Risperidone 0.5 Mg Orodispersible Tablets
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Package leaflet: Information for the user
Risperidone 0.5 mg orodispersible tablets Risperidone 1 mg orodispersible tablets Risperidone 2 mg orodispersible 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.
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.
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).
Warnings 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
• If 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
• If you have ever experienced involuntary movements of the tongue, mouth and face
• If 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)
• If you have Parkinson’s disease or dementia
• If you are diabetic
• If you have epilepsy
• If you are a man and you have ever had a prolonged or painful erection.
• If you have problems controlling your body temperature or overheating
• If you have kidney problems
• If you have liver problems
• If you have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin
• If 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.
Risperidone may cause you to gain weight. Significant weight gain may adversely affect your health. Your doctor should regularly measure your body weight.
As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking Risperidone, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
Elderly people with dementia
In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if you have dementia caused by stroke.
During treatment with risperidone you should frequently see your doctor.
Medical treatment should be sought straight away if you or your care-giver notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke.
Children and adolescents
Before treatment is started your or your child’s body weight may be measured and it may be regularly monitored during treatment.
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.
Other medicines and Risperidone
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
It is especially important to talk to your doctor or pharmacist if you are taking any of the following:
• Medicines that work on your brain such as to help you calm down (benzodiazepines) or some medicines for pain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these
• Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (antihistamines), some antidepressants or other medicines for mental problems
• Medicines that cause a slow heart beat
• Medicines that cause low blood potassium (e.g. certain diuretics)
• Medicines to treat high 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 and verapamil (used to treat high blood pressure)
• Phenothiazines, paliperidone (such as medicines used to treat psychosis or to calm down)
• Cimetidine, ranitidine (blockers of the acidity of stomach)
If you start or stop taking such medicines you may need a different dose of risperidone.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone.
Risperidone with food, drink and alcohol
You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone.
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 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.
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 contains aspartame (E951)
Aspartame contains a source of phenylalanine and may be harmful for people with phenylketonuria.
3. How to take Risperidone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how much medicine to take and for how long. This will depend on your condition and varies from person to person.
How much to take
For the treatment of schizophrenia
Adults
• The recommended 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.
Use in children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone for schizophrenia.
For the treatment of mania Adults
• Your starting dose will usually be 2 mg once a day
• Your dose may then be gradually adjusted by your doctor depending on how you respond to
the treatment
• Most people feel better with doses of 1 to 6 mg once a day.
Elderly people
• Your starting dose will usually be 0.5 mg twice a day
• Your dose may then be gradually adjusted by your doctor to 1 mg to 2 mg twice a day depending on how much you respond to the treatment.
Use in children and adolescents
• Children and adolescents under 18 years old should not be treated with Risperidone for mania. For the treatment of long-standing aggression in people with Alzheimer’s dementia
Adults (including elderly people)
• Your starting dose will normally be 0.25 mg twice a day
• Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment
• Most people feel better with 0.5 mg twice a day. Some patients may need 1 mg twice a day
• Treatment duration in patients with Alzheimer’s dementia should be not more than 6 weeks.
For the treatment of conduct disorder in children and adolescents from 5 to 18 years of age
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 recommended 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 recommended 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.
Please note, the 0.25 mg starting dose cannot be achieved with Risperidone as it cannot be split in two equal halves for dosing purposes. For doses in practicable with this medicinal product other medicinal products with appropriate pharmaceutical form are available.
Route and method of administration
Risperidone orodispersible tablets should be taken orally.
Only remove a tablet from the blister when it is time to take your medicine. See diagram below.
1. Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
2. Peel off the backing of the blister to expose the tablet.
3. Carefully take out the tablet from the packaging. Do not push the tablet through the blister because it may break. Remove the tablet from the package with dry hands.
4. Place the tablet on your tongue straight away. Allow it to dissolve directly in your mouth.
5. Swallow it with saliva or with a drink of water if you wish.
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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately or go to a hospital emergency department if you:
• Experience a severe rash, itching or hives on the skin; swelling of the face, lips, tongue or throat, shortness of breath, difficulty in breathing, dizziness and shock. These may be signs of a severe allergic reaction or angioedema.
• 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 loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart beat, unusual muscle pain or feeling weak, tired or uncomfortable. These may be signs of a rare life-threatening complication of uncontrolled diabetes called diabetic ketoacidosis.
Tell your doctor immediately if you experience any of the side effects above.
The following side effects may happen:
Very Common (may affect more than 1 in 10 people):
• Parkinsonism. This is a medical term that includes many symptoms. Each individual symptom may occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex)
• Headache, difficulty falling or staying asleep.
Common (may affect up to 1 in 10 people):
• 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 stomach 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
• Shaking (tremor), 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 (may affect up to 1 in 100 people):
• Excessive drinking of water, stool incontinence, feeling thirsty, very hard faeces, hoarseness or voice disorder
• Diabetes mellitus, high blood sugar
• 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
• Liver enzymes increased, white blood cell count decreased (including those that help to protect you against bacterial infection), 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), increased blood cholesterol and triglycerides (blood fats)
• 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, oedema, speech disorder, chills, abnormal coordination, abnormal taste
• 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, face oedema.
• Inability to urinate or incomplete emptying of the bladder.
Rare (may affect up to 1 in 1000 people):
• Inability to reach orgasm, menstrual disorder
• Dandruff
• 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, oedema
all over the body, drug withdrawal syndrome, decreased body temperature
• Fast shallow breathing, trouble breathing during sleep, chronic ear inflammation or infection (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 fibres and pain in muscles (rhabdomyolysis), movement disorder
• Shaking (tremor) of the head
• Coma due to uncontrolled diabetes
• Yellowing of the skin and the eyes (jaundice)
• Inflammation of the pancreas
• Low blood sugar
Not known (frequency cannot be estimated from the available data):
• No granulocytes (a type of white blood cell to help you against infection)
• Dangerously excessive intake of water
The following side effects have been reported with the use of long acting injections of risperidone. Even if you are not being treated with long acting injections of risperidone, if 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 (vertigo), falling over
• Slow beating heart, high blood pressure
• Toothache, tongue spasm
• Buttock pain
• Weight decreased.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to store Risperidone
This medicine does not require any special storage conditions.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. 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.
Contents of the pack and other information
6.
What Risperidone contains
The active substance is risperidone
Each Risperidone orodispersible tablet contains either 0.5 mg, 1 mg or 2 mg of risperidone.
The other ingredients are:
Polacrilin resin, crospovidone, silica colloidal anhydrous, cellulose microcrystalline (E460), guar gum (E412), mannitol (E421), aspartame (E951), iron oxide red (E172) and magnesium stearate (E572).
What Risperidone looks like and contents of the pack
Risperidone 0.5 mg: Plain or mottled light pink coloured, round, flat tablets engraved with ‘M’ on one side and ‘R05’ on the other side.
Risperidone 1 mg: Plain or mottled light pink coloured, round, flat tablets engraved with ‘M’ on one side and ‘R1’ on the other side.
Risperidone 2 mg: Plain or mottled light pink coloured, round, flat tablets engraved with ‘M’ on one side and ‘R2’ on the other side.
Pack sizes
Risperidone orodispersible tablets are available as:
OPA/Al/PVC-Aluminium/PET/peel paper perforated blisters will be packed in cardboard cartons to contain 14 x1, 28 x 1, 56 x 1 or 60 x 1 tablets per pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Manufacturer:
Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Marketing Authorisation Holder:
Mylan
Station Close,
Potters Bar,
Hertfordshire,
EN6 1TL United Kingdom
This leaflet was last revised in 09/2013.
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