RISPERIDONE 4MG TABLETS

Active substance: RISPERIDONE

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S630 LEAFLET Risperdal 20140901

S630 LEAFLET Risperdal 20140901



Shaking of the head

5. How to store Risperdal



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



Do not store above 30°C.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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



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



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.



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,



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





PACKAGE LEAFLET: INFORMATION FOR THE USER

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 1mg TABLETS
RISPERDAL 4mg TABLETS
(risperidone)
Your medicine is known with the either of the above names 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.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Irregular heart beat



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

What Risperdal contains



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)

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.

6. Contents of the pack and other information









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



Dangerously excessive intake of water








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

Contents of the pack and other information

What Risperdal looks like and contents of the pack

1

What Risperdal is and what it is used for



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

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

Elderly people with dementia

Risperdal is used to treat the following:

Risperdal 4mg Tablets are green, oblong, biconvex and marked
‘Ris|4’ on one side.



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”

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.



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.

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.

How to store Risperdal

Yellowing of the skin and the eyes (jaundice).

Additional side effects in children and adolescents

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

6

Symptoms of drug withdrawal

Lack of bowel muscle movement that causes blockage.

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.

Possible side effects



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 any of the above applies to you, talk to your
doctor or pharmacist before using Risperdal.

5





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

4



Life threatening complications of uncontrolled diabetes.



How to take Risperdal

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

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

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

What you need to know before you take Risperdal





You have liver problems



3

Hardening of the skin



You have kidney problems



What Risperdal is and what it is used for



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



2

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



What is in this leaflet:

You have problems controlling your body temperature or
overheating

1



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



Each 1mg tablet contains 1mg of the active ingredient,
risperidone.
Each 4mg tablet contains 4mg of the active ingredient,
risperidone.
Risperdal also contains the following inactive ingredients:
lactose, maize starch, microcrystalline cellulose, hypromellose,
magnesium stearate, colloidal anhydrous silica, sodium lauryl
sulphate, propylene glycol. Risperdal 4mg Tablets also contain
quinoline yellow (E104), indigo carmine (E132), titanium dioxide
(E171) and talc.



Risperdal are available in packs of 60 tablets. Risperdal 1mg
Tablets are also available as blister packs of 20 tablets.

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



Manufacturer
These products are manufactured by Janssen-Cilag, SpA, via
C.Janssen, Latina, Italy

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.

POM

PL No. 19488/0630
19488/0631

Risperdal 1mg Tablets
Risperdal 4mg Tablets

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.

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.

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

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

2

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

What you need to know before you take Risperdal

Leaflet revision date: 01 September 2014

Do not take Risperdal if:

Risperdal is a registered trademark of Janssen Cilag Ltd.



S630 LEAFLET Risperdal 20140901

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

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

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 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 to treat raised blood pressure. Risperdal can lower
blood pressure



Medicines for Parkinson’s disease (such as levodopa)



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)



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

Reporting of side effects

Talk to your doctor or pharmacist before taking Risperdal if:

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.



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



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 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

The following medicines may reduce the effect of risperidone



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

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

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





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

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





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

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

Rifampicin (a medicine for treating some infections)

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



Carbamazepine, phenytoin (medicines for epilepsy)

Adults (including elderly people)



Phenobarbital



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



The following medicines may increase the effect of risperidone





Quinidine (used for certain types of heart disease)



Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants





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

Use in children and adolescents


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

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

For the treatment of conduct disorder

Cimetidine, ranitidine (blockers of the acidity of stomach)





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

Risperdal with food, drink and alcohol



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

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

For children who weigh 50 kg or more

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.



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.

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.

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.
Sleep disorder, Irritability, Depression, Anxiety, Restlessness

Risperidone should be used with caution in this patient group.



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.

Risperdal film-coated tablets


You should swallow your tablet with a drink of water



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

If you take more Risperdal than you should


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



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



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.



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



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





Swelling of the face, mouth, eyes, or lips

Sore throat, Cough, Nosebleeds, Stuffy nose





Chills, An increase in body temperature

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



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.

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

Adults

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



Rash, Skin redness



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



Incontinence (lack of control) of urine

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

If you stop taking Risperdal



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.

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



Fall.



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

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

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

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

4

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

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

For the treatment of mania
Adults


Your starting dose will usually be 2 mg once a day



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



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.

Possible side effects

Tell your doctor immediately if you:

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

Elderly people






For the treatment of schizophrenia





Weight gain, Increased appetite, Decreased appetite





Convulsion (fits), Fainting

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



The recommended dose is as follows:





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.

If you forget to take Risperdal





Headache.

Common (affects 1 to 10 users in 100):

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.



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

Feeling sleepy, or less alert



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

3 How to take Risperdal





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

Risperdal contains lactose
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.

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



Difficulty falling or staying asleep



The starting dose will normally be 0.25 mg once a day





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

For children who weigh less than 50 kg

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

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,

The following side effects may happen:

The dose will depend on your child’s weight:

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







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

Uncommon (affects 1 to 10 users in 1000):

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







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





Inappropriate secretion of a hormone that controls urine volume



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



Lack of emotion, Inability to reach orgasm



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



Blood vessel problems in the brain



Coma due to uncontrolled diabetes

Weight loss, Loss of appetite resulting in malnutrition and low
body weight
Increased cholesterol in your blood





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



Infection

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

S630 LEAFLET Risperdal 20140901

S630 LEAFLET Risperdone 20140901

S630 LEAFLET Risperdone 20140901



Shaking of the head

5. How to store Risperdone



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



Do not store above 30°C.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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



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



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.



