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RISPERDAL QUICKLET 1MG TABLETS

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Patient Information Leaflet
Risperdal® Quicklet® 1mg Tablets
(risperidone)
Read all of this leaflet carefully before you start taking
this medicine.
• 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 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.
Your medicine is called Risperdal Quicklet 1mg Tablets but
will be referred to as Risperdal throughout the remainder of
this leaflet.
In this leaflet:
1. What Risperdal is and what it is used for
2. Before you take Risperdal
3. How to take Risperdal
4. Possible side effects
5. How to store Risperdal
6. Further information
1. What Risperdal is and what it is used for
Risperdal belongs to a group of medicines called ‘antipsychotics’.
Risperdal is used to treat the following:
• Schizophrenia, where you may see, hear or feel things
that are not there, believe things that are not true or feel
unusually suspicious, or confused
• Mania, where you may feel very excited, elated, agitated,
enthusiastic or hyperactive. Mania occurs in an illness
called “bipolar disorder”
• Short-term treatment (up to 6 weeks) of long-term
aggression in people with Alzheimer’s dementia, who
harm themselves or others. Alternative (non-drug)
treatments should have been used previously
• Short-term treatment (up to 6 weeks) of long-term,
aggression in intellectually disabled children (at least 5
years of age) and adolescents with conduct disorder.
2. Before you take Risperdal
Do not take Risperdal if:
• 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.
Take special care with Risperdal
Check with your doctor or pharmacist before taking Risperdal
if:
• You have a heart problem. Examples include an irregular
heart rhythm or if you are prone to low blood pressure or
if you are using medicines for your blood pressure.
Risperdal may cause low blood pressure. Your dose may
need to be adjusted.
• You know of any factors which would favour you having a
stroke, such as high blood pressure, cardiovascular
disorder or blood vessel problems in the brain
• You have ever experienced involuntary movements of the
tongue, mouth and face.
• You have a condition whose symptoms include high
temperature, muscle stiffness, sweating or a lowered level
of consciousness (also known as Neuroleptic Malignant
Syndrome)
• You have Parkinson’s disease or dementia
• You are diabetic









You have epilepsy
You are a man and you have ever had a prolonged or
painful erection.
You have problems controlling your body temperature or
overheating
You have kidney problems
You have liver problems
You have an abnormally high level of the hormone
prolactin in your blood or if you have a 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.

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



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

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.
The following medicines may increase the effect of
risperidone
• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants
• Medicines known as beta blockers (used to treat high
blood pressure)
• Phenothiazines (such as medicines used to treat
psychosis or to calm down)
• Cimetidine, rantidine (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.
Important information about some of the ingredients of
Risperdal
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.
3. How to take Risperdal
How much to take
For the treatment of schizophrenia
Adults
• The usual starting dose is 2 mg per day, this may be
increased to 4 mg per day on the second day
• Your dose may then be adjusted by your doctor
depending on how you respond to the treatment




Most people feel better with daily doses of 4 to 6 mg
This total daily dose can be divided into either one or two
doses a day. Your doctor will tell you which is the best for
you.

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.
Children and adolescents
• Children and adolescents under 18 years old should not
be treated with Risperdal for schizophrenia.
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
• Most people feel better with doses of 1 to 6 mg once a
day.
Elderly people
• Your starting dose will usually be 0.5 mg twice a day
• Your dose may then be gradually adjusted by your doctor
to 1 mg to 2 mg twice a day depending on how much you
respond to the treatment.
Children and adolescents
• Children and adolescents under 18 years old should not
be treated with Risperdal for bipolar mania
For the treatment of long-standing aggression in people
with Alzheimer’s dementia
Adults (including elderly people)
• Your starting dose will normally be 0.25 mg twice a day
• Your dose may then be gradually adjusted by your doctor
depending on how you respond to the treatment
• Most people feel better with 0.5 mg twice a day. Some
patients may need 1 mg twice a day
• Treatment duration in patients with Alzheimer’s dementia
should be not more than 6 weeks.
For the treatment of conduct disorder in children and
adolescents
The dose will depend on your child’s weight:
For children who weigh less than 50 kg
• The starting dose will normally be 0.25 mg once a day
• The dose may be increased every other day in steps of
0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once
a day.
For children who weigh 50 kg or more
• The starting dose will normally be 0.5 mg once a day
• The dose may be increased every other day in steps of
0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once a
day.
Treatment duration in patients with conduct disorder should
be not more than 6 weeks.
Children under 5 years old should not be treated with
Risperdal for conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting doses and
following doses of risperidone should be halved.
Dose increases should be slower in these patients.

