Risperidone 1mg 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 using
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you personally and you should 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, nurse or pharmacist.
In this leaflet:
1. What Risperidone Tablets are and what they are used for
2. Before you take Risperidone Tablets
3. How to take Risperidone Tablets
4. Possible side effects
5. How to store Risperidone Tablets
6. Further information
1. WHAT RISPERIDONE TABLETS ARE AND WHAT THEY ARE USED FOR
Risperidone is one of a group of medicines called antipsychotics.
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 six 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 six weeks) of long-term aggression in intellectually disabled children (at least five years of age) and adolescents with conduct disorder.
2. BEFORE YOU TAKE RISPERIDONE TABLETS
Do not take Risperidone Tablets if:
• you are allergic (hypersensitive) to risperidone or any of the other ingredients of Risperidone Tablets (see Section 6, 'Further information').
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Risperidone Tablets.
Take special care with Risperidone Tablets
Check with your doctor or pharmacist before taking Risperidone 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 Tablets may cause low blood pressure. Your dose may need to be adjusted.
• you know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular disorder or blood vessel problems in the brain
• you or someone in your family has a history of QT prolongation, a slow heart beat or too little potassium or magnesium in your body
• you have Parkinson's disease or dementia
• you have liver problems
• you have kidney problems
• you suffer from diabetes
• you suffer from epilepsy
• you are a man and you have ever had a prolonged or painful erection. If you experience this while taking Risperidone Tablets, contact your doctor straight away
• you have problems controlling your body temperature or overheating
• you have too much of a hormone called prolactin in your blood or you have a tumour which is affected by 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, speak to your doctor or pharmacist before taking Risperidone Tablets. Risperidone Tablets may cause you to gain weight.
Elderly people with dementia In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if you have dementia caused by stroke.
During treatment with risperidone you should frequently see your doctor.
Medical treatment should be sought straight away if you or your care-giver notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke.
There is a small increased risk of death when risperidone is used in elderly people with demenetia.
Children and adolescents
Before treatment is started in conduct disorder, other causes of aggressive behaviour should have been ruled out.
Before treatment is started your, or your child's body weight may be measured and it may be regularly monitored during treatment.
If the child feels tired as a result of taking risperidone and this affects his or her learning abilities, changing the time of day it is given it might make him or her more alert.
The doctor may want to measure the child's hormone levels and check for unusual body movements during treatment with Risperidone Tablets Taking other medicines
Please tell your doctor 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 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 chinice and mefloquine), heart rhythm problems (such as quinidine, dysopiramide, procainamide, amiodarone and sotalol), allergies (antihistamines), some antidepressants (such as amitriptylline and maprotiline) or other medicines for
mental health 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, fluoxetine, 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 the stomach)
• verapamil, used to treat high blood pressure, chest pain and certain heart rhythm disorders
• paliperidone, used for the maintenance and treatment of schizophrenia
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 Tablets 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 Tablets if you are pregnant, trying to become pregnant or are 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 Tablets. Do not drive or use any tools or machines without talking to your doctor first. Important information about some of the ingredients of Risperidone Tablets
This product contains lactose. If you have been told by your doctor that you have intolerance to some sugars, you should contact your doctor before taking Risperidone Tablets.
The 2mg and 6mg tablets contain sunset yellow FCF (E110) this may cause allergic reactions in some patients. Allergy is more common in those people who are allergic to aspirin.
3. HOW TO TAKE RISPERIDONE TABLETS
How much to take
For the treatment of schizophrenia
Adults
• The usual starting dose is 2mg per day, this may be increased to 4mg 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 6mg
• This total daily dose can be divided into either one or two doses a day. Your doctor will tell you which is best for you.
Elderly people
• Your starting dose will normally be 0.5mg twice a day
• Your dose may then be gradually increased by your doctor to 1mg to 2mg 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 Tablets for schizophrenia
For the treatment of mania Adults
• Your starting dose will usually be 2mg 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 6mg once a day Elderly people
• Your starting does will usually be 0.5mg twice a day
• Your dose may then be gradually adjusted by your doctor to 1mg 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 Tablets 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 0.25mg 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 0.5mg twice a day. Some patients may need 1mg twice a day
• Treatment duration in patients with Alzheimer's dementia should be not more than six 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 50kg
• The starting dose will normally be 0.25mg once a day
• The dose may be increased every other day in steps of 0.25mg per day
• The usual maintenance dose is 0.25mg to 0.75mg once a day For children who weigh 50kg or more
• The starting dose will normally be 0.5mg once a day
• The dose may be increased every other day in steps of 0.5mg per day
• The usual maintenance dose is 0.5mg to 1.5mg once a day Treatment duration in patients with conduct disorder should not be more than six weeks.
Children under 5 years old should not be treated with Risperidone Tablets 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 increase should be slower in these patients.
Risperidone should be used with caution in this patient group.
How to take Risperidone Tablets
You should swallow your tablet with a drink of water.
Always take Risperidone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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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 above. If you take more Risperidone Tablets 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 Tablets
• 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 Tablets You should not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If you stop taking Risperidone Tablets, you should do so gradually, especially if you have been taking a high dose, unless your doctor has told you otherwise. Stopping treatment suddenly may cause effects such as feeling sick, vomiting, sweating, sleeplessness, muscle stiffness or jerky movements, or your original problem may come back. Always follow your doctor's instructions carefully.
