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RISPERIDONE 4MG ORODISPERSIBLE TABLETS

Active substance(s): RISPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperdal® Quicklet® 4mg orodispersible tablets
(risperidone)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Risperdal Quicklet
4mg orodispersible tablets, but it will be referred
as Risperdal throughout this leaflet.

Please note that this leaflet also contains
information about other strengths and form
namely: Risperdal 0.5mg, 1mg, 2mg, 3mg, 4mg
and 6mg film-coated tablets and Risperdal
Quicklet 0.5mg, 1mg, 2mg and 3mg
orodispersible tablets.
What is in this leaflet:
1. What Risperdal is and what it is used for
2. What you need to know before you take
Risperdal
3. How to take Risperdal
4. Possible side effects
5. How to store Risperdal
6. Contents of the pack and other information

1. What Risperdal is and what it is used for
Risperdal belongs to a group of medicines called
‘anti-psychotics’.
Risperdal is used to treat the following:
Schizophrenia, where you may see, hear or
feel things that are not there, believe things
that are not true or feel unusually suspicious,
or confused
Mania, where you may feel very excited,
elated, agitated, enthusiastic or hyperactive.
Mania occurs in an illness called ‘bipolar
disorder’

Short-term treatment (up to 6 weeks) of longterm aggression in people with Alzheimer’s
dementia, who harm themselves or others.
Alternative (non-drug) treatments should have
been used previously
Short-term treatment (up to 6 weeks) of longterm aggression in intellectually disabled
children (at least 5 years of age) and
adolescents with conduct disorder.
Risperdal can help alleviate the symptoms of
your disease and stop your symptoms from
coming back.

2. What you need to know before you take Risperdal
Do not take Risperdal:
If you are allergic to risperidone or any of the
other ingredients of this medicine (listed in
section 6).
If you are not sure if the above applies to you,
talk to your doctor or pharmacist before using
Risperdal.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Risperdal if:
You have a heart problem. Examples include
an irregular heart rhythm or if you are prone to
low blood pressure or if you are using medicines
for your blood pressure. Risperdal may cause low
blood pressure. Your dose may need to be
adjusted
You know of any factors which would favour you
having a stroke, such as high blood pressure,
cardiovascular disorder or blood vessel problems
in the brain
You have ever experienced involuntary
movements of the tongue, mouth and face
You have ever had a condition whose
symptoms include high temperature, muscle
stiffness, sweating or a lowered level of
consciousness (also known as Neuroleptic
Malignant Syndrome)
You have Parkinson’s disease or dementia
You know that you have had low levels of white
blood cells in the past (which may or may not
have been caused by other medicines)
You are diabetic
You have epilepsy
You are a man and you have ever had a
prolonged or painful erection
You have problems controlling your body
temperature or overheating
You have kidney problems
You have liver problems
You have an abnormally high level of the
hormone prolactin in your blood or if you have a
possible prolactin-dependent tumour
You or someone else in your family has a
history of blood clots, as anti-psychotics have
been associated with formation of blood clots.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
using Risperdal.
As dangerously low numbers of a certain type of
white blood cell needed to fight infection in your
blood has been seen very rarely with patients
taking Risperdal, your doctor may check your
white blood cell counts.
Risperdal may cause you to gain weight. Significant
weight gain may adversely affect your health. Your
doctor should regularly measure your body weight.
As diabetes mellitus or worsening of pre-existing
diabetes mellitus have been seen with patients
taking Risperdal, your doctor should check for signs
of high blood sugar. In patients with pre-existing
diabetes mellitus blood glucose should
be monitored regularly.
Risperdal commonly raises levels of a hormone
called ‘prolactin’. This may cause side effects
such as menstrual disorders or fertility problems
in women, breast swelling in men (see Possible
side effects). If such side effects occur,
evaluation of the prolactin level in the blood is
recommended.
During an operation on the eye for cloudiness of
the lens (cataract), the pupil (the black circle in
the middle of your eye) may not increase in size
as needed. Also, the iris (the coloured part of the
eye) may become floppy during surgery and that
may lead to eye damage. If you are planning to
have an operation on your eye, make sure you
tell your eye doctor that you are taking this
medicine.
Elderly people with dementia
In elderly patients with dementia, there is an
increased risk of stroke. You should not take
risperidone if you have dementia caused by stroke.
During treatment with risperidone you should
frequently see your doctor.
Medical treatment should be sought straight away if
you or your care-giver notice a sudden change in
your mental state or sudden weakness or
numbness of your face, arms or legs, especially on
one side, or slurred speech, even for a short period
of time. These may be signs of a stroke.
Children and adolescents
Before treatment is started for conduct disorder,
other causes of aggressive behaviour should have
been ruled out.
If during treatment with risperidone tiredness
occurs, a change in the time of administration might
improve attention difficulties.
Before treatment is started your, or your child’s
body weight may be measured and it may be
regularly monitored during treatment.
A small and inconclusive study has reported an
increase in height in children who took risperidone,
but whether this is an effect of the drug or due to
some other reason is not known.

