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RISPERIDONE 4MG TABLETS

Active substance(s): RISPERIDONE

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S1029-32 LEAFLET Risperdal 20151028

5

How to store Risperdal





Do not store above 30°C.



Increased liver transaminases in your blood, Increased GGT (a
liver enzyme called gamma-glutamyltransferase) in your blood,
Increased liver enzymes in your blood
Procedural pain.

Rare (may affect up to 1 in 1,000 people):


Infection



Inappropriate secretion of a hormone that controls urine volume



Sugar in the urine, Low blood sugar, High blood triglycerides (a
fat)



Lack of emotion, Inability to reach orgasm



Neuroleptic malignant syndrome (confusion, reduced or loss of
consciousness, high fever, and severe muscle stiffness)



Blood vessel problems in the brain



Coma due to uncontrolled diabetes



Shaking of the head



Glaucoma (increased pressure within the eyeball), Problems
with movement of your eyes, Eye rolling, Eyelid margin crusting





Store in the original package in order to protect from light.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not take the tablets after the expiry date shown on the pack.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.





6



You are diabetic

PACKAGE LEAFLET: INFORMATION FOR THE USER



You have epilepsy

RISPERDAL 1mg TABLETS
RISPERDAL 2mg TABLETS
RISPERDAL 3mg TABLETS
RISPERDAL 4mg TABLETS
(risperidone)



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

Your medicine is known by any of the above names but will be
referred to as Risperdal throughout the following patient information
leaflet.



You have liver problems



You have an abnormally high level of the hormone prolactin in
your blood or if you have a possible prolactin-dependent
tumour.



You or someone else in your family has a history of blood clots,
as antipsychotics have been associated with formation of blood
clots.

S1029-32 LEAFLET Risperdal 20151028

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.
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.
Contents of the pack and other information

What Risperdal contains

Information for other strengths of Risperdal may also be present in
this leaflet.
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.

As dangerously low numbers of a certain type of white blood cell
needed to fight infection in your blood has been seen very rarely
with patients taking Risperdal, your doctor may check your white
blood cell counts.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

Risperdal may cause you to gain weight. Significant weight gain
may adversely affect your health. Your doctor should regularly
measure your body weight.



Eye problems during cataract surgery. During cataract surgery,
a condition called intraoperative floppy iris syndrome (IFIS) can
happen if you take or have taken Risperdal. If you need to have
cataract surgery, be sure to tell your eye doctor if you take or
have taken this medicine.

Each 1mg tablet contains 1mg of the active ingredient,
risperidone.



Each 2mg tablet contains 2mg of the active ingredient,
risperidone.



Each 3mg tablet contains 3mg of the active ingredient,
risperidone.

What is in this leaflet:
1

What Risperdal is and what it is used for

Dangerously low numbers of a certain type of white blood cell
needed to fight infection in your blood,



Each 4mg tablet contains 4mg of the active ingredient,
risperidone.

2

What you need to know before you take Risperdal



How to take Risperdal

Severe allergic reaction characterised by fever, swollen mouth,
face, lip or tongue, shortness of breath, itching, skin rash and
sometimes drop in blood pressure



3
4

Possible side effects

5

How to store Risperdal



Dangerously excessive intake of water

Risperdal Tablets also contain the following inactive
ingredients: lactose, maize starch, microcrystalline cellulose,
hypromellose, magnesium stearate, colloidal anhydrous silica,
sodium lauryl sulphate, propylene glycol.

6

Contents of the pack and other information

1

What Risperdal is and what it is used for





Risperdal 2mg Tablets also contain orange yellow S aluminium
lake (E110), titanium dioxide (E171) and talc.

Irregular heart beat



Blood clot in the legs, Blood clot in the lungs



Trouble breathing during sleep (sleep apnea), Fast, shallow
breathing

Risperdal 3mg Tablets also contain quinoline yellow (E104),
titanium dioxide (E171) and talc.
Risperdal 4mg Tablets also contain quinoline yellow (E104),
indigo carmine (E132), titanium dioxide (E171) and talc.



Inflammation of the pancreas, A blockage in the bowels



Swollen tongue, Chapped lips, Rash on skin related to drug

What Risperdal looks like and contents of the pack



Dandruff





Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis)

Risperdal 1mg Tablets are white, oblong tablet marked ‘Ris|1’
on one side and plain on the other.





A delay in menstrual periods, Enlargement of the glands in your
breasts, Breast enlargement, Discharge from the breasts

Risperdal 2mg Tablets are a pale orange, oblong tablet marked
‘Ris|2’ on one side and plain on the other.



Increased insulin (a hormone that controls blood sugar levels)
in your blood

Risperdal 3mg Tablets are yellow, oblong tablet marked ‘Ris|3’
on one side and plain on the other.



Priapism (a prolonged penile erection that may require surgical
treatment)

Risperdal 4mg Tablets are green, oblong tablet marked ‘Ris|4’
on one side and plain on the other.



