Risperidone 2 Mg Orodispersible Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine because it contains important information for you.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 itagain.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed foryou 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 orfeel 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. What you need to know before you take Risperidone
Do not take Risperidone:
• Ifyou are allergic to risperidone or any of the other ingredients of this medicine (listed in Section 6)
Warnings and precuations
Talk to you doctor or pharmacist before taking Risperidone if:
• You have a heart problem. Examples include an irregular heart rhythm or ifyou are prone to low blood pressure or ifyou are using medicines foryour 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. As diabetes mellitus or worsening of preexisting 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.
• You have epilepsy or are at risk of fits
• 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 ifyou have a tumor, which is possibly dependent on prolactin.
• If 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 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)
As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen very rarelywith patients taking Risperidone, yourdoctor may check your white blood cell counts.
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. Ifyou are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Tell your doctor immediately ifyou 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 doctoror 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.
Older people with dementia
In older 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, vision problems or slurred speech, even for a short period of time. These may be signs of a stroke.
Risperidone taken by itself or with furosemide may have an increased risk of stroke ordeath in older people with dementia.
Children and adolescents
Before treatment is started your, or your child's body weight may be measured and it may be regularly monitored during treatment. Before treatment is started in conduct disorder, other causes of aggressive behaviourshould have been ruled out.
If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
Other medicines and Risperidone
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 (such as quinine, mefloquine), heart rhythm problems (such as quinidine, dysopyramide, procainamide, propafene, amiodarone, sotalol), allergies (anti-histamines), some antidepressants (such as amitriptyline, maprotiline) or other medicines for mental problems
• Medicines that cause a slow heart beat
• Medicines that cause low blood potassium or magnesium (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).
The following medicines may reduce the effect of risperidone
• Rifampicin (a medicine fortreating some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital
Ifyou 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 orto calm down)
• Cimetidine, ranitidine (blockers ofthe acidity of stomach)
Ifyou 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 and drink
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.
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 Orodispersible Tablets contain aspartame
Your medicine also includes a certain inactive ingredient called aspartame. Aspartame contains a source of phenylalanine. This may be harmful for patients with phenylketonuria (a genetic disorder in which the body lacks the enzyme necessary to metabolize amino-acid phenylalanine to tyrosine). If your doctor has told you that you have phenylketonuria, contact your doctor before taking this medicinal product.
3. How to take Risperidone_
Always take this medicine exactly as your doctor has told you. Check with yourdoctor or pharmacist ifyou 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.
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. Yourdoctor will tell you which is the best foryou.
Older people
• Your starting dose will normally be 0.5 mg twice a day
• Your dose may then be gradually increased byyourdoctorto 1 mg to 2 mg twice a day
• Your doctor will tell you which is the best foryou.
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.
Older 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 older 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.
Risperidone Orodispersible Tablets
Only remove a tablet from the blister when it is time to take your medicine.
• Remove the tablet from the blister with dry hands
• Place the tablet on your tongue straight away
• The tablet will begin disintegrating within seconds
• It can then be swallowed with or without water
Ifyou 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.
Ifyou forget to take Risperidone
• Ifyou 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
Ifyou 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Serious side effects
If any of the following side effects happen, stop taking Riseridone
and tell your doctor immediately or go to the casualty department
at your nearest hospital.
• 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. Ifyou 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 the face, arms, or legs, especially on one side, or instances of slurred speech even for a short period of time. These may be signs of a stroke
• Fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome"). Immediate medical treatment may be needed.
• Prolonged and 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
• Severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash or drop in blood pressure
Otherside effects
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 ofthe 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 up to 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 on a blood test (which may or may not cause symptoms). When symptoms of high prolactin occur, they may include in men breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction. In women they may include breast discomfort, leakage of milk from the breasts, missed menstrual periods, or other problems with yourcycle.
• Weight gain, Increased appetite, Decreased appetite
• Sleep disorder, Irritability, Depression, Anxiety, Restlessness, Inability to sit
• 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 ofthe eyes, mouth, tongue, trunk or jaw. It includes: unusual muscle stiffness causing poor control of movement, problems opening your eye (blepharospasm), a twisted neck in which the head is tipped to one side while the chin is turned to the other (torticollis).
