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RISPERIDONE 3MG ORODISPERSIBLE TABLETS

Active substance(s): RISPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperdal® Quicklet® 3mg 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
3mg 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 0.5 mg, 1mg, and 2mg orodispersible
Tablets.
What is in this leaflet:
1

What Risperdal is and what it is used for

2
3

What you need to know before you take
Risperdal
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 antipsychotics 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 preexisting 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 antihistamines), 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 the treatment of mania
Adults
Your starting dose will usually be 2mg once a
day
Your dose may then be gradually adjusted by
your doctor depending on how you respond to
the treatment
Most people feel better with doses of 1 to 6mg
once a day.
Elderly people
Your starting dose will usually be 0.5mg twice
a day
Your dose may then be gradually adjusted by
your doctor to 1mg to 2mg twice a day
depending on how much you respond to the
treatment.
For the treatment of long-standing
aggression in people with Alzheimer’s
dementia
Adults (including elderly people)
Your starting dose will normally be 0.25mg
twice a day
Your dose may then be gradually adjusted by
your doctor depending on how you respond to
the treatment
Most people feel better with 0.5mg twice a day.
Some patients may need 1mg twice a day
Treatment duration in patients with Alzheimer‟s
dementia should be not more than 6 weeks.
Use in children and adolescents
Children and adolescents under 18 years old
should not be treated with Risperdal for
schizophrenia or mania.
For the treatment of conduct disorder
The dose will depend on your child‟s weight:
For children who weigh less than 50kg
The starting dose will normally be 0.25mg once
a day
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.

