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RISPERIDONE QUICKLET 2MG ORODISPERSIBLE TABLETS

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S776 LEAFLET Risperdal 20120515

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



Inability to reach orgasm, menstrual disorder
Dandruff

S776 LEAFLET Risperdal 20120515




Do not use after the expiry date printed on the carton label or
blister strip.



Glaucoma, reduced visual clarity, eyelid margin crusting, eye
rolling



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.



Change in consciousness with increased body temperature and
twitching of muscles, oedema all over the body, drug withdrawal
syndrome, decreased body temperature
Fast shallow breathing, trouble breathing during sleep, chronic
otitis media

You have epilepsy



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

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



Information for Risperdal Film-coated Tablets and other strength of
Risperdal Quicklet Orodispersible Tablets also may be present in
this leaflet

You have problems controlling your body temperature or
overheating



You have kidney problems



You have liver problems

Read all of this leaflet carefully before you start taking this
medicine.



You have an abnormally high level of the hormone prolactin in
your blood or if you have a tumour, which is possibly dependent
on prolactin



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

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.





You are diabetic







RISPERDAL QUICKLET 2mg ORODISPERSIBLE
TABLETS
(risperidone)

Do not store above 30°C. Store in the original package.

Drug allergy, coldness in arms and legs, lip swelling, lip
inflammation

Lack of emotion

You have Parkinson’s disease or dementia



PACKAGE LEAFLET: INFORMATION FOR THE USER







5. How to store Risperdal

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.



Obstruction of intestine



Reduced blood flow to the brain



6. Further information

Decrease in white blood cells, inappropriate secretion of a
hormone that controls urine volume
Breakdown of muscle fibres and pain in muscles
(rhabdomyolysis), movement disorder



Tremor of the head



Coma due to uncontrolled diabetes



Yellowing of the skin and the eyes (jaundice)



Inflammation of the pancreas

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



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



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

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

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

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

What Risperdal contains





 Low blood sugar.
Very rare (affects less than 1 user in 10,000):


Life threatening complications of uncontrolled diabetes.



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



Risperdal Quicklet Tablets also contain the following inactive
ingredients: polacrilex resin, gelatine type A, mannitol (E 421),
glycine, simethicone, carbomer, sodium hydroxide, aspartame
(E 951), red iron oxide (E172) and peppermint oil.
What Risperdal looks like and contents of the pack





In this leaflet:
1

What Risperdal is and what it is used for

2

Before you take Risperdal

3

How to take Risperdal

Risperdal Quicklet Tablets are light pink, round, biconvex tablet
marked ‘R2’ on one side and plain on the other

4

Possible side effects

Risperdal Quicklet Tablets are available as blister packs of 28
tablets.

5

How to store Risperdal

6

Further information

Product Licence holder
Unknown frequency of occurrence (frequency cannot be
estimated from the available data):


Severe allergic reaction resulting in difficulty in breathing and
shock



No granulocytes (a type of white blood cell to help you against
infection)



Prolonged and painful erection



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

Risperdal is used to treat the following:


Children and adolescents

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



Mania, where you may feel very excited, elated, agitated,
enthusiastic or hyperactive. Mania occurs in an illness called
“bipolar disorder”
Short-term treatment (up to 6 weeks) of long-term aggression in
people with Alzheimer’s dementia, who harm themselves or
others. Alternative (non-drug) treatments should have been
used previously



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

PL No. 19488/0776

RISPERDAL CONSTA
The following side effects have been reported with the use of
Risperdal Consta, a long acting injection. Even if you are not being
treated with long acting injections of Risperdal Consta but you
experience any of the following, talk to your doctor.

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



POM

Leaflet revision date: 15 May 2012
Risperdal is a registered trade mark of Johnson and Johnson, USA.
S776 LEAFLET Risperdal 20120515

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.

1. What Risperdal is and what it is used for

Dangerously excessive intake of water.

These products are manufactured by Janssen Farmaceutica
Portugal Lda, 69 A/B-Queluz de Baixo – 2734-503, Barcerena,
Portugal.