Other medicines and Risperdal
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
It is especially important to talk to your doctor
or pharmacist if you are taking any of the
following:
Medicines that work on your brain such as to help
you calm down (benzodiazepines) or some
medicines for pain (opiates), medicines for
allergy (some anti-histamines), as risperidone
may increase the sedative effect of all of these
Medicines that may change the electrical activity
of your heart, such as medicines for malaria,
heart rhythm problems, allergies (antihistamines), some antidepressants or other
medicines for mental problems
Medicines that cause a slow heart beat
Medicines that cause low blood potassium
(such as certain diuretics)
Medicines to treat raised blood pressure.
Risperdal can lower blood pressure
Medicines for Parkinson’s disease (such as
levodopa)
Water tablets (diuretics) used for heart problems
or swelling of parts of your body due to a build up
of too much fluid (such as furosemide or
chlorothiazide). Risperdal taken by itself or with
furosemide, may have an increased risk of stroke
or death in elderly people with dementia.
The following medicines may reduce the effect
of risperidone
Rifampicin (a medicine for treating some
infections)
Carbamazepine, phenytoin (medicines for
epilepsy)
Phenobarbital
If you start or stop taking such medicines you may
need a different dose of risperidone.
The following medicines may increase the effect
of risperidone
Quinidine (used for certain types of heart
disease)
Antidepressants such as paroxetine, fluoxetine,
tricyclic antidepressants
Medicines known as beta blockers (used to treat
high blood pressure)
Phenothiazines (such as medicines used to treat
psychosis or to calm down)
Cimetidine, ranitidine (blockers of the acidity of
stomach)
Itraconazole and ketoconazole (medicines for
treating fungal infections)
Certain medicines used in the treatment of HIV/
AIDS, such as ritonavir
Verapamil, a medicine used to treat high blood
pressure and/or abnormal heart rhythm
Sertraline and fluvoxamine, medicines used to
treat depression and other psychiatric disorders.
If you start or stop taking such medicines you may
need a different dose of risperidone.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before using
Risperdal.
Risperdal with food, drink and alcohol
You can take this medicine with or without food.
You should avoid drinking alcohol when taking
Risperdal.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine. Your doctor will decide if
you can take it.
The following symptoms may occur in newborn
babies, of mothers that have used Risperdal in
the last trimester (last three months of their
pregnancy): shaking, muscle stiffness, and/or
weakness, sleepiness, agitation, breathing
problems, and difficulty in feeding. If your baby
develops any of these symptoms you may need
to contact your doctor.
Risperdal can raise your levels of a hormone
called ‘prolactin’ that may impact fertility (see
‘Possible side effects’).
Driving and using machines
Dizziness, tiredness, and vision problems may
occur during treatment with Risperdal. Do not drive
or use any tools or machines without talking to your
doctor first.
Risperdal film-coated tablets contain lactose
The film-coated tablets contain lactose, a type of
sugar. If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicinal product.
Risperdal 2mg and 6mg film-coated tablets also
contain sunset yellow (E110) that may cause
allergic reactions.
Risperdal Quicklet orodispersible tablets
contain aspartame, a source of phenylalanine
which may be harmful for people with
phenylketonuria.

3. How to take Risperdal
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
The recommended dose is as follows:
For the treatment of schizophrenia
Adults
The usual starting dose is 2mg per day, this may
be increased to 4mg per day on the second day
Your dose may then be adjusted by your doctor
depending on how you respond to the treatment
Most people feel better with daily doses of 4 to
6mg
This total daily dose can be divided into either
one or two doses a day. Your doctor will tell you
which is the best for you
Elderly people
Your starting dose will normally be 0.5mg twice a
day
Your dose may then be gradually increased by
your doctor to 1mg to 2mg twice a day
Your doctor will tell you which is the best for you

For children who weigh 50kg or more
The starting dose will normally be 0.5mg once a
day
The dose may be increased every other day in
steps of 0.5mg per day
The usual maintenance dose is 0.5mg to 1.5mg
once a day.
Treatment duration in patients with conduct disorder
should be not more than 6 weeks.
Children under 5 years old should not be treated
with Risperdal for conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting
doses and following doses of risperidone should be
halved. Dose increases should be slower in these
patients.
Risperidone should be used with caution in this
patient group.
Method of administration
For oral use

Risperdal film-coated tablets
You should swallow your tablet with a drink of
For the treatment of mania
water
Adults
The score line is only there to help you break the
tablet if you have difficulty swallowing it whole
Your starting dose will usually be 2mg once a day
Your dose may then be gradually adjusted by
Risperdal Quicklet orodispersible tablets
your doctor depending on how you respond to
Only remove a tablet from the blister when it is time
the treatment
to take your medicine.
Most people feel better with doses of 1 to 6mg
Peel open a blister to expose the tablet
once a day
Do not push the tablet through the foil because it
may break
Elderly people
Remove the tablet from the blister with dry hands
Your starting dose will usually be 0.5mg twice a
day
Place the tablet on your tongue straight away
Your dose may then be gradually adjusted by
The tablet will begin disintegrating within seconds
your doctor to 1mg to 2mg twice a day depending
It can then be swallowed with or without water
on how much you respond to the treatment
If you take more Risperdal than you should
For the treatment of long-standing aggression
See a doctor right away. Take the medicine pack
in people with Alzheimer’s dementia
with you.
Adults (including elderly people)
In case of overdose you may feel sleepy or tired,
Your starting dose will normally be 0.25mg twice
or have abnormal body movements, problems
a day
standing and walking, feel dizzy due to low blood
Your dose may then be gradually adjusted by
pressure, or have abnormal heart beats or fits.
your doctor depending on how you respond to
the treatment
If you forget to take Risperdal
Most people feel better with 0.5mg twice a day.
If you forget to take a dose, take it as soon as
Some patients may need 1mg twice a day
you remember it. However, if it is almost time for
your next dose, skip the missed dose and
Treatment duration in patients with Alzheimer’s
continue as usual. If you miss two or more doses,
dementia should be not more than 6 weeks.
contact your doctor.
Use in children and adolescents
Do not take a double dose (two doses at the
same time) to make up for a forgotten dose.
Children and adolescents under 18 years old
should not be treated with Risperdal for
If you stop taking Risperdal
schizophrenia or mania.
You should not stop taking this medicine unless told
to do so by your doctor. Your symptoms may return.
For the treatment of conduct disorder
If your doctor decides to stop this medicine, your
The dose will depend on your child’s weight:
dose may be decreased gradually over a few days.
For children who weigh less than 50kg
The starting dose will normally be 0.25mg once a If you have any further questions on the use of this
day
medicine, ask your doctor or pharmacist.
The dose may be increased every other day in
steps of 0.25mg per day
The usual maintenance dose is 0.25mg to
0.75mg once a day.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately if you:
Experience blood clots in the veins, especially in
the legs (symptoms include swelling, pain, and
redness in the leg), which may travel through
blood vessels to the lungs causing chest pain
and difficulty in breathing. If you notice any of
these symptoms seek medical advice
immediately

