutic group and how it works      been no studies of its effects in
It does not take the place of talking                                             children.
                              2           etc.
to your doctor or pharmacist .
                                          [Medicine name] is used to open up      Alternative explanation:
All medicines have risks and
                                          the airways in people who have
benefits. Your doctor or pharmacist       asthma. Asthma is a disease             [Medicine name] is not
has weighed the risks of you taking       where the lining of the lungs           recommended for use in children
[Medicine name] against the               becomes inflamed (red and               (under the age of x), as there is
benefits they expect it will have for     swollen), making it difficult to        no/not enough experience with the
you.                                      breathe. This may be due to an          use of [Medicine name] in children.
                                          allergy to house dust mites, smoke
If you have any concerns about                              3
                                          or other irritants .
taking this medicine, ask your
                                                                                  Before you use
doctor or pharmacist.                     It may also be used to treat            [Medicine name]
                                          emphysema, bronchitis or other
Keep this leaflet with the                breathing problems.                     When you must not use it
You may need to read it again.            It may be especially helpful at night   (as per PI):
                                          or before exercise to keep your air
                                          passages open if you start to           Do not use Medicine Name if:
                                          wheeze or have difficulty breathing
                                          each time you exert yourself.           1. you have an allergy to:
                                          Non-approved uses:                       Medicine Name or any other
                                                                                     medicines used to treat
                                          Your doctor may have prescribed            breathing problems
                                          [Medicine name] for another              aminophylline, theophylline or
                                          reason. Ask your doctor if you have        caffeine
                                          any questions about why [Medicine
                                                                                   any of the ingredients listed at
                                          name] has been prescribed for you.
                                                                                     the end of this leaflet
                                          Statement about addictive
                                                                                  Symptoms of an allergic reaction to
                                                                                  these medicines may include:
                                          [Medicine name] is not addictive.
                                          If a prescription-only medicine:         list as per PI
  Depending on the length of your CMI,
consider using a table of contents (see
Second Edition of the Usability                                                    Consider this position if use in
Guidelines).                                                                      children is not a contraindication. Will
2                                         3
  The reference to pharmacists may be      This last sentence is optional. You    need to test to determine the most
especially relevant for S3 medicines.     may also like to add other irritants.   appropriate location.

[Medicine name]                                                                                                              1
                                         Tampering and expiry date
2. you have or have had heart            warnings:                               Like most ..... medicines, [Medicine
problems.                                                                        name] is not recommended while
                                         Do not use [Medicine name] after        you are breast-feeding.
3. you have or have had thyroid          the expiry date (EXP) printed on
problems.                                the pack.                               Like most ..... medicines, [Medicine
                                         If you take this medicine after the     name] is not recommended while
Any other contraindications as per       expiry date has passed, it may not      you are breast-feeding. If there is a
PI.                                      work (as well).                         need to consider [Medicine name]
                                                                                 while you are breast-feeding, your
If pregnancy a contraindication:         Do not use [Medicine name] if           doctor or pharmacist will discuss
                                         the packaging is torn or shows          with you the benefits and risks of
Do not take [Medicine name] if           signs of tampering.                     using it.
you are pregnant or intend to
become pregnant.                         If you are not sure whether you         Tell your doctor or pharmacist if
Like most ..... medicines, [Medicine     should start using [Medicine            you have or have had any of the
name] is not recommended for use         name], contact your doctor or           following medical conditions:
during pregnancy.                        pharmacist.
                                                                                  tuberculosis (TB) or any other
Alternative explanation:                                                           lung disease
                                         Before you use it
                                                                                  a viral or bacterial infection,
Like most ..... medicines, [Medicine                                               including lung infections
                                         Tell your doctor or pharmacist if
name] is not recommended for use         you have allergies to:                   stomach ulcer
during pregnancy, unless you and                                                  reflux
your doctor or pharmacist have
                                          any other medicines                    a fast or irregular heart beat, or
discussed the risks and benefits                                                   any other heart problems
                                          any other substances, such as
                                           foods, preservatives or dyes           liver problems
                                                                                  high blood pressure
[Medicine name] may affect your                                                   diabetes
developing baby if you take it during    Tell your doctor or pharmacist if
                                         you are pregnant or intend to            an overactive thyroid gland
pregnancy.                                                                        any others, as per PI.
                                         become pregnant.
If breastfeeding a contraindication:     Your doctor or pharmacist will
                                         discuss the possible risks and          If you have not told your doctor
                                         benefits of using [Medicine name]       or pharmacist about any of the
Do not take [Medicine name] if
                                         during pregnancy.                       above, tell them before you start
you are breast-feeding or plan to
                                                                                 using [Medicine name].
                                         Alternative explanations:
Like most ..... medicines, [Medicine
name] is not recommended while                                                   Taking other medicines
                                         Like most ..... medicines, [Medicine
you are breast-feeding.
                                         name] is not recommended for use        For relieving medicines:
                                         during pregnancy. If there is a
Alternative explanations:
                                         need to consider [Medicine name]        Tell your doctor or pharmacist if
                                         during your pregnancy, your doctor      you are using any other
[Medicine name] passes into breast
                                         or pharmacist will discuss with you     medicines, including any that
milk and therefore there is a
                                         the benefits and risks of using it.     you buy without a prescription
possibility that the breast-fed baby
may be affected.                                                                 from your pharmacy,
                                         [Medicine name] may affect your         supermarket or health food shop.
                                         developing baby if you use it during    Some medicines and [Medicine
It is not known whether [Medicine
                                         pregnancy. If it is necessary for you   name] may interfere with each
name] passes into breast milk.
                                         to use [Medicine name], your doctor     other. These include:
                                         or pharmacist will discuss the risks
                                         and benefits of using it during
                                                                                  medicines used to treat
                                                                                   hayfever, coughs and colds
If use in children a contraindication:                                            medicines used for weight
                                         Tell your doctor or pharmacist if
                                                                                   reduction purposes
                                         you are breast-feeding or plan to
Do not give [Medicine name] to a                                                  vaccine for the flu
child under x years, unless                                                       erythromycin, clarithromycin,
                                         Your doctor or pharmacist will
directed to by the child’s doctor                                                  ciprofloxacin, enoxacin or
                                         discuss the possible risks and
or pharmacist.                                                                     rifampicin, antibiotics used to
                                         benefits of using [Medicine name]
[Medicine name] is not                                                             treat infections
                                         during breastfeeding.
recommended for use in children                                                   thiabendazole, a medicine used
under x years.                                                                     to treat some parasitic (worm)
                                         Alternative explanations:

[Medicine name]                                                                                                         2
 cimetidine, a medicine used to       the dose will depend on the patient
  treat stomach reflux and ulcers      and will be determined by the           It does not matter if you take
 allopurinol, a medicine used to      doctor or pharmacist.                   [Medicine name] before or after
  treat gout                                                                   food.
 propranolol, mexiletine and          Your doctor or pharmacist will tell
  verapamil, medicines used to         you how many tablets/capsules you       Take [Medicine name] on an
  treat high blood pressure and        will need to take each day. This        empty stomach, for example, 1
  other heart problems                 depends on your condition and           hour before food or 2 hours after
 tacrine, a medicine used to treat    whether or not you are taking any       food.
  dementia in Alzheimers Disease       other medicines.                        Food can interfere with the
 phenytoin, phenobarbitone and                                                absorption of [Medicine name].
  carbamazepine, medicines used        Follow all directions given to you
  to treat epilepsy and fits or        by your doctor and pharmacist           Take [Medicine name] during or
  convulsions                          carefully.                              immediately after a meal, at
 lithium or fluvoxamine,              They/These directions may differ        about the same time each day.
  medicines used to treat some         from the information contained in       If you take [Medicine name] on an
  forms of depression                  this leaflet.                           empty stomach, it may cause
 propylthiouracil, a medicine used                                            stomach upset.
  to treat an overactive thyroid       If you do not understand the
  gland                                instructions on the box/bottle,         If you forget to use it
 oral contraceptives                  ask your doctor or pharmacist
 interferon                           for help.                               If it is almost time for your next
 ephedrine                                                                    dose (within x hours), skip the
 alcohol, tobacco or marihuana        How to take it                          dose you missed and take your
 any others, as per PI                                                        next dose when you are meant
                                       Including taking with water or any      to.
These medicines may be affected        other special precautions, if
by [Medicine name], or may affect      appropriate.                            Otherwise, use it as soon as you
how well it works. You may need                                                remember, and then go back to
different amounts of your medicine,    Some examples from the Second           taking your medicine as you
or you may need to use different       Edition of the Usability Guidelines:    would normally.
medicines. Your doctor or
pharmacist will advise you.            Swallow [Medicine name] with a          Do not take a double dose to
                                       glass of water.                         make up for the dose that you
If you are not sure if you are                                                 missed.
taking any of the above                Swallow [Medicine name] whole           This may increase the chance of
medicines, ask your doctor or          with a full glass of water.             you getting an unwanted side
pharmacist.                            Do not chew the tablets/                effect.
Your doctor and pharmacist may         The tablets/capsules have a special     If you are not sure what to do,
have more information on               coating to stop them dissolving until   ask your doctor or pharmacist.
medicines to be careful with or        they have passed through the
avoid while using [Medicine name].     stomach into the intestines where       If you have trouble remembering
                                       they work. Chewing them destroys        to take your medicine, ask your
                                       the coating.
How to use [Medicine                                                           pharmacist for some hints.
name]                                  When to take it                         How long to use it
This information will be product       Include time with respect to food,      [Medicine name] helps control your
specific, consistent with the          dosing intervals, etc.                  condition, but does not cure it.
approved PI. The following order of                                            Therefore you must continue taking
information is suggested, but will     Some examples from the Second           the medicine for as long as your
depend upon the particular product     Edition of the Usability Guidelines:    doctor or pharmacist tells you.
and the amount of information.
These subheadings and information      Take [Medicine name] at about           Do not stop using it unless your
are suggested but may not be           the same time each day.                 doctor or pharmacist tells you to -
necessary in all cases.                Taking your tablets/capsules at the     even if you feel better.
                                       same time each day will have the
How much to take                       best effect. It will also help you
                                                                               If you take too much
                                       remember when to take the
                                       tablets/capsules.                       (overdose)5
Include dosage ranges, usual
doses for each indication or patient                                           5
group, or a general statement that     Alternatives:                             This section may only be applicable
                                                                               to the relieving medicines.