As diabetes mellitus or worsening of pre-existing diabetes mellitus
have been seen with patients taking Risperdal, your doctor should
check for signs of high blood sugar. In patients with pre-existing
diabetes mellitus blood glucose should be monitored regularly.
Elderly people with dementia



Infection of the intestine



Depression
Convulsion

Do not take Risperdal if:



Eye blinking





Sensation of spinning or swaying



Slow beating heart, high blood pressure



Toothache, tongue spasm

Take special care with Risperdal



Buttock pain

Check with your doctor or pharmacist before taking Risperdal if:

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription and herbal medicines.


It is especially important to talk to your doctor or
pharmacist if you are taking any of the following: Medicines
that work on your brain such as to help you calm down
(benzodiazepines) or some medicines for pain (opiates),
medicines for allergy (some antihistamines), as risperidone may
increase the sedative effect of all of these



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



Medicines that cause a slow heart beat



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



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



Medicines for Parkinson's disease (such as levodopa)

2. Before you take Risperdal



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

Abscess under the skin, tingling pricking or numbness of skin,
inflammation of the skin



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

 Weight decreased.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

You are allergic (hypersensitive) to risperidone or any of the
other ingredients of Risperdal (listed in Section 6 below).

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



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)



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


Rifampicin (a medicine for treating some infections)



Carbamazepine, phenytoin (medicines for epilepsy)



Phenobarbital

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

S776 LEAFLET Risperdal 20120515

S776 LEAFLET Risperdal 20120515

The following medicines may increase the effect of risperidone

For the treatment of mania

Risperdal Quicklet orodispersible tablets

Common (affects 1 to 10 users in 100):



Quinidine (used for certain types of heart disease)

Adults





Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants



Your starting dose will usually be 2 mg once a day

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



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



Peel open a blister to expose the tablet

Drowsiness, fatigue, restlessness, inability to sit still, irritability,
anxiety, sleepiness, dizziness, poor attention, feeling
exhausted, sleep disorder



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





Remove the tablet from the blister with dry hands

Vomiting, diarrhoea, constipation, nausea, increased appetite,
abdominal pain or discomfort, sore throat, dry mouth



Place the tablet on your tongue straight away



Weight increased, increase in body temperature, decreased
appetite

Elderly people



The tablet will begin disintegrating within seconds





Your starting dose will usually be 0.5 mg twice a day



It can then be swallowed with or without water.



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.

Difficulty breathing, lung infection (pneumonia), flu, infection of
the breathing passages, blurred vision, nose congestion, nose
bleeding, cough

If you take more Risperdal than you should



Urinary tract infection, bed wetting



Tremor, muscle spasm, involuntary movements of face or arms
and legs, joint pain, back pain, swelling of arms and legs, pain
in arms and legs



Rash, skin redness



Fast beating heart, chest pain



Blood prolactin hormone level increased.



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



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



Cimetidine, ranitidine (blockers of the acidity of stomach)

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



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




Talk to your doctor before using Risperdal if you are pregnant,
trying to become pregnant or breast-feeding. Your doctor will
decide if you can take it
The following symptoms may occur in newborn babies, of
mothers that have used Risperdal in the last trimester (last
three months of their pregnancy): shaking, muscle stiffness,
and/or weakness, sleepiness, agitation, breathing problems,
and difficulty in feeding. If your baby develops any of these
symptoms you may need to contact your doctor.

Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Dizziness, tiredness, and vision problems may occur during
treatment with Risperdal. Do not drive or use any tools or machines
without talking to your doctor first.

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

Children and adolescents




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



In case of overdose you may feel sleepy or tired, or have
abnormal body movements, problems standing and walking,
feel dizzy due to low blood pressure, or have abnormal
heartbeats or fits.

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

For the treatment of long-standing aggression in people with
Alzheimer’s dementia
Adults (including elderly people)


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





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



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



For the treatment of conduct disorder in children and
adolescents
The dose will depend on your child’s weight:

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

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.



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.

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



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




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



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

The starting dose will normally be 0.5 mg once a 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.

3. How to take Risperdal
How much to take

People with kidney or liver problems

For the treatment of schizophrenia

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.

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.