Have dementia and experience a sudden change
in your mental state or sudden weakness or
numbness of your face, arms or legs, especially
on one side, or slurred speech, even for a short
period of time. These may be signs of a stroke
Experience fever, muscle stiffness, sweating or a
lowered level of consciousness (a disorder called
‘Neuroleptic Malignant Syndrome’). Immediate
medical treatment may be needed
Are a man and experience prolonged or painful
erection. This is called priapism. Immediate
medical treatment may be needed

4. Possible side effects (continued)
Experience involuntary rhythmic movements of
the tongue, mouth and face. Withdrawal of
risperidone may be needed
Experience severe allergic reaction characterised
by fever, swollen mouth, face, lip or tongue,
shortness of breath, itching, skin rash or drop in
blood pressure
The following side effects may happen:
Very Common (may affect more than 1 in 10
people):
Difficulty falling or staying asleep
Parkinsonism: This condition may include: slow
or impaired movement, sensation of stiffness or
tightness of the muscles (making your
movements jerky), and sometimes even a
sensation of movement ‘freezing up’ and then
restarting. Other signs of parkinsonism include a
slow shuffling walk, a tremor while at rest,
increased saliva and/or drooling, and a loss of
expression on the face
Feeling sleepy, or less alert
Headache

Stomach or intestinal infection, Stool
incontinence, Very hard stool, Difficulty
swallowing, Excessive passing of gas or wind
Hives (or ‘nettle rash’), Itching, Hair loss,
Thickening of skin, Eczema, Dry skin, Skin
discoloration, Acne, Flaky, itchy scalp or skin,
Skin disorder, Skin lesion
An increase of CPK (creatine phosphokinase) in
your blood, an enzyme which is sometimes
released with muscle breakdown
Abnormal posture, Joint stiffness, Joint swelling,
Muscle weakness, Neck pain
Frequent passing of urine, Inability to pass urine,
Pain when passing urine
Erectile dysfunction, Ejaculation disorder
Loss of menstrual periods, Missed menstrual
periods or other problems with your cycle
(females)
Development of breasts in men, Leakage of milk
from the breasts, Sexual dysfunction, Breast
pain, Breast discomfort, Vaginal discharge
Swelling of the face, mouth, eyes, or lips
Chills, An increase in body temperature
A change in the way you walk
Feeling thirsty, Feeling unwell, Chest discomfort,
Feeling ‘out of sorts’, Discomfort
Increased liver transaminases in your blood,
Increased GGT (a liver enzyme called gammaglutamyltransferase) in your blood, Increased
liver enzymes in your blood
Procedural pain.