Risperdal are available in packs of 20 and 60 tablets with each
blister containing 10 tablets.





Hardening of the skin



Decreased body temperature, Coldness in arms and legs



Symptoms of drug withdrawal

 Yellowing of the skin and the eyes (jaundice).
Very rare (may affect up to 1 in 10,000 people):


Life threatening complications of uncontrolled diabetes.



Serious allergic reaction with swelling that may involve the
throat and lead to difficulty breathing.



Lack of bowel muscle movement that causes blockage.

The following side effect has been seen with the use of another
medicine called paliperidone that is very similar to risperidone, so
these can also be expected with Risperdal: Rapid heartbeat upon
standing.
Additional side effects in children and adolescents
In general, side effects in children are expected to be similar to
those in adults.
The following side effects were reported more often in children and
adolescents (5 to 17 years) than in adults: feeling sleepy, or less
alert, fatigue (tiredness), headache, increased appetite, vomiting,
common cold symptoms, nasal congestion, abdominal pain,
dizziness, cough, fever, tremor (shaking), diarrhoea, and
incontinence (lack of control) of urine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.

Risperdal belongs to a group of medicines called ‘anti-psychotics’.
Risperdal is used to treat the following:


Schizophrenia, where you may see, hear or feel things that are
not there, believe things that are not true or feel unusually
suspicious, or confused



Mania, where you may feel very excited, elated, agitated,
enthusiastic or hyperactive Mania occurs in an illness called
“bipolar disorder”



Short-term treatment (up to 6 weeks) of long-term aggression in
people with Alzheimer’s dementia, who harm themselves or
others. Alternative (non-drug) treatments should have been
used previously



Short-term treatment (up to 6 weeks) of long-term, aggression
in intellectually disabled children (at least 5 years of age) and
adolescents with conduct disorder.

Risperdal can help alleviate the symptoms of your disease and stop
your symptoms from coming back.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.

2

Do not take Risperdal:


Manufacturer
These products are manufactured by Janssen-Cilag SpA, 04010
Borgo San Michele, Latina, Italy.

What you need to know before you take Risperdal
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 Risperdal.
Warnings and precautions

POM

PL 19488/1029
PL 19488/1030
PL 19488/1031
PL 19488/1032

Risperdal 1mg Tablets
Risperdal 2mg Tablets
Risperdal 3mg Tablets
Risperdal 4mg Tablets

Leaflet revision date: 28 October 2015.

Talk to your doctor or pharmacist before taking Risperdal if:


You have a heart problem. Examples include an irregular heart
rhythm or if you are prone to low blood pressure or if you are
using medicines for your blood pressure. Risperdal may cause
low blood pressure. Your dose may need to be adjusted



You know of any factors which would favour you having a
stroke, such as high blood pressure, cardiovascular disorder or
blood vessel problems in the brain



You have ever experienced involuntary movements of the
tongue, mouth and face



You have ever had a condition whose symptoms include high
temperature, muscle stiffness, sweating or a lowered level of
consciousness (also known as Neuroleptic Malignant
Syndrome)

Risperdal is a registered trademark of Janssen Cilag Ltd.
S1029-32 LEAFLET Risperdal 20151028



You have Parkinson’s disease or dementia



You know that you have had low levels of white blood cells in
the past (which may or may not have been caused by other
medicines)

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

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.
Risperdal commonly raises levels of a hormone called "prolactin".
This may cause side effects such as menstrual disorders or fertility
problems in women, breast swelling in men (see Possible side
effects). If such side effects occur, evaluation of the prolactin level
in the blood is recommended.
During an operation on the eye for cloudiness of the lens (cataract),
the pupil (the black circle in the middle of your eye) may not
increase in size as needed. Also, the iris (the coloured part of the
eye) may become floppy during surgery and that may lead to eye
damage. If you are planning to have an operation on your eye,
make sure you tell your eye doctor that you are taking this
medicine.
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.
Before treatment is started your, or your child’s body weight may be
measured and it may be regularly monitored during treatment.
A small and inconclusive study has reported an increase in height in
children who took risperidone, but whether this is an effect of the
drug or due to some other reason is not known.
Other medicines and Risperdal
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
It is especially important to talk to your doctor or pharmacist if
you are taking any of the following:


Medicines that work on your brain such as to help you calm
down (benzodiazepines) or some medicines for pain (opiates),
medicines for allergy (some antihistamines), as risperidone may
increase the sedative effect of all of these



Medicines that may change the electrical activity of your heart,
such as medicines for malaria, heart rhythm problems, allergies
(anti-histamines), some antidepressants or other medicines for
mental problems



Medicines that cause a slow heart beat



Medicines that cause low blood potassium (such as certain
diuretics)



Medicines to treat raised blood pressure. Risperdal can lower
blood pressure



Medicines for Parkinson’s disease (such as levodopa)



Water tablets (diuretics) used for heart problems or swelling of
parts of your body due to a build up of too much fluid (such as
furosemide or chlorothiazide). Risperdal taken by itself or with
furosemide, may have an increased risk of stroke or death in
elderly people with dementia.

