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RISPERIDONE 0.25 MG FILM-COATED TABLETS

Active substance(s): RISPERIDONE

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PACKAGE INFORMATION LEAFLET:
Risperidone 0.25 mg film-coated Tablets
Risperidone

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Risperidone is and what it is used for
2. What you need to know before you take Risperidone
3. How to take Risperidone
4. Possible side effects
5. How to store Risperidone
6. Contents of the pack and other 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.
Risperidone can help alleviate the symptoms of your disease and stop your symptoms from
coming back.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE
Do not take Risperidone:
- If you are allergic to risperidone or any of the other ingredients of this medicine (listed in
Section 6).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using
Risperidone Film-coated Tablets.
Warning and precautions
Talk to 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)
• You have Parkinson’s disease or dementia
• You know that you have had low levels of white blood cells in the past (which may or may not
have been caused by other medicines)
• 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
possible prolactin-dependent tumour
• 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 Risperidone
As dangerously low numbers of a certain type of white blood cell needed to fight infection in your
blood has been seen very rarely with patients taking Risperidone, your doctor may check your
white blood cell counts.
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 preexisting diabetes mellitus blood glucose should be monitored regularly.
During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in
the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the
eye) may become floppy during surgery and that may lead to eye damage. If you are planning
to have an operation on your eye, make sure you tell your eye doctor that you are taking this
medicine.
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.
Before treatment is started your, or your child’s body weight may be measured and it may be
regularly monitored during treatment.
A small and inconclusive study has reported an increase in height in children who took
risperidone, but whether this is an effect of the drug or due to some other reason is not known.
Other medicines and Risperidone
Tell your doctor or pharmacist if you are taking or have recently taken any other 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






 edicines that cause low blood potassium (such as certain diuretics)
M
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.

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 (such as medicines used to treat psychosis or to calm down)
• Cimetidine, ranitidine (blockers of the acidity of stomach)
• Itraconazole and ketoconazole (medicines for treating fungal infections)
• Certain medicines used in the treatment of HIV/AIDS, such as ritonavir
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.
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.
Risperidone with food, drink and alcohol
You can take this medicine with or without food. You should avoid drinking alcohol when taking
Risperidone.
Pregnancy breast-feeding and fertility
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine. 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
• Risperidone can raise your levels of a hormone called “prolactin” that may impact fertility (see
Possible side effects).
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.
Risperidone film-coated tablets contain lactose
The film-coated tablets contain lactose, a type of sugar. If you have been told by your doctor that
you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE RISPERIDONE
Always take this medicine exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The recommended dose is as follows:
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.
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.
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.
Use in children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone for
schizophrenia or mania.
For the treatment of conduct disorder
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.
Method of administration
For oral use
Risperidone film-coated tablets
• You should swallow your tablet with a drink of water



T he score line is only there to help you break the tablet if you have difficulty swallowing it
whole.
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.
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
• Experience severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue,
shortness of breath, itching, skin rash or drop in blood pressure.
The following side effects may happen:
Very Common (may affect more than 1 in 10 people):
• Difficulty falling or staying asleep
• Parkinsonism: This condition may include: slow or impaired movement, sensation of stiffness
or tightness of the muscles (making your movements jerky), and sometimes even a sensation
of movement “freezing up” and then restarting. Other signs of parkinsonism include a slow
shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression
on the face
• Feeling sleepy or less alert
• Headache.
Common (may affect 1 in 10 people):
• Pneumonia, infection of the chest (bronchitis), common cold symptoms, sinus infection,
urinary tract infection, ear infection, feeling like you have the flu
• Risperidone can raise your levels of a hormone called “prolactin” found in a blood test (which
may or may not cause symptoms). When symptoms of high prolactin occur uncommonly and
may include in men breast swelling, difficulty in getting or maintaining erections, decreased
sexual desire or other sexual dysfunction. In women they may include breast discomfort,
leakage of milk from the breasts, missed menstrual periods, or other problems with your cycle
or fertility problems
• Weight gain, increased appetite, decreased appetite
• Sleep disorder, irritability, depression, anxiety, restlessness
• Dystonia: This is a condition involving slow or sustained involuntary contraction of muscles.
While it can involve any part of the body (and may result in abnormal posture), dystonia often
involves muscles of the face, including abnormal movements of the eyes, mouth, tongue or
jaw
• Dizziness
• Dyskinesia: This is a condition involving involuntary muscle movements, and can include
repetitive, spastic or writhing movements, or twitching
• Tremor (shaking)
• Blurry vision, eye infection or “pink eye”
• Rapid heart rate, high blood pressure, shortness of breath
• Sore throat, cough, nosebleeds, stuffy nose
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion,
dry mouth, toothache
• Rash, skin redness
• Muscle spasms, bone or muscle ache, back pain, joint pain
• Incontinence (lack of control) of urine
• Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain
• Fall.
Uncommon (may affect up to 1 to 100 people):
• Infection of the breathing passages, bladder infection, eye infection, tonsillitis, fungal infection
of nails, infection of the skin, an infection confined to a single area of skin or part of the body,
viral infection, skin infection causes by mites
• Decrease in the type of white blood cells that help to protect you against infection, White
blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding),
anemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell) in your
blood
• Allergic reaction
• Diabetes or worsening diabetes, high blood sugar level, excessive drinking of water
• Weight loss, loss of appetite resulting in malnutrition and low body weight
• Increased cholesterol in your blood
• Elated mood (mania), confusion, decreased sexual drive, nervousness, nightmares
• Tardive dyskinesia (twitching or jerking movements that you cannot control in your face,
tongue, or other parts of your body). Tell your doctor immediately if you experience
involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of Risperidone
may be needed
• Sudden loss of blood supply to brain (stroke or “mini” stroke)
• Unresponsive to stimuli, loss of consciousness, low level of consciousness.
• Convulsions (fits), fainting
• A restless urge to move parts of your body, balance disorder, abnormal coordination, dizziness
upon standing, disturbance in attention, problems with speech, loss or abnormal sense
of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or
numbness skin
• Oversensitivity of the eyes to light, dry eye, increased tears, redness of the eyes
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (an abnormal heart rhythm), an interruption in conduction between the
upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation
of the QT interval from your heart, slow heart rate, abnormal electrical tracing of the heart
(electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
• Low blood pressure, low blood pressure upon standing (consequently, some people taking
Risperidone may feel faint, dizzy, or may pass out when they stand up or sit up suddenly,
flushing
• Pneumonia caused by inhaling food, lung congestion, congestion of breathing passages,
crackly lung sounds, wheezing, voice disorder, breathing passage disorder
• Stomach or intestinal infection, stool incontinence, very hard stool, difficulty swallowing,
excessive passing of gas or wind
• Hives (or “nettle rash”), itching, hair loss, thickening of skin, eczema, dry skin, skin discoloration,
acne, flaky, itchy scalp or skin, skin disorder, skin lesion



