RISPERDAL 1MG/1ML ORAL SOLUTION

Active substance: RISPERIDONE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.

In this leaflet:





1



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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

The name of your medicine is Risperdal Liquid mg/ml oral solution but will be referred to as
Risperdal throughout this leaflet.

What Risperdal is and what it is used for

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

2

Before you take Risperdal

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

3

How to take Risperdal

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

4

Possible side effects

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

5

How to store Risperdal

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

6

Further information

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

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




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




Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s
dementia, who harm themselves or others. Alternative (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.

2 Before you take Risperdal
Do not take Risperdal if:

Taking other medicines



Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription and herbal medicines.

You are allergic (hypersensitive) to risperidone or any of the other ingredients of Risperdal (listed
in Section 6 below).

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using
Risperdal.

Take special care with Risperdal
Check with 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 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 tumour,
which is possibly dependent on prolactin
• 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.
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.

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 in 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.

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 (e.g. 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.

Taking Risperdal with food and Drink
You can take this medicine with or without food.
You should avoid drinking alcohol when taking Risperdal.

Pregnancy and breast-feeding



Talk to your doctor before using Risperdal if you are pregnant, trying to become pregnant or
breast-feeding. 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.

Ask your doctor or pharmacist for advice before taking any medicine.

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.

3 How to take Risperdal
How much to take
For the treatment of schizophrenia
Adults
• The usual starting dose is 2 mg per day, this may be increased to 4 mg per day on the second day
• Your dose may then be adjusted by your doctor depending on how you respond to the treatment
• Most people feel better with daily doses of 4 to 6 mg
• This total daily dose can be divided into either one or two doses a day. Your doctor will tell you
which is the best for you.
Elderly people
• Your starting dose will normally be 0.5 mg twice a day
• Your dose may then be gradually increased by your doctor to 1 mg to 2 mg twice a day
• Your doctor will tell you which is the best for you.
Children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperdal for
schizophrenia.

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.

Children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperdal for bipolar
mania.

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.

For the treatment of conduct disorder in children and adolescents
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

If you take more Risperdal than you should

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.




How to take Risperdal
Always take Risperdal exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Your doctor will tell you how much medicine to take and for how long. This will depend on your
condition and varies from person to person. The amount of medicine you should take is explained
under the ‘How much to take’ sub-heading.

If you forget to take Risperdal


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.

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 a dose, take it as soon as you
remember it. However, if it is almost time for your
next dose, skip the missed dose and continue as
usual. If you miss two or more doses, contact your
doctor
Do not take a double dose (two doses at the
same time) to make up for a forgotten dose

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

4 Possible side effects
Like all medicines, Risperdal 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

The following side effects may happen:

Very Common (affects more than 1 user in 10):




Parkinsonism. This is a medical term that includes many symptoms. Each individual symptom may
occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion or
watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or
impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle
stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking,
persistent blinking in response to tapping of the forehead (an abnormal reflex)
Headache, difficulty falling or staying asleep.

Common (affects 1 to 10 users in 100):










Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, dizziness, poor
attention, feeling exhausted, sleep disorder
Vomiting, diarrhoea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore
throat, dry mouth
Weight increased, increase in body temperature, decreased appetite
Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, blurred
vision, nose congestion, nose bleeding, cough
Urinary tract infection, bed wetting
Tremor, muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain,
swelling of arms and legs, pain in arms and legs
Rash, skin redness
Fast beating heart, chest pain
Blood prolactin hormone level increased.