Diabetes mellitus, high blood sugar



Lung infection caused by inhaling of food into the breathing
passages, bladder infection, ‘pink eye’, sinus infection, viral
infection, ear infection, tonsil infection, infection under the skin,
eye infection, stomach infection, eye discharge, yeast infection
of nails



Abnormal electrical conduction of the heart, drop in blood
pressure after standing, low blood pressure, feeling dizzy after
changing body position, abnormal electric activity tracing of the
heart (ECG), abnormal heart rhythm, awareness of heart
beating, heart rate increased or decreased
Urinary incontinence, pain when passing urine, frequent
passing of urine



Confused, disturbance in attention, low level of consciousness,
excessive sleep, nervousness, elated mood (mania), lack of
energy and interest



Liver enzymes increased, white blood cell count decreased
(including those that help to protect you against bacterial
infection), low haemoglobin or red blood cell count (anaemia),
increase in eosinophils (special white blood cells), blood
creatinine phosphokinase increased, decrease in platelets
(blood cells that help you stop bleeding), increased blood
cholesterol and triglycerides (blood fats)



Muscle weakness, muscle pain, ear pain, neck pain, joint
swelling, abnormal posture, joint stiffness, musculoskeletal
chest pain, chest discomfort



Skin lesion, skin disorder, dry skin, intense itching of skin, acne,
hair loss, skin inflammation caused by mites, skin
discolouration, thickening of skin, flushing, reduced skin
sensitivity to pain or touch, inflammation of oily skin



No menstruation, sexual dysfunction, erectile dysfunction,
ejaculation disorder, breast discharge, enlargement of breast in
men, decreased sexual drive, irregular menstruation, vaginal
discharge



Fainting, gait disturbance, sluggishness, decreased appetite
resulting in malnutrition and low body weight, feeling ‘out of
sorts’, balance disorder, allergy, oedema, speech disorder,
chills, abnormal coordination, abnormal taste



Painful oversensitivity to light, increased blood flow to the eye,
eye swelling, dry eye, increase in tears



Breathing passage disorder, lung congestion, crackly lung
noise, congestion of breathing passages, trouble speaking,
difficulty swallowing, cough with sputum, coarse/whistling sound
during breathing, flu-like illness, sinus congestion



Unresponsive to stimuli, loss of consciousness, sudden swelling
of lips and eyes along with difficulty breathing, sudden
weakness or numbness of the face, arms, or legs, especially on
one side, or instances of slurred speech that last for less than
24 hours (these are called mini-strokes or strokes), involuntary
movements of face, arms, or legs, ringing in ears, face oedema



Inability to urinate or incomplete emptying of the bladder.

Tell your doctor immediately if you:

The 2 mg and 6 mg Risperdal tablets contain a colour called sunset
yellow (E110). E110 can cause allergic reactions. Allergy is more
common in those people who are allergic to aspirin.





4. Possible side effects

For children who weigh 50 kg or more

Adults

Excessive drinking of water, stool incontinence, thirsty, very
hard faeces, hoarseness or voice disorder

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

For children who weigh less than 50 kg

Risperdal tablets contain lactose. If your doctor has told you that
you are intolerant of some sugars, discuss it with them before taking
this medicine.

Risperdal Quicklet contains aspartame (E951). Aspartame (E951) is
a source of phenylalanine and may be harmful for people with
phenylketonuria. Risperdal Quicklet also contains mannitol (E421).
This may cause a mild stomach upset or diarrhoea.



If you stop taking Risperdal


Important information about some of the ingredients of
Risperdal

Uncommon (affects 1 to 10 users in 1000):



Your starting dose will normally be 0.25 mg twice a day



If you forget to take Risperdal

Risperidone should be used with caution in this patient group.
How to take Risperdal
Always take Risperdal exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.



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



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



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

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


Your doctor will tell you how much medicine to take and for how
long. This will depend on your condition and varies from person to
person.
The amount of medicine you should take is explained under the
‘How much to take’ sub-heading.
Risperdal film-coated tablets




Parkinsonism. This is a medical term that includes many
symptoms. Each individual symptom may occur less frequently
than in 1 in 10 people. Parkinsonism includes: increase in saliva
secretion or watery mouth, musculoskeletal stiffness, drooling,
jerks when bending the limbs, slow, reduced or impaired body
movements, no expression on the face, muscle tightness, stiff
neck, muscle stiffness, small, shuffling, hurried steps and lack
of normal arm movements when walking, persistent blinking in
response to tapping of the forehead (an abnormal reflex)
Headache, difficulty falling or staying asleep.

