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Tablets; QUICKLET(R) Orally-disintegrating Tablets; Oral Solution

Consumer Medicine Information (CMI)

What is in this leaflet                    pressured speech, racing             Before you use
                                           thoughts, distractibility or poor    RISPERDAL
This leaflet answers some of the           judgement including disruptive
common questions about Risperdal.          or aggressive behaviours
                                        * treatment of behavioural
                                                                                When you must not use it
It does not contain all of the
available information. It does not        problems in patients with a           Do not use RISPERDAL:
take the place of talking to your         decline in mental ability
                                          (dementia). These problems            * if you know you are allergic to
doctor or pharmacist.
                                          include: aggression through             any of its ingredients (signs of
If you have any concerns about                                                    allergy include skin rash, itching,
                                          words or action, morbid
using Risperdal, ask your doctor or                                               shortness of breath, and/or
                                          suspiciousness, agitation or
pharmacist.                                                                       swollen face - see the last section
Your doctor and pharmacist have                                                   of this leaflet for a list of
                                        * treatment of conduct and other
more information.                                                                 ingredients)
                                          disruptive behaviours such as
                                          aggression, impulsiveness and         * if the packaging is torn or shows
Keep this leaflet with your
medicine.                                 self-injury in children (over 5         signs of being tampered with
                                          years old), adolescents and adults    * if the tablets or the oral solution
You may need to read it again.
                                          who are intellectually disabled.        do not look right
                                        * Treatment of behavioural              * to treat any other complaints
                                          symptoms of autism in children          unless your doctor says it is safe
                                          and adolescent                          to do so.
used for                                Risperdal helps to correct a chemical
                                        imbalance in the brain associated       Before you start to use it
                                        with these conditions.                  RISPERDAL should be used with
Risperdal belongs to a group of
medicines called antipsychotic agents   This medicine has been approved for     caution in some patients.
which improve the symptoms of           the uses mentioned above. However,
                                                                                Tell your doctor if you have or
certain types of mental illness.        your doctor may prescribe it for        have ever had any medical
                                        another use. If you want more           conditions, especially the
It is used for:
                                        information, ask your doctor. It is     following:
* treatment of sudden (acute) and       only available with a doctor’s
  long-term (chronic)                                                           * heart or blood vessel problems,
  schizophrenia and other types of                                                including high and low blood
  related psychoses. These are          Risperdal is not addictive.               pressure.
  disorders related to thought,                                                    Low blood pressure can result
  feeling and/or action.                                                           from using RISPERDAL together
* short term treatment of acute                                                    with medications to treat high
  mania associated with bipolar 1                                                  blood pressure. So, if you need
  disorder. This condition is                                                      to use both RISPERDAL and
  characterised by symptoms such                                                   medications to reduce blood
  as elevated, expansive or irritable                                              pressure, consult your doctor.
  mood, inflated self esteem,                                                      RISPERDAL should be used
  decreased need for sleep,                                                        with caution, and only after

RISPERDAL(R)                                                                                                            1
    consultation with your doctor, if      Tell your doctor if you are taking
                                           any other medicines, including any
                                                                                   Using RISPERDAL
    you have heart problems,
    particularly irregular heart           that you buy without a
    rhythm, abnormalities in               prescription from your pharmacy,        How much to take
    electrical activity of the heart, or   supermarket or health food shop.
                                                                                   Your doctor will decide the dose
    if using medications that can          Ask your doctor or pharmacist           suitable for you.
    change the heart’s electrical          before taking any other medicines.
    activity.                              RISPERDAL can increase the              Follow your doctor's instructions
*   disease of the blood vessels of the    effects of medicines which slow         carefully and do not change or stop
                                           your reactions.                         the required dosage without
    brain including stroke
                                                                                   consulting your doctor first.
*   dehydration                            These include herbal treatments and
*   kidney or liver problems               those bought in a pharmacy or           Important note:
                                           supermarket.                            Never take more tablets or solution
*   Parkinson's disease
*   dementia or Lewy body dementia         Tell your doctor if you are taking:     than your doctor tells you to take.