• Dizziness
• Dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, ortwitching.
• Tremor(shaking)
• Blurry vision, Eye infection or“pinkeye”
• Rapid heartrate, High blood pressure, Shortness of breath
• Sore throat, Cough, Nosebleeds, Stuffy nose
• Abdominal pain, Abdominal discomfort, Vomiting, Nausea, Constipation, Diarrhoea, Indigestion, Dry mouth, Toothache
• Rash, Skin redness
• Muscle spasms, Bone or muscle ache, involuntary movements of face or arms and legs
• Back pain, Joint pain
• Incontinence (lack of control) of urine
• Swelling ofthe body, arms or legs, Fever,
• Chest pain, Weakness, Fatigue (tiredness), Pain
• Fall
Uncommon (may affect up to 1 in 100 people):
• Infection of the breathing passages, Bladder infection, 'Eye infection, Tonsillitis, Fungal infection of the nails, Infection of the skin, An infection confined to a single area of skin or part of the body, Viral infection, Skin inflammation caused 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, High blood sugar, Excessive drinking of water
• Weight loss, Loss of appetite resulting in malnutrition and low body weight
• Increased cholesterol in yourblood
• Elated mood (mania), Hyperactivity, 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
• Convulsion (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, Asensation of tingling, pricking, or numbness skin
• Oversensitivity of the eyes to light, Dry eye, Increased tears, Redness ofthe eyes, increased blood flow to the eye
• 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 ofthe heart (electrocardiogram or ECG), Afl uttering or pounding feeling in your chest (palpitations)
• Low blood pressure, Low blood pressure upon standing (consequently, some people taking 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 win
• 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
• An increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes 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 yourcycle (females),
• Development of breasts in men, Leakage of milk from the
breasts, Sexual dysfunction, Breast pain, Breast discomfort, Vaginal discharge_
• Edema all over the body
• Swelling ofthe face, mouth, eyes, or lips
• Chills, An increase in body temperature
• Achangeinthewayyouwalk
• 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 yourblood
• 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 ofthe head
• Glaucoma (increased pressure within the eyeball), Problems with movement of your eyes, Eye rolling, Eyelid margin crusting
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen ifyou take or have taken risperidone. Ifyou 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 ofthe pancreas, A blockage in the bowels
• Swollen tongue, Chapped lips, Rash on skin related to drug
• Dandruff
• Breakdown of muscle fibers 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 yourblood
• Priapism (a prolonged penile erection that may require surgical treatment)
• Hardening ofthe skin
• Decreased body temperature, A decrease in body temperature, Coldness in arms and legs
• Symptoms of drug withdrawal
• Yellowing ofthe skin and the eyes (jaundice)
Very rare (may affect up to 1 in 10,000 people):
• Life threatening complications of uncontrolled diabetes (which includes symptoms such as loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart beat, unusual muscle pain or feeling weak, tired or uncomfortable)
• 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.
In older people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.
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
Ifyou 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 Yellow Card Scheme at: 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 label, carton, or bottle.. The expiry date refers to the last date of that month.
Do not store above 25° C. Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.
6. Contents ofthe pack and information
What Risperidone Orodispersible Tablets contain
Risperidone 2mg Orodispersible Tablets
Each orodispersible tablet contains 2 mg of risperidone.
The other ingredients are mannitol, croscarmellose sodium, magnesium carbonate, heavy, ferric oxide red (E172), magnesium stearate, hyd roxyp ropylce 11 u lose, aspartame (E951), saccharin sodium, talc, flavour peppermint 517, levomenthol and silican colloidal anhydrous.
What Risperidone looks like and contents ofthe pack
Risperidone 2mg Orodispersible Tablets
The orodispersible tablets are pink coloured, mottled, circular, flat beveled tablets, debossed with 'R' on one side and '2' on the other side.
Pack sizes: 20,28,30,56,60 and 98 orodispersible tablets. Not all packsizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, London, W4 5YE, United Kingdom
Manufacturer
Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co-Tipperary, Ireland.
This medicinal product is authorized in the Member States of the EEAunderthe following names:
UK Risperidone 2mg Orodispersible Tablets
Poland Ranperidon Orodispersible 2 mg Tablets
This leaflet was last revised inAugust2014.