RISPERIDONE 2MG TABLETS

Active substance: RISPERIDONE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
®
RISPERDAL 1mg TABLETS
®
RISPERDAL 2mg TABLETS
®
RISPERDAL 3mg TABLETS
®
RISPERDAL 4mg TABLETS
(risperidone)
Read all of this leaflet carefully before you start
Please note that this leaflet also contains
taking this medicine.
information about other strengths such as
 Keep this leaflet. You may need to read it again.
Risperdal 0.5mg, and 6mg Tablets and Risperdal
 If you have any further questions, ask your
Quicklet 0.5mg, 1mg, 2mg, 3mg and 4mg
doctor or pharmacist.
Orodispersible tablets.
 This medicine has been prescribed for you. Do
In this leaflet:
not pass it on to others. It may harm them, even
1 What Risperdal is and what it is used for
if their symptoms are the same as yours.
2 Before you take Risperdal
 If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
3 How to take Risperdal
please tell your doctor or pharmacist.
4 Possible side effects
The name of your medicine is Risperdal 1mg
5 How to store Risperdal
Tablets, Risperdal 2mg Tablets, Risperdal 3mg
6 Further information
Tablets and Risperdal 4mg Tablets, but it will be
referred as RISPERDAL throughout this leaflet.

1 What RISPERDAL is and what it is used for

3 How to take RISPERDAL

Risperdal belongs to a group of medicines called
„anti-psychotics‟.

How much to take

How to take Risperdal

For the treatment of schizophrenia

Always take Risperdal exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

 Short-term treatment (up to 6 weeks) of long-term
aggression in people with Alzheimer‟s dementia,
who harm themselves or others. Alternative (nonRisperdal is used to treat the following:
drug) treatments should have been used
 Schizophrenia, where you may see, hear or feel
previously.
things that are not there, believe things that are
 Short-term treatment (up to 6 weeks) of
not true or feel unusually suspicious, or confused
long-term, aggression in intellectually disabled
 Mania, where you may feel very excited, elated,
children (at least 5 years of age) and adolescents
agitated, enthusiastic or hyperactive. Mania
with conduct disorder.
occurs in an illness called “bipolar disorder”

2 Before you take RISPERDAL
Do not take RISPERDAL if:
 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 for conduct disorder,
other causes of aggressive behaviour should have
been ruled out.
If during treatment with risperidone tiredness
occurs, a change in the time of administration
might improve attention difficulties.
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, allergies
(anti-histamines), some antidepressants or other
medicines for mental problems
 Medicines that cause a slow heart beat
 Medicines that cause low blood potassium
(such as certain diuretics)
 Medicines to treat raised blood pressure.
Risperdal can lower blood pressure
 Medicines for Parkinson's disease (such as
levodopa)
 Water tablets (diuretics) used for heart problems
or swelling of parts of your body due to a build
up of too much fluid (such as furosemide or
chlorothiazide). Risperdal taken by itself or with
furosemide, may have an increased risk of stroke
or death in elderly people with dementia.
The following medicines may reduce the effect of
risperidone
 Rifampicin (a medicine for treating some
infections)
 Carbamazepine, phenytoin (medicines for
epilepsy)
 Phenobarbital
If you start or stop taking such medicines you may
need a different dose of risperidone.
The following medicines may increase the effect of
risperidone
 Quinidine (used for certain types of heart
disease)
 Antidepressants such as paroxetine, fluoxetine,
tricyclic antidepressants
 Medicines known as beta blockers (used to treat
high blood pressure)
 Phenothiazines such as medicines used to treat
psychosis or to calm down)
 Cimetidine, ranitidine (blockers of the acidity of
stomach)
If you start or stop taking such medicines you may
need a different dose of risperidone.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before using
Risperdal.
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 breastfeeding. 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.
Important information about some of the
ingredients of Risperdal
The film-coated tablets contain lactose, a type of
sugar. If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product. The 2 mg
and 6 mg film-coated tablets contain sunset yellow
(E110) that may cause allergic reactions.
The orodispersible tablets contain aspartame, a
source of phenylalanine which may be harmful for
people with phenylketonuria.