Elderly people

If you forget to take Risperdal



Rash, Skin redness



Your starting dose will normally be 0.5 mg twice a day





Muscle spasms, Bone or muscle ache, Back pain, Joint pain



Your dose may then be gradually increased by your doctor to
1 mg to 2 mg twice a day



Incontinence (lack of control) of urine



Swelling of the body, arms or legs, Fever, Chest pain,
Weakness, Fatigue (tiredness), Pain



Rifampicin (a medicine for treating some infections)

 Your doctor will tell you which is the best for you.
For the treatment of mania



Carbamazepine, phenytoin (medicines for epilepsy)

Adults



Phenobarbital

The following medicines may reduce the effect of risperidone

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)



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.



Phenothiazines (such as medicines used to treat psychosis or
to calm down)

For the treatment of long-standing aggression in people with
Alzheimer’s dementia



Cimetidine, ranitidine (blockers of the acidity of stomach)

Adults (including elderly people)








Your starting dose will normally be 0.25 mg twice a day



Certain medicines used in the treatment of HIV/AIDS, such as
ritonavir

Your dose may then be gradually adjusted by your doctor
depending on how you respond to the treatment



Verapamil, a medicine used to treat high blood pressure and/or
abnormal heart rhythm.

Most people feel better with 0.5 mg twice a day. Some patients
may need 1 mg twice a day



Itraconazole and ketoconazole (medicines for treating fungal
infections)

Sertraline and fluvoxamine, medicines used to treat depression
and other psychiatric disorders.

Treatment duration in patients with Alzheimer’s dementia
should be not more than 6 weeks.
Use in children and adolescents

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



If you stop taking Risperdal

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

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

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.



Infection of the breathing passages, Bladder infection, ‘Eye
infection, Tonsillitis, Fungal infection of the nails, Infection of the
skin, An infection confined to a single area of skin or part of the
body, Viral infection, Skin inflammation caused by mites

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



Decrease in the type of white blood cells that help to protect
you against infection, White blood cell count decreased
Decrease in platelets (blood cells that help you stop bleeding),
Anemia, Decrease in red blood cells, Increase in eosinophils (a
type of white blood cell) in your blood



Allergic reaction



Diabetes or worsening of diabetes, High blood sugar, Excessive
drinking of water



Weight loss, Loss of appetite resulting in malnutrition and low
body weight



Increased cholesterol in your blood



Elated mood (mania), Confusion, Decreased sexual drive,
Nervousness, Nightmares



Tardive dyskinesia (twitching or jerking movements that you
cannot control in your face, tongue, or other parts of your body).
Tell your doctor immediately if you experience involuntary
rhythmic movements of the tongue, mouth and face. Withdrawal
of Risperdal may be needed,

4

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Tell your doctor immediately if you:




Experience blood clots in the veins, especially in the legs
(symptoms include swelling, pain, and redness in the leg),
which may travel through blood vessels to the lungs causing
chest pain and difficulty breathing. If you notice any of these
symptoms seek medical advice immediately
Have dementia and experience a sudden change in your
mental state or sudden weakness or numbness of your face,
arms or legs, especially on one side, or slurred speech, even
for a short period of time. These may be signs of a stroke



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



Sudden loss of blood supply to brain (stroke or “mini” stroke)



Are a man and experience prolonged or painful erection. This is
called priapism. Immediate medical treatment may be needed



Unresponsive to stimuli, Loss of consciousness, Low level of
consciousness



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



Convulsion (fits), Fainting



A restless urge to move parts of your body, Balance disorder,
Abnormal coordination, Dizziness upon standing, Disturbance
in attention, Problems with speech, Loss or abnormal sense of
taste, Reduced sensation of skin to pain and touch, A sensation
of tingling, pricking, or numbness skin



Oversensitivity of the eyes to light, Dry eye, Increased tears,
Redness of the eyes



Sensation of spinning (vertigo), Ringing in the ears, Ear pain



Atrial fibrillation (an abnormal heart rhythm), An interruption in
conduction between the upper and lower parts of the heart,
Abnormal electrical conduction of the heart, Prolongation of the
QT interval from your heart, Slow heart rate, Abnormal electrical
tracing of the heart (electrocardiogram or ECG), A fluttering or
pounding feeling in your chest (palpitations)



Low blood pressure, Low blood pressure upon standing
(consequently, some people taking Risperdal may feel faint,
dizzy, or may pass out when they stand up or sit up suddenly,
Flushing

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.

For the treatment of conduct disorder

Risperdal with food, drink and alcohol

For children who weigh less than 50 kg

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



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.

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine. Your doctor
will decide if you can take it



The usual maintenance dose is 0.25 mg to 0.75 mg once a day.



The starting dose will normally be 0.5 mg once a day

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.



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.