*   epilepsy, seizures                     * diuretics like frusemide (trade       The maximum daily dose of
*   low blood potassium levels               names LASIX, UREMIDE,                 RISPERDAL is 5 milligrams taken
    (hypokalaemia)                           UREX, FRUSID, or                      twice a day. Check with your doctor
                                             FRUSEHEXAL),, a drug used to          if more than this has been prescribed.
*   breast cancer
                                             treat high blood pressure, or to      The effects of high doses are not yet
*   disease of the pituitary gland
                                             treat swelling of parts of the body   known.
*   diabetes                                 caused by the build-up of too         RISPERDAL cannot be
*   Tardive dyskinesia (a reaction to        much fluid, There is an increased     recommended for use in children
    some medicines with                      risk of side effects or death in      with schizophrenia under 15 years at
    uncontrollable twitching or              elderly people if frusemide is also   the present time as there is little
    jerking movements of the arms            taken with RISPERDAL.                 experience with the product in this
    and legs)
                                           * sleeping tablets, tranquillisers,     group.
*   Neuroleptic Malignant Syndrome           pain-killers, antihistamines
    (a serious reaction to some                                                    For Schizophrenia and Related
                                           * carbamazepine, a drug mainly          Psychoses
    medicines with a sudden increase
                                             used for epilepsy or trigeminal
    in body temperature, extremely                                                 The usual starting dose of
                                             neuralgia (severe pain attacks in
    high blood pressure and severe                                                 RISPERDAL is 1 mg twice a day.
                                             the face) may decrease the level
    convulsions).                                                                  This will be gradually increased by
                                             of RISPERDAL in your blood.
Tell your doctor if you are                                                        your doctor to suit your needs.
                                           * medicines to treat Parkinson's
pregnant or intend to become                                                       From then on, the dose can be taken
                                             disease or a tremor
pregnant. Your doctor will advise                                                  once a day or twice a day according
you whether or not you should take         * medicines to treat epilepsy
                                                                                   to your doctor's instructions. For
RISPERDAL.                                 * medicines to treat depression,        long-term treatment, 4 to 6
Shaking, muscle stiffness and                panic disorder, anxiety or            milligrams per day is usually
difficulty in feeding, all of which are      obsessive-compulsive disorder.        sufficient but your doctor will
reversible, may occur in newborns, if        For example fluoxetine and            determine the dose most suitable for
a mother uses the medicine in the last       paroxetine may increase the level     you.
trimester of her pregnancy                   of RISPERDAL in your blood.
                                             So tell your doctor if you start      For Elderly Patients with
Tell your doctor if you are                  and/or stop taking fluoxetine or      Schizophrenia or Related
breast-feeding.                                                                    Psychoses
RISPERDAL is excreted in breast            * medicines for your heart or blood     For older patients a starting dose of
milk. It is recommended that you do          pressure                              0.5 mg (or 0.5 mL of solution) twice
not breast-feed while taking the                                                   a day (in the morning and in the
                                           * medicines to treat pre-menstrual
medicine.                                                                          evening is usual). The dose may be
                                             dysphoric disorder
                                                                                   increased by 0.5 mg twice daily to 1
                                           * other medicines to treat mental       to 2 mg twice a day (in the morning
Taking other medicines
                                             illness or psychotic conditions       and in the evening).
RISPERDAL can increase the effect          * medicines to relieve severe
of other medicines which slow your           nausea and vomiting.

RISPERDAL(R)                                                                                                               2
Patients with impaired kidney and        For Behavioural Disorders                and strength of the tablets or the
liver function.                          Associated with Autism in                amount of solution until the desired
If you have kidney or liver disease a    Children and Adolescents                 effect is obtained.
starting dose of 0.5 mg (or 0.5 mL of    For people weighing less than 20kg
solution) twice a day (in the morning    the usual starting dose is 0.25mg. On    How to use
and in the evening) is usual. The        day 4 this dose can be increased to
dose may be increased by 0.5 mg          0.5mg.                                   Directions for opening the bottle
twice daily to 1 to 2 mg twice a day                                              and using the pipette for
                                         For people weighing 20kg or more         RISPERDAL Oral Solution
(in the morning and in the evening).     the usual starting dose is 0.5mg. On
For acute mania                          day 4 this dose can be increased to      Step 1:
The recommended starting dose is         1.0mg.                                   The bottle comes with a
2mg once a day. This dose can be         Response should be assessed at day       child-resistant cap.
