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RISPERIDONE 0.5MG FILM-COATED TABLETS

Active substance(s): RISPERIDONE

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S1661 LEAFLET Risperdal 20160114

5

How to store Risperdal

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Infection





Inappropriate secretion of a hormone that controls urine volume

Do not store above 30°C. Store in the original package in order
to protect from light.



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.



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



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.



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



6

S1661 LEAFLET Risperdal 20160114

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

RISPERDAL® 0.5mg TABLETS
(risperidone)
The name of your medicine is Risperdal 0.5mg Tablets but will be
referred to as Risperdal throughout the following leaflet.
Please note that information regarding other strengths of Risperdal
is also present in the below leaflet.



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).



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



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



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



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

What is in this leaflet:
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

What Risperdal looks like and contents of the pack

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



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

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



Blood clot in the legs, Blood clot in the lungs

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



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

Product Licence holder

Risperdal belongs to a group of medicines called ‘anti-psychotics’.

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

Risperdal is used to treat the following:



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



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)

Manufacturer



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

This product is manufactured by Janssen-Cilag S.p.A., Via C.
Janssen, Borgo S. Michele, 04100 Latina, Italy.



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, Coldness in arms and legs



Symptoms of drug withdrawal



Yellowing of the skin and the eyes (jaundice).

POM



PL 19488/1661

Leaflet revision date: 14 January 2016.



Risperdal is a registered trademark of Janssen Cilag Ltd.
S1661 LEAFLET Risperdal 20160114

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

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.

Very rare (may affect up to 1 in 10,000 people):
Life threatening complications of uncontrolled diabetes.

2



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

Do not take Risperdal:



Lack of bowel muscle movement that causes blockage.





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).

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.

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

Additional side effects in children and adolescents



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

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.

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.

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

Contents of the pack and other information

What Risperdal contains



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)

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



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)

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.



You are diabetic



You have epilepsy



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

The following medicines may reduce the effect of risperidone

For the treatment of mania

If you stop taking Risperdal

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



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

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,



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 doses of 1 to 6 mg once a day.

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

4



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.

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




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





Itraconazole and ketoconazole (medicines for treating fungal
infections)



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



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



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



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



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



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

Use in children and adolescents

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



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:

Risperdal with food, drink and alcohol



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.

Pregnancy, breast-feeding and fertility






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 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

For children who weigh less than 50 kg

For children who weigh 50 kg or more


The starting dose will normally be 0.5 mg once a day



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



The usual maintenance dose is 0.5 mg to 1.5 mg once a day.

Treatment duration in patients with conduct disorder should be not
more than 6 weeks.
Children under 5 years old should not be treated with Risperdal for
conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting doses and
following doses of risperidone should be halved. Dose increases
should be slower in these patients.
Risperidone should be used with caution in this patient group.

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.
Peel open a blister to expose the tablet



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



Place the tablet on your tongue straight away



The tablet will begin disintegrating within seconds



It can then be swallowed with or without water.




The usual starting dose is 2 mg per day, this may be increased
to 4 mg per day on the second day
Your dose may then be adjusted by your doctor depending on
how you respond to the treatment



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



This total daily dose can be divided into either one or two doses
a day. Your doctor will tell you which is the best for you.

Elderly people


Your starting dose will normally be 0.5 mg twice a day



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



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

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



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


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):


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),



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.

Risperdal film-coated tablets


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



For oral use



Adults



Method of administration

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



Your starting dose will normally be 0.25 mg twice a day

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperdal.
You can take this medicine with or without food. You should avoid
drinking alcohol when taking Risperdal.

Tell your doctor immediately if you:

Adults (including elderly people)



Possible side effects



Dizziness



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

If you take more Risperdal than you should



Tremor (shaking)



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



Blurry vision, Eye infection or “pink eye”



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.



Rapid heart rate, High blood pressure, Shortness of breath



Sore throat, Cough, Nosebleeds, Stuffy nose



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



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.

If you forget to take Risperdal




If you forget to take a dose, take it as soon as you remember it.
However, if it is almost time for your next dose, skip the missed
dose and continue as usual. If you miss two or more doses,
contact your doctor
Do not take a double dose (two doses at the same time) to
make up for a forgotten dose

S1661 LEAFLET Risperdal 20160114

S1661 LEAFLET Risperidone 20160114

5

How to store Risperidone Tablets



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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Store in the original package in order
to protect from light.

Procedural pain.



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.



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)





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.