Risperdal can raise your levels of a hormone called “prolactin”
that may impact fertility (see Possible side effects).

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.



Pneumonia, Infection of the chest (bronchitis), Common cold
symptoms, Sinus infection Urinary tract infection Ear infection,
Feeling like you have the flu



Pneumonia caused by inhaling food, Lung congestion,
Congestion of breathing passages, Crackly lung sounds,
Wheezing, Voice disorder, Breathing passage disorder



Raised levels of a hormone called "prolactin" found in a blood
test (which may or may not cause symptoms). Symptoms of
high prolactin occur uncommonly and may include in men
breast swelling, difficulty in getting or maintaining erections,
decreased sexual desire or other sexual dysfunction. In women
they may include breast discomfort, leakage of milk from the
breasts, missed menstrual periods, or other problems with your
cycle or fertility problems.



Stomach or intestinal infection, Stool incontinence, Very hard
stool, Difficulty swallowing, Excessive passing of gas or wind



Hives (or “nettle rash”), Itching, Hair loss, Thickening of skin,
Eczema, Dry skin, Skin discoloration, Acne, Flaky, itchy scalp
or skin, Skin disorder, Skin lesion



An increase of CPK (creatine phosphokinase) in your blood, an
enzyme which is sometimes released with muscle breakdown



Weight gain, Increased appetite, Decreased appetite





Sleep disorder, Irritability, Depression, Anxiety, Restlessness

Abnormal posture, Joint stiffness, Joint swelling, Muscle
weakness, Neck pain



Dystonia: This is a condition involving slow or sustained
involuntary contraction of muscles. While it can involve any part
of the body (and may result in abnormal posture), dystonia
often involves muscles of the face, including abnormal
movements of the eyes, mouth, tongue or jaw.



Frequent passing of urine, Inability to pass urine, Pain when
passing urine



Erectile dysfunction, Ejaculation disorder



Loss of menstrual periods, Missed menstrual periods or other
problems with your cycle (females),

Pregnancy, breast-feeding and fertility






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.
Risperdal film-coated tablets contain lactose
The film-coated tablets contain lactose, a type of sugar. If you have
been told by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.
Risperdal 2 mg and 6 mg film-coated tablets also contain sunset
yellow (E110) that may cause allergic reactions.
Risperdal Quicklet orodispersible tablets contain aspartame, a
source of phenylalanine which may be harmful for people with
phenylketonuria.
3

How to take Risperdal

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

The dose will depend on your child’s weight:

For children who weigh 50 kg or more



You should swallow your tablet with a drink of water



The score line is only there to help you break the tablet if you
have difficulty swallowing it whole.

Risperdal Quicklet orodispersible tablets
Only remove a tablet from the blister when it is time to take your
medicine.


Do not push the tablet through the foil because it may break

The recommended dose is as follows:



Remove the tablet from the blister with dry hands

For the treatment of schizophrenia



Place the tablet on your tongue straight away

Adults



The tablet will begin disintegrating within seconds

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.

Difficulty falling or staying asleep



Parkinsonism: This condition may include: slow or impaired
movement, sensation of stiffness or tightness of the muscles
(making your movements jerky), and sometimes even a
sensation of movement “freezing up” and then restarting. Other
signs of parkinsonism include a slow shuffling walk, a tremor
while at rest, increased saliva and/or drooling, and a loss of
expression on the face.
Feeling sleepy, or less alert

 Headache.
Common (may affect up to 1 in 10 people):

Risperdal film-coated tablets

Peel open a blister to expose the tablet





For oral use



The usual starting dose is 2 mg per day, this may be increased
to 4 mg per day on the second day

Very Common (may affect more than 1 in 10 people):

Risperidone should be used with caution in this patient group.
Method of administration

Experience severe allergic reaction characterised by fever,
swollen mouth, face, lip or tongue, shortness of breath, itching,
skin rash or drop in blood pressure.

The following side effects may happen:

Treatment duration in patients with conduct disorder should be not
more than 6 weeks.

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







Dizziness



 It can then be swallowed with or without water.
If you take more Risperdal than you should



Development of breasts in men, Leakage of milk from the
breasts, Sexual dysfunction, Breast pain, Breast discomfort,
Vaginal discharge



Dyskinesia: This is a condition involving involuntary muscle
movements, and can include repetitive, spastic or writhing
movements, or twitching.

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



Swelling of the face, mouth, eyes, or lips





Tremor (shaking)

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
heartbeats or fits.





Chills, An increase in body temperature

Blurry vision, Eye infection or “pink eye”





A change in the way you walk

Rapid heart rate, High blood pressure, Shortness of breath





Sore throat, Cough, Nosebleeds, Stuffy nose

Feeling thirsty, Feeling unwell, Chest discomfort, Feeling “out of
sorts”, Discomfort



Abdominal pain, Abdominal discomfort, Vomiting, Nausea,
Constipation, Diarrhea, Indigestion, Dry mouth, Toothache
S1029-32 LEAFLET Risperdal 20151028

S1029-32 LEAFLET Risperidone 20151028

5

How to store Risperidone Tablets





Do not store above 30°C.



