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RISPERDAL QUICKLET 0.5 MG ORODISPERSIBLE TABLETS

Active substance: RISPERIDONE

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Package lea et: Information for the user

© J-C 2015

GBIE - AW_103225

0.5, 1, 2, 3, 4 and 6 mg film-coated tablets
0.5, 1, 2, 3 and 4 mg
orodispersible tablets
Risperidone
Read all of this lea et carefully before
you start taking this medicine because it
contains important information for you.

• Keep this lea et. 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 e ects, talk to your doctor
or pharmacist. This includes any possible side
e ects not listed in this lea et. See section 4.

What is in this lea et:
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 e ects
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 long-term
aggression in people with Alzheimer’s dementia,
who harm themselves or others. Alternative (nondrug) 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 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 sti ness,
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 ght 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. Signi cant
weight gain may adversely a ect 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 e ects such as
menstrual disorders or fertility problems in women,
breast swelling in men (see Possible side e ects). If
such side e ects 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 oppy 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 di culties.
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 e ect 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 e ect of all of these
• Medicines that may change the electrical activity of
your heart, such as medicines for malaria, heart
rhythm problems, allergies (anti-histamines), 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 uid (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
e ect 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 di erent dose of risperidone.

The following medicines may increase
the e ect of risperidone

• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, uoxetine,
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 uvoxamine, medicines used to treat
depression and other psychiatric disorders.
If you start or stop taking such medicines you may
need a di erent 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 sti ness, and/or weakness,
sleepiness, agitation, breathing problems, and
di culty 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 e ects).

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
rst.
Risperdal lm-coated tablets contain lactose
The lm-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 lm-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 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 lm-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 di culty 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 ts.

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 e ects
Like all medicines, this medicine can cause side
e ects, 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
di culty breathing. If you notice any ofthese
if 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 sti ness, 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

© J-C 2015

GBIE - AW_103225

4 Possible side e ects (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 e ects may happen:
Very Common (may a ect more than 1 in
10 people):
• Di culty falling or staying asleep
• Parkinsonism: This condition may include: slow or
impaired movement, sensation of sti ness 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 shu ing 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 a ect 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 u
• 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, di culty 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
a
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, Stu y 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 a ect 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 con ned
to a single area of skin or part of the body, Viral
infection, Skin in ammation 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 ( ts), 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 brillation (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 uttering 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, Di culty 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 sti ness, 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 a ect 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 sti ness)
• 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
oppy 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 ght 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
• In ammation of the pancreas, A blockage in the
bowels
• Swollen tongue, Chapped lips, Rash on skin
related to drug
• Dandru
• Breakdown of muscle bers 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 a ect 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 di culty breathing.
• Lack of bowel muscle movement that causes
blockage.
The following side e ect 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 heartbeat upon standing.
Additional side e ects in children and
adolescents
In general, side e ects in children are expected to be
similar to those in adults.
The following side e ects 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 e ects

If you get any side e ects, talk to your doctor or
pharmacist. This includes any possible side e ects
not listed in this lea et. You can also report side
e ects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
g
y
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
p
e-mail: medsafety@hpra.ie
By reporting side e ects 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 lm-coated tablets

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.