Uncommon (affects 1 to 10 users in 1000):











Excessive drinking of water, stool incontinence, thirsty, very hard faeces, hoarseness or voice
disorder
Diabetes mellitus, high blood sugar
Lung infection caused by inhaling of food into the breathing passages, bladder infection, ‘pink eye’,
sinus infection, viral infection, ear infection, tonsil infection, infection under the skin, eye infection,
stomach infection, eye discharge, yeast infection of nails
Abnormal electrical conduction of the heart, drop in blood pressure after standing, low blood
pressure, feeling dizzy after changing body position, abnormal electric activity tracing of the heart
(ECG), abnormal heart rhythm, awareness of heart beating, heart rate increased or decreased
Urinary incontinence, pain when passing urine, frequent passing of urine
Confused, disturbance in attention, low level of consciousness, excessive sleep, nervousness,
elated mood (mania), lack of energy and interest
Liver enzymes increased, white blood cell count decreased (including those that help to protect
you against bacterial infection), low haemoglobin or red blood cell count (anaemia), increase in
eosinophils (special white blood cells), blood creatinine phosphokinase increased, decrease in
platelets (blood cells that help you stop bleeding), increased blood cholesterol and triglycerides
(blood fats).
Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint
stiffness, musculoskeletal chest pain, chest discomfort
Skin lesion, skin disorder, dry skin, intense itching of skin, acne, hair loss, skin inflammation
caused by mites, skin discolouration, thickening of skin, flushing, reduced skin sensitivity to pain or
touch, inflammation of oily skin







No menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge,
enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge
Fainting, gait disturbance, sluggishness, decreased appetite resulting in malnutrition and low body
weight, feeling ‘out of sorts’, balance disorder, allergy, oedema, speech disorder, chills, abnormal
coordination, abnormal taste.
Painful oversensitivity to light, increased blood flow to the eye, eye swelling, dry eye, increase in
tears
Breathing passage disorder, lung congestion, crackly lung noise, congestion of breathing
passages, trouble speaking, difficulty swallowing, cough with sputum, coarse/ whistling sound
during breathing, flu-like illness, sinus congestion
Unresponsive to stimuli, loss of consciousness, sudden swelling of lips and eyes along with
difficulty breathing, sudden weakness or numbness of the face, arms, or legs, especially on one
side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes
or strokes), involuntary movements of face, arms, or legs, ringing in ears, face oedema
Inability to urinate or incomplete emptying of the bladder.

Rare (affects 1 to 10 users in 10,000):

















Inability to reach orgasm, menstrual disorder
Dandruff
Drug allergy, coldness in arms and legs, lip swelling, lip inflammation
Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling
Lack of emotion
Change in consciousness with increased body temperature and twitching of muscles, oedema all
over the body, drug withdrawal syndrome, decreased body temperature
Fast shallow breathing, trouble breathing during sleep, chronic otitis media
Obstruction of intestine,
Reduced blood flow to the brain
Decrease in white blood cells, inappropriate secretion of a hormone that controls urine volume
Breakdown of muscle fibers and pain in muscles (rhabdomyolysis), movement disorder
Tremor of the head
Coma due to uncontrolled diabetes
Yellowing of the skin and the eyes (jaundice)
Inflammation of the pancreas
Low blood sugar.

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


Life threatening complications of uncontrolled diabetes.

Unknown frequency of occurrence (frequency cannot be estimated from the available
data):





Severe allergic reaction resulting in difficulty in breathing and shock
No granulocytes (a type of white blood cell to help you against infection)
Prolonged and painful erection
Dangerously excessive intake of water.

Risperdal CONSTA
The following side effects have been reported with the use of Risperdal CONSTA, a long acting
injection. Even if you are not being treated with long acting injections of Risperdal CONSTA but you
experience any of the following, talk to your doctor.












Infection of the intestine
Abscess under the skin, tingling pricking or numbness of skin, inflammation of the skin
Depression
Convulsion
Eye blinking
Sensation of spinning or swaying
Slow beating heart, high blood pressure
Toothache, tongue spasm
Buttock pain
Weight decreased.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5 How to store Risperdal
Keep out of the reach and sight 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 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 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.

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

What Risperdal looks like and contents of the pack

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

Oral solution

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

Risperdal Liquid is supplied in an amber glass bottle containing 100 ml of a clear, colourless liquid.

Leaflet date: 02.04.2012

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 3 ml. Calibration marks every 0.25 ml up to 3 ml are
printed on this pipette.