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

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.
Risperdal film-coated tablets
 You should swallow your tablet with a drink of
water
Risperdal Quicklet orodispersible tablets
Only remove a tablet from the blister when it is
time to take your medicine.
 Peel open a blister to expose the tablet
 Do not push the tablet through the foil because it
may break
 Remove the tablet from the blister with dry hands
 Place the tablet on your tongue straight away
 The tablet will begin disintegrating within
seconds
 It can then be swallowed with or without water.

Adults
If you take more Risperdal than you should
 Your starting dose will usually be 2mg once a day
 See a doctor right away. Take the medicine pack
 Your dose may then be gradually adjusted by
with you
your doctor depending on how you respond to the
 In case of overdose you may feel sleepy or tired,
treatment
or have abnormal body movements, problems
 Most people feel better with doses of 1 to 6mg
standing and walking, feel dizzy due to low blood
once a day.
pressure, or have abnormal heart beats or fits.
Elderly people
If you forget to take Risperdal
 Your starting dose will usually be 0.5mg twice a
 If you forget to take a dose, take it as soon as you
day
remember it. However, if it is almost time for
 Your dose may then be gradually adjusted by
your next dose, skip the missed dose and
your doctor to 1mg to 2mg twice a day
continue as usual. If you miss two or more doses,
depending on how much you respond to
contact your doctor
the treatment.
 Do not take a double dose (two doses at the
Children and adolescents
 Children and adolescents under 18 years old
should not be treated with Risperdal for mania.

same time) to make up for a forgotten dose

If you stop taking Risperdal
You should not stop taking this medicine unless
For the treatment of long-standing aggression in told to do so by your doctor. Your symptoms may
return. If your doctor decides to stop this medicine,
people with Alzheimer’s dementia
your dose may be decreased gradually over a few
Adults (including elderly people)
days.
 Your starting dose will normally be 0.25mg twice If you have any further questions on the use of this
a day
product, ask your doctor or pharmacist.
 Your dose may then be gradually adjusted by
your doctor depending on how you respond to the
treatment
 Most people feel better with 0.5mg twice a day.
Some patients may need 1mg twice a day
 Treatment duration in patients with Alzheimer‟s
dementia should be not more than 6 weeks.
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 50kg
 The starting dose will normally be 0.25mg once
a day
 The dose may be increased every other day in
steps of 0.25mg per day.
 The usual maintenance dose is 0.25mg to
0.75mg once a day.
For children who weigh 50kg or more
 The starting dose will normally be 0.5mg once a
day
 The dose may be increased every other day in
steps of 0.5mg per day.
 The usual maintenance dose is 0.5 mg to 1.5 mg
once a day.
Treatment duration in patients with conduct
disorder should be not more than 6 weeks.
Children under 5 years old should not be treated
with Risperdal for conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all
starting doses and following doses of risperidone
should be halved. Dose increases should be
slower in these patients.
Risperidone should be used with caution in this
patient group.