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

6



Coma due to uncontrolled diabetes

What Risperidone Tablets contains



Shaking of the head





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

The active substance is risperidone. Each Risperidone filmcoated 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).






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.
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

S1661 LEAFLET Risperidone 20160114

PACKAGE LEAFLET: INFORMATION FOR THE USER

RISPERDONE 0.5mg TABLETS
The name of your medicine is Risperidone 0.5mg Tablets but will be
referred to as Risperidone Tablets throughout the following leaflet.
Please note that information regarding other strengths of
Risperidone Tablets is also present in the below leaflet.



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



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



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



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

What is in this leaflet:
1

What Risperidone Tablets are and what they are used for

2

What you need to know before you take Risperidone
Tablets

3

How to take Risperidone Tablets

4

Possible side effects

5

How to store Risperidone Tablets

6

Contents of the pack and other information

Risperidone Tablets are available in blister packs of 20 and 50
tablets.

1

What Risperidone Tablets are and what they are used for

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

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



Dangerously excessive intake of water



Irregular heart beat

Product Licence holder



Blood clot in the legs, Blood clot in the lungs
Trouble breathing during sleep (sleep apnea), Fast, shallow
breathing

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 are used to treat the following:







Inflammation of the pancreas, A blockage in the bowels

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



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

Manufacturer





Dandruff



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

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, 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):

This product is manufactured by Janssen-Cilag S.p.A., Via C.
Janssen, Borgo S. Michele, 04100 Latina, Italy.
POM



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.

PL 19488/1661

Leaflet revision date: 14 January 2016.
S1661 LEAFLET Risperidone 20160114

Risperidone Tablets 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
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).



Life threatening complications of uncontrolled diabetes.



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

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



Lack of bowel muscle movement that causes blockage.

Warnings and precautions

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.

Talk to your doctor or pharmacist before taking Risperidone Tablets
if:


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.

You have epilepsy



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



You have problems controlling your body temperature or
overheating



You have kidney problems



You have liver problems



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

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

Contents of the pack and other information

What Risperidone Tablets looks like and contents of the pack





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

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



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)



Medicines that cause a slow heart beat



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



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)

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



Medicines for Parkinson’s disease (such as levodopa)



You are diabetic



Elderly people

If you forget to take Risperidone Tablets



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

The following medicines may reduce the effect of risperidone



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



Rifampicin (a medicine for treating some infections)

For the treatment of mania



Carbamazepine, phenytoin (medicines for epilepsy)

Adults



Phenobarbital

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 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

The following medicines may increase the effect of risperidone



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



Quinidine (used for certain types of heart disease)

Elderly people



Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants

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











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.

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

Itraconazole and ketoconazole (medicines for treating fungal
infections)
Certain medicines used in the treatment of HIV/AIDS, such as
ritonavir



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

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.

Use in children and adolescents

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

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 Tablets.

For the treatment of conduct disorder

Risperidone Tablets 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 Risperidone Tablets.



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.

Pregnancy, breast-feeding and fertility






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.

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

The dose will depend on your child’s weight:

For children who weigh 50 kg or more


The starting dose will normally be 0.5 mg once a day



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



The usual maintenance dose is 0.5 mg to 1.5 mg once a day.

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



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.

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

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



Remove the tablet from the blister with dry hands



Place the tablet on your tongue straight away



The tablet will begin disintegrating within seconds



It can then be swallowed with or without water.



Fall.

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


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 Tablets may be needed,



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

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



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



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



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



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 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



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



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

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


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.



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



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.

Risperidone Tablets film-coated tablets



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



For oral use

Peel open a blister to expose the tablet



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

Risperidone should be used with caution in this patient group.



Incontinence (lack of control) of urine



Headache.

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

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



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

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

Risperidone Tablets Quicklet orodispersible tablets

Rash, Skin redness







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



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

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.

You should swallow your tablet with a drink of water

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

Possible side effects

People with kidney or liver problems



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

4

Feeling sleepy, or less alert





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



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

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.

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

Method of administration

3

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

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.



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



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.





Erectile dysfunction, Ejaculation disorder

Dizziness





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

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

If you take more Risperidone Tablets than you should


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





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.



Blurry vision, Eye infection or “pink eye”



Swelling of the face, mouth, eyes, or lips



Rapid heart rate, High blood pressure, Shortness of breath



Chills, An increase in body temperature



Sore throat, Cough, Nosebleeds, Stuffy nose



A change in the way you walk



Feeling thirsty, Feeling unwell, Chest discomfort, Feeling “out of
sorts”, Discomfort
S1661 LEAFLET Risperidone 20160114

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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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