Eye problems during cataract surgery. During cataract surgery,
a condition called intraoperative floppy iris syndrome (IFIS) can
happen if you take or have taken Risperdone. 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





PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

RISPERDONE 1mg TABLETS
RISPERDONE 4mg TABLETS
Your medicine is known with the either of the above names but will
be referred to as Risperdone throughout the following leaflet.
Please note that information regarding other strengths of
Risperdone is also present in the below leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Irregular heart beat



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

What Risperdone contains



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)

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.

6. Contents of the pack and other information









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



Dangerously excessive intake of water









What Risperdone is and what it is used for

2

What you need to know before you take Risperdone

3

How to take Risperdone

4

Possible side effects

5

How to store Risperdone

6

Contents of the pack and other information

What Risperdone looks like and contents of the pack

1

What Risperdone is and what it is used for



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

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

Risperdone 4mg Tablets are green, oblong, biconvex and
marked ‘Ris|4’ on one side.



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”

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).



Life threatening complications of uncontrolled diabetes.



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



Lack of bowel muscle movement that causes blockage.

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

What is in this leaflet:
1



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

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

Each 1mg tablet contains 1mg of the active ingredient,
risperidone.
Each 4mg tablet contains 4mg of the active ingredient,
risperidone.
Risperdone also contains the following inactive ingredients:
lactose, maize starch, microcrystalline cellulose, hypromellose,
magnesium stearate, colloidal anhydrous silica, sodium lauryl
sulphate, propylene glycol. Risperdone 4mg Tablets also
contain quinoline yellow (E104), indigo carmine (E132), titanium
dioxide (E171) and talc.

Risperdone are available in packs of 60 tablets. Risperdone
1mg Tablets are also available as blister packs of 20 tablets.

Risperdone is used to treat the following:

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



Manufacturer
These products are manufactured by Janssen-Cilag, SpA, via
C.Janssen, Latina, Italy

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.

POM

PL No. 19488/0630
19488/0631

Risperdone 1mg Tablets
Risperdone 4mg Tablets

Leaflet revision date: 01 September 2014
S630 LEAFLET Risperdone 20140901



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.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperdone.
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 Risperdone, your doctor may check your white
blood cell counts.
Risperdone 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 Risperdone, 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
Before treatment is started for conduct disorder, other causes of
aggressive behaviour should have been ruled out.

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

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

2

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

What you need to know before you take Risperdone

Do not take Risperdone if:


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

Other medicines and Risperdone

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

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

Warnings and precautions

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



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. Risperdone can lower
blood pressure



Medicines for Parkinson’s disease (such as levodopa)



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

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



You have epilepsy



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

Reporting of side effects

Talk to your doctor or pharmacist before taking Risperdone if:

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.



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



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 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. Risperdone may
cause low blood pressure. Your dose may need to be adjusted

The following medicines may reduce the effect of risperidone



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

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

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





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

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





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

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

Rifampicin (a medicine for treating some infections)

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



Carbamazepine, phenytoin (medicines for epilepsy)

Adults (including elderly people)



Phenobarbital



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



The following medicines may increase the effect of risperidone





Quinidine (used for certain types of heart disease)



Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants





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

Use in children and adolescents


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

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

For the treatment of conduct disorder

Cimetidine, ranitidine (blockers of the acidity of stomach)





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

Risperdone with food, drink and alcohol



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

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

For children who weigh 50 kg or more

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 Risperdone 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.
Risperdone 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 Risperdone. Do not drive or use any tools or
machines without talking to your doctor first.



The starting dose will normally be 0.5 mg once a day



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



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

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.

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

Risperidone should be used with caution in this patient group.



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.

Risperdone film-coated tablets


You should swallow your tablet with a drink of water



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

If you take more Risperdone than you should



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.
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



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.

Low blood pressure, Low blood pressure upon standing
(consequently, some people taking Risperdone 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



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

Blurry vision, Eye infection or “pink eye”



Rapid heart rate, High blood pressure, Shortness of breath





Swelling of the face, mouth, eyes, or lips

Sore throat, Cough, Nosebleeds, Stuffy nose





Chills, An increase in body temperature

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

If you stop taking Risperdone



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





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.

Fall.

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

Tell your doctor immediately if you:

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





Tremor (shaking)

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.

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

Elderly people

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)

Incontinence (lack of control) of urine

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











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

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



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

4





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

Rash, Skin redness

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

Your starting dose will usually be 2 mg once a day

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

Dizziness



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 0.5 mg twice a day

Adults

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



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



For the treatment of mania

Risperdone 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.
Sleep disorder, Irritability, Depression, Anxiety, Restlessness

Adults







For the treatment of schizophrenia

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



Weight gain, Increased appetite, Decreased appetite





Convulsion (fits), Fainting

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



The recommended dose is as follows:

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



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.

If you forget to take Risperdone





Headache.

Common (affects 1 to 10 users in 100):

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.

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

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

Feeling sleepy, or less alert



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

3 How to take Risperdone





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

Risperdone contains lactose
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.

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



Difficulty falling or staying asleep



The starting dose will normally be 0.25 mg once a day





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

For children who weigh less than 50 kg

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

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 Risperdone may be needed,

The following side effects may happen:

The dose will depend on your child’s weight:

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







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

Uncommon (affects 1 to 10 users in 1000):

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



Coma due to uncontrolled diabetes



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

S630 LEAFLET Risperdone 20140901

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

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

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