Common (may affect up to 1 in 10 people):
Pneumonia, Infection of the chest (bronchitis),
Common cold symptoms, Sinus infection, Urinary
tract infection, Ear infection, Feeling like you
have the flu
Raised levels of a hormone called ‘prolactin’
found in a blood test (which may or may not
cause symptoms). Symptoms of high prolactin
occur uncommonly and may include in men
breast swelling, difficulty in getting or maintaining
erections, decreased sexual desire or other
Rare (may affect up to 1 in 1,000 people):
sexual dysfunction. In women they may include
Infection
breast discomfort, leakage of milk from the
breasts, missed menstrual periods, or other
Inappropriate secretion of a hormone that
problems with your cycle, or fertility problems
controls urine volume
Weight gain, Increased appetite, Decreased
Sugar in the urine, Low blood sugar, High blood
appetite
triglycerides (a fat)
Sleep disorder, Irritability, Depression, Anxiety,
Lack of emotion, Inability to reach orgasm
Restlessness
Neuroleptic malignant syndrome (confusion,
Dystonia: This is a condition involving slow or
reduced or loss of consciousness, high fever, and
sustained involuntary contraction of muscles.
severe muscle stiffness)
While it can involve any part of the body (and
Blood vessel problems in the brain
may result in abnormal posture), dystonia often
Coma due to uncontrolled diabetes
involves muscles of the face, including abnormal
movements of the eyes, mouth, tongue or jaw.
Shaking of the head
Dizziness
Glaucoma (increased pressure within the
eyeball), Problems with movement of your eyes,
Dyskinesia: This is a condition involving
Eye rolling, Eyelid margin crusting
involuntary muscle movements, and can include
repetitive, spastic or writhing movements, or
Eye problems during cataract surgery. During
twitching.
cataract surgery, a condition called intraoperative
floppy iris syndrome (IFIS) can happen if you
Tremor (shaking)
take or have taken Risperdal. If you need to have
Blurry vision, Eye infection or ‘pink eye’
cataract surgery, be sure to tell your eye doctor if
Rapid heart rate, High blood pressure, Shortness
you take or have taken this medicine
of breath
Dangerously low numbers of a certain type of
Sore throat, Cough, Nosebleeds, Stuffy nose
white blood cell needed to fight infection in your
blood
Abdominal pain, Abdominal discomfort, Vomiting,
Nausea, Constipation, Diarrhea, Indigestion, Dry
Severe allergic reaction characterised by fever,
mouth, Toothache
swollen mouth, face, lip or tongue, shortness of
breath, itching, skin rash and sometimes drop in
Rash, Skin redness
blood pressure
Muscle spasms, Bone or muscle ache, Back
Dangerously excessive intake of water
pain, Joint pain
Irregular heart beat
Incontinence (lack of control) of urine
Blood clot in the legs, Blood clot in the lungs
Swelling of the body, arms or legs, Fever, Chest
pain, Weakness, Fatigue (tiredness), Pain
Trouble breathing during sleep (sleep apnea),
Fast, shallow breathing
Fall
Inflammation of the pancreas, A blockage in the
Uncommon (may affect up to 1 in 100 people):
bowels
Infection of the breathing passages, Bladder
Swollen tongue, Chapped lips, Rash on skin
infection, Eye infection, Tonsillitis, Fungal
related to drug
infection of the nails, Infection of the skin, An
Dandruff
infection confined to a single area of skin or part
of the body, Viral infection, Skin inflammation
Breakdown of muscle fibers and pain in muscles
caused by mites
(rhabdomyolysis)
Decrease in the type of white blood cells that
A delay in menstrual periods, Enlargement of the
help to protect you against infection, White blood
glands in your breasts, Breast enlargement,
cell count decreased, Decrease in platelets
Discharge from the breasts
(blood cells that help you stop bleeding), Anemia,
Increased insulin (a hormone that controls blood
Decrease in red blood cells, Increase in
sugar levels) in your blood
eosinophils (a type of white blood cell) in your
Priapism (a prolonged penile erection that may
blood
require surgical treatment)
Allergic reaction
Hardening of the skin
Diabetes or worsening of diabetes, High blood
Decreased body temperature, Coldness in arms
sugar, Excessive drinking of water
and legs
Weight loss, Loss of appetite resulting in
Symptoms of drug withdrawal
malnutrition and low body weight
Yellowing of the skin and the eyes (jaundice)
Increased cholesterol in your blood
Elated mood (mania), Confusion, Decreased
Very rare (may affect up to 1 in 10,000 people):
sexual drive, Nervousness, Nightmares
Life-threatening complications of uncontrolled
Tardive dyskinesia (twitching or jerking
diabetes.
movements that you cannot control in your face,
Serious allergic reaction with swelling that may
tongue, or other parts of your body). Tell your
involve the throat and lead to difficulty in
doctor immediately if you experience involuntary
breathing.
rhythmic movements of the tongue, mouth and
Lack of bowel muscle movement that causes
face. Withdrawal of Risperdal may be needed
blockage.
Sudden loss of blood supply to brain (stroke or
‘mini’ stroke)
Unresponsive to stimuli, Loss of consciousness,
Low level of consciousness
Convulsion (fits), Fainting
A restless urge to move parts of your body,
Balance disorder, Abnormal coordination,
Dizziness upon standing, Disturbance in
attention, Problems with speech, Loss or
abnormal sense of taste, Reduced sensation of
skin to pain and touch, A sensation of tingling,
pricking, or numbness of the skin
Oversensitivity of the eyes to light, Dry eye,
Increased tears, Redness of the eyes
Sensation of spinning (vertigo), Ringing in the
ears, Ear pain
Atrial fibrillation (an abnormal heart rhythm), An
interruption in conduction between the upper and
lower parts of the heart, Abnormal electrical
conduction of the heart, Prolongation of the QT
interval from your heart, Slow heart rate,
Abnormal electrical tracing of the heart
(electrocardiogram or ECG), A fluttering or
pounding feeling in your chest (palpitations)
Low blood pressure, Low blood pressure upon
standing (consequently, some people taking
Risperdal may feel faint, dizzy, or may pass out
when they stand up or sit up suddenly, Flushing
Pneumonia caused by inhaling food, Lung
congestion, Congestion of breathing passages,
Crackly lung sounds, Wheezing, Voice disorder,
Breathing passage disorder

The following side effect has been seen with the
use of another medicine called paliperidone that is
very similar to risperidone, so these can also be
expected with Risperdal: Rapid heart beat upon
standing.
Additional side effects in children and
adolescents
In general, side effects in children are expected to
be similar to those in adults.
The following side effects were reported more often
in children and adolescents (5 to 17 years) than in
adults: feeling sleepy, or less alert, fatigue
(tiredness), headache, increased appetite, vomiting,
common cold symptoms, nasal congestion,
abdominal pain, dizziness, cough, fever, tremor
(shaking), diarrhoea, and incontinence (lack of
control) of urine.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Risperdal
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 30°C. Store in the original
package in order to protect form light and
moisture.
Do not take your tablets after the expiry date which
is stated on the carton and blister label after ‘Exp’.
The expiry date refers to the last day of that
month.
If your tablets become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.

Remember if your doctor tells you to stop taking
this medicine; return any unused tablets to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Risperdal contains
Each orodispersible tablet contains 4mg
risperidone.

Manufactured by: Janssen-Cilag S.p.A., Via C.
Janssen, Borgo San Michelle, Latina, I-04010,
Italy.

The other ingredients are:
polacrilex resin, gelatin, mannitol, glycine,
simeticone, carbomer, sodium hydroxide,
aspartame E951, peppermint oil, xanthan gum and
red ferric oxide (E172).

Procured from within the EU and repackaged by
the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU UK.

