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RISPERDAL 1MG/1ML ORAL SOLUTION

Active substance(s): RISPERIDONE

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Package leaflet: Information for the user

Risperidone 1mg/ml oral solution
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 1mg/ml oral solution but will be referred as Risperidone
through out this leaflet.



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’

What is in this leaflet:
1 What Risperidone is and what it is used for
2 What you need to know before you take Risperidone
3 How to take Risperidone
4 Possible side effects
5 How to store Risperidone
6 Contents of the pack and other information



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.
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.

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 0.25 mg twice a day
Your dose may then be gradually adjusted by your doctor depending on how you respond to the
treatment

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 (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. 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.

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 oral solution
The solution comes with a syringe (pipette). This should be used to
help you measure the exact amount of medicine you need.
Follow these steps:
1. Remove the child-proof cap. Push the plastic screw cap down
while turning it counter clockwise (Figure 1)

2. Insert the syringe into the bottle
3. While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of
millilitres or mg you need to take (Figure 2)
4. Holding the bottom ring, remove the entire syringe from the bottle (Figure 3)
5. Empty the syringe into any non-alcoholic drink, except for tea. Slide the upper ring down
6. Close the bottle
7. Rinse the syringe with some water

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

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
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
Experience involuntary rhythmic movement 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 affects 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 affects 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 on 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, 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
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 fl uttering or pounding feeling in your chest (palpitations)

Low blood pressure, Low blood pressure upon standing (consequently, some people taking 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 win
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 affects 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 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via 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 use after the expiry date which is stated on the carton, or bottle after ‘Exp’. The expiry date
refers to the last day of that month.
Do not store above 30°C.
Do not refrigerate or freeze

6. Content of the pack and other information
What Risperidone contains
The active substance is risperidone 1mg/ml.
The other ingredients are: tartaric acid, benzoic acid, sodium hydroxide and purified water.

What Risperidone looks like and contents of the pack
Risperidone is supplied in an amber glass bottle containing 100ml of a clear, colourless liquid.
The pipette supplied with the 100ml bottle is calibrated in milligrams and milliliters with a minimum
volume of 0.25ml and a maximum volume of 3ml. Calibration marks every 0.25ml up to 3ml are
printed on this pipette.
Manufactured by: Janssen-Cilag SpA Via M. Buonarroti, 23, 20093 COLOGNO MONZESE, Italy.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
POM
Risperidone 1mg/ml oral solution; PL No: 18799/2029
Leaflet date: 14.09.2015

Store in the original pack.
Once the bottle is opened, any unused portion of Risperidone should be discarded after 3 months.
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.

Package leaflet: Information for the user

Risperdal® 1mg/ml oral solution
(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 1mg/ml oral solution but will be referred as Risperdal
through out this leaflet.



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’

2. What you need to know before you take Risperdal
Do not take Risperdal:

What is in this leaflet:
1 What Risperdal is and what it is used for
2 What you need to know before you take Risperdal
3 How to take Risperdal
4 Possible side effects
5 How to store Risperdal
6 Contents of the pack and other information



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.



Other medicines and Risperdal

Warnings and precautions

It is especially important to talk to your doctor or pharmacist if you are taking any of the
following:

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.
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 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.

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 0.25 mg twice a day
Your dose may then be gradually adjusted by your doctor depending on how you respond to the
treatment

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

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 (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 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.

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 oral solution
The solution comes with a syringe (pipette). This should be used to
help you measure the exact amount of medicine you need.
Follow these steps:
1. Remove the child-proof cap. Push the plastic screw cap down
while turning it counter clockwise (Figure 1)
2. Insert the syringe into the bottle

3. While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of
millilitres or mg you need to take (Figure 2)
4. Holding the bottom ring, remove the entire syringe from the bottle (Figure 3)
5. Empty the syringe into any non-alcoholic drink, except for tea. Slide the upper ring down
6. Close the bottle
7. Rinse the syringe with some water

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

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
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
Experience involuntary rhythmic movement 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 affects 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 affects 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 on 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, 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
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 fl 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, Difficulty swallowing,
Excessive passing of gas or win
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 affects 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 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via 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 use after the expiry date which is stated on the carton, or bottle after ‘Exp’. The expiry date
refers to the last day of that month.
Do not store above 30°C.
Do not refrigerate or freeze

6. Content of the pack and other information
What Risperdal contains
The active substance is risperidone 1mg/ml.
The other ingredients are: tartaric acid, benzoic acid, sodium hydroxide and purified water.

What Risperdal looks like and contents of the pack
Risperdal is supplied in an amber glass bottle containing 100ml of a clear, colourless liquid.
The pipette supplied with the 100ml bottle is calibrated in milligrams and milliliters with a minimum
volume of 0.25ml and a maximum volume of 3ml. Calibration marks every 0.25ml up to 3ml are
printed on this pipette.
Manufactured by: Janssen-Cilag SpA Via M. Buonarroti, 23, 20093 COLOGNO MONZESE, Italy.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
POM
Risperdal® 1mg/ml oral solution; PL No: 18799/2029
Leaflet date: 14.09.2015
Rieperdal is a registered trademark of Janssen–Cilag group of companies.

Store in the original pack.
Once the bottle is opened, any unused portion of Risperdal should be discarded after 3 months.
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.

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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