You should swallow your tablet with a drink of water

Children and adolescents


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

S776 LEAFLET Risperidone 20120515

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



Inability to reach orgasm, menstrual disorder
Dandruff

S776 LEAFLET Risperidone 20120515




Do not use after the expiry date printed on the carton label or
blister strip.



Glaucoma, reduced visual clarity, eyelid margin crusting, eye
rolling



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.



Change in consciousness with increased body temperature and
twitching of muscles, oedema all over the body, drug withdrawal
syndrome, decreased body temperature
Fast shallow breathing, trouble breathing during sleep, chronic
otitis media

You have epilepsy



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

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



Information for Risperdal Film-coated Tablets and other strength of
Risperdal Quicklet Orodispersible Tablets also may be present in
this leaflet.

You have problems controlling your body temperature or
overheating



You have kidney problems



You have liver problems

Read all of this leaflet carefully before you start taking this
medicine.



You have an abnormally high level of the hormone prolactin in
your blood or if you have a tumour, which is possibly dependent
on prolactin



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

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.





You are diabetic







RISPERIDONE QUICKLET 2mg ORODISPERSIBLE
TABLETS
(risperidone)

Do not store above 30°C. Store in the original package.

Drug allergy, coldness in arms and legs, lip swelling, lip
inflammation

Lack of emotion

You have Parkinson’s disease or dementia



PACKAGE LEAFLET: INFORMATION FOR THE USER







5. How to store Risperidone

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.



Obstruction of intestine



Reduced blood flow to the brain



6. Further information

Decrease in white blood cells, inappropriate secretion of a
hormone that controls urine volume
Breakdown of muscle fibres and pain in muscles
(rhabdomyolysis), movement disorder



Tremor of the head



Coma due to uncontrolled diabetes



Yellowing of the skin and the eyes (jaundice)



Inflammation of the pancreas

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



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



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

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

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

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

What Risperidone contains





 Low blood sugar.
Very rare (affects less than 1 user in 10,000):


Life threatening complications of uncontrolled diabetes.



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



Risperidone Quicklet Tablets also contain the following inactive
ingredients: polacrilex resin, gelatine type A, mannitol (E 421),
glycine, simethicone, carbomer, sodium hydroxide, aspartame
(E 951), red iron oxide (E172) and peppermint oil.
What Risperidone looks like and contents of the pack





How to take Risperidone

As diabetes mellitus or worsening of pre-existing diabetes mellitus
have been seen with patients taking Risperidone, your doctor
should check for signs of high blood sugar. In patients with preexisting diabetes mellitus blood glucose should be monitored
regularly.

Risperidone Quicklet Tablets are light pink, round, biconvex
tablet marked ‘R2’ on one side and plain on the other

4

Possible side effects

Elderly people with dementia



Risperidone Quicklet Tablets are available as blister packs of
28 tablets.

5

How to store Risperidone

6

Further information

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 this leaflet:
1

What Risperidone is and what it is used for

2

Before you take Risperidone

3

Product Licence holder
Unknown frequency of occurrence (frequency cannot be
estimated from the available data):


Severe allergic reaction resulting in difficulty in breathing and
shock



No granulocytes (a type of white blood cell to help you against
infection)



Prolonged and painful erection



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

1. What Risperidone is and what it is used for

Risperidone is used to treat the following:

These products are manufactured by Janssen Farmaceutica
Portugal Lda, 69 A/B-Queluz de Baixo – 2734-503, Barcerena,
Portugal.

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

Dangerously excessive intake of water.

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


POM

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



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



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

PL No. 19488/0776

RISPERIDONE CONSTA
The following side effects have been reported with the use of
Risperidone Consta, a long acting injection. Even if you are not
being treated with long acting injections of Risperidone Consta but
you experience any of the following, talk to your doctor.

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

Leaflet revision date: 15 May 2012
S776 LEAFLET Risperidone 20120515



Infection of the intestine



Abscess under the skin, tingling pricking or numbness of skin,
inflammation of the skin



Depression



Convulsion



Eye blinking



Sensation of spinning or swaying



Slow beating heart, high blood pressure



Toothache, tongue spasm

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



Buttock pain

Take special care with Risperidone

 Weight decreased.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Before treatment is started for conduct disorder, other causes of
aggressive behaviour should have been ruled out.
If during treatment with risperidone tiredness occurs, a change in
the time of administration might improve attention difficulties.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription and herbal medicines.