[Medicine name]                                                                                                        3
                                          Tell any other doctors, dentists,      could be dangerous if you are dizzy
Immediately telephone your                and pharmacists who are                or light-headed. If this occurs do
doctor or pharmacist or the               treating you that you are using        not drive. If you drink alcohol,
Poisons Information Centre                [Medicine name].                       dizziness or light-headedness may
(telephone 13 11 26) , or go to                                                  be worse.
accident and emergency at your            If you are about to be started on
nearest hospital, if you think that       any new medicine, tell your            Any other precautions as per PI.
you or anyone else may have               doctor or pharmacist that you
used too much [Medicine name].            are using [Medicine name].             Side effects
Do this even if there are no signs
of discomfort or poisoning.               If you plan to have surgery (that      The side effects for a particular
You may need urgent medical               needs a general anaesthetic), tell     product will depend on the Product
attention .                               your doctor or dentist that you        Information and the company’s
                                          are using [Medicine name].             disclosure policy.
If you take too much [Medicine
name], you may get shaky hands,           If you become pregnant while           The side effects in the CMI can be
feel sick, anxious, tense, restless,      using [Medicine name], tell your       arranged in order of potential
excited and unable to sleep, or get       doctor or pharmacist.                  severity or frequency, depending on
a headache. (Any others, as per                                                  which is more appropriate for the
PI).                                      Things you must not do                 product.

While you are using                       Do not take any other medicines        Outlined below is the format as
                                          for your breathing problems            recommended by the Second
[Medicine name]                           without checking with your             Edition of the Usability Guidelines:
Things you must do                                                               Tell your doctor or pharmacist as
                                          Do not give [Medicine name] to         soon as possible if you do not
If you have an Asthma Action              anyone else, even if they have         feel well while you are using
Plan that you have agreed with            the same condition as you.             [Medicine name].
your doctor, follow it closely at                                                All medicines can have side effects.
all times.                                Do not use [Medicine name] to          Sometimes they are serious, most
If you find that the usual dose of        treat any other complaints             of the time they are not. You may
[Medicine name] is not giving as          unless your doctor or pharmacist       need medical treatment if you get
much relief as before, or you are         tells you to.                          some of the side effects .
needing to use it more often,             Do not stop using [Medicine
please contact your doctor so             name], or lower the dosage,            Ask your doctor or pharmacist to
that your condition can be                without checking with your             answer any questions you may
          8                                                                      have.
checked .                                 doctor or pharmacist.
This is important to ensure your
breathing problem is controlled           For some relieving medicines:          Tell your doctor or pharmacist if
properly.                                                                        you notice any of the following
                                          Do not use [Medicine name] to          and they worry you:
Continue taking [Medicine name]           relieve acute attacks of asthma.
for as long as your doctor or             If you become wheezy or tight in          headache
pharmacist tells you.                     the chest before your next dose           drowsiness
                                          of [Medicine name] is due, use a          feeling anxious, nervous,
Visit your doctor regularly to            ‘reliever puffer’ in the usual way.        restless or upset
check on your asthma condition.                                                     difficulty sleeping
                                          Any others, as per PI.                    dizziness
Make sure you keep [Medicine                                                        sweating
name] with you at all times.              Things to be careful of                   trembling or shakiness
                                                                                    aching, twitching or cramping
Any other precautions or warnings         Be careful driving or operating            muscles
as per PI.                                machinery until you know how              unpleasant taste in your mouth
                                          [Medicine name] affects you.              loss of appetite
                                          As with other ..... medicines,            stomach pain
  Consider including the relevant New     [Medicine name] may cause                 nausea or vomiting
Zealand telephone numbers here.
7                                         dizziness, light-headedness,               diarrhoea
  The reference to accident and
emergency and urgent medical
                                          tiredness, drowsiness (as per PI) in       flushing
attention could be left out, depending    some people. Make sure you know
on the type of product.                   how you react to [Medicine name]       9
                                                                                   Some medicines might need a
  Testing will determine if this is the   before you drive a car, operate        statement concerning the increased
best place for this paragraph.            machinery, or do anything else that    risk of side effects in the elderly.

