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RISPERDAL 3MG FILM-COATED TABLETS

Active substance(s): RISPERIDONE

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Package leaflet: Information for the user

© J-C 2017

GB-IE - AW_131416

0.5, 1, 2, 3, 4 and 6 mg
film-coated tablets
Quicklet 0.5, 1, 2, 3 and 4 mg
orodispersible tablets
Risperidone
Read all of this leaflet carefully before
you start taking this medicinebecause 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.

What is in this leaflet
1 What Risperdalis 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
‘antipsychotics’.
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 long-term
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 long-term
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 (hypersensitive) 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 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 caregiver 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-feedingand
fertility

• If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor orpharmacist 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 2 mg and 6 mg film-coated tablets
also contain sunset yellow (E110) that may cause
allergic reactions.
Risperdal 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 2 mg per day, this may
be increased to 4 mg 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 6 mg
• 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 0.5 mg twice a day
• Your dose may then be gradually increased by your
doctor to 1 mg to 2 mg 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 2 mg 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 6 mg
once a day.
Elderly people
• Your starting dose will usually be 0.5 mg twice
a day
• Your dose may then be gradually adjusted by your
doctor to 1 mg to 2 mg 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 0.25 mg 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 0.5 mg twice a day.
Some patients may need 1 mg 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 50 kg
• The starting dose will normally be 0.25 mg once
a day
• The dose may be increased every other day in
steps of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg
once a day.
For children who weigh 50 kg or more
• The starting dose will normally be 0.5 mg once
a day
• The dose may be increased every other day in
steps of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg
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 heartbeats 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.

© J-C 2017

GB-IE - AW_131416

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
any of the following uncommon side effects
(may affect up to 1 in 100 people):
• 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 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
Tell your doctor immediately if you experience
any of the following rare side effects (may affect
up to 1 in 1,000 people):
• 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
• 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
• 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 other side effects may also 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, rritability, 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, nose bleeds, stuffy nose
• Abdominal pain, abdominal discomfort, vomiting,
nausea, constipation, diarrhea, 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
• 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 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"), ttching, 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
• 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
• Dangerously excessive intake of water
• Irregular heart beat
• 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
• 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
withRisperdal: Rapid heartbeat 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
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Risperdal
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the blister, carton, or bottle. The expiry
date refers to the last day of that month.
Do not store above 30°C.

Risperdal film-coated tablets

Blister packs: Store in the original package in order
to protect from light.

Risperdal Quicklet orodispersible
tablets

Store in the original package in order to protect from
moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6 Contents of the pack and other information
What Risperdal contains

The active substance is risperidone.
Each Risperdal film-coated tablet contains either 0.5 mg,
1 mg, 2 mg, 3 mg, 4 mg or 6 mg of risperidone.
The other ingredients are:
Risperdal 0.5 mg film-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose (E464),
Magnesium stearate, Silica colloidal anhydrous,
Sodium laurilsulfate. Film-coating: Hypromellose
(E464), Propylene glycol (E490), Titanium dioxide
(E171), Talc (E553B), Red Ferric Oxide (E172).
Risperdal 1 mg film-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose
(E464), Magnesium stearate, Silica colloidal
anhydrous, Sodium laurilsulfate. Film-coating:
Hypromellose (E464), Propylene glycol (E490).
Risperdal 2 mg film-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose
(E464), Magnesium stearate,Silica colloidal
anhydrous, Sodium laurilsulfate. Film-coating:
Hypromellose (E464), Propylene glycol (E490),
Titanium dioxide (E171), Talc (E553B), Orange
yellow S aluminium lake (Sunset yellow) E110
Risperdal 3 mg film-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose
(E464, Magnesium stearate, Silica colloidal anhydrous,
Sodium laurilsulfate. Film-coating: Hypromellose
(E464), Propylene glycol (E490), Titanium dioxide
(E171), Talc (E553B), Quinoline yellow (E104).
Risperdal 4 mg film-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose (E464),
Magnesium stearate, Silica colloidal anhydrous,
Sodium laurilsulfate. Film-coating: Hypromellose
(E464), Propylene glycol (E490), Titanium dioxide
(E171), Talc(E553B), Quinoline yellow (E104),
Indigotindisulfonate aluminium lake (E132).
Risperdal 6 mg film-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Magnesium
stearate, Silica colloidal anhydrous, Sodium
laurilsulfate. Film-coating: Hypromellose (E464),
Propylene glycol (E490), Titanium dioxide (E171),
Talc (E553B), Quinoline yellow (E104), Orange
yellow S aluminium lake (Sunset yellow) E110.
Each Risperdal orodispersible tablet contains either
0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone.
The other ingredients are:
Square 2 mg, round 3 mg and round 4 mg orodispersible
tablets:
Polacrilex resin, Gelatin, Mannitol, Glycine, Simeticone,
Carbomer, Sodium hydroxide, Aspartame (E951),
Red Ferric Oxide (E172), Peppermint oil, Xanthan gum.
Round 0.5 mg and square 1 mg orodispersible tablets
Polacrilex resin, Gelatin, Mannitol, Glycine, Simeticone,
Carbomer, Sodium hydroxide, Aspartame (E951),
Red Ferric Oxide (E172), Peppermint oil.

