RISPERIDONE 0.25 MG FILM-COATED TABLETS

Active substance: 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
1.
2.
3.
4.
5.
6.

this leaflet:
What Risperidone is and what it is used for.
Before you take Risperidone.
How to take Risperidone.
Possible side effects.
How to store Risperidone.
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:
• 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 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 - 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
• 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 (eg. 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.

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.

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 (eg. 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.

Risperidone film-coated tablets:
• you should swallow your tablet with a drink of water.

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.
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.

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.
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.

3. HOW TO TAKE RISPERIDONE

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.

How much to take:

The following side effects may happen:

For the treatment of schizophrenia:

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.

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:
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.

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 ), 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.
• 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
Each 1 mg film-coated tablet contains 1
Each 2 mg film-coated tablet contains 2
Each 3 mg film-coated tablet contains 3
Each 4 mg film-coated tablet contains 4
Each 6 mg film-coated tablet contains 6

0.5 mg risperidone.
mg risperidone.
mg risperidone.
mg risperidone.
mg risperidone.
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).
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.

This leaflet was last revised in: 05/2012

LD4271 10003930

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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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