Store in the original package in order to protect from light.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not take the tablets after the expiry date shown on the pack.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



Increased liver transaminases in your blood, Increased GGT (a
liver enzyme called gamma-glutamyltransferase) in your blood,
Increased liver enzymes in your blood
Procedural pain.

Rare (may affect up to 1 in 1,000 people):


Infection



Inappropriate secretion of a hormone that controls urine volume



Sugar in the urine, Low blood sugar, High blood triglycerides (a
fat)



Lack of emotion, Inability to reach orgasm



Neuroleptic malignant syndrome (confusion, reduced or loss of
consciousness, high fever, and severe muscle stiffness)



Blood vessel problems in the brain



Coma due to uncontrolled diabetes



Shaking of the head



Glaucoma (increased pressure within the eyeball), Problems
with movement of your eyes, Eye rolling, Eyelid margin crusting







6

You know that you have had low levels of white blood cells in
the past (which may or may not have been caused by other
medicines)



You are diabetic



You have epilepsy



You are a man and you have ever had a prolonged or painful
erection

Your medicine is known by any of the above names but will be
referred to as Risperidone Tablets throughout the following patient
information leaflet.



You have problems controlling your body temperature or
overheating



You have kidney problems

Information for other strengths of Risperidone Tablets may also be
present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



You have liver problems





You have an abnormally high level of the hormone prolactin in
your blood or if you have a possible prolactin-dependent
tumour.

Keep this leaflet. You may need to read it again.





If you have any further questions, ask your doctor or
pharmacist.

You or someone else in your family has a history of blood clots,
as antipsychotics have been associated with formation of blood
clots.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

PACKAGE LEAFLET: INFORMATION FOR THE USER

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.
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.
Contents of the pack and other information

What Risperidone Tablets contains




S1029-32 LEAFLET Risperidone 20151028

Each 1mg tablet contains 1mg of the active ingredient,
risperidone.

RISPERIDONE 1mg TABLETS
RISPERIDONE 2mg TABLETS
RISPERIDONE 3mg TABLETS
RISPERIDONE 4mg TABLETS

Eye problems during cataract surgery. During cataract surgery,
a condition called intraoperative floppy iris syndrome (IFIS) can
happen if you take or have taken Risperidone Tablets. If you
need to have cataract surgery, be sure to tell your eye doctor if
you take or have taken this medicine.



Each 2mg tablet contains 2mg of the active ingredient,
risperidone.



Each 3mg tablet contains 3mg of the active ingredient,
risperidone.

What is in this leaflet:
1

What Risperidone Tablets are and what they are used for



Dangerously low numbers of a certain type of white blood cell
needed to fight infection in your blood,



Each 4mg tablet contains 4mg of the active ingredient,
risperidone.

2

What you need to know before you take Risperidone
Tablets



Severe allergic reaction characterised by fever, swollen mouth,
face, lip or tongue, shortness of breath, itching, skin rash and
sometimes drop in blood pressure



Risperidone Tablets Tablets also contain the following inactive
ingredients: lactose, maize starch, microcrystalline cellulose,
hypromellose, magnesium stearate, colloidal anhydrous silica,
sodium lauryl sulphate, propylene glycol.

3

How to take Risperidone Tablets

4

Possible side effects

5

How to store Risperidone Tablets

Risperidone Tablets 2mg Tablets also contain orange yellow S
aluminium lake (E110), titanium dioxide (E171) and talc.

6

Contents of the pack and other information

Risperidone Tablets 3mg Tablets also contain quinoline yellow
(E104), titanium dioxide (E171) and talc.

1

What Risperidone Tablets are and what they are used for



Dangerously excessive intake of water



Irregular heart beat



Blood clot in the legs, Blood clot in the lungs



Trouble breathing during sleep (sleep apnea), Fast, shallow
breathing



Inflammation of the pancreas, A blockage in the bowels



Swollen tongue, Chapped lips, Rash on skin related to drug

What Risperidone Tablets looks like and contents of the pack



Dandruff





Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis)

Risperidone 1mg Tablets are white, oblong tablet marked ‘Ris|1’
on one side and plain on the other.





A delay in menstrual periods, Enlargement of the glands in your
breasts, Breast enlargement, Discharge from the breasts

Risperidone 2mg Tablets are a pale orange, oblong tablet
marked ‘Ris|2’ on one side and plain on the other.





Increased insulin (a hormone that controls blood sugar levels)
in your blood

Risperidone 3mg Tablets are yellow, oblong tablet marked
‘Ris|3’ on one side and plain on the other.





Priapism (a prolonged penile erection that may require surgical
treatment)

Risperidone 4mg Tablets are green, oblong tablet marked
‘Ris|4’ on one side and plain on the other.





Hardening of the skin

Risperidone Tablets are available in packs of 20 and 60 tablets
with each blister containing 10 tablets.