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
water
The score line is only there to help you break
the tablet if you have difficulty swallowing it
whole.
Risperdal Quicklet orodispersible tablets
Only remove a tablet from the blister when it is
time to take your medicine.
Peel open a blister to expose the tablet
Do not push the tablet through the foil because
it may break
Remove the tablet from the blister with dry
hands
Place the tablet on your tongue straight away
The tablet will begin disintegrating within
seconds
It can then be swallowed with or without water.
If you take more Risperdal than you should
See a doctor right away. Take the medicine
pack with you
In case of overdose you may feel sleepy or
tired, or have abnormal body movements,
problems standing and walking, feel dizzy due
to low blood pressure, or have abnormal heart
beats or fits.
If you forget to take Risperdal
If you forget to take a dose, take it as soon as
you remember it. However, if it is almost time
for your next dose, skip the missed dose and
continue as usual. If you miss two or more
doses, contact your doctor
Do not take a double dose (two doses at the
same time) to make up for a forgotten dose
If you stop taking Risperdal
You should not stop taking this medicine unless
told to do so by your doctor. Your symptoms may
return. If your doctor decides to stop this
medicine, your dose may be decreased gradually
over a few days.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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 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
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 sexual dysfunction. In women they
may include breast discomfort, leakage of milk
from the breasts, missed menstrual periods, or
other problems with your cycle or fertility
problems
Weight gain, Increased appetite, Decreased
appetite
Sleep disorder, Irritability, Depression, Anxiety,
Restlessness
Dystonia: This is a condition involving slow or
sustained involuntary contraction of muscles.
While it can involve any part of the body (and
may result in abnormal posture), dystonia often
involves muscles of the face, including
abnormal movements of the eyes, mouth,
tongue or jaw
Dizziness
Dyskinesia: This is a condition involving
involuntary muscle movements, and can
include repetitive, spastic or writhing
movements, or twitching
Tremor (shaking)
Blurry vision, Eye infection or „pink eye‟
Rapid heart rate, High blood pressure,
Shortness of breath
Sore throat, Cough, Nosebleeds, Stuffy nose
Abdominal pain, Abdominal discomfort,
Vomiting, Nausea, Constipation, Diarrhoea,
Indigestion, Dry mouth, Toothache
Rash, Skin redness
Muscle spasms, Bone or muscle ache, Back
pain, Joint pain
Incontinence (lack of control) of urine
Swelling of the body, arms or legs, Fever,
Chest pain, Weakness, Fatigue (tiredness),
Pain
Fall
Uncommon (may affect up to 1 in 100
people):
Infection of the breathing passages, Bladder
infection, Eye infection, Tonsillitis, Fungal
infection of the nails, Infection of the skin, An
infection confined to a single area of skin or
part of the body, Viral infection, Skin
inflammation caused by mites
Decrease in the type of white blood cells that
help to protect you against infection, White
blood cell count decreased, Decrease in
platelets (blood cells that help you stop
bleeding), Anemia, Decrease in red blood cells,
Increase in eosinophils (a type of white blood
cell) in your blood
Allergic reaction
Diabetes or worsening of diabetes, High blood
sugar, Excessive drinking of water
Weight loss, Loss of appetite resulting in
malnutrition and low body weight
Increased cholesterol in your blood
Elated mood (mania), Confusion, Decreased
sexual drive, Nervousness, Nightmares
Tardive dyskinesia (twitching or jerking
movements that you cannot control in your
face, tongue, or other parts of your body). Tell
your doctor immediately if you experience
involuntary rhythmic movements of the tongue,
mouth and face. Withdrawal of Risperdal may
be needed,
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 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
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.
Rare (may affect up to 1 in 1,000 people):
Infection
Inappropriate secretion of a hormone that
controls urine volume
Sugar in the urine, Low blood sugar, High blood
triglycerides (a fat)
Lack of emotion, Inability to reach orgasm
Neuroleptic malignant syndrome (confusion,
reduced or loss of consciousness, high fever,
and severe muscle stiffness)
Blood vessel problems in the brain
Coma due to uncontrolled diabetes
Shaking of the head
Glaucoma (increased pressure within the
eyeball), Problems with movement of your
eyes, Eye rolling, Eyelid margin crusting
Eye problems during cataract surgery. During
cataract surgery, a condition called
intraoperative floppy iris syndrome (IFIS) can
happen if you take or have taken Risperdal. If
you need to have cataract surgery, be sure to
tell your eye doctor if you take or have taken
this medicine
Dangerously low numbers of a certain type of
white blood cell needed to fight infection in your
blood
Severe allergic reaction characterised by fever,
swollen mouth, face, lip or tongue, shortness of
breath, itching, skin rash and sometimes drop
in blood pressure
Dangerously excessive intake of water
Irregular heart beat
Blood clot in the legs, Blood clot in the lungs
Trouble breathing during sleep (sleep apnea),
Fast, shallow breathing
Inflammation of the pancreas, A blockage in the
bowels
Swollen tongue, Chapped lips, Rash on skin
related to drug
Dandruff
Breakdown of muscle fibers and pain in
muscles (rhabdomyolysis)
A delay in menstrual periods, Enlargement of
the glands in your breasts, Breast enlargement,
Discharge from the breasts
Increased insulin (a hormone that controls
blood sugar levels) in your blood
Priapism (a prolonged penile erection that may
require surgical treatment)
Hardening of the skin
Decreased body temperature, Coldness in
arms and legs
Symptoms of drug withdrawal
Yellowing of the skin and the eyes (jaundice).
Very rare (may affect up to 1 in 10,000
people):
Life-threatening complications of uncontrolled
diabetes.
Serious allergic reaction with swelling that may
involve the throat and lead to difficulty
breathing.
Lack of bowel muscle movement that causes
blockage.
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 or
pharmacist. 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.
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.
Always return any left-over medicine to your
pharmacist. Only keep it if your doctor tells you
to.
Store in the original package.

If your tablets become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
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
The active substance is risperidone.
Each orodispersible tablet contains 3mg
risperidone.
The other ingredients are: polacrilex resin,
gelatin, mannitol, glycine, simeticone, carbomer,
sodium hydroxide, aspartame (E951), red iron
oxide (E172), peppermint oil and xanthan gum.
What Risperdal looks like and contents of the
pack
Risperdal is biconvex, circular, coral color
orodispersible tablet and embossed with “R3” on
one side and plain on the reverse.
Risperdal tablet is available in blister packs of 28
tablets.