What Risperdal looks like and contents of the
pack

Risperdal® Quicklet® 4mg orodispersible tablets;
PL 18799/2462
Leaflet date: 19.10.2015

Risperdal are round, coral coloured biconvex
orodispersible tablets embossed with ‘R4’on one
side and plain on the reverse.
Risperdal is available in blister packs of 28 tablets.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone 4mg orodispersible tablets
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it
again.
If you have any further questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is risperidone 4mg
orodispersible tablets, but it will be referred
as Risperidone throughout this leaflet.

Please note that this leaflet also contains
information about other strengths and form
namely: Risperidone 0.5mg, 1mg, 2mg, 3mg, 4mg
and 6mg film-coated tablets and Risperidone
0.5mg, 1mg, 2mg and 3mg
orodispersible tablets.
What is in this leaflet:
1. What Risperidone is and what it is used for
2. What you need to know before you take
Risperidone
3. How to take Risperidone
4. Possible side effects
5. How to store Risperidone
6. Contents of the pack and other information

1. What Risperidone is and what it is used for
Risperidone belongs to a group of medicines called
‘anti-psychotics’.
Risperidone is used to treat the following:
Schizophrenia, where you may see, hear or
feel things that are not there, believe things
that are not true or feel unusually suspicious,
or confused
Mania, where you may feel very excited,
elated, agitated, enthusiastic or hyperactive.
Mania occurs in an illness called ‘bipolar
disorder’

Short-term treatment (up to 6 weeks) of longterm aggression in people with Alzheimer’s
dementia, who harm themselves or others.
Alternative (non-drug) treatments should have
been used previously
Short-term treatment (up to 6 weeks) of longterm aggression in intellectually disabled
children (at least 5 years of age) and
adolescents with conduct disorder.
Risperidone can help alleviate the symptoms of
your disease and stop your symptoms from
coming back.

2. What you need to know before you take Risperidone
Do not take Risperidone:
If you are allergic to risperidone or any of the
other ingredients of this medicine (listed in
section 6).
If you are not sure if the above applies to you,
talk to your doctor or pharmacist before using
Risperidone.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Risperidone if:
You have a heart problem. Examples include
an irregular heart rhythm or if you are prone to
low blood pressure or if you are using medicines
for your blood pressure. Risperidone may cause
low
blood pressure. Your dose may need to be
adjusted
You know of any factors which would favour you
having a stroke, such as high blood pressure,
cardiovascular disorder or blood vessel problems
in the brain
You have ever experienced involuntary
movements of the tongue, mouth and face
You have ever had a condition whose
symptoms include high temperature, muscle
stiffness, sweating or a lowered level of
consciousness (also known as Neuroleptic
Malignant Syndrome)
You have Parkinson’s disease or dementia
You know that you have had low levels of white
blood cells in the past (which may or may not
have been caused by other medicines)
You are diabetic
You have epilepsy
You are a man and you have ever had a
prolonged or painful erection
You have problems controlling your body
temperature or overheating
You have kidney problems
You have liver problems
You have an abnormally high level of the
hormone prolactin in your blood or if you have a
possible prolactin-dependent tumour
You or someone else in your family has a
history of blood clots, as anti-psychotics have
been associated with formation of blood clots.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
using Risperidone.
As dangerously low numbers of a certain type of
white blood cell needed to fight infection in your
blood has been seen very rarely with patients
taking Risperidone, your doctor may check your
white blood cell counts.
Risperidone may cause you to gain weight.
Significant weight gain may adversely affect your
health. Your doctor should regularly measure your
body weight.
As diabetes mellitus or worsening of pre-existing
diabetes mellitus have been seen with patients
taking Risperidone, your doctor should check for
signs of high blood sugar. In patients with preexisting diabetes mellitus blood glucose should
be monitored regularly.
Risperidone commonly raises levels of a hormone
called ‘prolactin’. This may cause side effects
such as menstrual disorders or fertility problems
in women, breast swelling in men (see Possible
side effects). If such side effects occur,
evaluation of the prolactin level in the blood is
recommended.
During an operation on the eye for cloudiness of
the lens (cataract), the pupil (the black circle in
the middle of your eye) may not increase in size
as needed. Also, the iris (the coloured part of the
eye) may become floppy during surgery and that
may lead to eye damage. If you are planning to
have an operation on your eye, make sure you
tell your eye doctor that you are taking this
medicine.
Elderly people with dementia
In elderly patients with dementia, there is an
increased risk of stroke. You should not take
risperidone if you have dementia caused by stroke.
During treatment with risperidone you should
frequently see your doctor.
Medical treatment should be sought straight away if
you or your care-giver notice a sudden change in
your mental state or sudden weakness or
numbness of your face, arms or legs, especially on
one side, or slurred speech, even for a short period
of time. These may be signs of a stroke.
Children and adolescents
Before treatment is started for conduct disorder,
other causes of aggressive behaviour should have
been ruled out.
If during treatment with risperidone tiredness
occurs, a change in the time of administration might
improve attention difficulties.
Before treatment is started your, or your child’s
body weight may be measured and it may be
regularly monitored during treatment.
A small and inconclusive study has reported an
increase in height in children who took risperidone,
but whether this is an effect of the drug or due to
some other reason is not known.