Decreased body temperature, Coldness in arms and legs



Symptoms of drug withdrawal

 Yellowing of the skin and the eyes (jaundice).
Very rare (may affect up to 1 in 10,000 people):


Life threatening complications of uncontrolled diabetes.



Serious allergic reaction with swelling that may involve the
throat and lead to difficulty breathing.



Lack of bowel muscle movement that causes blockage.

The following side effect has been seen with the use of another
medicine called paliperidone that is very similar to risperidone, so
these can also be expected with Risperidone Tablets: Rapid
heartbeat upon standing.
Additional side effects in children and adolescents
In general, side effects in children are expected to be similar to
those in adults.
The following side effects were reported more often in children and
adolescents (5 to 17 years) than in adults: feeling sleepy, or less
alert, fatigue (tiredness), headache, increased appetite, vomiting,
common cold symptoms, nasal congestion, abdominal pain,
dizziness, cough, fever, tremor (shaking), diarrhoea, and
incontinence (lack of control) of urine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.

Risperidone Tablets 4mg Tablets also contain quinoline yellow
(E104), indigo carmine (E132), titanium dioxide (E171) and talc.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.

Risperidone Tablets belongs to a group of medicines called ‘antipsychotics’.
Risperidone Tablets are used to treat the following:


Schizophrenia, where you may see, hear or feel things that are
not there, believe things that are not true or feel unusually
suspicious, or confused



Mania, where you may feel very excited, elated, agitated,
enthusiastic or hyperactive Mania occurs in an illness called
“bipolar disorder”



Short-term treatment (up to 6 weeks) of long-term aggression in
people with Alzheimer’s dementia, who harm themselves or
others. Alternative (non-drug) treatments should have been
used previously



Short-term treatment (up to 6 weeks) of long-term, aggression
in intellectually disabled children (at least 5 years of age) and
adolescents with conduct disorder.

Risperidone Tablets can help alleviate the symptoms of your
disease and stop your symptoms from coming back.
2

Manufacturer
These products are manufactured by Janssen-Cilag SpA, 04010
Borgo San Michele, Latina, Italy.
POM

PL 19488/1029
PL 19488/1030
PL 19488/1031
PL 19488/1032

Risperidone 1mg Tablets
Risperidone 2mg Tablets
Risperidone 3mg Tablets
Risperidone 4mg Tablets

Leaflet revision date: 28 October 2015.

What you need to know before you take Risperidone
Tablets

Do not take Risperidone Tablets:


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 Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Tablets
if:


S1029-32 LEAFLET Risperidone 20151028

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 Tablets
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)

By reporting side effects, you can help provide more information on
the safety of this medicine.


You have Parkinson’s disease or dementia

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperidone Tablets.
As dangerously low numbers of a certain type of white blood cell
needed to fight infection in your blood has been seen very rarely
with patients taking Risperidone Tablets, your doctor may check
your white blood cell counts.
Risperidone Tablets 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 Tablets, your
doctor should check for signs of high blood sugar. In patients with
pre-existing diabetes mellitus blood glucose should be monitored
regularly.
Risperidone Tablets commonly raises levels of a hormone called
"prolactin". This may cause side effects such as menstrual
disorders or fertility problems in women, breast swelling in men (see
Possible side effects). If such side effects occur, evaluation of the
prolactin level in the blood is recommended.
During an operation on the eye for cloudiness of the lens (cataract),
the pupil (the black circle in the middle of your eye) may not
increase in size as needed. Also, the iris (the coloured part of the
eye) may become floppy during surgery and that may lead to eye
damage. If you are planning to have an operation on your eye,
make sure you tell your eye doctor that you are taking this
medicine.
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.
Before treatment is started your, or your child’s body weight may be
measured and it may be regularly monitored during treatment.
A small and inconclusive study has reported an increase in height in
children who took risperidone, but whether this is an effect of the
drug or due to some other reason is not known.
Other medicines and Risperidone Tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
It is especially important to talk to your doctor or pharmacist if
you are taking any of the following:


Medicines that work on your brain such as to help you calm
down (benzodiazepines) or some medicines for pain (opiates),
medicines for allergy (some antihistamines), as risperidone may
increase the sedative effect of all of these



Medicines that may change the electrical activity of your heart,
such as medicines for malaria, heart rhythm problems, allergies
(anti-histamines), some antidepressants or other medicines for
mental problems



Medicines that cause a slow heart beat



Medicines that cause low blood potassium (such as certain
diuretics)



Medicines to treat raised blood pressure. Risperidone Tablets
can lower blood pressure





Medicines for Parkinson’s disease (such as levodopa)

Elderly people



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 Tablets taken by
itself or with furosemide, may have an increased risk of stroke
or death in elderly people with dementia.



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

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.