[Medicine name]                                                                                                         4
   skin rash                          You may not experience any of
                                       them.                                   Active ingredients:
These side effects are usually mild.
                                                                                list actives
Alternative explanations:
                                       After using [Medicine
                                       name]                                   Other ingredients:
These are the more common side
effects of [Medicine name].            This information will be product         list excipients
                                       specific. See general statements in
These are the more common side         Second Edition of the Usability         [Medicine name] does not contain
effects of [Medicine name]. Mostly     Guidelines, including:                  lactose, sucrose, gluten, tartrazine
these are mild and short-lived.                                                or any other azo dyes.
Tell your doctor or pharmacist                                                 Where Australian Food Standard
immediately if you notice any of       Keep your tablets/capsules in the       codes exist, these could follow each
the following:                         pack/bottle until it is time to take    Australian Approved name.
   high sugar (glucose) levels in     If you take the tablets/capsules out    Manufacturer/Distributor/
    the blood. Symptoms include        of the pack/bottle they will not keep   Supplier
    passing large amounts of           well.
    urine, excessive thirst and                                                Include:
    having a dry mouth and skin        Keep your tablets/capsules in a              Name and address of
   dizziness or feeling light-        cool dry place where the                      sponsor
    headed, which may be caused        temperature stays below 30C.                ARTG number
    by low blood pressure
                                                                                    Date of preparation
   high blood pressure                Do not store [Medicine name] or
   rapid breathing                    any other medicine in the
   fast, pounding or irregular
                                                                               Note: The statements in
                                       bathroom or near a sink.                this core document are
    heart beat
   changes in the amount of urine     Do not leave it in the car on hot       optional. Some may not be
    produced by your body              days or on window sills.                appropriate for a given
   hair loss                          Heat and dampness can destroy           product. In order to
                                       some medicines.                         achieve consistency,
These may be serious side effects.
You may need urgent medical                                                    however, CMI writers are
                                       Keep it where children cannot
attention. Serious side effects are    reach it.                               encouraged to use these
rare.                                  A locked cupboard at least one-         statements and follow the
If any of the following happen,
                                       and-a-half metres above the ground      Second Edition of the
                                       is a good place to store medicines.     Usability Guidelines
tell your doctor or pharmacist
immediately or go to casualty at                                               wherever possible.
your nearest hospital:
                                       If your doctor or pharmacist tells
   blood in your urine
                                       you to stop using [Medicine
   blood in your vomit
                                       name] or the tablets/capsules
   bloody or tar-like bowel
                                       have passed their expiry date,
                                       ask your pharmacist what to do
   fits, seizures or convulsions
                                       with any that are left over.
These are very serious side effects.
You may need urgent medical            Product description
attention or hospitalisation.
                                       This information will be product
Other side effects not listed          specific. The Second Edition of the
above may occur in some                Usability Guidelines suggest the
patients. Tell your doctor or          following order:
pharmacist if you notice
anything else that is making you       What it looks like
feel unwell.
Do not be alarmed by this list of
possible side effects.
                                         Consider placing this statement at
                                       the beginning of this section.

[Medicine name]                                                                                                       5

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Description: Medicine name if phonetic spelling is required the Second asthma