adjusted by dose increases of 1mg        14; only in patients not achieving       To open, push the screw cap down
when needed every 24 hours. Most         sufficient clinical response should      while turning it anti-clockwise.
people feel better with doses between    additional dose increases be             Remove the unscrewed cap.
2mg and 6mg a day. Your doctor           considered. Your doctor will advise
may decide you should take another       you on how much RISPERDAL you            Step 2:
drug called a mood stabiliser as well    need. When trialled, the maximum         Use the pipette from the container.
as RISPERDAL.                            dose in patients with autism did not     While holding the bottom ring, pull
For Behavioural Problems in              exceed 1.5mg/day in patients less        the top ring up to the mark that
People with Dementia                     than 20kg, 2.5mg in patients 20kg or     corresponds to the dose you need.
                                         more, or 3.5mg in patients more than
The usual starting dose is 0.25 mg                                                Step 3:
twice daily. This may be gradually
                                                                                  Holding the bottom ring, remove the
increased by your doctor to suit your
                                                                                  entire pipette from the bottle.
needs.                                   When to take it
From then on the dose can be taken                                                Step 4:
                                         RISPERDAL may be taken as a
once a day or twice a day according      single dose, once a day or it may be     Empty the contents of the pipette
to your doctor’s instructions. For       taken in divided doses twice a day (in   into a non-alcoholic drink by sliding
long-term treatment, 1 mg daily is       the morning and in the evening).         the upper ring down. Mineral water,
the usual dose but your doctor will      You may take RISPERDAL either            orange juice, coffee and milk are
determine the dose most suitable for     with or between meals.                   suitable. Do not use tea.
                                                                                  Step 5:
For Disruptive Behaviour                 How to take it
Disorders in Adults and Children                                                  Rinse and dry the pipette after use
                                         Swallow RISPERDAL tablets with           and store it in its case. Close the
For people who weigh 50 kg or more,      water or other liquid.                   bottle.
the usual starting dose is 0.5 mg (or
0.5 mL of solution) once a day. The      Place RISPERDAL QUICKLET                 Directions for RISPERDAL
                                         orally-disintegrating tablets on the     QUICKLET Orally-disintegrating
dose may be increased by 0.5 mg
                                         tongue.                                  Tablets
once every two days, to the usual
dose of 0.5 to 1.5 mg once a day.        It begins disintegrating in the mouth    1. Open blister by opening corner
For people who weigh less than 50        within seconds and then can be              fold. Do not push the tablets
kg, the usual starting dose is 0.25 mg   swallowed with or without water. If         through the foil as this will
once a day. The dose may be              you take with food, your mouth              damage the tablets. Do not
increased by 0.25 mg once every two      should be empty before placing the          attempt to split the tablet.
days, to the usual dose of 0.25 to       tablet on the tongue.
                                                                                  2. Take RISPERDAL QUICKLET
0.75 mg once a day.                      Mix RISPERDAL oral solution                 orally-disintegrating tablets
Your doctor will advise you on how       with a non-alcoholic drink.                 immediately as it can not be
much RISPERDAL you need.                 Mineral water, orange juice, coffee         stored once removed from the
RISPERDAL cannot be                      and milk are suitable. Do not use tea.      blister foil
recommended for use in children                                                   3. Place the tablet on the tongue
                                         It is very important that you take the
with disruptive behaviour disorders
                                         correct amount of RISPERDAL, but
under 5 years at the present time as
                                         this will vary from person to person.
there is little experience with the
                                         Your doctor will adjust the number
product in this group.

RISPERDAL(R)                                                                                                              3
How long to take it                      While you are using                       Things you must not do
Continue taking the tablets for as       RISPERDAL                                 Do not drink alcohol.
long as your doctor tells you.