The following medicines may reduce the effect of risperidone

 Your doctor will tell you which is the best for you.
For the treatment of mania



Rifampicin (a medicine for treating some infections)

Adults



Carbamazepine, phenytoin (medicines for epilepsy)



Phenobarbital



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

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

 Most people feel better with doses of 1 to 6 mg once a day.
Elderly people



Quinidine (used for certain types of heart disease)



Your starting dose will usually be 0.5 mg twice a day



Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants



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.



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)



Itraconazole and ketoconazole (medicines for treating fungal
infections)



Certain medicines used in the treatment of HIV/AIDS, such as
ritonavir



Verapamil, a medicine used to treat high blood pressure and/or
abnormal heart rhythm.



Sertraline and fluvoxamine, medicines used to treat depression
and other psychiatric disorders.

If you start or stop taking such medicines you may need a different
dose of risperidone.

For the treatment of long-standing aggression in people with
Alzheimer’s dementia

If you forget to take Risperidone Tablets



Rash, Skin redness





Muscle spasms, Bone or muscle ache, Back pain, Joint pain



Incontinence (lack of control) of urine



Swelling of the body, arms or legs, Fever, Chest pain,
Weakness, Fatigue (tiredness), Pain



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.

Use in children and adolescents


Children and adolescents under 18 years old should not be
treated with Risperidone Tablets for schizophrenia or mania.

For the treatment of conduct disorder

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

If you stop taking Risperidone Tablets



Infection of the breathing passages, Bladder infection, ‘Eye
infection, Tonsillitis, Fungal infection of the nails, Infection of the
skin, An infection confined to a single area of skin or part of the
body, Viral infection, Skin inflammation caused by mites

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



Decrease in the type of white blood cells that help to protect
you against infection, White blood cell count decreased
Decrease in platelets (blood cells that help you stop bleeding),
Anemia, Decrease in red blood cells, Increase in eosinophils (a
type of white blood cell) in your blood



Allergic reaction



Diabetes or worsening of diabetes, High blood sugar, Excessive
drinking of water



Weight loss, Loss of appetite resulting in malnutrition and low
body weight



Increased cholesterol in your blood



Elated mood (mania), Confusion, Decreased sexual drive,
Nervousness, Nightmares



Tardive dyskinesia (twitching or jerking movements that you
cannot control in your face, tongue, or other parts of your body).
Tell your doctor immediately if you experience involuntary
rhythmic movements of the tongue, mouth and face. Withdrawal
of Risperidone Tablets may be needed,

4

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Tell your doctor immediately if you:




Experience blood clots in the veins, especially in the legs
(symptoms include swelling, pain, and redness in the leg),
which may travel through blood vessels to the lungs causing
chest pain and difficulty breathing. If you notice any of these
symptoms seek medical advice immediately
Have dementia and experience a sudden change in your
mental state or sudden weakness or numbness of your face,
arms or legs, especially on one side, or slurred speech, even
for a short period of time. These may be signs of a stroke



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



Sudden loss of blood supply to brain (stroke or “mini” stroke)



Are a man and experience prolonged or painful erection. This is
called priapism. Immediate medical treatment may be needed



Unresponsive to stimuli, Loss of consciousness, Low level of
consciousness



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



Convulsion (fits), Fainting



A restless urge to move parts of your body, Balance disorder,
Abnormal coordination, Dizziness upon standing, Disturbance
in attention, Problems with speech, Loss or abnormal sense of
taste, Reduced sensation of skin to pain and touch, A sensation
of tingling, pricking, or numbness skin



Oversensitivity of the eyes to light, Dry eye, Increased tears,
Redness of the eyes



Sensation of spinning (vertigo), Ringing in the ears, Ear pain



Atrial fibrillation (an abnormal heart rhythm), An interruption in
conduction between the upper and lower parts of the heart,
Abnormal electrical conduction of the heart, Prolongation of the
QT interval from your heart, Slow heart rate, Abnormal electrical
tracing of the heart (electrocardiogram or ECG), A fluttering or
pounding feeling in your chest (palpitations)



Low blood pressure, Low blood pressure upon standing
(consequently, some people taking Risperidone Tablets may
feel faint, dizzy, or may pass out when they stand up or sit up
suddenly, Flushing

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

The dose will depend on your child’s weight:

Risperidone Tablets with food, drink and alcohol



The starting dose will normally be 0.25 mg once a day

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



The dose may be increased every other day in steps of 0.25 mg
per day.

The following side effects may happen:

Pregnancy, breast-feeding and fertility



The usual maintenance dose is 0.25 mg to 0.75 mg once a day.



Difficulty falling or staying asleep



Parkinsonism: This condition may include: slow or impaired
movement, sensation of stiffness or tightness of the muscles
(making your movements jerky), and sometimes even a
sensation of movement “freezing up” and then restarting. Other
signs of parkinsonism include a slow shuffling walk, a tremor
while at rest, increased saliva and/or drooling, and a loss of
expression on the face.





