RISPERIDONE 0.5MG FILM-COATED TABLETS

Active substance: RISPERIDONE

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S1661 LEAFLET Risperdal 20131128

Additional side effects in children and adolescents



Loss of menstrual periods, Missed menstrual periods or other
problems with your cycle (females),
Development of breasts in men, Leakage of milk from the
breasts, Sexual dysfunction, Breast pain, Breast discomfort,
Vaginal discharge

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



You have problems controlling your body temperature or
overheating

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



You have kidney problems



You have liver problems

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



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.

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.



S1661 LEAFLET Risperdal 20131128





Swelling of the face, mouth, eyes, or lips



Chills, An increase in body temperature



A change in the way you walk



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



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


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



Shaking of the head



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.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.



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



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

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.

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



5

How to store Risperdal

What is in this leaflet:



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

1

What Risperdal is and what it is used for

2

What you need to know before you take Risperdal

3

How to take Risperdal

4

Possible side effects

5

How to store Risperdal

6

Contents of the pack and other information

1

What Risperdal is and what it is used for






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



RISPERDAL 0.5mg FILM-COATED TABLETS
(risperidone)



Reporting of side effects

Coma due to uncontrolled diabetes



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

PACKAGE LEAFLET: INFORMATION FOR THE USER



6

Do not store above 30°C.
Do not use after the expiry date which is stated on the blister,
foil, carton, or bottle. The expiry date refers to the last day of
that month.
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.

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.

Contents of the pack and other information

What Risperdal contains


The active substance is risperidone.
Each Risperdal film-coated tablet contains 0.5 mg risperidone.



The other ingredients are: lactose monohydrate, maize starch,
magnesium stearate (Ph. Eur), sodium lauryl sulphate,
propylene glycol, hypromellose, microcrystalline cellulose,
fumed silica, talc, iron (III) oxide (E172), titanium dioxide
(E171).



Dangerously excessive intake of water



Irregular heart beat

What Risperdal looks like and contents of the pack



Blood clot in the legs, Blood clot in the lungs



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

Risperdal is a brownish-red oblong biconvex film-coated tablet
engraved with “Janssen” on one side and “Ris|0.5” on the other.



Risperdal is available in blister packs of 20 and 50 tablets.

Inflammation of the pancreas, A blockage in the bowels



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



Dandruff



Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis)

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



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



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



Priapism (a prolonged penile erection that may require surgical
treatment)
Decreased body temperature, A decrease in body temperature,
Coldness in arms and legs



Symptoms of drug withdrawal



Yellowing of the skin and the eyes (jaundice).
Life threatening complications of uncontrolled diabetes.



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

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.

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.
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

2

If during treatment with risperidone tiredness occurs, a change in
the time of administration might improve attention difficulties.

What you need to know before you take Risperdal

Do not take Risperdal if:
You are allergic (hypersensitive) to risperidone or any of the
other ingredients of this medicine (listed in section 6).

Before treatment is started your, or your child’s body weight may be
measured and it may be regularly monitored during treatment.
Other medicines and Risperdal

Talk to your doctor or pharmacist before taking Risperdal if:

This product is manufactured by Janssen-Cilag S.p.A., Via C.
Janssen, 04010 Borgo San Michele (Latina), Italy.
POM

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

Warnings and precautions
Manufacturer

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

It is especially important to talk to your doctor or pharmacist if
you are taking any of the following:



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



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



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

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



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)



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



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



You have Parkinson’s disease or dementia



Medicines for Parkinson’s disease (such as levodopa)



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

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.

PL No: 19488/1661

Leaflet revision date: 28 November 2013.
Risperdal is a registered trade mark of Janseen-Cilag.
S1661 LEAFLET Risperdal 20131128

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


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

Before treatment is started for conduct disorder, other causes of
aggressive behaviour should have been ruled out.

Hardening of the skin



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.

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



Product Licence holder



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

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

The following medicines may reduce the effect of risperidone

For the treatment of mania

If you forget to take Risperdal



Sore throat, Cough, Nosebleeds, Stuffy nose



Rifampicin (a medicine for treating some infections)

Adults







Carbamazepine, phenytoin (medicines for epilepsy)



Your starting dose will usually be 2 mg once a day

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



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



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



Fall.



Phenobarbital

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



The following medicines may increase the effect of risperidone

Elderly people



Quinidine (used for certain types of heart disease)



Your starting dose will usually be 0.5 mg twice a day

If you stop taking Risperdal



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.

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.