                                                                                   RISPERDAL can increase the effects
RISPERDAL helps control your             Things you must do                        of alcohol.
condition, but does not cure it.
                                         Always follow your doctor's
Therefore you must take                                                            Things to be careful of
                                         instructions carefully, and seek
RISPERDAL every day.
                                         your doctor's advice before
                                                                                   Be careful driving or operating
Do not stop taking it unless your        changing or stopping treatment.
                                                                                   machinery until you know how
doctor tells you to - even if you feel   Your doctor will be happy to discuss      RISPERDAL affects you.
better.                                  any questions you may have with
                                                                                   RISPERDAL may cause dizziness or
                                         your treatment.                           light-headedness in some people,
If you forget to take
                                         Try to eat a moderate diet.               especially after the first dose. Make
RISPERDAL                                                                          sure you know how you react to
                                         RISPERDAL can cause weight gain.
* If you forget to take                                                            RISPERDAL before you drive a car,
  RISPERDAL, take the missed             You should make sure you are not          operate machinery, or do anything
  dose as soon as you remember           pregnant.                                 else that could be dangerous if you
  instead of your next dose. Then        Pre-menopausal women should tell          are dizzy.
  go back to taking it as you would      their doctor if they do not have a        Avoid excessive eating, as there is a
  normally.                              period for more than six months           possibility of weight gain when
* Do not take a double dose to           while taking RISPERDAL.                   taking RISPERDAL.
  make up for the one you missed.        Tell your doctor immediately if
* If you forget to take                  you notice any worm-like
  RISPERDAL for 5 days or more,          movements of the tongue, or other
  tell your doctor before starting       uncontrolled movements of the             Side Effects
  your medicine again.                   tongue, mouth, cheeks or jaw
                                         which may progress to the arms            All medicines can have some
If you have problems remembering         and legs.                                 unwanted side effects. Sometimes
when to take your medicine, ask your
                                         These are symptoms of a condition         they are serious, but most of the time
pharmacist for some hints.
                                         called tardive dyskinesia, which may      they are not. Your doctor has
                                         develop in people taking                  weighed the risks of using this
If you take too much                     antipsychotic medicines, including        medicine against the benefits they
Immediately telephone your doctor        RISPERDAL. This condition is              expect it will have for you.
or the Poisons Information Centre,       more likely to occur during long          All medicines can have side effects.
or go to Accident and Emergency          term treatment with RISPERDAL,            You may need medical treatment if
at your nearest hospital, if you         especially in elderly women. In very      you get some of the side effects.
think that you or anyone else may        rare cases, this may be permanent.
have taken too much RISPERDAL.                                                     Ask your doctor or pharmacist to
                                         However, if detected early, these
Do this even if there are no signs of                                              answer any questions you may
                                         symptoms are usually reversible.
discomfort or poisoning.                                                           have.
                                         Tell any other doctors, dentists,
You can contact the Poisons                                                        Tell your doctor or pharmacist as
                                         and pharmacists who are treating
Information Centre by dialling:                                                    soon as possible if you do not feel
                                         you that you are taking
                                                                                   well while you are taking
* Australia: 13 11 26                    RISPERDAL.                                RISPERDAL
* New Zealand: 0800 POISON or            Try to drink plenty of water,             You may need medical treatment if
  0800 764 766.                          especially if you are elderly and         you get some of the side effects.
Signs of overdose may include            taking frusemide (a diuretic). This       Taking it for the first time.
drowsiness, sleepiness, excessive        will help decrease your risk of certain
trembling, excessive muscle              side effects.                             At the start of treatment you may
stiffness, increased heart rate, very                                              have a fall in blood pressure making
low blood pressure causing fainting                                                you feel dizzy on standing up, or
or unconsciousness.                                                                your heart may beat faster. These
                                                                                   should go away after a few days.
                                                                                   Tell your doctor if they continue or
                                                                                   worry you.