Rieperdal is a registered trademark of Janssen–Cilag group of companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone Liquid 1 mg/ml oral solution
Read all of this leaflet carefully before you start taking this medicine.

In this leaflet:





1



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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

The name of your medicine is Risperidone Liquid mg/ml oral solution but will be referred to as
Risperidone throughout this leaflet.

What Risperidone is and what it is used for

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

2

Before you take Risperidone

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

3

How to take Risperidone

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

4

Possible side effects

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

5

How to store Risperidone

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

6

Further 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.

2 Before you take Risperidone
Do not take Risperidone if:

Taking other medicines



Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription and herbal medicines.

You are allergic (hypersensitive) to risperidone or any of the other ingredients of Risperidone
(listed in Section 6 below).

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using
Risperidone.

Take special care with Risperidone
Check with 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 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 tumour,
which is possibly dependent on prolactin
• 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.
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.

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 in 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.

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 (e.g. 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.

Taking Risperidone with food and Drink
You can take this medicine with or without food.
You should avoid drinking alcohol when taking Risperidone.

Pregnancy and breast-feeding



Talk to your doctor before using Risperidone if you are pregnant, trying to become pregnant or
breast-feeding. 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.

Ask your doctor or pharmacist for advice before taking any medicine.

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.

3 How to take Risperidone
How much to take
For the treatment of schizophrenia
Adults
• The usual starting dose is 2 mg per day, this may be increased to 4 mg per day on the second day
• Your dose may then be adjusted by your doctor depending on how you respond to the treatment
• Most people feel better with daily doses of 4 to 6 mg
• This total daily dose can be divided into either one or two doses a day. Your doctor will tell you
which is the best for you.
Elderly people
• Your starting dose will normally be 0.5 mg twice a day
• Your dose may then be gradually increased by your doctor to 1 mg to 2 mg twice a day
• Your doctor will tell you which is the best for you.
Children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone for
schizophrenia.

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.

Children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone for bipolar
mania.

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.

For the treatment of conduct disorder in children and adolescents
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

If you take more Risperidone than you should

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.




How to take Risperidone
Always take Risperidone exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Your doctor will tell you how much medicine to take and for how long. This will depend on your
condition and varies from person to person. The amount of medicine you should take is explained
under the ‘How much to take’ sub-heading.

If you forget to take Risperidone


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.

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 a dose, take it as soon as you
remember it. However, if it is almost time for your
next dose, skip the missed dose and continue as
usual. If you miss two or more doses, contact your
doctor
Do not take a double dose (two doses at the
same time) to make up for a forgotten dose

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

4 Possible side effects
Like all medicines, Risperidone 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

The following side effects may happen:

Very Common (affects more than 1 user in 10):




Parkinsonism. This is a medical term that includes many symptoms. Each individual symptom may
occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion or
watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or
impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle
stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking,
persistent blinking in response to tapping of the forehead (an abnormal reflex)
Headache, difficulty falling or staying asleep.

Common (affects 1 to 10 users in 100):










Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, dizziness, poor
attention, feeling exhausted, sleep disorder
Vomiting, diarrhoea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore
throat, dry mouth
Weight increased, increase in body temperature, decreased appetite
Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, blurred
vision, nose congestion, nose bleeding, cough
Urinary tract infection, bed wetting
Tremor, muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain,
swelling of arms and legs, pain in arms and legs
Rash, skin redness
Fast beating heart, chest pain
Blood prolactin hormone level increased.

