RISPERDAL 1MG/1ML ORAL SOLUTION

Active substance: RISPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperdal® Liquid 1mg/ml oral solution
(risperidone)
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.

In this leaflet:




----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 Liquid 1mg/ml oral solution but will be referred to as
Risperdal throughout this leaflet.

1
2

What Risperdal is and what it is used for
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

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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 (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.
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.

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.

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 (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)
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



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



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.

Before treatment is started for conduct disorder, other causes of aggressive behaviour should have
been ruled out.

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

Use in children and adolescents

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.
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.

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.



Do not take a double dose (two doses at the same
time) to make up for a forgotten dose

If you stop taking Risperdal

If you take more Risperdal than you should

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.

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

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 characterized 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 (affects more than 1 user in 10):






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 (affects 1 to 10 users in 100):




















Pneumonia, Infection of the chest (bronchitis), Common cold symptoms, Sinus infection Urinary
tract infection Ear infection, Feeling like you have the flu
Risperdal can raise your levels of a hormone called “prolactin” found on a blood test (which may or
may not cause symptoms). When symptoms of high prolactin occur, they may include in men
breast swelling, difficulty in getting or maintaining erections, 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.
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, Stuff 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 (affects 1 to 10 users in 1000):















Infection of the breathing passages, Bladder infection, ‘Eye infection, Tonsillitis, Fungal infection of
the nails, Infection of the skin, An infection confined to a single area of skin or part of the body,
Viral infection, Skin inflammation caused by mites
Decrease in the type of white blood cells that help to protect you against infection, White blood cell
count decreased Decrease in platelets (blood cells that help you stop bleeding), Anemia,
Decrease in red blood cells, Increase in eosinophils (a type of white blood cell) in your blood
Allergic reaction
Diabetes or worsening of diabetes, High blood sugar, Excessive drinking of water
Weight loss, Loss of appetite resulting in malnutrition and low body weight
Increased cholesterol in your blood
Elated mood (mania), Confusion, Decreased sexual drive, Nervousness, Nightmares
Tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or
other parts of your body). Tell your doctor immediately if you experience involuntary rhythmic
movements of the tongue, mouth and face. Withdrawal of Risperdal may be needed,
Sudden loss of blood supply to brain (stroke or “mini” stroke)
Unresponsive to stimuli, Loss of consciousness, Low level of consciousness
Convulsion (fits), Fainting
A restless urge to move parts of your body, Balance disorder, Abnormal coordination, Dizziness
upon standing, Disturbance in attention, Problems with speech, Loss or abnormal sense of taste,
Reduced sensation of skin to pain and touch, A sensation of tingling, pricking, or numbness skin
Oversensitivity of the eyes to light, Dry eye, Increased tears, Redness of the eyes
Sensation of spinning (vertigo), Ringing in the ears, Ear pain


















Atrial fibrillation (an abnormal heart rhythm), An interruption in conduction between the upper and
lower parts of the heart, Abnormal electrical conduction of the heart, Prolongation of the QT
interval from your heart, Slow heart rate, Abnormal electrical tracing of the heart
(electrocardiogram or ECG), A fluttering or pounding feeling in your chest (palpitations)
Low blood pressure, Low blood pressure upon standing (consequently, some people taking 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 (affects 1 to 10 users in 10,000):




























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, A decrease in body temperature, Coldness in arms and legs
Symptoms of drug withdrawal
Yellowing of the skin and the eyes (jaundice).

Very rare (affects less than 1 user in 10,000):




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.

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 blister, foil, carton, or bottle. The expiry date
refers to the last day of that month.
Do not store above 30°C
Do not refrigerate or freeze

Store in the original package
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.

6 Further information
What Risperdal contains

Manufactured by: Janssen-Cilag SpA Via M. Buonarroti, 23, 20093 COLOGNO MONZESE Italy

The active substance is risperidone 1mg/ml.
The other ingredients are: tartaric acid, benzoic acid, sodium hydroxide and purified water.

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

What Risperdal looks like and contents of the pack

Risperdal® Liquid 1 mg/ml oral solution PL No: 18799/2029

Risperdal Liquid is supplied in an amber glass bottle containing 100 ml of a clear, colourless liquid.
The pipette supplied with the 100 ml bottle is calibrated in milligrams and milliliters with a minimum
volume of 0.25ml and a maximum volume of 3 ml. Calibration marks every 0.25ml up to 3ml are
printed on this pipette.

Procured from within the EU and repackaged by the Product Licence holder:
POM

Leaflet date: 27.08.2014
Rieperdal is a registered trademark of Janssen–Cilag group of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone Liquid 1mg/ml oral solution
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.

In this leaflet:




----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 Liquid 1mg/ml oral solution but will be referred to as
Risperidone throughout this leaflet.