Risperidone should be used with caution in this patient group.
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.
Your doctor will tell you how much medicines to take and for
how long. This will depend on your condition and varies from
person to person. The amount of medicines you should take
is explained under the ‘How much to take’ sub-heading.
Risperdal film-coated tablets
• You should swallow your tablet with a drink of water.
Risperdal Quicklet orodispersible tablets
Only remove a tablet from the blister when its time to take
your medicine.
• Peel open a blister to expose the tablet
• Do not push the tablet through the foil because it may
break
• Remove the tablet from the blister with dry hands
• Place the tablet on your tongue straight away
• The tablet will begin disintegrating within seconds
• It can then be swallowed with or without water.
If you take more Risperdal than you should
• See a doctor right away. Take the medicine pack with
you
• In case of overdose you may feel sleepy or tired, or have
abnormal body movements, problems standing and
walking, feel dizzy due to low blood pressure, or have
abnormal heart beats or fits.
If you forget to take Risperdal
• If you forget to take a dose, take it as soon as you
remember it. However, if it is almost time for your next
dose, skip the missed dose and continue as usual. If you
miss two or more doses, contact your doctor
• Do not take a double dose (two doses at the same
time) to make up for a forgotten dose
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.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Risperdal can cause side effects, although
not everybody gets them.
Tell your doctor immediately if you:
• Experience blood clots in the veins, especially in the legs
(symptoms include swelling, pain, and redness in the leg),
which may travel through blood vessels to the lungs
causing chest pain and difficulty breathing. If you notice
any of these symptoms seek medical advice immediately.
• Have dementia and experience a sudden change in your
mental state or sudden weakness or numbness of your
face, arms or legs, especially on one side or slurred
speech, even for a short period of time. These may be
signs of a stroke.
• Experience fever, muscle stiffness, sweating or a lowered
level of consciousness (a disorder called ‘Neuroleptic
Malignant Syndrome’). Immediate medical treatment may
be needed.
• 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.
Tell your doctor immediately if you experience any of the side
effects above.
The following side effects may happen:
Very Common (affects more than 1 user in 10):
• 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.
Common (affects 1 to 10 users in 100):
• Drowsiness, fatigue, restlessness, inability to sit still,
irritability, anxiety, sleepiness, dizziness, poor attention,
feeling exhausted, sleep disorder
• Vomiting, diarrhoea, constipation, nausea, increased
appetite, abdominal pain or discomfort, sore throat, dry
mouth.
• Weight increased, increase in body temperature,
decreased appetite
• Difficulty breathing, lung infection (pneumonia), flu,
infection of the breathing passages, blurred vision, nose
congestion, nose bleeding, cough.
• Urinary tract infection, bed wetting
• Tremor, muscle spasm, involuntary movements of the
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.
Uncommon (affects 1 to 10 users in 1000):
• Excessive drinking of water, stool incontinence, thirsty,
very hard faeces, hoarseness or voice disorder
• 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 electrical 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, disturbances 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 the
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 disturbances, 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.

Rare (affects 1 to 10 users in 10,000):
• Inability to reach orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip
inflammation
• Glaucoma, redness visual clarity, eyelid margin crusting,
eye rolling
• Lack of emotion
• 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
• Obstruction of intestine
• Reduced blood flow to the brain
• 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 eyes (jaundice)
• Inflammation of the pancreas.
• Low blood sugar
Very rare (affects less than 1 user in 10,000):
• Life threatening complications of uncontrolled diabetes.
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
• Dangerously excessive intake of water.

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.
• Infection of the intestines
• Abscess under the skin, tingling prickling 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
• Buttock pain
• 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.
5. How to store Risperdal
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Store the Risperdal Quicklet 1mg tablets in their original
container. Do not store above 30°C.
Do not use after the expiry date which is stated on the blister,
foil, carton, or bottle. The expiry date refers to the last day of
that month.
If the tablets show any signs of discolouration or deterioration
consult your pharmacist for advice.
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.
6. Further information
What Risperdal contains
Each Risperdal Quicklet 1mg tablet contains 1mg risperidone
as active ingredient. Each Risperdal Quicklet 1mg tablet also
contains several inactive ingredients which allow it to be
made. These are: polacrilex resin, gelatin, mannitol (E421),
glycine, simethicone, carbomer, sodium hydroxide,
aspartame, peppermint oil and red ferric oxide E172.
Each Risperdal Quicklet 1mg tablet is square, light coral,
biconvex, etched “R1”. The tablets are orodispersible, which
means that they break up in the mouth and can be taken with
or without water.
Risperdal Quicklet 1mg tablets come in blister packs
containing 28 tablets.
This medicine is manufactured by: Janssen Ortho LLC, State
Road 933, KM 0.1 Mamey Ward, Gurabo, Puerto Rico.
Procured from within the EU by the product licence holder:
Quadrant Pharmaceuticals Ltd, and repackaged by Maxearn
Ltd, Lynstock House, Lynstock Way, Lostock, Bolton BL6
4SA.
Risperdal Quicklet 1mg tablets

PL 20774/0840

Risperdal & Quicklet are registered trademarks of
Janssen-Cilag Ltd.
PP4/0840/V3
Date of Preparation of Leaflet: 23rd April 2012

POM

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Source: Medicines and Healthcare Products Regulatory Agency

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

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