Risperidone 4mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Risperidone 0.5mg, 1mg, 2mg, 3mg, 4mg and 6mg 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Risperidone film-coated Tablets are and what they are used for
2. What you need to know before you take Risperidone film-coated Tablets
3. How to take Risperidone film-coated Tablets
4. Possible side effects
5. How to store your Risperidone film-coated Tablets
6. Contents of the pack and other information
1. What Risperidone film-coated Tablets are and what they are used for
Risperidone is a type of medicine called an antipsychotic, which helps to improve the way you think, feel and/or act.
Risperidone film-coated Tablets are used to treat:
• 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 or 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 film-coated Tablets
Do not take Risperidone film-coated Tablets if you are:
• Allergic (hypersensitive) to risperidone or any of the other ingredients of these 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 these tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone film-coated Tablets 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 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 abnormally high levels 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 antipsychotics have been associated with the 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 film-coated Tablets.
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 pre-existing diabetes mellitus blood glucose should be monitored regularly.
Risperidone commonly raises levels of a hormone called "prolactin”. This may cause side effects such as menstrual disorders or fertility problems in women, breast-swelling in men (see Possible side effects). If such side effects occur, evaluation of the prolactin level in the blood is recommended.
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 for 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 film-coated Tablets
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 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
• Medicines that cause low blood potassium (such as certain diuretics)
• 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, fluoxetine, tricyclic antidepressants
• Medicines known as beta blockers (used to treat high blood pressure)
• Phenothiazines (medicines used to treat psychosis or to calm down)
• Cimetidine, ranitidine (blockers of the acidity of the 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
• Serrtraline 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 any of the above applies to you, talk to your doctor or pharmacist before using Risperidone film-coated Tablets.
Risperidone film-coated Tablets with food, drink and alcohol
You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone film-coated Tablets.
Pregnancy and breast-feeding
• 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 stiff ness, 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
This product contains lactose, a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine. The 2mg tablets also contains sunset yellow (El 10), which may cause an allergic reaction.
3. How to take Risperidone film-coated Tablets
Always take Risperidone film-coated Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
.You should swallow your tablet with a drink of water. Your doctor will tell you how many tablets to take, and when to take them. You may divide your dose into one or two doses daily. Tablets can easily be broken in half to aid swallowing.
The recommended dose is as follows:
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 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.
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 0.5mg 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 mania.
Treatment of long-standing aggression in people with Alzheimer's dementia
Adults (including elderly people)
• Your starting dose will normally be 0.25mg 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.
• T reatment duration in patients with Alzheimer's dementia should be not more than 6 weeks.
Treatment of conduct disorder in children and adolescents
The dose depends 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 o.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 film-coated Tablets for conduct disorder.
Patients 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.
If you forget to take Risperidone film-coated Tablets
If you forget to take your tablets, take them as soon as you remember unless it is almost time for the next dose. If you miss two or more doses, contact your doctor. Do not take a double dose to make up for a forgotten individual dose.
If you take more Risperidone film-coated Tablets than you should
• See a doctor right away. T ake 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 heartbeats or fits.
If you stop taking Risperidone film-coated Tablets
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 film-coated Tablets may 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 legs), 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 of 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 a 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):
• parkinsonism. This condition may include: slow or impaired movement, sensation of stiff ness 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
• difficulty falling or staying asleep
• 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
• blood prolactin hormone level increased. 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 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”
• fast beating heart, chest pain, 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, back pain, joint pain
• incontinence (lack of control) of urine
• swelling of the body, arms or legs, fever, weakness, fatigue (tiredness), pain
• fall.