Other medicines and Risperidone
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
It is especially important to talk to your doctor
or pharmacist if you are taking any of the
following:
Medicines that work on your brain such as to help
you calm down (benzodiazepines) or some
medicines for pain (opiates), medicines for
allergy (some anti-histamines), as risperidone
may increase the sedative effect of all of these
Medicines that may change the electrical activity
of your heart, such as medicines for malaria,
heart rhythm problems, allergies (antihistamines), some antidepressants or other
medicines for mental problems
Medicines that cause a slow heart beat
Medicines that cause low blood potassium
(such as certain diuretics)
Medicines to treat raised blood pressure.
Risperidone can lower blood pressure
Medicines for Parkinson’s disease (such as
levodopa)
Water tablets (diuretics) used for heart problems
or swelling of parts of your body due to a build up
of too much fluid (such as furosemide or
chlorothiazide). Risperidone taken by itself or
with furosemide, may have an increased risk of
stroke or death in elderly people with dementia.
The following medicines may reduce the effect
of risperidone
Rifampicin (a medicine for treating some
infections)
Carbamazepine, phenytoin (medicines for
epilepsy)
Phenobarbital
If you start or stop taking such medicines you may
need a different dose of risperidone.
The following medicines may increase the effect
of risperidone
Quinidine (used for certain types of heart
disease)
Antidepressants such as paroxetine, fluoxetine,
tricyclic antidepressants
Medicines known as beta blockers (used to treat
high blood pressure)
Phenothiazines (such as medicines used to treat
psychosis or to calm down)
Cimetidine, ranitidine (blockers of the acidity of
stomach)
Itraconazole and ketoconazole (medicines for
treating fungal infections)
Certain medicines used in the treatment of HIV/
AIDS, such as ritonavir
Verapamil, a medicine used to treat high blood
pressure and/or abnormal heart rhythm
Sertraline and fluvoxamine, medicines used to
treat depression and other psychiatric disorders.
If you start or stop taking such medicines you may
need a different dose of risperidone.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before using
Risperidone.
Risperidone with food, drink and alcohol
You can take this medicine with or without food.
You should avoid drinking alcohol when taking
Risperidone.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine. Your doctor will decide if
you can take it.
The following symptoms may occur in newborn
babies, of mothers that have used Risperidone in
the last trimester (last three months of their
pregnancy): shaking, muscle stiffness, and/or
weakness, sleepiness, agitation, breathing
problems, and difficulty in feeding. If your baby
develops any of these symptoms you may need
to contact your doctor.
Risperidone can raise your levels of a hormone
called ‘prolactin’ that may impact fertility (see
‘Possible side effects’).
Driving and using machines
Dizziness, tiredness, and vision problems may
occur during treatment with Risperidone. Do not
drive or use any tools or machines without talking to
your doctor first.
Risperidone film-coated tablets contain lactose
The film-coated tablets contain lactose, a type of
sugar. If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicinal product.
Risperidone 2mg and 6mg film-coated tablets
also contain sunset yellow (E110) that may cause
allergic reactions.
Risperidone orodispersible tablets contain
aspartame, a source of phenylalanine which may
be harmful for people with phenylketonuria.

3. How to take Risperidone
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
The recommended dose is as follows:
For the treatment of schizophrenia
Adults
The usual starting dose is 2mg per day, this may
be increased to 4mg per day on the second day
Your dose may then be adjusted by your doctor
depending on how you respond to the treatment
Most people feel better with daily doses of 4 to
6mg
This total daily dose can be divided into either
one or two doses a day. Your doctor will tell you
which is the best for you
Elderly people
Your starting dose will normally be 0.5mg twice a
day
Your dose may then be gradually increased by
your doctor to 1mg to 2mg twice a day
Your doctor will tell you which is the best for you

For children who weigh 50kg or more
The starting dose will normally be 0.5mg once a
day
The dose may be increased every other day in
steps of 0.5mg per day
The usual maintenance dose is 0.5mg to 1.5mg
once a day.
Treatment duration in patients with conduct disorder
should be not more than 6 weeks.
Children under 5 years old should not be treated
with Risperidone for conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting
doses and following doses of risperidone should be
halved. Dose increases should be slower in these
patients.
Risperidone should be used with caution in this
patient group.
Method of administration
For oral use

Risperidone film-coated tablets
You should swallow your tablet with a drink of
For the treatment of mania
water
Adults
The score line is only there to help you break the
tablet if you have difficulty swallowing it whole
Your starting dose will usually be 2mg once a day
Your dose may then be gradually adjusted by
Risperidone orodispersible tablets
your doctor depending on how you respond to
Only remove a tablet from the blister when it is time
the treatment
to take your medicine.
Most people feel better with doses of 1 to 6mg
Peel open a blister to expose the tablet
once a day
Do not push the tablet through the foil because it
may break
Elderly people
Remove the tablet from the blister with dry hands
Your starting dose will usually be 0.5mg twice a
day
Place the tablet on your tongue straight away
Your dose may then be gradually adjusted by
The tablet will begin disintegrating within seconds
your doctor to 1mg to 2mg twice a day depending
It can then be swallowed with or without water
on how much you respond to the treatment
If you take more Risperidone than you should
For the treatment of long-standing aggression
See a doctor right away. Take the medicine pack
in people with Alzheimer’s dementia
with you.
Adults (including elderly people)
In case of overdose you may feel sleepy or tired,
Your starting dose will normally be 0.25mg twice
or have abnormal body movements, problems
a day
standing and walking, feel dizzy due to low blood
Your dose may then be gradually adjusted by
pressure, or have abnormal heart beats or fits.
your doctor depending on how you respond to
the treatment
If you forget to take Risperidone
Most people feel better with 0.5mg twice a day.
If you forget to take a dose, take it as soon as
Some patients may need 1mg twice a day
you remember it. However, if it is almost time for
your next dose, skip the missed dose and
Treatment duration in patients with Alzheimer’s
continue as usual. If you miss two or more doses,
dementia should be not more than 6 weeks.
contact your doctor.
Use in children and adolescents
Do not take a double dose (two doses at the
same time) to make up for a forgotten dose.
Children and adolescents under 18 years old
should not be treated with Risperidone for
If you stop taking Risperidone
schizophrenia or mania.
You should not stop taking this medicine unless told
to do so by your doctor. Your symptoms may return.
For the treatment of conduct disorder
If your doctor decides to stop this medicine, your
The dose will depend on your child’s weight:
dose may be decreased gradually over a few days.
For children who weigh less than 50kg
The starting dose will normally be 0.25mg once a If you have any further questions on the use of this
day
medicine, ask your doctor or pharmacist.
The dose may be increased every other day in
steps of 0.25mg per day
The usual maintenance dose is 0.25mg to
0.75mg once a day.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately if you:
Experience blood clots in the veins, especially in
the legs (symptoms include swelling, pain, and
redness in the leg), which may travel through
blood vessels to the lungs causing chest pain
and difficulty in breathing. If you notice any of
these symptoms seek medical advice
immediately