 n increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes
A
released with muscle breakdown
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent passing of urine, Inability to pass urine, Pain when passing urine
• Erectile dysfunction, ejaculation disorder
• Loss of menstrual periods, missed menstrual periods or other problems with your cycle
(females),
• Development of breasts in men, leakage of milk from the breasts, sexual dysfunction, breast
pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes, or lips
• Chills, an increase in body temperature
• A change in the way you walk
• Feeling thirsty, feeling unwell, chest discomfort, feeling “out of sorts”, discomfort
• Increased liver transaminases in your blood, increased GGT (a liver enzyme called gammaglutamyltransferase) in your blood, increased liver enzymes in your blood
• Procedural pain.
Rare (may affect up to 1 in 1,000 people):
• Infection
• Inappropriate secretion of a hormone that controls urine volume
• Sugar in the urine, low blood sugar, high blood triglycerides (a fat)
• Lack of emotion, inability to reach orgasm
• Neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and
severe muscle stiffness)
• Blood vessel problems in the brain
• Coma due to uncontrolled diabetes
• Shaking of the head
• Glaucoma (increased pressure within the eyeball), problems with movement of the eye, eye
rolling eyelid margin crusting
• Eye problems during cataract surgery. During cataract surgery, a condition called
intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Risperidone
Tablets. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have
taken this medicine
• Dangerously low numbers of a certain type of white blood cell needed to fight infection in
your blood
• Severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of
breath, itching, skin rash and sometimes drop in blood pressure
• Dangerously excessive intake of water
• Irregular heart beat
• Blood clot in the legs, blood clot in the lungs
• Trouble breathing during sleep (sleep apnea), fast shallow breathing
• Inflammation of the pancreas, a blockage in the bowels
• Swollen tongue, chapped lips, rash on skin related to drug
• Dandruff
• Breakdown of muscle fibres and pain in muscles (rhabdomyolysis)
• A delay in menstrual periods, enlargement of the glands in your breasts, breast enlargement,
discharge from the breasts
• Increased insulin (a hormone that controls blood sugar levels) in your blood
• Priapism (a prolonged penile erection that may require surgical treatment)
• Hardening of the skin
• Decreased body temperature, coldness in arms and legs
• Symptoms of drug withdrawal.
• Yellowing of the skin and the eyes (jaundice).
Very rare (may affect up to 1 in 10,000 people):
• Life threatening complications of uncontrolled diabetes
• Serious allergic reaction with swelling that may involve the throat and lead to difficulty
breathing
• Lack of bowel muscle movement that causes blockage.
The following side effect has been seen with the use of another medicine called paliperidone that
is very similar to risperidone, so these can also be expected with Risperidone: Rapid heartbeat
upon standing.
Additional side effects in children and adolescents
In general, side effects in children are expected to be similar to those in adults.
The following side effects were reported more often in children and adolescents (5 to 17 years)
than in adults: feeling sleepy, or less alert, fatigue (tiredness), headache, increased appetite,
vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever,
tremor (shaking), diarrhoea, and incontinence (lack of control) of urine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the UK Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE RISPERIDONE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, carton, or bottle. . The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Risperidone contains
The active substance is risperidone.
Each Risperidone film-coated tablet contains either 0.25 mg, 0.5 mg 1 mg, 2 mg, 3 mg, 4 mg or
6 mg of risperidone.
The other ingredients are:
Risperidone 0.25 mg film-coated tablet: Yellow Iron Oxide (E172), Sunset Yellow FCF Aluminium
Lake (E110), Brilliant Blue Aluminium Lake (E133)
What Risperidone looks like and contents of the pack
Risperidone film-coated tablets
0.25 mg tablet: light brown colour, round, scored biconvex film-coated tablet
Packaging:
Tablets 0,25 mg, 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:
Marketing Authorisation Holder:
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton, Middlesex
HA3 0BU
United Kingdom
Manufacturer:
Chanelle Medical, Loughrea, Co Galway, Ireland
This leaflet was last revised in: 07/2016

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