1
2

What Risperidone is and what it is used for
What you need to know before you take Risperidone

- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

3

How to take Risperidone

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

4

Possible side effects

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

5

How to store Risperidone

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

6

Contents of the pack and other information

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

1 What Risperidone is and what it is used for
Risperidone belongs to a group of medicines called ‘anti-psychotics’.
Risperidone is used to treat the following:




Schizophrenia, where you may see, hear or feel things that are not there, believe things that are
not true or feel unusually suspicious, or confused
Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania
occurs in an illness called “bipolar disorder”



Short-term treatment (up to 6 weeks) of 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 (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
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.
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.

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.

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)
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



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



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.

Before treatment is started for conduct disorder, other causes of aggressive behaviour should have
been ruled out.

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

Use in children and adolescents

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.
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 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 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.

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 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.



Do not take a double dose (two doses at the same
time) to make up for a forgotten dose

If you stop taking Risperidone
You should not stop taking this medicine unless told to do so
by your doctor. Your symptoms may return. If your doctor
decides to stop this medicine, your dose may be decreased
gradually over a few days.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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

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 characterized 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 (affects more than 1 user in 10):






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 (affects 1 to 10 users in 100):




















Pneumonia, Infection of the chest (bronchitis), Common cold symptoms, Sinus infection Urinary
tract infection Ear infection, Feeling like you have the flu
Risperidone can raise your levels of a hormone called “prolactin” found on a blood test (which may
or may not cause symptoms). When symptoms of high prolactin occur, they may include in men
breast swelling, difficulty in getting or maintaining erections, 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.
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, Stuff 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 (affects 1 to 10 users in 1000):















Infection of the breathing passages, Bladder infection, ‘Eye infection, Tonsillitis, Fungal infection of
the nails, Infection of the skin, An infection confined to a single area of skin or part of the body,
Viral infection, Skin inflammation caused by mites
Decrease in the type of white blood cells that help to protect you against infection, White blood cell
count decreased Decrease in platelets (blood cells that help you stop bleeding), Anemia,
Decrease in red blood cells, Increase in eosinophils (a type of white blood cell) in your blood
Allergic reaction
Diabetes or worsening of diabetes, High blood sugar, Excessive drinking of water
Weight loss, Loss of appetite resulting in malnutrition and low body weight
Increased cholesterol in your blood
Elated mood (mania), Confusion, Decreased sexual drive, Nervousness, Nightmares
Tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or
other parts of your body). Tell your doctor immediately if you experience involuntary rhythmic
movements of the tongue, mouth and face. Withdrawal of Risperidone may be needed,
Sudden loss of blood supply to brain (stroke or “mini” stroke)
Unresponsive to stimuli, Loss of consciousness, Low level of consciousness
Convulsion (fits), Fainting
A restless urge to move parts of your body, Balance disorder, Abnormal coordination, Dizziness
upon standing, Disturbance in attention, Problems with speech, Loss or abnormal sense of taste,
Reduced sensation of skin to pain and touch, A sensation of tingling, pricking, or numbness skin
Oversensitivity of the eyes to light, Dry eye, Increased tears, Redness of the eyes
Sensation of spinning (vertigo), Ringing in the ears, Ear pain


















Atrial fibrillation (an abnormal heart rhythm), An interruption in conduction between the upper and
lower parts of the heart, Abnormal electrical conduction of the heart, Prolongation of the QT
interval from your heart, Slow heart rate, Abnormal electrical tracing of the heart
(electrocardiogram or ECG), A fluttering or pounding feeling in your chest (palpitations)
Low blood pressure, Low blood pressure upon standing (consequently, some people taking 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 (affects 1 to 10 users in 10,000):




























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, A decrease in body temperature, Coldness in arms and legs
Symptoms of drug withdrawal
Yellowing of the skin and the eyes (jaundice).

Very rare (affects less than 1 user in 10,000):




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.

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 blister, foil, carton, or bottle. The expiry date
refers to the last day of that month.
Do not store above 30°C
Do not refrigerate or freeze

Store in the original package
Once the bottle is opened, any unused portion of Risperidone oral solution 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.

6 Further information
What Risperidone contains

Manufactured by: Janssen-Cilag SpA Via M. Buonarroti, 23, 20093 COLOGNO MONZESE Italy

The active substance is risperidone 1mg/ml.
The other ingredients are: tartaric acid, benzoic acid, sodium hydroxide and purified water.

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

What Risperidone looks like and contents of the pack

Risperidone Liquid 1mg/ml oral solution , PL No: 18799/2029

Risperidone is supplied in an amber glass bottle containing 100 ml of a clear, colourless liquid.
The pipette supplied with the 100 ml bottle is calibrated in milligrams and milliliters with a minimum
volume of 0.25 ml and a maximum volume of 3ml. Calibration marks every 0.25 ml up to 3 ml are
printed on this pipette.

Procured from within the EU and repackaged by the Product Licence holder:

Leaflet date: 27.08.2014

POM

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Source: Medicines and Healthcare Products Regulatory Agency

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

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