Have dementia and experience a sudden change
in your mental state or sudden weakness or
numbness of your face, arms or legs, especially
on one side, or slurred speech, even for a short
period of time. These may be signs of a stroke
Experience fever, muscle stiffness, sweating or a
lowered level of consciousness (a disorder called
‘Neuroleptic Malignant Syndrome’). Immediate
medical treatment may be needed
Are a man and experience prolonged or painful
erection. This is called priapism. Immediate
medical treatment may be needed

4. Possible side effects (continued)
Experience involuntary rhythmic movements of
the tongue, mouth and face. Withdrawal of
risperidone may be needed
Experience severe allergic reaction characterised
by fever, swollen mouth, face, lip or tongue,
shortness of breath, itching, skin rash or drop in
blood pressure
The following side effects may happen:
Very Common (may affect more than 1 in 10
people):
Difficulty falling or staying asleep
Parkinsonism: This condition may include: slow
or impaired movement, sensation of stiffness or
tightness of the muscles (making your
movements jerky), and sometimes even a
sensation of movement ‘freezing up’ and then
restarting. Other signs of parkinsonism include a
slow shuffling walk, a tremor while at rest,
increased saliva and/or drooling, and a loss of
expression on the face
Feeling sleepy, or less alert
Headache

Stomach or intestinal infection, Stool
incontinence, Very hard stool, Difficulty
swallowing, Excessive passing of gas or wind
Hives (or ‘nettle rash’), Itching, Hair loss,
Thickening of skin, Eczema, Dry skin, Skin
discoloration, Acne, Flaky, itchy scalp or skin,
Skin disorder, Skin lesion
An increase of CPK (creatine phosphokinase) in
your blood, an enzyme which is sometimes
released with muscle breakdown
Abnormal posture, Joint stiffness, Joint swelling,
Muscle weakness, Neck pain
Frequent passing of urine, Inability to pass urine,
Pain when passing urine
Erectile dysfunction, Ejaculation disorder
Loss of menstrual periods, Missed menstrual
periods or other problems with your cycle
(females)
Development of breasts in men, Leakage of milk
from the breasts, Sexual dysfunction, Breast
pain, Breast discomfort, Vaginal discharge
Swelling of the face, mouth, eyes, or lips
Chills, An increase in body temperature
A change in the way you walk
Feeling thirsty, Feeling unwell, Chest discomfort,
Feeling ‘out of sorts’, Discomfort
Increased liver transaminases in your blood,
Increased GGT (a liver enzyme called gammaglutamyltransferase) in your blood, Increased
liver enzymes in your blood
Procedural pain.