It is especially important to talk to your doctor or
pharmacist if you are taking any of the following: Medicines
that work on your brain such as to help you calm down
(benzodiazepines) or some medicines for pain (opiates),
medicines for allergy (some antihistamines), as risperidone may
increase the sedative effect of all of these



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



Medicines that cause a slow heart beat



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



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



Medicines for Parkinson's disease (such as levodopa)



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

2. Before you take Risperidone
Do not take Risperidone if:


You are allergic (hypersensitive) to risperidone or any of the
other ingredients of Risperidone (listed in Section 6 below).

Check with your doctor or pharmacist before taking Risperidone if:


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



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



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



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

The following medicines may reduce the effect of risperidone


Rifampicin (a medicine for treating some infections)



Carbamazepine, phenytoin (medicines for epilepsy)



Phenobarbital

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

S776 LEAFLET Risperidone 20120515

S776 LEAFLET Risperidone 20120515

The following medicines may increase the effect of risperidone

For the treatment of mania

Risperidone Quicklet orodispersible tablets

Common (affects 1 to 10 users in 100):



Quinidine (used for certain types of heart disease)

Adults





Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants



Your starting dose will usually be 2 mg once a day

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



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



Peel open a blister to expose the tablet

Drowsiness, fatigue, restlessness, inability to sit still, irritability,
anxiety, sleepiness, dizziness, poor attention, feeling
exhausted, sleep disorder



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





Remove the tablet from the blister with dry hands

Vomiting, diarrhoea, constipation, nausea, increased appetite,
abdominal pain or discomfort, sore throat, dry mouth



Place the tablet on your tongue straight away



Weight increased, increase in body temperature, decreased
appetite

Elderly people



The tablet will begin disintegrating within seconds





Your starting dose will usually be 0.5 mg twice a day



It can then be swallowed with or without water.



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.

Difficulty breathing, lung infection (pneumonia), flu, infection of
the breathing passages, blurred vision, nose congestion, nose
bleeding, cough

If you take more Risperidone than you should



Urinary tract infection, bed wetting



Tremor, muscle spasm, involuntary movements of face or arms
and legs, joint pain, back pain, swelling of arms and legs, pain
in arms and legs



Rash, skin redness



Fast beating heart, chest pain



Blood prolactin hormone level increased.



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



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



Cimetidine, ranitidine (blockers of the acidity of stomach)

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



If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperidone.
Taking Risperidone with food and drink
You can take this medicine with or without food. You should avoid
drinking alcohol when taking Risperidone.
Pregnancy and breast-feeding




Talk to your doctor before using Risperidone if you are
pregnant, trying to become pregnant or breast-feeding. Your
doctor will decide if you can take it
The following symptoms may occur in newborn babies, of
mothers that have used Risperidone in the last trimester (last
three months of their pregnancy): shaking, muscle stiffness,
and/or weakness, sleepiness, agitation, breathing problems,
and difficulty in feeding. If your baby develops any of these
symptoms you may need to contact your doctor.

Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Dizziness, tiredness, and vision problems may occur during
treatment with Risperidone. Do not drive or use any tools or
machines without talking to your doctor first.

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

Children and adolescents




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



In case of overdose you may feel sleepy or tired, or have
abnormal body movements, problems standing and walking,
feel dizzy due to low blood pressure, or have abnormal
heartbeats or fits.

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

For the treatment of long-standing aggression in people with
Alzheimer’s dementia
Adults (including elderly people)


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





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



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



For the treatment of conduct disorder in children and
adolescents
The dose will depend on your child’s weight:

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

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.



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.

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



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




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



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

The starting dose will normally be 0.5 mg once a day



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

Treatment duration in patients with conduct disorder should be not
more than 6 weeks.
Children under 5 years old should not be treated with Risperidone
for conduct disorder.

3. How to take Risperidone
How much to take

People with kidney or liver problems

For the treatment of schizophrenia

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.

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.