Uncommon (affects 1 to 10 users in 1000):











Excessive drinking of water, stool incontinence, thirsty, very hard faeces, hoarseness or voice
disorder
Diabetes mellitus, high blood sugar
Lung infection caused by inhaling of food into the breathing passages, bladder infection, ‘pink eye’,
sinus infection, viral infection, ear infection, tonsil infection, infection under the skin, eye infection,
stomach infection, eye discharge, yeast infection of nails
Abnormal electrical conduction of the heart, drop in blood pressure after standing, low blood
pressure, feeling dizzy after changing body position, abnormal electric activity tracing of the heart
(ECG), abnormal heart rhythm, awareness of heart beating, heart rate increased or decreased
Urinary incontinence, pain when passing urine, frequent passing of urine
Confused, disturbance in attention, low level of consciousness, excessive sleep, nervousness,
elated mood (mania), lack of energy and interest
Liver enzymes increased, white blood cell count decreased (including those that help to protect
you against bacterial infection), low haemoglobin or red blood cell count (anaemia), increase in
eosinophils (special white blood cells), blood creatinine phosphokinase increased, decrease in
platelets (blood cells that help you stop bleeding), increased blood cholesterol and triglycerides
(blood fats).
Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint
stiffness, musculoskeletal chest pain, chest discomfort
Skin lesion, skin disorder, dry skin, intense itching of skin, acne, hair loss, skin inflammation
caused by mites, skin discolouration, thickening of skin, flushing, reduced skin sensitivity to pain or
touch, inflammation of oily skin







No menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge,
enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge
Fainting, gait disturbance, sluggishness, decreased appetite resulting in malnutrition and low body
weight, feeling ‘out of sorts’, balance disorder, allergy, oedema, speech disorder, chills, abnormal
coordination, abnormal taste.
Painful oversensitivity to light, increased blood flow to the eye, eye swelling, dry eye, increase in
tears
Breathing passage disorder, lung congestion, crackly lung noise, congestion of breathing
passages, trouble speaking, difficulty swallowing, cough with sputum, coarse/ whistling sound
during breathing, flu-like illness, sinus congestion
Unresponsive to stimuli, loss of consciousness, sudden swelling of lips and eyes along with
difficulty breathing, sudden weakness or numbness of the face, arms, or legs, especially on one
side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes
or strokes), involuntary movements of face, arms, or legs, ringing in ears, face oedema
Inability to urinate or incomplete emptying of the bladder.

Rare (affects 1 to 10 users in 10,000):

















Inability to reach orgasm, menstrual disorder
Dandruff
Drug allergy, coldness in arms and legs, lip swelling, lip inflammation
Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling
Lack of emotion
Change in consciousness with increased body temperature and twitching of muscles, oedema all
over the body, drug withdrawal syndrome, decreased body temperature
Fast shallow breathing, trouble breathing during sleep, chronic otitis media
Obstruction of intestine,
Reduced blood flow to the brain
Decrease in white blood cells, inappropriate secretion of a hormone that controls urine volume
Breakdown of muscle fibers and pain in muscles (rhabdomyolysis), movement disorder
Tremor of the head
Coma due to uncontrolled diabetes
Yellowing of the skin and the eyes (jaundice)
Inflammation of the pancreas
Low blood sugar.

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


Life threatening complications of uncontrolled diabetes.

Unknown frequency of occurrence (frequency cannot be estimated from the available
data):





Severe allergic reaction resulting in difficulty in breathing and shock
No granulocytes (a type of white blood cell to help you against infection)
Prolonged and painful erection
Dangerously excessive intake of water.

Risperidone CONSTA
The following side effects have been reported with the use of Risperidone CONSTA, a long acting
injection. Even if you are not being treated with long acting injections of Risperidone CONSTA but you
experience any of the following, talk to your doctor.












Infection of the intestine
Abscess under the skin, tingling pricking or numbness of skin, inflammation of the skin
Depression
Convulsion
Eye blinking
Sensation of spinning or swaying
Slow beating heart, high blood pressure
Toothache, tongue spasm
Buttock pain
Weight decreased.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5 How to store Risperidone
Keep out of the reach and sight 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.

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

What Risperidone looks like and contents of the pack
Oral solution
Risperidone 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 0.25 ml and a maximum volume of 3 ml. Calibration marks every 0.25 ml up to 3 ml are
printed on this pipette.

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Risperidone Liquid 1 mg/ml oral solution PL No: 18799/2029
Leaflet date: 02.04.2012

POM

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.

Hide
(web1)