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 Tablets can cause side effects,
although not everybody gets them.
The following side-effects may happen:
• 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
• Severe allergic reaction resulting in difficulty in breathing and shock
• 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).
If you notice any of these symptoms seek medical advice
immediately.
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 one 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 incontinence, pain when passing urine, frequent passing of urine
• Confused, disturbance in attention, low level of consciousness, excessive sleep, nervousness, elated mood (mania) , lack of energy and interest
• Blood sugar increased, liver enzymes increased, white blood cell count decreased, low haemoglobin or red blood cell count (anaemia), increase in eosinophils (special white blood cells), blood creatinine phosphokinase increased, decrease in platelets (blood cells that help you stop bleeding)
• Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, musculoskeletal chest pain, chest discomfort
• Skin lesion, skin disorder, dry skin, intense itching of skin, acne, hair loss, skin inflammation caused by mites, skin discoloration, thickening of skin, flushing, reduced skin sensitivity to pain or touch, inflammation of oily skin
• No menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge, enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge
• Fainting, gait disturbance, sluggishness, decreased appetite resulting in malnutrition and low body weight, feeling 'out of sorts', balance disorder, allergy, edema, 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
• Involuntary movements of face, arms, or legs, ringing in ears, swelling of the face.
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.
Very rare (affects less than1 user in 10,000):
• Life threatening complications of uncontrolled diabetes
• Sudden death.
Unknown frequency of
occurrence (frequency cannot be estimated from the available data):
• No granulocytes (a type of white blood cell to help you against infection)
• Prolonged and painful erection
• Dangerously excessive intake of water
• In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.
Long acting injection formulation of risperidone
The following side effects have been reported with the use of a long acting injection formulation of risperidone. Even if you are not being treated with long acting injections of risperidone but you experience any of the following, talk to your doctor.
• Infection of the intestine
• Abscess under the skin, tingling pricking or numbness of skin, inflammation of the skin
• Decrease in white blood cell counts that helps to protect you against bacterial infection
• Depression
• Convulsion
• Eye blinking
• Sensation of spinning or swaying
• Slow beating heart, high blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight decreased.
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 national reporting systems listed below.
United Kingdom Yellow Card Scheme www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie, e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE RISPERIDONE TABLETS
Keep out of the reach and sight of children.
Store the tablets below 30°C. Store in the original package. Do not use Risperidone Tablets after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of the month.
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 Tablets contain
The active substance is risperidone. Each tablet contains
0.5mg, 1mg, 2mg, 3mg, 4mg or 6mg risperidone.
Other ingredients are sodium laurilsulphate, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, hypromellose and magnesium stearate.
The tablets also contain:
0.5mg: hypromellose 6 cP, titanium dioxide (E171), talc, propylene glycol(E1520) and iron oxide red (E172)
1mg: hypromellose 15 cP, propylene glycol (E1520)
2mg: titanium dioxide (E171), hypromellose 15 cP, propylene glycol (E1520), talc, sunset yellow FCF ( E110) 3mg: hypromellose, quinoline yellow (E104), titanium dioxide (E171), propylene glycol (E1520), talc, yellow iron oxide (E172)
4mg: hypromellose, quinoline yellow (E104), propylene glycol (E1520), titanium dioxide (E171), talc, indigo carmine (E132) 6mg: hypromellose, titanium dioxide (E171), quinoline yellow (E104), propylene glycol (E1520), talc, sunset yellow FCF (E110)
What Risperidone Tablets look like and contents of the pack 0.5mg: brown, capsule-shaped, film-coated tablets with breakline on one side and plain on the other side - 20 tablet pack
1mg: white, capsule-shaped, film-coated tablets with breakline on one side and plain on the other side - 20 or 60 tablet pack
2mg: orange, capsule-shaped, film-coated tablets with breakline on one side and plain on the other side - 60 tablet pack
3mg: yellow, capsule-shaped, film-coated tablets with breakline on one side and plain on the other side - 60 tablet pack
4mg: green, capsule-shaped, film-coated tablets with breakline on one side and plain on the other side - 60 tablet pack
6mg: orange, round, film-coated tablets - 28 tablet pack The 0.5mg, 1mg, 2mg, 3mg & 4mg tablets can be divided into equal halves.
Risperidone Tablets - PIL Information
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0800 198 5000 (UK Only)
Please be ready to give the following information:
|
Product Name |
Reference Number |
|
Risperidone 0.5mg Film-Coated Tablets |
29831/0343 |
|
Risperidone 1mg Film-Coated Tablets |
29831/0344 |
|
Risperidone 2mg Film-Coated Tablets |
29831/0345 |
|
Risperidone 3mg Film-Coated Tablets |
29831/0346 |
|
Risperidone 4mg Film-Coated Tablets |
29831/0347 |
|
Risperidone 6mg Film-Coated Tablets |
29831/0348 |
This is a service provided by the Royal National Institute of Blind People.
For the Republic of Ireland please call + 44 1978 669272 Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
This leaflet was last revised in 08/2015