RISPERIDONE 2 MG FILM COATED TABLETS

Active substance: RISPERIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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 using 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

You are allergic (hypersensitive) to risperidone or any of the other ingredients of Risperidone
(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.

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 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

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.
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. 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
Risperidone, 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 (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.
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
Risperidone film-coated tablets contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3.

HOW TO TAKE RISPERIDONE

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
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 below.
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.
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
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 retention, 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, 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),
Diabetes mellitus, high blood sugar
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, 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 fibers and pain in muscles (rhabdomyolysis), movement disorder

Coma due to uncontrolled diabetes

Yellowing of the skin and the 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
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.

Long-acting injectable risperidone formulation
The following side effects have been reported with the use of long-acting injectable risperidone
formulation. 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 after the expiry date stated on the package.
Risperidone 0.5 mg tablets: store below 30°C.
Risperidone 1 mg, 2 mg, 3 mg, 4 mg, 6 mg tablets: This medicinal product doesn 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 ingredient is risperidone. Each tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or
6 mg risperidone.
The other ingredients are:
Core:
lactose monohydrate, cellulose powdered, cellulose microcrystalline, croscarmellose sodium,
silica colloidal anhydrous, sodium laurilsulphate, magnesium stearate
Coating:
hypromellose, titanium dioxide (E171), talc, propylene glycol
0.5 mg:
red iron oxide (E172)
2 mg:

red iron oxide (E172), yellow iron oxide (E172)
3 mg:
quinoline yellow (E104)
4 mg:
quinoline yellow (E104), indigotine (E132)
6 mg:
yellow iron oxide (E172)
What Risperidone looks like and contents of the pack
Film-coated tablet:
0.5 mg tablet: Red-brown, oval, biconvex, film-coated tablet scored on one side.
1 mg tablet: White, oval, biconvex, film-coated tablet scored on one side.
2 mg tablet: Orange, oval, biconvex, film-coated tablet scored on one side.
3 mg tablet: Yellow, oval, biconvex, film-coated tablet scored on one side.
4 mg tablet: Green, oval, biconvex, film-coated tablet scored on one side.
6 mg tablet: Yellow-brown, oval, biconvex, film-coated tablet.
0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tablets: The tablet can be divided into equal halves.
Contents of the packs:
Blister pack: 20, 28, 30, 50, 56, 60 or 100 film-coated tablets in blister pack for all strengths.
Plastic container: 500 film-coated tablets in the plastic container for 1 mg and 2 mg tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This leaflet was last approved 10/2012.

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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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