4 Possible side effects

5 How to store RISPERDAL

Like all medicines, Risperdal can cause side effects,  Breathing passage disorder, lung congestion,
although not everybody gets them.
crackly lung noise, congestion of breathing
passages, trouble speaking, difficulty swallowing,
Tell your doctor immediately if you:
cough with sputum, coarse/whistling sound during
 Experience blood clots in the veins, especially in
breathing, flu-like illness, sinus congestion
the legs (symptoms include swelling, pain, and
 Unresponsive to stimuli, loss of consciousness,
redness in the leg), which may travel through
sudden swelling of lips and eyes along with
blood vessels to the lungs causing chest pain and
difficulty breathing, sudden weakness or
difficulty breathing. If you notice any of these
numbness of the face, arms, or legs, especially
symptoms seek medical advice immediately
on one side, or instances of slurred speech that
 Have dementia and experience a sudden change
last for less than 24 hours (these are called
in your mental state or sudden weakness or
mini-strokes or strokes), involuntary movements
numbness of your face, arms or legs, especially
of face, arms, or legs, ringing in ears, face
on one side, or slurred speech, even for a short
oedema
period of time. These may be signs of a stroke
 Inability to urinate or incomplete emptying of the
 Experience fever, muscle stiffness, sweating or a
bladder.
lowered level of consciousness (a disorder called
“Neuroleptic Malignant Syndrome”). Immediate
Rare (affects 1 to 10 users in 10,000):
medical treatment may be needed
 Inability to reach orgasm, menstrual disorder
 Are a man and experience prolonged or painful
 Dandruff
erection. This is called priapism. Immediate
 Drug allergy, coldness in arms and legs, lip
medical treatment may be needed
swelling, lip inflammation
 Experience involuntary rhythmic movements of
 Glaucoma, reduced visual clarity, eyelid margin
the tongue, mouth and face. Withdrawal of
crusting, eye rolling
risperidone may be needed
 Lack of emotion
 Change in consciousness with increased body
The following side effects may happen:
temperature and twitching of muscles, oedema all
Very Common (affects more than 1 user in 10):
over the body, drug withdrawal syndrome,
decreased body temperature
 Parkinsonism. This is a medical term that includes
many symptoms. Each individual symptom may
 Fast shallow breathing, trouble breathing during
occur less frequently than in 1 in 10 people.
sleep, chronic otitis media
Parkinsonism includes: increase in saliva
 Obstruction of intestine
secretion or watery mouth, musculoskeletal
 Reduced blood flow to the brain
stiffness, drooling, jerks when bending the limbs,
 Decrease in white blood cells, inappropriate
slow, reduced or impaired body movements, no
secretion of a hormone that controls urine volume
expression on the face, muscle tightness, stiff
 Breakdown of muscle fibres and pain in muscles
neck, muscle stiffness, small, shuffling, hurried
(rhabdomyolysis), movement disorder
steps and lack of normal arm movements when
 Tremor of the head
walking, persistent blinking in response to tapping  Coma due to uncontrolled diabetes
of the forehead (an abnormal reflex)
 Yellowing of the skin and the eyes (jaundice)
 Headache, difficulty falling or staying asleep.
 Inflammation of the pancreas.
 Low blood sugar
Common (affects 1 to 10 users in 100):
 Drowsiness, fatigue, restlessness, inability to sit
Very rare (affects less than 1 user in 10,000):
still, irritability, anxiety, sleepiness, dizziness,
 Life threatening complications of uncontrolled
poor attention, feeling exhausted, sleep disorder
diabetes.
 Vomiting, diarrhoea, constipation, nausea,
increased appetite, abdominal pain or discomfort, Unknown frequency of occurrence (frequency
sore throat, dry mouth
cannot be estimated from the available data):
 Weight increased, increase in body temperature,  Severe allergic reaction resulting in difficulty in
decreased appetite
breathing and shock
 Difficulty breathing, lung infection (pneumonia),
 No granulocytes (a type of white blood cell to
flu, infection of the breathing passages, blurred
help you against infection)
vision, nose congestion, nose bleeding, cough
 Prolonged and painful erection
 Urinary tract infection, bed wetting
 Dangerously excessive intake of water.
 Tremor, muscle spasm, involuntary movements of
face or arms and legs, joint pain, back pain,
RISPERDAL CONSTA
swelling of arms and legs, pain in arms and legs
The following side effects have been reported with
the use of Risperdal Consta, a long acting
 Rash, skin redness
injection. Even if you are not being treated with
 Fast beating heart, chest pain
long acting injections of Risperdal Consta but you
 Blood prolactin hormone level increased.
experience any of the following, talk to your doctor.
Uncommon (affects 1 to 10 users in 1000):
 Excessive drinking of water, stool incontinence,
 Infection of the intestine
thirsty, very hard faeces, hoarseness or voice
 Abscess under the skin, tingling pricking or
disorder
numbness of skin, inflammation of the skin
 Diabetes mellitus, high blood sugar
 Depression
 Lung infection caused by inhaling of food into the  Convulsion
breathing passages, bladder infection, „pink eye‟,  Eye blinking
sinus infection, viral infection, ear infection, tonsil  Sensation of spinning or swaying
infection, infection under the skin, eye infection,
 Slow beating heart, high blood pressure
stomach infection, eye discharge, yeast infection
 Toothache, tongue spasm
of nails
 Buttock pain
 Abnormal electrical conduction of the heart, drop
 Weight decreased.
in blood pressure after standing, low blood

KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store the tablets above 30°C.
Do not use the tablets after the expiry date printed
on the packaging.
Always return any left-over medicine to your
pharmacist. Only keep it if your doctor tells you to.















pressure, feeling dizzy after changing body
If any of the side effects gets serious, or if you
position, abnormal electric activity tracing of the
notice any side effects not listed in this leaflet,
heart (ECG), abnormal heart rhythm, awareness
please tell your doctor or pharmacist.
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.

If the tablets become discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist
Medicines should not be disposed of via wastewater
or household waste. These measures will help
protect the environment. Return any leftover
Risperdal tablets to your pharmacist. Only keep it if
your doctor tells you to.

6 Further information
What RISPERDAL contains
The active substance is Risperdal tablets is
risperidone.
Each film-coated tablet contains 1mg, 2mg, 3mg or
4mg of risperidone.
The other ingredients are lactose, maize starch,
microcrystalline cellulose, hypromellose,
magnesium stearate, colloidal anhydrous silica,
sodium lauryl sulphate and propylene glycol.
The 2mg tablets also contain: sunset yellow (E110),
titanium dioxide (E171) and talc.
The 3mg tablets also contain: quinoline yellow
(E104), titanium dioxide (E171) and talc.
The 4mg tablets also contain quinoline yellow
(E104), indigo carmine aluminium lake (E132),
titanium dioxide (E171) and talc.
What Risperdal tablet looks like and contents
of the pack
Each white, oblong, film-coated, half-scored
Risperdal 1mg tablet is marked „RIS/1‟ on one side
and „Janssen‟ on the other side
Each pale orange, oblong, film-coated, half-scored
Risperdal 2mg tablet is marked „RIS/2‟ on one side
and „Janssen‟ on the other side
Each yellow, oblong, film-coated, half-scored
Risperdal 3mg tablet is marked „RIS/3‟ on one side
and „Janssen‟ on the other side
Each green, oblong, film-coated, half-scored
Risperdal 4mg tablet is marked „RIS/4‟ on one side
and „Janssen‟ on the other side
All the tablets are available in blister packs of 20
tablets.

Manufactured by: Famar A.B.E., Anthousa, Attiki,
Greece.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU
POM
®

Risperdal 1mg tablets– PL No:
®
Risperdal 2mg tablets– PL No:
®
Risperdal 3mg tablets– PL No:
®
Risperdal 4mg tablets– PL No:

18799/0718
18799/0719
18799/0720
18799/0721

Leaflet date: 29.10.2012
RISPERDAL is a trademark of JANSSEN- CILAG Ltd

Assessed against UK PIL dated April 2012
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE 1mg TABLETS
RISPERIDONE 2mg TABLETS
RISPERIDONE 3mg TABLETS
RISPERIDONE 4mg TABLETS
Read all of this leaflet carefully before you start
taking 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.
The name of your medicine is Risperidone 1mg
Tablets, Risperidone 2mg Tablets, Risperidone 3mg
Tablets and Risperidone 4mg Tablets, but it will be
referred as Risperidone throughout this leaflet.