RISPERDAL(R)                                                                                                                4
Tell your doctor if you notice any        RISPERDAL. You may need urgent          Keep RISPERDAL QUICKLET
of the following and they worry           medical attention.                      orally-disintegrating tablets below
you:                                      Serious side effects are uncommon.      30 degrees C.
difficulty thinking or working                                                    Keep RISPERDAL oral solution
                                          If any of the following happen, stop
because of:                               taking RISPERDAL and tell your          below 30 degrees C. The oral
* sleeplessness                           doctor immediately or go to             solution should not be refrigerated.
* headache                                Accident and Emergency at your          * Do not store it or any medicines
* trembling                               nearest hospital:                         in the bathroom or near a sink.
* drowsiness, tiredness, difficulty       * rash, itching or hives on the skin;     Heat and dampness can destroy
    in concentrating                        shortness of breath, wheezing or        some medicines.
behavioural changes such as:                difficulty breathing; swelling of     * Keep it where young children
* agitation                                 the face, lips, tongue or other         cannot reach it. A locked
                                            parts of the body. If you have          cupboard at least one-and-a-half
* anxiety
                                            them, you may have had a serious        metres above the ground is a
joint or movement changes such
                                            allergic reaction to RISPERDAL.         good place to store medicines.
                                          * sudden weakness or numbness of        * Do not use RISPERDAL beyond
* muscle stiffness
                                            the face, arms, or legs, especially     the date (month and year) printed
* restlessness in the legs
                                            on one side, or instances of            on the pack after the letters
other changes such as:                      slurred speech (these are called        "EXP", even if it has been stored
* weight gain                               mini-strokes)                           properly. Medicines cannot be
* indigestion, nausea, abdominal          * in elderly patients with dementia,      stored indefinitely.
    pain, constipation                      occurrence of following even for      * Do not use RISPERDAL if the
* excessive thirst                          a short period time: sudden             appearance of the tablets or oral
* frequent urination                        weakness or numbness of the             solution has changed.
* unusual secretion of breast milk          face, arms or legs, especially on
* breast swelling                           one side, instances of slurred        Disposal
* missed or irregular menstrual             speech and stroke
                                                                                  If your doctor tells you to stop taking
    periods                               These are very serious side effects.
                                                                                  RISPERDAL or if it has passed the
* involuntary movements of the            You may need urgent medical
                                                                                  expiry date, ask your pharmacist
    tongue, face, mouth, jaws, arms,      attention or hospitalisation.
                                                                                  what to do with any that are left over.
    legs or trunk                         Tell your doctor if you notice
These are mild side effects of            anything else that is making you
RISPERDAL but may require                 feel unwell.
medical attention.                        Other side effects not listed above     Product Description
Tell your doctor immediately, or          may occur in some consumers.
go to Accident and Emergency at
your nearest hospital if you notice       Do not hesitate to report any other
                                          side effects to your doctor or          What it looks like
any of the following:
heart or blood pressure problems                                                  RISPERDAL Tablets
such as:                                  Do not be alarmed by this list of
                                                                                  You can identify RISPERDAL
                                          possible side effects.
* fall in blood pressure,                                                         Tablets by their colour and shape.
    particularly on standing. This        You may not experience any of them.     This is important because there are 5
    will be apparent to you as                                                    types of RISPERDAL, each
    light-headedness or dizziness that                                            containing a different amount of
    passes after a few seconds or after                                           risperidone:
    sitting down again                    After using                             * 0.5 mg brownish red, oblong
* faster heart rate, slowed heart         RISPERDAL                                 biconvex grooved tablets marked
    rate, heart beat irregularities                                                 with “Ris 0.5” on the grooved
body temperature changes such as:                                                   side and “JANSSEN” on the
* fever                                                                             other side.
* abnormally high body                    Keep RISPERDAL tablets in a dry         * 1 mg white, oblong grooved
    temperature                           place where the temperature stays         tablets marked “Ris 1” on the
These may be serious side effects of      below 25 degrees C.                       grooved side.

RISPERDAL(R)                                                                                                              5
* 2 mg orange, oblong grooved           0.5, 1, 2, 3 or 4 mg (milligrams) of    Registration Numbers
  tablets marked “Ris 2” on the         risperidone. The tablets also contain
                                        lactose, maize starch,                  0.5mg Tablet AUST R 71849
  grooved side.