If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine. Your doctor
will decide if you can take it
The following symptoms may occur in newborn babies, of
mothers that have used Risperidone Tablets in the last
trimester (last three months of their pregnancy): shaking,
muscle stiffness, and/or weakness, sleepiness, agitation,
breathing problems, and difficulty in feeding. If your baby
develops any of these symptoms you may need to contact your
doctor.



Risperidone Tablets can raise your levels of a hormone called
“prolactin” that may impact fertility (see Possible side effects).
Driving and using machines
Dizziness, tiredness, and vision problems may occur during
treatment with Risperidone Tablets. Do not drive or use any tools or
machines without talking to your doctor first.



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.

Children under 5 years old should not be treated with Risperidone
Tablets for conduct disorder.

 Headache.
Common (may affect up to 1 in 10 people):

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.

Pneumonia, Infection of the chest (bronchitis), Common cold
symptoms, Sinus infection Urinary tract infection Ear infection,
Feeling like you have the flu



Pneumonia caused by inhaling food, Lung congestion,
Congestion of breathing passages, Crackly lung sounds,
Wheezing, Voice disorder, Breathing passage disorder



Raised levels of a hormone called "prolactin" found in a blood
test (which may or may not cause symptoms). Symptoms of
high prolactin occur uncommonly and may include in men
breast swelling, difficulty in getting or maintaining erections,
decreased sexual desire or other sexual dysfunction. In women
they may include breast discomfort, leakage of milk from the
breasts, missed menstrual periods, or other problems with your
cycle or fertility problems.



Stomach or intestinal infection, Stool incontinence, Very hard
stool, Difficulty swallowing, Excessive passing of gas or wind



Hives (or “nettle rash”), Itching, Hair loss, Thickening of skin,
Eczema, Dry skin, Skin discoloration, Acne, Flaky, itchy scalp
or skin, Skin disorder, Skin lesion



An increase of CPK (creatine phosphokinase) in your blood, an
enzyme which is sometimes released with muscle breakdown



Weight gain, Increased appetite, Decreased appetite





Sleep disorder, Irritability, Depression, Anxiety, Restlessness

Abnormal posture, Joint stiffness, Joint swelling, Muscle
weakness, Neck pain



Dystonia: This is a condition involving slow or sustained
involuntary contraction of muscles. While it can involve any part
of the body (and may result in abnormal posture), dystonia
often involves muscles of the face, including abnormal
movements of the eyes, mouth, tongue or jaw.



Frequent passing of urine, Inability to pass urine, Pain when
passing urine



Erectile dysfunction, Ejaculation disorder



Loss of menstrual periods, Missed menstrual periods or other
problems with your cycle (females),

Risperidone should be used with caution in this patient group.
Method of administration

Risperidone Tablets 2 mg and 6 mg film-coated tablets also
contain sunset yellow (E110) that may cause allergic reactions.



How to take Risperidone Tablets

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is as follows:
For the treatment of schizophrenia
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

Very Common (may affect more than 1 in 10 people):



For oral use

3

Experience severe allergic reaction characterised by fever,
swollen mouth, face, lip or tongue, shortness of breath, itching,
skin rash or drop in blood pressure.

Treatment duration in patients with conduct disorder should be not
more than 6 weeks.

Risperidone Tablets film-coated tablets contain lactose
The film-coated tablets contain lactose, a type of sugar. If you have
been told by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.

Risperidone Tablets Quicklet orodispersible tablets contain
aspartame, a source of phenylalanine which may be harmful for
people with phenylketonuria.



For children who weigh less than 50 kg

For children who weigh 50 kg or more

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

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.

Adults (including elderly people)


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

Risperidone Tablets film-coated tablets


You should swallow your tablet with a drink of water

The score line is only there to help you break the tablet if you
have difficulty swallowing it whole.
Risperidone Tablets Quicklet orodispersible tablets
Only remove a tablet from the blister when it is time to take your
medicine.

Feeling sleepy, or less alert



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



Dizziness







Place the tablet on your tongue straight away



The tablet will begin disintegrating within seconds

Dyskinesia: This is a condition involving involuntary muscle
movements, and can include repetitive, spastic or writhing
movements, or twitching.

Development of breasts in men, Leakage of milk from the
breasts, Sexual dysfunction, Breast pain, Breast discomfort,
Vaginal discharge





Swelling of the face, mouth, eyes, or lips

Tremor (shaking)





Chills, An increase in body temperature

Blurry vision, Eye infection or “pink eye”





A change in the way you walk

Rapid heart rate, High blood pressure, Shortness of breath





Sore throat, Cough, Nosebleeds, Stuffy nose

Feeling thirsty, Feeling unwell, Chest discomfort, Feeling “out of
sorts”, Discomfort



Abdominal pain, Abdominal discomfort, Vomiting, Nausea,
Constipation, Diarrhea, Indigestion, Dry mouth, Toothache

 It can then be swallowed with or without water.
If you take more Risperidone Tablets 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
heartbeats or fits.

S1029-32 LEAFLET Risperidone 20151028

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.

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