Manufactured by:
Janssen-Cilag, S.A. Paseo de Las Doce
Estrellas, 5-7 28042 Madrid , Spain
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU UK.
Risperdal® Quicklet® 3mg orodispersible
tablets– PL 18799/2322
POM
Leaflet date: 04.09.2015

PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone 3mg 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 Risperidone 3mg
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
Quicklet 0.5 mg, 1mg, and 2mg orodispersible
Tablets.
What is in this leaflet:
1

What Risperidone is and what it is used
for

2
3

What you need to know before you take
Risperidone
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 antipsychotics 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 antihistamines), 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 Quicklet 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 the treatment of mania
Adults
Your starting dose will usually be 2mg once a
day
Your dose may then be gradually adjusted by
your doctor depending on how you respond to
the treatment
Most people feel better with doses of 1 to 6mg
once a day.
Elderly people
Your starting dose will usually be 0.5mg twice
a day
Your dose may then be gradually adjusted by
your doctor to 1mg to 2mg twice a day
depending on how much you respond to the
treatment.
For the treatment of long-standing
aggression in people with Alzheimer’s
dementia
Adults (including elderly people)
Your starting dose will normally be 0.25mg
twice a day
Your dose may then be gradually adjusted by
your doctor depending on how you respond to
the treatment
Most people feel better with 0.5mg twice a day.
Some patients may need 1mg twice a day
Treatment duration in patients with Alzheimer‟s
dementia should be not more than 6 weeks.
Use in children and adolescents
Children and adolescents under 18 years old
should not be treated with Risperidone for
schizophrenia or mania.
For the treatment of conduct disorder
The dose will depend on your child‟s weight:
For children who weigh less than 50kg
The starting dose will normally be 0.25mg once
a day
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.

