RISPERIDONE 0.5 MG ORODISPERSIBLE TABLETS

Active substance: RISPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone 0.5 mg
orodispersible tablets

Risperidone 1 mg
orodispersible tablets

Risperidone 2 mg
orodispersible tablets
Risperidone
Read all of this leaflet carefully before you start using
this medicine.
• 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.
In this leaflet:
1. 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 ‘antipsychotics’.
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
• 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 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 If you experience this while taking
Risperidone, contact your doctor straight away
• 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 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. 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 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.
Before treatment is started your, or your child’s body
weight may be measured and it may be regularly
monitored during treatment.
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.

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 (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, fluoxetines, 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.
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
• Shaking, muscle stiffness and problems feeding, all of
which are reversible, have been seen in newborn babies
when risperidone was used during the last trimester of
pregnancy.
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.

Important information about some of the ingredients of
Risperidone
Risperidone orodispersible tablets contain aspartame
(E951) which is a source of phenylalanine. Aspartame may
be harmful for people with phenylketonuria.

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

2. Pull up the edge of the foil and peel foil off completely.
3. Tip the tablet out onto your hand.
4. Put the tablet on the tongue as soon as it is removed
from the packaging.

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
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
below.
Risperidone orodispersible tablets are fragile. They should
not be pushed through the foil in the blister pack as this will
cause damage to the tablet. Remove a tablet from the
package as follows:
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.

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
In a few seconds it begins disintegrating in the mouth and
subsequently can be swallowed with or without water. The
mouth should be empty before placing the tablet on the
tongue.
You can also put the tablet in a full glass or cup of water
and drink it straight away.
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
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







Like all medicines, Risperidone can cause side effects,
although not everybody gets them.
Very common:
Common:
Uncommon:
Rare:

Very rare:
Not known:



affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from
the available data.

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
• 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
• 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 retention, 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, 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)
• Diabetes mellitus, high blood sugar
• 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
discoloration, 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, edema,
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, 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 edema.
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, edema 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
• 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
• 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 in breathing. If you notice any of these
symptoms seek medical advice immediately.
Long-acting injectable risperidone formulation
The following side effects have been reported with the use
of long-acting 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
• 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 exiry date stated on the package.
This medicinal product does not require any special
storage conditions.
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
• The active ingredient is risperidone. Each tablet contains
0.5 mg, 1 mg or 2 mg risperidone.
• Other ingredients are mannitol (E421), basic butylated
methacrylate copolymer, povidone K-25, microcrystalline
cellulose, hydroxypropylcellulose, aspartame (E951),
crospovidone, red iron oxide (E172), spearmint flavour,
peppermint flavour, calcium silicate, magnesium stearate.
What Risperidone looks like and contents of the pack
Orodispersible tablets:
Tablets are round, slightly convex, pink marbled tablets.
Contents of the packs: 20, 28, 30, 50, 56, 60, 98 or 100
tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
This leaflet was last approved 06/2013
xxxxxx

• 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.

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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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