Common (may affect up to 1 in 10 people):
Pneumonia, Infection of the chest (bronchitis),
Common cold symptoms, Sinus infection, Urinary
tract infection, Ear infection, Feeling like you
have the flu
Raised levels of a hormone called ‘prolactin’
found in a blood test (which may or may not
cause symptoms). Symptoms of high prolactin
occur uncommonly and may include in men
breast swelling, difficulty in getting or maintaining
erections, decreased sexual desire or other
Rare (may affect up to 1 in 1,000 people):
sexual dysfunction. In women they may include
Infection
breast discomfort, leakage of milk from the
breasts, missed menstrual periods, or other
Inappropriate secretion of a hormone that
problems with your cycle, or fertility problems
controls urine volume
Weight gain, Increased appetite, Decreased
Sugar in the urine, Low blood sugar, High blood
appetite
triglycerides (a fat)
Sleep disorder, Irritability, Depression, Anxiety,
Lack of emotion, Inability to reach orgasm
Restlessness
Neuroleptic malignant syndrome (confusion,
Dystonia: This is a condition involving slow or
reduced or loss of consciousness, high fever, and
sustained involuntary contraction of muscles.
severe muscle stiffness)
While it can involve any part of the body (and
Blood vessel problems in the brain
may result in abnormal posture), dystonia often
Coma due to uncontrolled diabetes
involves muscles of the face, including abnormal
movements of the eyes, mouth, tongue or jaw.
Shaking of the head
Dizziness
Glaucoma (increased pressure within the
eyeball), Problems with movement of your eyes,
Dyskinesia: This is a condition involving
Eye rolling, Eyelid margin crusting
involuntary muscle movements, and can include
repetitive, spastic or writhing movements, or
Eye problems during cataract surgery. During
twitching.
cataract surgery, a condition called intraoperative
floppy iris syndrome (IFIS) can happen if you
Tremor (shaking)
take or have taken Risperidone. If you need to
Blurry vision, Eye infection or ‘pink eye’
have cataract surgery, be sure to tell your eye
Rapid heart rate, High blood pressure, Shortness
doctor if you take or have taken this medicine
of breath
Dangerously low numbers of a certain type of
Sore throat, Cough, Nosebleeds, Stuffy nose
white blood cell needed to fight infection in your
blood
Abdominal pain, Abdominal discomfort, Vomiting,
Nausea, Constipation, Diarrhea, Indigestion, Dry
Severe allergic reaction characterised by fever,
mouth, Toothache
swollen mouth, face, lip or tongue, shortness of
breath, itching, skin rash and sometimes drop in
Rash, Skin redness
blood pressure
Muscle spasms, Bone or muscle ache, Back
Dangerously excessive intake of water
pain, Joint pain
Irregular heart beat
Incontinence (lack of control) of urine
Blood clot in the legs, Blood clot in the lungs
Swelling of the body, arms or legs, Fever, Chest
pain, Weakness, Fatigue (tiredness), Pain
Trouble breathing during sleep (sleep apnea),
Fast, shallow breathing
Fall
Inflammation of the pancreas, A blockage in the
Uncommon (may affect up to 1 in 100 people):
bowels
Infection of the breathing passages, Bladder
Swollen tongue, Chapped lips, Rash on skin
infection, Eye infection, Tonsillitis, Fungal
related to drug
infection of the nails, Infection of the skin, An
Dandruff
infection confined to a single area of skin or part
of the body, Viral infection, Skin inflammation
Breakdown of muscle fibers and pain in muscles
caused by mites
(rhabdomyolysis)
Decrease in the type of white blood cells that
A delay in menstrual periods, Enlargement of the
help to protect you against infection, White blood
glands in your breasts, Breast enlargement,
cell count decreased, Decrease in platelets
Discharge from the breasts
(blood cells that help you stop bleeding), Anemia,
Increased insulin (a hormone that controls blood
Decrease in red blood cells, Increase in
sugar levels) in your blood
eosinophils (a type of white blood cell) in your
Priapism (a prolonged penile erection that may
blood
require surgical treatment)
Allergic reaction
Hardening of the skin
Diabetes or worsening of diabetes, High blood
Decreased body temperature, Coldness in arms
sugar, Excessive drinking of water
and legs
Weight loss, Loss of appetite resulting in
Symptoms of drug withdrawal
malnutrition and low body weight
Yellowing of the skin and the eyes (jaundice)
Increased cholesterol in your blood
Elated mood (mania), Confusion, Decreased
Very rare (may affect up to 1 in 10,000 people):
sexual drive, Nervousness, Nightmares
Life-threatening complications of uncontrolled
Tardive dyskinesia (twitching or jerking
diabetes.
movements that you cannot control in your face,
Serious allergic reaction with swelling that may
tongue, or other parts of your body). Tell your
involve the throat and lead to difficulty in
doctor immediately if you experience involuntary
breathing.
rhythmic movements of the tongue, mouth and
Lack of bowel muscle movement that causes
face. Withdrawal of Risperidone may be needed
blockage.
Sudden loss of blood supply to brain (stroke or
‘mini’ stroke)
Unresponsive to stimuli, Loss of consciousness,
Low level of consciousness
Convulsion (fits), Fainting
A restless urge to move parts of your body,
Balance disorder, Abnormal coordination,
Dizziness upon standing, Disturbance in
attention, Problems with speech, Loss or
abnormal sense of taste, Reduced sensation of
skin to pain and touch, A sensation of tingling,
pricking, or numbness of the skin
Oversensitivity of the eyes to light, Dry eye,
Increased tears, Redness of the eyes
Sensation of spinning (vertigo), Ringing in the
ears, Ear pain
Atrial fibrillation (an abnormal heart rhythm), An
interruption in conduction between the upper and
lower parts of the heart, Abnormal electrical
conduction of the heart, Prolongation of the QT
interval from your heart, Slow heart rate,
Abnormal electrical tracing of the heart
(electrocardiogram or ECG), A fluttering or
pounding feeling in your chest (palpitations)
Low blood pressure, Low blood pressure upon
standing (consequently, some people taking
Risperidone may feel faint, dizzy, or may pass
out when they stand up or sit up suddenly,
Flushing
Pneumonia caused by inhaling food, Lung
congestion, Congestion of breathing passages,
Crackly lung sounds, Wheezing, Voice disorder,
Breathing passage disorder

The following side effect has been seen with the
use of another medicine called paliperidone that is
very similar to risperidone, so these can also be
expected with Risperidone: Rapid heart beat upon
standing.
Additional side effects in children and
adolescents
In general, side effects in children are expected to
be similar to those in adults.
The following side effects were reported more often
in children and adolescents (5 to 17 years) than in
adults: feeling sleepy, or less alert, fatigue
(tiredness), headache, increased appetite, vomiting,
common cold symptoms, nasal congestion,
abdominal pain, dizziness, cough, fever, tremor
(shaking), diarrhoea, and incontinence (lack of
control) of urine.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Risperidone
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 30°C. Store in the original
package in order to protect form light and
moisture.
Do not take your tablets after the expiry date which
is stated on the carton and blister label after ‘Exp’.
The expiry date refers to the last day of that
month.
If your tablets become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.

Remember if your doctor tells you to stop taking
this medicine; return any unused tablets to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Risperidone contains
Each orodispersible tablet contains 4mg
risperidone.

Manufactured by: Janssen-Cilag S.p.A., Via C.
Janssen, Borgo San Michelle, Latina, I-04010,
Italy.

The other ingredients are:
polacrilex resin, gelatin, mannitol, glycine,
simeticone, carbomer, sodium hydroxide,
aspartame E951, peppermint oil, xanthan gum and
red ferric oxide (E172).

Procured from within the EU and repackaged by
the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU UK.

What Risperidone looks like and contents of the
pack

Risperidone 4mg orodispersible tablets;
PL 18799/2462
Leaflet date: 19.10.2015

Risperidone are round, coral coloured biconvex
orodispersible tablets embossed with ‘R4’on one
side and plain on the reverse.
Risperidone is available in blister packs of 28
tablets.

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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