Diabetes mellitus, high blood sugar



Lung infection caused by inhaling of food into the breathing
passages, bladder infection, ‘pink eye’, sinus infection, viral
infection, ear infection, tonsil infection, infection under the skin,
eye infection, stomach infection, eye discharge, yeast infection
of nails



Abnormal electrical conduction of the heart, drop in blood
pressure after standing, low blood pressure, feeling dizzy after
changing body position, abnormal electric activity tracing of the
heart (ECG), abnormal heart rhythm, awareness of heart
beating, heart rate increased or decreased
Urinary incontinence, pain when passing urine, frequent
passing of urine



Confused, disturbance in attention, low level of consciousness,
excessive sleep, nervousness, elated mood (mania), lack of
energy and interest



Liver enzymes increased, white blood cell count decreased
(including those that help to protect you against bacterial
infection), low haemoglobin or red blood cell count (anaemia),
increase in eosinophils (special white blood cells), blood
creatinine phosphokinase increased, decrease in platelets
(blood cells that help you stop bleeding), increased blood
cholesterol and triglycerides (blood fats)



Muscle weakness, muscle pain, ear pain, neck pain, joint
swelling, abnormal posture, joint stiffness, musculoskeletal
chest pain, chest discomfort



Skin lesion, skin disorder, dry skin, intense itching of skin, acne,
hair loss, skin inflammation caused by mites, skin
discolouration, thickening of skin, flushing, reduced skin
sensitivity to pain or touch, inflammation of oily skin



No menstruation, sexual dysfunction, erectile dysfunction,
ejaculation disorder, breast discharge, enlargement of breast in
men, decreased sexual drive, irregular menstruation, vaginal
discharge



Fainting, gait disturbance, sluggishness, decreased appetite
resulting in malnutrition and low body weight, feeling ‘out of
sorts’, balance disorder, allergy, oedema, speech disorder,
chills, abnormal coordination, abnormal taste



Painful oversensitivity to light, increased blood flow to the eye,
eye swelling, dry eye, increase in tears



Breathing passage disorder, lung congestion, crackly lung
noise, congestion of breathing passages, trouble speaking,
difficulty swallowing, cough with sputum, coarse/whistling sound
during breathing, flu-like illness, sinus congestion



Unresponsive to stimuli, loss of consciousness, sudden swelling
of lips and eyes along with difficulty breathing, sudden
weakness or numbness of the face, arms, or legs, especially on
one side, or instances of slurred speech that last for less than
24 hours (these are called mini-strokes or strokes), involuntary
movements of face, arms, or legs, ringing in ears, face oedema



Inability to urinate or incomplete emptying of the bladder.

Tell your doctor immediately if you:

The 2 mg and 6 mg Risperidone tablets contain a colour called
sunset yellow (E110). E110 can cause allergic reactions. Allergy is
more common in those people who are allergic to aspirin.





4. Possible side effects

For children who weigh 50 kg or more

Adults

Excessive drinking of water, stool incontinence, thirsty, very
hard faeces, hoarseness or voice disorder

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

For children who weigh less than 50 kg

Risperidone tablets contain lactose. If your doctor has told you that
you are intolerant of some sugars, discuss it with them before taking
this medicine.

Risperidone Quicklet contains aspartame (E951). Aspartame
(E951) is a source of phenylalanine and may be harmful for people
with phenylketonuria. Risperidone Quicklet also contains mannitol
(E421). This may cause a mild stomach upset or diarrhoea.



If you stop taking Risperidone


Important information about some of the ingredients of
Risperidone

Uncommon (affects 1 to 10 users in 1000):



Your starting dose will normally be 0.25 mg twice a day



If you forget to take Risperidone

Risperidone should be used with caution in this patient group.
How to take Risperidone
Always take Risperidone exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.



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



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



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

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


Your doctor will tell you how much medicine to take and for how
long. This will depend on your condition and varies from person to
person.
The amount of medicine you should take is explained under the
‘How much to take’ sub-heading.
Risperidone film-coated tablets




Parkinsonism. This is a medical term that includes many
symptoms. Each individual symptom may occur less frequently
than in 1 in 10 people. Parkinsonism includes: increase in saliva
secretion or watery mouth, musculoskeletal stiffness, drooling,
jerks when bending the limbs, slow, reduced or impaired body
movements, no expression on the face, muscle tightness, stiff
neck, muscle stiffness, small, shuffling, hurried steps and lack
of normal arm movements when walking, persistent blinking in
response to tapping of the forehead (an abnormal reflex)
Headache, difficulty falling or staying asleep.

You should swallow your tablet with a drink of water

Children and adolescents


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

Expand Transcript

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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