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
water
The score line is only there to help you break
the tablet if you have difficulty swallowing it
whole.
Risperidone Quicklet orodispersible tablets
Only remove a tablet from the blister when it is
time to take your medicine.
Peel open a blister to expose the tablet
Do not push the tablet through the foil because
it may break
Remove the tablet from the blister with dry
hands
Place the tablet on your tongue straight away
The tablet will begin disintegrating within
seconds
It can then be swallowed with or without water.
If you take more Risperidone than you
should
See a doctor right away. Take the medicine
pack with you
In case of overdose you may feel sleepy or
tired, or have abnormal body movements,
problems standing and walking, feel dizzy due
to low blood pressure, or have abnormal heart
beats or fits.
If you forget to take Risperidone
If you forget to take a dose, take it as soon as
you remember it. However, if it is almost time
for your next dose, skip the missed dose and
continue as usual. If you miss two or more
doses, contact your doctor
Do not take a double dose (two doses at the
same time) to make up for a forgotten dose
If you stop taking Risperidone
You should not stop taking this medicine unless
told to do so by your doctor. Your symptoms may
return. If your doctor decides to stop this
medicine, your dose may be decreased gradually
over a few days.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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 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
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 sexual dysfunction. In women they
may include breast discomfort, leakage of milk
from the breasts, missed menstrual periods, or
other problems with your cycle or fertility
problems
Weight gain, Increased appetite, Decreased
appetite
Sleep disorder, Irritability, Depression, Anxiety,
Restlessness
Dystonia: This is a condition involving slow or
sustained involuntary contraction of muscles.
While it can involve any part of the body (and
may result in abnormal posture), dystonia often
involves muscles of the face, including
abnormal movements of the eyes, mouth,
tongue or jaw
Dizziness
Dyskinesia: This is a condition involving
involuntary muscle movements, and can
include repetitive, spastic or writhing
movements, or twitching
Tremor (shaking)
Blurry vision, Eye infection or „pink eye‟
Rapid heart rate, High blood pressure,
Shortness of breath
Sore throat, Cough, Nosebleeds, Stuffy nose
Abdominal pain, Abdominal discomfort,
Vomiting, Nausea, Constipation, Diarrhoea,
Indigestion, Dry mouth, Toothache
Rash, Skin redness
Muscle spasms, Bone or muscle ache, Back
pain, Joint pain
Incontinence (lack of control) of urine
Swelling of the body, arms or legs, Fever,
Chest pain, Weakness, Fatigue (tiredness),
Pain
Fall
Uncommon (may affect up to 1 in 100
people):
Infection of the breathing passages, Bladder
infection, Eye infection, Tonsillitis, Fungal
infection of the nails, Infection of the skin, An
infection confined to a single area of skin or
part of the body, Viral infection, Skin
inflammation caused by mites
Decrease in the type of white blood cells that
help to protect you against infection, White
blood cell count decreased, Decrease in
platelets (blood cells that help you stop
bleeding), Anemia, Decrease in red blood cells,
Increase in eosinophils (a type of white blood
cell) in your blood
Allergic reaction
Diabetes or worsening of diabetes, High blood
sugar, Excessive drinking of water
Weight loss, Loss of appetite resulting in
malnutrition and low body weight
Increased cholesterol in your blood
Elated mood (mania), Confusion, Decreased
sexual drive, Nervousness, Nightmares
Tardive dyskinesia (twitching or jerking
movements that you cannot control in your
face, tongue, or other parts of your body). Tell
your doctor immediately if you experience
involuntary rhythmic movements of the tongue,
mouth and face. Withdrawal of Risperidone
may be needed,
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 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
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.
Rare (may affect up to 1 in 1,000 people):
Infection
Inappropriate secretion of a hormone that
controls urine volume
Sugar in the urine, Low blood sugar, High blood
triglycerides (a fat)
Lack of emotion, Inability to reach orgasm
Neuroleptic malignant syndrome (confusion,
reduced or loss of consciousness, high fever,
and severe muscle stiffness)
Blood vessel problems in the brain
Coma due to uncontrolled diabetes
Shaking of the head
Glaucoma (increased pressure within the
eyeball), Problems with movement of your
eyes, Eye rolling, Eyelid margin crusting
Eye problems during cataract surgery. During
cataract surgery, a condition called
intraoperative floppy iris syndrome (IFIS) can
happen if you take or have taken Risperidone .
If you need to have cataract surgery, be sure to
tell your eye doctor if you take or have taken
this medicine
Dangerously low numbers of a certain type of
white blood cell needed to fight infection in your
blood
Severe allergic reaction characterised by fever,
swollen mouth, face, lip or tongue, shortness of
breath, itching, skin rash and sometimes drop
in blood pressure
Dangerously excessive intake of water
Irregular heart beat
Blood clot in the legs, Blood clot in the lungs
Trouble breathing during sleep (sleep apnea),
Fast, shallow breathing
Inflammation of the pancreas, A blockage in the
bowels
Swollen tongue, Chapped lips, Rash on skin
related to drug
Dandruff
Breakdown of muscle fibers and pain in
muscles (rhabdomyolysis)
A delay in menstrual periods, Enlargement of
the glands in your breasts, Breast enlargement,
Discharge from the breasts
Increased insulin (a hormone that controls
blood sugar levels) in your blood
Priapism (a prolonged penile erection that may
require surgical treatment)
Hardening of the skin
Decreased body temperature, Coldness in
arms and legs
Symptoms of drug withdrawal
Yellowing of the skin and the eyes (jaundice).
Very rare (may affect up to 1 in 10,000
people):
Life-threatening complications of uncontrolled
diabetes.
Serious allergic reaction with swelling that may
involve the throat and lead to difficulty
breathing.
Lack of bowel muscle movement that causes
blockage.
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 or
pharmacist. 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.
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.
Always return any left-over medicine to your
pharmacist. Only keep it if your doctor tells you
to.
Store in the original package.

If your tablets become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
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
The active substance is risperidone.
Each orodispersible tablet contains 3mg
risperidone.
The other ingredients are: polacrilex resin,
gelatin, mannitol, glycine, simeticone, carbomer,
sodium hydroxide, aspartame (E951), red iron
oxide (E172), peppermint oil and xanthan gum.
What Risperidone looks like and contents of
the pack
Risperidone is biconvex, circular, coral color
orodispersible tablet and embossed with “R3” on
one side and plain on the reverse.
Risperidone tablet is available in blister packs of
28 tablets.

Manufactured by:
Janssen-Cilag, S.A. Paseo de Las Doce
Estrellas, 5-7 28042 Madrid , Spain
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU UK.
Risperidone 3mg orodispersible tablets– PL
18799/2322
POM
Leaflet date: 04.09.2015

Expand view ⇕

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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