Mock up

By AWhitney at 2:34 pm, Oct 31, 2012

Please note that this leaflet also contains
information about other strengths such as
Risperidone 0.5mg, and 6mg Tablets and
Risperidone Quicklet 0.5mg, 1mg, 2mg, 3mg and
4mg Orodispersible tablets.
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

 Short-term treatment (up to 6 weeks) of long-term
aggression in people with Alzheimer‟s dementia,
who harm themselves or others. Alternative (nonRisperidone is used to treat the following:
drug) treatments should have been used
 Schizophrenia, where you may see, hear or feel
previously.
things that are not there, believe things that are
 Short-term treatment (up to 6 weeks) of
not true or feel unusually suspicious, or confused
long-term, aggression in intellectually disabled
 Mania, where you may feel very excited, elated,
children (at least 5 years of age) and adolescents
agitated, enthusiastic or hyperactive. Mania
with conduct disorder.
occurs in an illness called “bipolar disorder”
Risperidone belongs to a group of medicines called
„anti-psychotics‟.

2 Before you take RISPERIDONE
Do not take RISPERIDONE if:
 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
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 for conduct disorder,
other causes of aggressive behaviour should have
been ruled out.
If during treatment with risperidone tiredness
occurs, a change in the time of administration
might improve attention difficulties.
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, allergies
(anti-histamines), some antidepressants or other
medicines for mental problems
 Medicines that cause a slow heart beat
 Medicines that cause low blood potassium
(such as certain diuretics)
 Medicines to treat raised blood pressure.
Risperidone can lower blood pressure
 Medicines for Parkinson's disease (such as
levodopa)
 Water tablets (diuretics) used for heart problems
or swelling of parts of your body due to a build
up of too much fluid (such as furosemide or
chlorothiazide). Risperidone taken by itself or with
furosemide, may have an increased risk of stroke
or death in elderly people with dementia.
The following medicines may reduce the effect of
risperidone
 Rifampicin (a medicine for treating some
infections)
 Carbamazepine, phenytoin (medicines for
epilepsy)
 Phenobarbital
If you start or stop taking such medicines you may
need a different dose of risperidone.
The following medicines may increase the effect of
risperidone
 Quinidine (used for certain types of heart
disease)
 Antidepressants such as paroxetine, fluoxetine,
tricyclic antidepressants
 Medicines known as beta blockers (used to treat
high blood pressure)
 Phenothiazines such as medicines used to treat
psychosis or to calm down)
 Cimetidine, ranitidine (blockers of the acidity of
stomach)
If you start or stop taking such medicines you may
need a different dose of risperidone.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before using
Risperidone.
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 breastfeeding. 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.
Important information about some of the
ingredients of Risperidone
The film-coated tablets contain lactose, a type of
sugar. If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product. The 2 mg
and 6 mg film-coated tablets contain sunset yellow
(E110) that may cause allergic reactions.
The orodispersible tablets contain aspartame, a
source of phenylalanine which may be harmful for
people with phenylketonuria.

3 How to take RISPERIDONE
How much to take

How to take Risperidone

For the treatment of schizophrenia

Always take Risperidone exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.

