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.
What RISPERDAL is
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
consultation with your doctor, if Tell your doctor if you are taking
any other medicines, including any
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
* 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
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
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.
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.
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
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.
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
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
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.
* 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
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