Medicines known as beta blockers (used to treat high blood
pressure)

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

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



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



Your starting dose will normally be 0.25 mg twice a day

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

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



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

Tell your doctor immediately if you:

Risperdal with food, drink and alcohol



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

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

Use in children and adolescents

Pregnancy, breast-feeding and fertility





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



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

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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

Uncommon (affects 1 to 10 users in 1000):










Phenothiazines (such as medicines used to treat psychosis or
to calm down)
Cimetidine, ranitidine (blockers of the acidity of stomach)

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 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.
Risperdal 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 Risperdal. Do not drive or use any tools or machines
without talking to your doctor first.
Risperdal contains lactose or aspartame
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 Risperdal
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Adults (including elderly people)

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

For the treatment of conduct disorder





The dose will depend on your child’s weight:
For children who weigh less than 50 kg


The starting dose will normally be 0.25 mg once a day



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



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

For children who weigh 50 kg or more

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

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



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,



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



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



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

The dose may be increased every other day in steps of 0.5 mg
per day.

The following side effects may happen:



Convulsion (fits), Fainting

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

The usual maintenance dose is 0.5 mg to 1.5 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.

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



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



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



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



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



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



Erectile dysfunction, Ejaculation disorder



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.



Feeling sleepy, or less alert

Risperidone should be used with caution in this patient group.



Headache.

Risperdal film-coated tablets

Common (affects 1 to 10 users in 100):



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.

Adults



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

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





Risperdal Quicklet orodispersible tablets



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

The starting dose will normally be 0.5 mg once a day

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

Allergic reaction





The recommended dose is as follows:





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 if these
symptoms seek medical advice immediately

Pneumonia, Infection of the chest (bronchitis), Common cold
symptoms, Sinus infection Urinary tract infection Ear infection,
Feeling like you have the flu
Risperdal can raise your levels of a hormone called “prolactin”
found on a blood test (which may or may not cause symptoms).
When symptoms of high prolactin occur, they may include in
men breast swelling, difficulty in getting or maintaining
erections, 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.



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



Weight gain, Increased appetite, Decreased appetite



Most people feel better with daily doses of 4 to 6 mg



Place the tablet on your tongue straight away







Sleep disorder, Irritability, Depression, Anxiety, Restlessness

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 tablet will begin disintegrating within seconds





It can then be swallowed with or without water.

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.

Elderly people

If you take more Risperdal than you should



Your starting dose will normally be 0.5 mg twice a day





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

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





Your doctor will tell you which is the best for you.

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.



Dizziness



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



Tremor (shaking)



Blurry vision, Eye infection or “pink eye”



Rapid heart rate, High blood pressure, Shortness of breath
S1661 LEAFLET Risperdal 20131128

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





Life threatening complications of uncontrolled diabetes.

PACKAGE LEAFLET: INFORMATION FOR THE USER



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



You have epilepsy



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



S1661 LEAFLET Risperidone 20131128

S1661 LEAFLET Risperidone 20131128

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 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.

RISPERIDONE 0.5mg FILM-COATED TABLETS



Abnormal posture, Joint stiff ness, Joint swelling, Muscle
weakness, Neck pain
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),



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



Chills, An increase in body temperature



A change in the way you walk



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



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


Infection



Inappropriate secretion of a hormone that controls urine volume



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

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: Rapid heartbeat upon
standing.

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

Additional side effects in children and adolescents

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

In general, side effects in children are expected to be similar to
those in adults.

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



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

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.



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



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

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



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

Reporting of side effects

What is in this leaflet:

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

1

What Risperidone is and what it is used for

2

What you need to know before you take Risperidone

3

How to take Risperidone

By reporting side effects, you can help provide more information on
the safety of this medicine.
5. How to store Risperidone

4

Possible side effects

5

How to store Risperidone

6

Contents of the pack and other information
What Risperidone is and what it is used for



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Lack of emotion, Inability to reach orgasm



Do not store above 30°C.

1



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



Risperidone belongs to a group of medicines called ‘antipsychotics’.



Blood vessel problems in the brain

Do not use after the expiry date which is stated on the blister,
foil, carton, or bottle. The expiry date refers to the last day of
that month.



Coma due to uncontrolled diabetes







Shaking of the head

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.



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



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





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.

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.

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

6

Contents of the pack and other information



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.



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



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



Dangerously excessive intake of water



Irregular heart beat



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

What Risperidone Tablets contain




The active substance is risperidone.
Each Risperidone film-coated tablet contains 0.5 mg
risperidone.
The other ingredients are: lactose monohydrate, maize starch,
magnesium stearate (Ph. Eur), sodium lauryl sulphate,
propylene glycol, hypromellose, microcrystalline cellulose,
fumed silica, talc, iron (III) oxide (E172), titanium dioxide
(E171).