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

6 Contents of the pack and other information
What Risperdal contains

The active substance is risperidone
Each Risperdal lm-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 lm-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose
(E464), Magnesium stearate, Silica colloidal
anhydrous, Sodium laurilsulfate. Film-coating:
g
Hypromellose (E464), Propylene glycol (E490),
Titanium dioxide (E171), Talc (E553B), Red Ferric
Oxide (E172)
RISPERDAL 1 mg lm-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose
(E464), Magnesium stearate, Silica colloidal
anhydrous, Sodium laurilsulfate. Film-coating:
g
Hypromellose (E464), Propylene glycol (E490)
RISPERDAL 2 mg lm-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose
(E464), Magnesium stearate,Silica colloidal
anhydrous, Sodium laurilsulfate. Film-coating:
g
Hypromellose (E464), Propylene glycol (E490),
Titanium dioxide (E171), Talc (E553B), Orange yellow
S aluminium lake (Sunset yellow) E110
RISPERDAL 3 mg lm-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose
(E464, Magnesium stearate, Silica colloidal
anhydrous, Sodium laurilsulfate. Film-coating:
g
Hypromellose (E464), Propylene glycol (E490),
Titanium dioxide (E171), Talc (E553B), Quinoline
yellow (E104)
RISPERDAL 4 mg lm-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Hypromellose
(E464), Magnesium stearate, Silica colloidal
anhydrous, Sodium laurilsulfate. Film-coating:
g
Hypromellose (E464), Propylene glycol (E490),
Titanium dioxide (E171),Talc (E553B), Quinoline yellow
(E104), Indigotindisulfonate aluminium lake (E132)
RISPERDAL 6 mg lm-coated tablets:
Tablet core: Lactose monohydrate, Maize starch,
Cellulose microcrystalline (E460), Magnesium
stearate, Silica colloidal anhydrous, Sodium
laurilsulfate. Film-coating: Hypromellose (E464),
g
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 lm-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 lm/foil orAluminium/
Aluminium foil/foil blisters.

Risperdal lm-coated Tablets

• 0.5 mg risperidone are brownish-red half-scored
oblong biconvex lm-coated tablets
• 1 mg risperidone are white half-scored oblong
biconvex lm-coated tablets
• 2 mg risperidone are orange half-scored oblong
biconvex lm-coated tablets
• 3 mg risperidone are yellow half-scored oblong
biconvex lm-coated tablets
• 4 mg risperidone are green half-scored oblong
biconvex lm-coated tablets
• 6 mg risperidone are yellow circular biconvex lmcoated tablets.
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 lm-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 sizes may be marketed

Risperdal Quicklet orodispersible tablets

• 0.5 mg risperidone are light coral, round, biconvex
orodispersible tablets
• 1 mg risperidone are light coral, square, biconvex
orodispersible tablets
• 2 mg risperidone are coral, square, biconvex
orodispersible tablets
• 3 mg risperidone are coral, round, biconvex
orodispersible tablets
• 4 mg risperidone are coral, round, biconvex
orodispersible tablets.
Orodispersible tablets are imprinted on one side with
R 0.5, 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 lm-coated tablets and Risperdal
Quicklet orodispersible tablets are made by:
Janssen-Cilag SpA, Via C. Janssen, 04010 Borgo
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 /
RISPERDALINSTASOLV
France:
RISPERDAL/ RISPERDALORO
Germany:
RISPERDAL 1mg; 2mg; 3mg; 4mg/
Risperdal Filmtabletten 0,5mg;
6mg /
RISPERDAL QUICKLET 0,5 mg
Schmelztabletten/ RISPERDAL
QUICKLET 1 mg; 2 mg, 3 mg;
4 mg/ Risperdal Lösung 1mg/ml
Greece:
RISPERDAL/
RISPERDAL QUICKLET
Hungary:
RISPERDAL
Iceland:
RISPERDAL
Ireland:
RISPERDAL/RISPERDALQuicklet
Italy:
RISPERDAL
Lithuania:
RISPOLEPT
Latvia:
RISPOLEPT/ RISPERDALQuicklet
Luxembourg:
RISPERDALRISPERDAL Instasolv
Malta:
RISPERDAL
Netherlands:
RISPERDAL/
RISPERDAL Quicklet
Norway:
RISPERDAL/
RISPERDALsmeltetabletter
Poland:
RISPOLEPT
Portugal:
RISPERDAL/
RISPERDAL QUICKLET
Romania:
RISPOLEPT
Slovenia:
RISPERDAL
Spain:
RISPERDAL / RISPERDAL FLAS
Sweden:
RISPERDAL
United Kingdom: RISPERDAL/ RISPERDALQuicklet
This lea et was last revised in 05/2015
06/2015

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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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