                                        microcrystalline cellulose,             1 mg Tablet - AUST R 47008
* 3 mg yellow, oblong grooved
  tablets marked “Ris 3” on the         hypromellose, magnesium stearate,       2 mg Tablet - AUST R 48486
  grooved side.                         colloidal anhydrous silica, sodium      3 mg Tablet - AUST R 47010
                                        lauryl sulphate, propylene glycol.
* 4 mg green, oblong grooved                                                    4 mg Tablet - AUST R 47011
  tablets marked “Ris 4” on the         The 0.5 mg tablets also contain
  grooved side.                         titanium dioxide, purified talc and
                                        red iron oxide.                         0.5mg Quicklet(R) tablet - AUST R
All strengths come in boxes of 60                                               94192
tablets, except the 0.5 mg which        The 2 mg tablets also contain
                                                                                1mg Quicklet(R) tablet - AUST R
comes in a box of 20 tablets.           titanium dioxide, purified talc and
                                        sunset yellow (CI 15985).
RISPERDAL QUICKLET                                                              2mg Quicklet(R) tablet - AUST R
orally-disintegrating tablets            The 3 mg tablets also contain          115461
                                        titanium dioxide, purified talc and
There are five kinds of RISPERDAL                                               3mg Quicklet(R) tablet - AUST R
QUICKLET orally-disintegrating          quinoline yellow (CI 47005).
tablets containing different amounts    The 4 mg tablets also contain           4mg Quicklet(R) tablet - AUST R
of the medically active substance.      titanium dioxide, purified talc,
You can identify the strength as        quinoline yellow (CI 47005) and
follows.                                indigo carmine (CI 73015).
                                                                                1 mg/mL Oral Solution - AUST R
* 0.5 mg light coral, round             RISPERDAL QUICKLET                      56444
  biconvex tablets marked “R0.5”        orally-disintegrating tablets
  on one side.                          RISPERDAL QUICKLET
* 1 mg light coral, square biconvex                                             This leaflet was prepared in August
                                        orally-disintegrating tablets contain
  tablets marked “R1” on one side.                                              2009.
                                        either 0.5, 1, 2 mg, 3 mg or 4 mg
* 2 mg coral, square biconvex           (milligrams) of risperidone. They
  tablets marked “R2” on one side.      also contain polacrillin, gelatin,
* 3 mg coral, round, biconvex           mannitol, glycine, simethicone,
  tablets marked “R3” on one side.      carbomer, sodium hydroxide,
                                        aspartame, peppermint oil and red
* 4 mg coral, round, biconvex
                                        iron oxide. In addition, the 2 mg, 3
  tablets marked “R4” on one side.
                                        mg and 4 mg RISPERDAL
The RISPEDAL QUICKLET                   QUICKLET orally-disintegrating
orally-disintegrating tablets come in   tablets contain xanthan gum.
boxes of 28 tablets.
                                        Phenylketonuric patients should note
RISPERDAL oral solution                 RISPERDAL QUICKLET
RISPERDAL oral solution is a clear,     orally-disintegrating tablets contain
colourless solution. It is packed in    aspartame.
an amber bottle (30 or 100mL) with a    RISPERDAL oral solution
pipette which measures the dose in
milligrams (mg) and millilitres (mL).   The RISPERDAL oral solution
                                        contains 1 mg/mL of risperidone, as
One full pipette contains 3 mL (or 3
mg) of oral solution. The smallest      well as tartaric acid, benzoic acid,
amount you can measure with the         sodium hydroxide and purified water.
pipette is 0.25 mL.
Ingredients                             Janssen-Cilag Pty Ltd
The active ingredient in                1-5 Khartoum Road North Ryde
RISPERDAL is risperidone.               NSW 2113
                                        Telephone: 1800 226 334
                                        NZ Office: Auckland, New Zealand
RISPERDAL tablets contain either        Telephone: 0800 800 806

RISPERDAL(R)                                                                                                          6