Skip to Content

UK Edition. Click here for US version.

RISPERIDONE 3MG ORODISPERSIBLE TABLET

Active substance(s): RISPERIDONE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package Leaflet: Information for the user
Risperidone 3 mg orodispersible tablets
Risperidone 4 mg orodispersible tablets
Risperidone
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1.
What Risperidone is and what it is used for
2.
What you need to know before you take Risperidone
3.
How to take Risperidone
4.
Possible side effects
5.
How to store Risperidone
6.
Contents of the pack and other information

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:





2.

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.

What you need to know before you take Risperidone

Do not take Risperidone

if you are allergic to risperidone or any of the other ingredients of this medicine (listed in
Section 6 ).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using
Risperidone.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone:

Page 1 of 9













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
if 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
if you have Parkinson’s disease or dementia
if you are diabetic
if you have epilepsy
if you are a man and you have ever had a prolonged or painful erection If you experience this
while taking Risperidone, contact your doctor straight away
if you have problems controlling your body temperature or overheating
if you have kidney problems
if you have liver problems
if 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.
If you or someone else in your family has a history of blood clots, as medicines like these have
been associated with formation of blood clots.

Tell your doctor immediately if you experience

involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of risperidone
may be needed

fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called
“neuroleptic malignant syndrome). Immediate medical treatment may be needed.
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.
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 your, or your child’s body weight may be measured and it may be
regularly monitored during treatment.
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.
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

Page 2 of 9








Medicines that may change the electrical activity of your heart, such as medicines for malaria,
heart rhythm problems (such as quinidine), 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 elevated 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 (e.g. 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 and drink
You can take this medicine with or without food. You should avoid drinking alcohol when taking
Risperidone.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.


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.

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.
Risperidone contains aspartame and sorbitol
Risperidone orodispersible tablets contain aspartame (E951) which is a source of phenylalanine. May
be harmful for people with phenylketonuria.
Risperidone orodispersible tablets also contain sorbitol. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Page 3 of 9

3.

How to take Risperidone

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
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 the best is 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 the best is 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.

Page 4 of 9

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
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
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.
Only remove a tablet from the blister when it is time to take your medicine.
1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently
tearing along the perforations around it.
2. Peel open a blister to expose the tablet.
Do not push the tablet through the foil because it may break.
3. Remove the tablet from the blister with dry hands.
4. Place the tablet on your tongue straight away. The tablet will begin disintegrating within
seconds. It can then be swallowed with or without water.

If you take more Risperidone than you should

See a doctor right away. Take the medicine pack with you

In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems
standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats or fits.
If you forget to take Risperidone

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for
your next dose, skip the missed dose and continue as usual. If you miss two or more doses,
contact your doctor

Do not take a double dose (two doses at the same time) to make up for a forgotten dose
Page 5 of 9

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, 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 (Not known)

Experience fever, muscle stiffness, sweating (common) or a lowered level of consciousness (a
disorder called“Neuroleptic Malignant Syndrome”). Immediate medical treatment may be
needed (Rare)

Are a man and experience prolonged or painful erection. This is called priapism. Immediate
medical treatment may be needed (Not known)

Experience involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of
risperidone may be needed (Common)

Experience a severe allergic reaction resulting in difficulty in breathing and shock (Not
known)

Experience life threatening complications of uncontrolled diabetes (Very rare).

Experience a coma due to uncontrolled diabetes (Rare)

Experience sudden swelling of lips and eyes along with difficulty breathing (Uncommon)

Experience 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), (Uncommon)
The following side effects may occur:
Very Common (may affect more than 1 in 10 people):

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 (may affect up to 1 in 10 people):

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

Muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain, swelling
of arms and legs, pain in arms and legs
Page 6 of 9





Rash, skin redness
Fast beating heart, chest pain
Blood prolactin hormone level increased.

Uncommon (may affect up to 1 in 100 people):

Increase of sugar level in your blood, excessive drinking of water, stool incontinence, thirsty,
very hard faeces, hoarseness or voice disorder

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 increase or decrease

Urinary incontinence, pain when passing urine, frequent passing of urine

Confusion, disturbance in attention, low level of consciousness, excessive sleep, nervousness,
elated mood (mania), lack of energy and interest

Liver enzymes increase, white blood cell count decrease, low haemoglobin or red blood cell
count (anaemia), increase in eosinophils (special white blood cells ), blood creatinine
phosphokinase increase, decrease in platelets (blood cells that help you stop bleeding)

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

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, involuntary movements of face, arms, or legs,
ringing in ears, face oedema.
Rare (may affect up to 1 in 1,000 people):

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, body temperature decreased

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

Yellowing of the skin and the eyes (jaundice)

Inflammation of the pancreas.
Page 7 of 9

Not known frequency (frequency cannot be estimated from the available data):

No granulocytes (a type of white blood cell to help you against infection)

Dangerously excessive intake of water.
Injectable risperidone (Long-acting injection)
The following side effects have been reported with the use of a long-acting injection of an injectable
risperidone formulation. Even if you are not being treated with long acting injections of risperidone
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
Decrease in white blood cell counts that helps to protect you against bacterial infection
Depression
Fits (convulsion)
Eye blinking difficulty
Sensation of spinning or swaying
Slow beating heart, high blood pressure
Toothache, tongue spasm
Buttock pain, general pain
Weight decreased.
Fall

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Risperidone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and outer carton after EXP.
The expiry date refers to the last day of that month.
Store in the original blister in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Risperidone contains
The active substance is risperidone. Each orodispersible tablet contains 3 mg or 4 mg
risperidone.
The other ingredients are mannitol, basic butylated methacrylate copolymer, povidone K25,
microcrystalline cellulose, low-substituted hydroxypropylcellulose, aspartame (E951),
crospovidone, red iron oxide (E172), spearmint flavour (containing in particular sorbitol
(E420)), peppermint flavour (containing in particular sorbitol (E420)), levomenthol, calcium
silicate, magnesium stearate.
Page 8 of 9

What Risperidone looks like and contents of the pack
Round, slightly convex, pink marbled orodispersible tablets.
Pack sizes: 10, 14, 20, 28, 30, 56, 60, 84, 90 100, 180 and 200 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Krka, d.d., Smarjeska cesta 6, 8501 Novo mesto, Slovenia
Mylan Hungary Kft. H-2900, Komárom, Mylan utca 1, Hungary

This leaflet was last revised: 04/2014

Page 9 of 9

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