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RISPERIDONE 6 MG FILM-COATED TABLETS

Active substance(s): RISPERIDONE

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PACKAGE INFORMATION LEAFLET:
Risperidone 0.5 mg film-coated Tablets
Risperidone 1 mg film-coated Tablets
Risperidone 2 mg film-coated Tablets
Risperidone 3 mg film-coated Tablets
Risperidone 4 mg film-coated Tablets
Risperidone 6 mg film-coated 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.
In this leaflet:
1.
What Risperidone is and what it is used for
2.
Before you take Risperidone
3.
How to take Risperidone
4.
Possible side effects
5.
How to store Risperidone
6.
Further information
1.
WHAT RISPERIDONE IS AND WHAT IT IS USED FOR
Risperidone belongs to a group of medicines called ‘anti-psychotics’ .
Risperidone is used to treat the following:




2.

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.
BEFORE YOU TAKE RISPERIDONE

Do not take Risperidone if:
You are allergic (hypersensitive) to risperidone or any of the other ingredients of Risperidone
Film-coated Tablets (listed in Section 6 below)
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using
Risperidone Film-coated Tablets.
Take special care with Risperidone
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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 or someone else in your family has a history of blood clots, as medicines like these have been
associated with formation of blood clots
• 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. If you experience this while
taking Risperidone, contact your doctor straight away
• 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.
Tell your doctor immediately if you experience
• involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of risperidone may
be needed
• fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called
“neuroleptic malignant syndrome”). Immediate medical treatment may be needed.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Risperidone
Risperidone may cause you to gain weight.
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
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• Medicines that may change the electrical activity of your heart, such as medicines for malaria,
heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or
other medicines for mental problems
• Medicines that cause a slow heart beat
• Medicines that cause low blood potassium (e.g. certain diuretics)
• Medicines to treat elevated 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.
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, fluoxetines, tricyclic antidepressants
• Medicines known as beta blockers (used to treat high blood pressure)
• Phenothiazines (e.g. 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.
• Shaking, muscle stiffness and problems feeding, all of which are reversible, have been seen
in newborn babies when Risperidone was used during the last trimester of pregnancy.
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.
Important information about some of the ingredients of Risperidone Film-coated Tablets
The tablets contain lactose monohydrate. If you cannot tolerate certain types of sugar, you should
contact your doctor before taking this medicine.
0,5, 2, 3 and 6 mg film-coated tablets contain sunset yellow as colouring agent which may cause
allergic reactions.

3.

HOW TO TAKE RISPERIDONE
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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 Risperidone 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 Risperidone 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

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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 Risperidone for conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting doses and following doses of risperidone should
be halved. Dose increases should be slower in these patients.
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.
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
• You should swallow your tablet with a drink of water
If you take more Risperidone 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 Risperidone
• 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 Risperidone
You should not stop taking this medicine unless told to do so by your doctor. Your symptoms may
return. If your doctor decides to stop this medicine, your dose may be decreased gradually over a
few days.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Risperidone can cause side effects, although not everybody gets them.

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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 in
breathing. If you notice any of these symptoms, seek medical advice immediately.
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data.
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
• 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.
Uncommon (affects 1 to 10 users in 1000):
• Excessive drinking of water, stool incontinence, thirsty, very hard faeces, hoarseness or voice
disorder
• 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
• Blood sugar increased, liver enzymes increased, white blood cell count decreased, low
haemoglobin or red blood cell count (anaemia), increase in eosinophils (special white blood cells ),

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blood creatinine phosphokinase increased, decrease in platelets (blood cells that help you stop
bleeding)
• 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 discoloration, 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, edema (swelling in body tissues), speech
disorder, chills, abnormal coordination
• 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 edema.
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, reduced visual clarity, eyelid margin crusting, eye rolling
• Lack of emotion
• Change in consciousness with increased body temperature and twitching of muscles, edema all
over the body, drug withdrawal syndrome, body temperature decreased
• 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
• Coma due to uncontrolled diabetes
• Yellowing of the skin and the eyes (jaundice)
• Inflammation of the pancreas.
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


The following side effects have been reported with the use of a long acting injection of risperidone.
Even if you are not being treated with long acting injections of risperidone but you experience any
of the following, talk to your doctor.
7













Infection of the intestine
Abscess under the skin, tingling pricking or numbness of skin, inflammation of the skin
Decrease in white blood cell counts that helps to protect you against bacterial infection
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 RISPERIDONE
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Risperidone contains
The active substance is risperidone.
Each 0.5 mg film coated tablet contains 0.5 mg risperidone.
Each 1 mg film coated tablet contains 1 mg risperidone.
Each 2 mg film coated tablet contains 2 mg risperidone.
Each 3 mg film coated tablet contains 3 mg risperidone.
Each 4 mg film coated tablet contains 4 mg risperidone.
Each 6 mg film coated tablet contains 6 mg risperidone.
The other ingredients are sodium starch glycolate, lactose monohydrate, microcrystalline cellulose,
colloidal silica anhydrous, magnesium stearate, sodium lauryl sulphate, pregelatinised starch,
hypromellose, macrogol, titanium dioxide (E171)
The tablets also contain:
0.5 mg: Yellow Iron Oxide (E172), Sunset Yellow FCF Aluminium Lake (E110), Indigo Carmine
(E132)
2 mg: Yellow Iron Oxide (E172), Sunset Yellow FCF Aluminium Lake (E110)
3 mg: Sunset Yellow FCF Aluminium Lake (E110), Quinoline Yellow (E104), Indigo Carmine
(E132)
4 mg: Indigo Carmine (E132), Quinoline Yellow (E104)
6 mg: Yellow Iron Oxide (E172), Sunset Yellow FCF Aluminium Lake (E110), Quinoline Yellow
(E104)

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What Risperidone looks like and contents of the pack
0.5 mg tablet: red-brown colour, round, scored biconvex film-coated tablet
1 mg tablet: white colour, round, scored biconvex film-coated tablet
2 mg tablet: peach colour, round, scored biconvex film-coated tablet
3 mg tablet: yellow colour, round, film-coated tablet
4 mg tablets: green colour, round, scored biconvex film-coated tablet
6 mg tablets: yellow colour, round biconvex film-coated tablet
Packaging:
Tablets 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg:
Blister composed of clear colourless PVC/PVDC and plain aluminium foil. The blisters are packed
in cardboard cartons containing 6, 20, 28, 30, 50, 56, 60 and 500 tablets.
Not all pack sizes may be marketed
Marketing authorisation holder and Manufacturer:
Chanelle Medical, Loughrea, Co Galway, Ireland
The distributor is:
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
This leaflet was last approved in: 05/2010

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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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