What Risperdal looks like and
contents of the pack

Risperdal film-coated tablets are packaged in
PVC/LDPE/PVDC/aluminium foil blisters and HDPE
bottles with PP screw cap.
Risperdal orodispersible tablets are packaged
in PCTFE/PE/PVC/Al blister film/foil or Aluminium/
Aluminium foil/foil blisters.

Risperdal film-coated tablets

• 0.5 mg risperidone are brownish-red, half-scored,
oblong, biconvex film-coated tablets of 9 mm x 5 mm
• 1 mg risperidone are white, half-scored, oblong,
biconvex film-coated tablets of 10.5 mm x 5 mm
• 2 mg risperidone are orange, half-scored, oblong,
biconvex film-coated tablets of 10.5 mm x 5 mm
• 3 mg risperidone are yellow, half-scored, oblong,
biconvex film-coated tablets of 13.5 mm x 5 mm
• 4 mg risperidone are green, half-scored, oblong,
biconvex film-coated tablets of 15 mm x 6.5 mm
• 6 mg risperidone are yellow, circular, biconvex filmcoated tablets of 8 mm.
Film-coated tablets are etched on one side with RIS
0.5, RIS 1, RIS 2, RIS 3, RIS 4, and RIS 6 respectively.
Additionally JANSSEN may be etched on the other side.

Pack sizes
Risperdal film-coated tablets are available in the
following pack sizes:
• 0.5 mg: blister packs containing 20 or 50 tablets
and bottles containing 500 tablets
• 1 mg: blister packs containing 6, 20, 50, 60,
or 100 tablets and bottles containing 500 tablets
• 2 mg: blister packs containing 10, 20, 50, 60,
or 100 tablets and bottles containing 500 tablets
• 3 mg: blister packs containing 20, 50, 60,
or 100 tablets
• 4 mg: blister packs containing 10, 20, 30, 50, 60,
or 100 tablets
• 6 mg: blister packs containing 28, 30, or 60 tablets.
Not all pack sizesmay be marketed

Risperdal Quicklet orodispersible
tablets

• 0.5 mg risperidone are light coral, round,
biconvex orodispersible tablets of 10 mm
• 1 mg risperidone are light coral, square,
biconvex orodispersible tablets of 11 mm
• 2 mg risperidone are coral, square,
biconvex orodispersible tablets of 11 mm
• 3 mg risperidone are coral, round,
biconvex orodispersible tablets of 14 mm
• 4 mg risperidone are coral, round,
biconvex orodispersible tablets of 16 mm.
Orodispersible tablets are imprinted on one side with
R0.5, R1, R2, R3, and R4 respectively.
Pack sizes
• 0.5 mg: packs containing 28 or 56 tablets
• 1 mg: packs containing 28 or 56 tablets
• 2 mg: packs containing 28 or 56 tablets
• 3 mg: packs containing 28 or 56 tablets
• 4 mg: packs containing 28 or 56 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The marketing authorization is held by:
Janssen-Cilag Ltd., 50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire, HP12 4EG, UK
Risperdal film-coated tablets and Risperdal
Quicklet orodispersible tablets are made by:
Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo
San Michele, Latina, Italy
OR
McGregor Cory Ltd, Middleton Road, Banbury,
OX16 4RS, UK
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria:
Risperdal / Risperdal Quicklet
Belgium:
RISPERDAL / RISPERDAL Instasolv
Cyprus:
RISPERDAL
Czech Republic: RISPERDAL
Denmark:
RISPERDAL
Estonia:
RISPOLEPT /
Finland:
RISPERDAL / RISPERDAL
INSTASOLV
France:
RISPERDAL / RISPERDALORO
Germany:
RISPERDAL 1 mg;2 mg;3 mg;4
mg/ Risperdal 0,5mg;6mg /
RISPERDAL QUICKLET 0,5 mg /
RISPERDAL QUICKLET 1 mg; 2 mg,
3 mg; 4 mg / Risperdal Lösung
1 mg/ml
Greece:
RISPERDAL / RISPERDAL
QUICKLET
Hungary:
RISPERDAL
Iceland:
RISPERDAL
Ireland:
RISPERDAL / RISPERDAL Quicklet
Italy:
RISPERDAL
Lithuania:
RISPOLEPT
Latvia:
RISPOLEPT / RISPERDAL Quicklet
Luxembourg:
RISPERDAL RISPERDAL Instasolv
Malta:
RISPERDAL
Netherlands:
RISPERDAL / RISPERDAL Quicklet
Norway:
RISPERDAL / RISPERDAL
smeltetabletter
Poland:
RISPOLEPT /
Portugal:
RISPERDAL / RISPERDAL
QUICKLET
Romania:
RISPOLEPT
Slovenia:
RISPERDAL
Spain:
RISPERDAL / RISPERDAL FLAS
Sweden:
RISPERDAL
United Kingdom: RISPERDAL / RISPERDAL Quicklet
This leaflet was last revised in 09/2017.

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