Uncommon (may affect up to 1 in 100 people):
• infection of the breathing passages, bladder infection, eye infection, tonsil 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), anaemia, decrease in red blood cells, increase in eosinophils (a type of white blood cell) in your blood
• allergic reaction
• diabetes mellitus or worsening of diabetes, high blood sugar, excessive drinking of water
• weight loss, loss of appetite resulting in malnutrition and low body weight
• increased cholesterol in your blood
• confused, disturbance in attention, low level of consciousness, excessive sleep, nervousness, elated mood (mania), lack of energy and interest, decreased sexual drive, 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 the brain (stroke or "mini” stroke)
• unresponsive to stimuli, loss of consciousness, low level of consciousness
• fainting, gait disturbance, sluggishness, feeling 'out of sorts', a restless urge to move parts of your body, balance disorder, speech disorder, abnormal coordination, dizziness upon standing, disturbance in attention, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking or skin numbness
• convulsions (fits)
• painful oversensitivity of the eyes to light, dry eye, increase in tears, redness of the eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• abnormal electrical conduction of the heart, abnormal electric activity tracing of the heart (ECG), abnormal heart rhythm, awareness of heart beating, heart rate increased or decreased
• 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 sound, wheezing, voice disorder, breathing passage disorder
• stomach or intestinal infection, stool incontinence, very hard stool, difficulty swallowing, excessive passing of gas or wind
• skin lesion, hives (or "nettle rash”), dry skin, intense itching of skin, acne, hair loss, skin discolouration, thickening of skin, reduced skin sensitivity to pain or touch, inflammation of oily skin
• an increase in 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
• no menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast pain, breast discomfort, breast discharge, enlargement of breast in men, irregular menstruation, 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 transaminase in your blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) 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 movements of your eyes, eyelid margin crusting, eye rolling
• eye problems during cataract surgery. During cateract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take Risperidone. 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, lips or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure
• dangerously excessive intake of water
• irregular heartbeat
• blood clots in the legs, blood clots in the lungs
• fast shallow breathing, trouble breathing during sleep (sleep apnea)
• inflammation of the pancreas, a blockage in the bowels
• swollen tongue, chapped lips. rash on skin related to the 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 the 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 your Risperidone film-coated Tablets
Keep this medicine out of the sight and reach of children. Do not store above 25°C and keep the tablets in their original package
Do not use Risperidone film-coated Tablets after the expiry date which is stated on the carton after 'Expiry:' The expiry date refers to the last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What Risperidone film-coated Tablets contain
The active substance is Risperidone.
The other ingredients in the tablet are: lactose monohydrate (Section 2 Important information about some of the ingredients of Risperidone film-coated tablets), starch pregelatinised, cellulose microcrystalline, sodium laurilsulfate, silica colloidal anhydrous, talc, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol 400. Tablet coatings contain:
0.5mg tablet: red and yellow iron oxides (E172), and hydroxypropyl methylcellulose.
2mg tablet: sunset yellow (E110) and quinoline yellow (E104)
3mg tablet: quinoline yellow (E104)
4mg tablet: quinoline yellow (E104) and indigo carmine (E132).
6mg tablet: hypromellose and FD&C Yellow #5/tartrazine Aluminum Lake (E102).
What Risperidone film-coated Tablets look like and contents of the pack
Each brown tablet contains equivalent to 0.5mg of Risperidone.
Each white tablet contains equivalent to 1mg of Risperidone.
Each orange tablet contains equivalent to 2mg of Risperidone.
Each yellow tablet contains equivalent to 3mg of Risperidone.
Each green tablet contains equivalent to 4mg of Risperidone.
Each yellow tablet contains equivalent to 6mg of Risperidone.
Your Risperidone Tablets are supplied in boxes containing 20 or 50 tablets for 0.5mg, 20, 28, 50 or 60 tablets for 1mg, 2mg, 3mg and 4mg Risperidone. The 6mg strength is packaged in boxes of 28, 50 or 60 tablets.
Marketing Authorisation Holder and Manufacturer: Dr Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK
Risperidone 3mg Tablets Risperidone 4mg Tablets Risperidone 6mg Tablets
PL 08553/0257 PL 08553/0258 PL 08553/0260
Risperidone 0.5mg Tablets PL 08553/0259
Risperidone 1mg Tablets PL 08553/0255
Risperidone 2mg Tablets PL 08553/0256
Date of preparation 09/2015 Component code Dr. Reddy's Laboratories (UK) Ltd