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

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.
Risperidone film-coated tablets
 You should swallow your tablet with a drink of
water
Risperidone Quicklet orodispersible tablets
Only remove a tablet from the blister when it is
time to take your medicine.
 Peel open a blister to expose the tablet
 Do not push the tablet through the foil because it
may break
 Remove the tablet from the blister with dry hands
 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
Adults
 See a doctor right away. Take the medicine pack
 Your starting dose will usually be 2mg once a day
with you
 Your dose may then be gradually adjusted by
 In case of overdose you may feel sleepy or tired,
your doctor depending on how you respond to the
or have abnormal body movements, problems
treatment
standing and walking, feel dizzy due to low blood
 Most people feel better with doses of 1 to 6mg
pressure, or have abnormal heart beats or fits.
once a day.
If you forget to take Risperidone
Elderly people
 If you forget to take a dose, take it as soon as you
 Your starting dose will usually be 0.5mg twice a
remember it. However, if it is almost time for
day
your next dose, skip the missed dose and
 Your dose may then be gradually adjusted by
continue as usual. If you miss two or more doses,
your doctor to 1mg to 2mg twice a day
contact your doctor
depending on how much you respond to
 Do not take a double dose (two doses at the
the treatment.
same time) to make up for a forgotten dose
Children and adolescents
If you stop taking Risperidone
 Children and adolescents under 18 years old
You should not stop taking this medicine unless
should not be treated with Risperidone for mania. told to do so by your doctor. Your symptoms may
For the treatment of long-standing aggression in return. If your doctor decides to stop this medicine,
your dose may be decreased gradually over a few
people with Alzheimer’s dementia
days.
Adults (including elderly people)
If you have any further questions on the use of this
 Your starting dose will normally be 0.25mg twice product, ask your doctor or pharmacist.
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 0.5mg twice a day.
Some patients may need 1mg twice a day
 Treatment duration in patients with Alzheimer‟s
dementia should be not more than 6 weeks.
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 50kg
 The starting dose will normally be 0.25mg once
a day
 The dose may be increased every other day in
steps of 0.25mg per day.
 The usual maintenance dose is 0.25mg to
0.75mg once a day.
For children who weigh 50kg or more
 The starting dose will normally be 0.5mg once a
day
 The dose may be increased every other day in
steps of 0.5mg per day.
 The usual maintenance dose is 0.5 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.

5 How to store RISPERIDONE

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

 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
The following side effects may happen:
temperature and twitching of muscles, oedema all
Very Common (affects more than 1 user in 10):
over the body, drug withdrawal syndrome,
decreased body temperature
 Parkinsonism. This is a medical term that includes
many symptoms. Each individual symptom may
 Fast shallow breathing, trouble breathing during
occur less frequently than in 1 in 10 people.
sleep, chronic otitis media
Parkinsonism includes: increase in saliva
 Obstruction of intestine
secretion or watery mouth, musculoskeletal
 Reduced blood flow to the brain
stiffness, drooling, jerks when bending the limbs,
 Decrease in white blood cells, inappropriate
slow, reduced or impaired body movements, no
secretion of a hormone that controls urine volume
expression on the face, muscle tightness, stiff
 Breakdown of muscle fibres and pain in muscles
neck, muscle stiffness, small, shuffling, hurried
(rhabdomyolysis), movement disorder
steps and lack of normal arm movements when
 Tremor of the head
walking, persistent blinking in response to tapping  Coma due to uncontrolled diabetes
of the forehead (an abnormal reflex)
 Yellowing of the skin and the eyes (jaundice)
 Headache, difficulty falling or staying asleep.
 Inflammation of the pancreas.
 Low blood sugar
Common (affects 1 to 10 users in 100):
 Drowsiness, fatigue, restlessness, inability to sit
Very rare (affects less than 1 user in 10,000):
still, irritability, anxiety, sleepiness, dizziness,
 Life threatening complications of uncontrolled
poor attention, feeling exhausted, sleep disorder
diabetes.
 Vomiting, diarrhoea, constipation, nausea,
increased appetite, abdominal pain or discomfort, Unknown frequency of occurrence (frequency
sore throat, dry mouth
cannot be estimated from the available data):
 Weight increased, increase in body temperature,  Severe allergic reaction resulting in difficulty in
decreased appetite
breathing and shock
 Difficulty breathing, lung infection (pneumonia),
 No granulocytes (a type of white blood cell to
flu, infection of the breathing passages, blurred
help you against infection)
vision, nose congestion, nose bleeding, cough
 Prolonged and painful erection
 Urinary tract infection, bed wetting
 Dangerously excessive intake of water.
 Tremor, muscle spasm, involuntary movements of
face or arms and legs, joint pain, back pain,
RISPERIDONE CONSTA
swelling of arms and legs, pain in arms and legs
The following side effects have been reported with
the use of Risperidone Consta, a long acting
 Rash, skin redness
injection. Even if you are not being treated with
 Fast beating heart, chest pain
long acting injections of Risperidone Consta but you
 Blood prolactin hormone level increased.
experience any of the following, talk to your doctor.
Uncommon (affects 1 to 10 users in 1000):
 Excessive drinking of water, stool incontinence,
 Infection of the intestine
thirsty, very hard faeces, hoarseness or voice
 Abscess under the skin, tingling pricking or
disorder
numbness of skin, inflammation of the skin
 Diabetes mellitus, high blood sugar
 Depression
 Lung infection caused by inhaling of food into the  Convulsion
breathing passages, bladder infection, „pink eye‟,  Eye blinking
sinus infection, viral infection, ear infection, tonsil  Sensation of spinning or swaying
infection, infection under the skin, eye infection,
 Slow beating heart, high blood pressure
stomach infection, eye discharge, yeast infection
 Toothache, tongue spasm
of nails
 Buttock pain
 Abnormal electrical conduction of the heart, drop
 Weight decreased.
in blood pressure after standing, low blood