Blood clot in the legs, Blood clot in the lungs




Inflammation of the pancreas, A blockage in the bowels



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



Dandruff



Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis)



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



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



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



Hardening of the skin



Decreased body temperature, A decrease in body temperature,
Coldness in arms and legs



Symptoms of drug withdrawal



Yellowing of the skin and the eyes (jaundice).

Risperidone is used to treat the following:

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

What you need to know before you take Risperidone

Do not take Risperidone if:

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperidone.
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, your doctor may check your white
blood cell counts.
Risperidone may cause you to gain weight. Significant weight gain
may adversely affect your health. Your doctor should regularly
measure your body weight.
As diabetes mellitus or worsening of pre-existing diabetes mellitus
have been seen with patients taking Risperidone, your doctor
should check for signs of high blood sugar. In patients with preexisting diabetes mellitus blood glucose should be monitored
regularly.
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.

What Risperidone Tablets look like and contents of the pack



Risperidone Tablets are brownish-red oblong biconvex film-coated
tablets engraved with “Janssen” on one side and “Ris|0.5” on the
other.

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

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

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

It is especially important to talk to your doctor or pharmacist if
you are taking any of the following:



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



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



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

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



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



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)

Risperidone Tablets are available in blister packs of 20 and 50
tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Janssen-Cilag S.p.A., Via C.
Janssen, 04010 Borgo San Michele (Latina), Italy.
POM

PL No: 19488/1661

Leaflet revision date: 28 November 2013
S1661 LEAFLET Risperidone 20131128

You are allergic (hypersensitive) to risperidone or any of the
other ingredients of this medicine (listed in section 6).



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)



You are diabetic

Other medicines and Risperidone



Elderly people

If you take more Risperidone than you should



Your starting dose will normally be 0.5 mg twice a day





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



Your doctor will tell you which is the best for you.

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.

The following medicines may reduce the effect of risperidone

For the treatment of mania



Rifampicin (a medicine for treating some infections)

Adults



Carbamazepine, phenytoin (medicines for epilepsy)



Your starting dose will usually be 2 mg once a day



Phenobarbital



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



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

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)

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



Tremor (shaking)



Blurry vision, Eye infection or “pink eye”



Rapid heart rate, High blood pressure, Shortness of breath



Sore throat, Cough, Nosebleeds, Stuffy nose



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



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



Rash, Skin redness



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



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



Fall.

Elderly people


If you forget to take Risperidone

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





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



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.



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.

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

If you stop taking Risperidone
You should not stop taking this medicine unless told to do so by
your doctor. Your symptoms may return. If your doctor decides to
stop this medicine, your dose may be decreased gradually over a
few days.



Your starting dose will normally be 0.25 mg twice a day

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



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



Risperidone with food, drink and alcohol



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

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

Use in children and adolescents

Pregnancy, breast-feeding and fertility





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



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 may be needed,



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



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



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

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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

Uncommon (affects 1 to 10 users in 1000):

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.







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

Adults (including elderly people)

Tell your doctor immediately if you:


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

For the treatment of conduct disorder



The dose will depend on your child’s weight:
For children who weigh less than 50 kg

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.



The starting dose will normally be 0.25 mg once a day



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



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

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



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.

Driving and using machines
Dizziness, tiredness, and vision problems may occur during
treatment with Risperidone. Do not drive or use any tools or
machines without talking to your doctor first.
Risperidone contains lactose or aspartame
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
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

For children who weigh 50 kg or more

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

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 if 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

The following side effects may happen:
Very Common (affects more than 1 user in 10):


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.



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 may feel faint,
dizzy, or may pass out when they stand up or sit up suddenly,
Flushing



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



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



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

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.



Feeling sleepy, or less alert

Risperidone should be used with caution in this patient group.



Headache.

Risperidone film-coated tablets

Common (affects 1 to 10 users in 100):



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 Quicklet orodispersible tablets



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



Risperidone can raise your levels of a hormone called
“prolactin” found on a blood test (which may or may not cause
symptoms). When symptoms of high prolactin occur, they may
include in men breast swelling, difficulty in getting or
maintaining erections, 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.

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



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



Peel open a blister to expose the tablet



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



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



Remove the tablet from the blister with dry hands



Most people feel better with daily doses of 4 to 6 mg



Place the tablet on your tongue straight away



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 tablet will begin disintegrating within seconds



It can then be swallowed with or without water.



Weight gain, Increased appetite, Decreased appetite



Sleep disorder, Irritability, Depression, Anxiety, Restlessness



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.



Dizziness
S1661 LEAFLET Risperidone 20131128

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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