pressure, feeling dizzy after changing body
If any of the side effects gets serious, or if you
position, abnormal electric activity tracing of the
notice any side effects not listed in this leaflet,
heart (ECG), abnormal heart rhythm, awareness
please tell your doctor or pharmacist.
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.

KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store the tablets above 30°C.
Do not use the tablets after the expiry date printed
on the packaging.
Always return any left-over medicine to your
pharmacist. Only keep it if your doctor tells you to.

If the tablets become discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist
Medicines should not be disposed of via wastewater
or household waste. These measures will help
protect the environment. Return any leftover
Risperidone tablets to your pharmacist. Only keep it
if your doctor tells you to.

6 Further information
What RISPERIDONE contains
The active substance is Risperidone tablets is
risperidone.
Each film-coated tablet contains 1mg, 2mg, 3mg or
4mg of risperidone.
The other ingredients are lactose, maize starch,
microcrystalline cellulose, hypromellose,
magnesium stearate, colloidal anhydrous silica,
sodium lauryl sulphate and propylene glycol.
The 2mg tablets also contain: sunset yellow (E110),
titanium dioxide (E171) and talc.
The 3mg tablets also contain: quinoline yellow
(E104), titanium dioxide (E171) and talc.
The 4mg tablets also contain quinoline yellow
(E104), indigo carmine aluminium lake (E132),
titanium dioxide (E171) and talc.
What RISPERIDONE looks like and contents
of the pack
Each white, oblong, film-coated, half-scored
Risperidone 1mg tablet is marked „RIS/1‟ on one
side and „Janssen‟ on the other side
Each pale orange, oblong, film-coated, half-scored
Risperidone 2mg tablet is marked „RIS/2‟ on one
side and „Janssen‟ on the other side
Each yellow, oblong, film-coated, half-scored
Risperidone 3mg tablet is marked „RIS/3‟ on one
side and „Janssen‟ on the other side
Each green, oblong, film-coated, half-scored
Risperidone 4mg tablet is marked „RIS/4‟ on one
side and „Janssen‟ on the other side
All the tablets are available in blister packs of 20
tablets.

Manufactured by: Famar A.B.E., Anthousa, Attiki,
Greece.
Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU
POM
Risperidone 1mg tablets– PL No:
Risperidone 2mg tablets– PL No:
Risperidone 3mg tablets– PL No:
Risperidone 4mg tablets– PL No:
Leaflet date: 29.10.2012

18799/0718
18799/0719
18799/0720
18799/0721

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
(web5)