Risperidone 1mg/Ml Oral Solution
package leaflet: INFORMATION FOR THE USER
RISPERIDONE 1mg/ml ORAL SOLUTION
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 Oral Solution is and what it is used for
2. Before you take Risperidone Oral Solution
3. How to take Risperidone Oral Solution
4. Possible side effects
5. How to store Risperidone Oral Solution
6. Further information
1. what risperidone oral solution is and what it is 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 ORAL SOLUTION
Do not take Risperidone Oral Solution if:
• you are allergic (hypersensitive) to risperidone or any of the other ingredients of Risperidone Oral Solution (see ‘Further information’ section).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Risperidone Oral Solution.
Take special care with Risperidone Oral Solution:
Check with your doctor or pharmacist before taking Risperidone Oral Solution 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 Oral Solution 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 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 Oral Solution, contact your doctor straight away
• you have problems controlling your body temperature or overheating
• 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
• 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 Oral Solution.
Risperidone Oral Solution 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.
children and adolescents
Before treatment is started in conduct disorder, other causes of aggressive behaviour should have been ruled out.
If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
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, heart rhythm problems (such as quinidine), allergies (antihistamines), some antidepressants 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)
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 Oral Solution with food and drink
You should be careful how much alcohol you drink as the combined effect of risperidone and alcohol may make you feel drowsy.
Risperidone Oral Solution can be taken with or without food.
Pregnancy and breast-feeding
• talk to your doctor before using Risperidone Oral Solution 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 Oral Solution. Do not drive or use anY tools or machines without talking to your doctor first.
Important information about some of the ingredients of Risperidone Oral Solution
This medicinal product contains sodium methylparaben (E219), which may cause allergic reactions (possibly delayed).
3. how to take risperidone oral solution
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 Img 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 Oral Solution 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 dose will usually be 0.5mg twice a day
• Your dose may then be gradually adjusted by your doctor to Img 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 Oral Solution 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 Img 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 Oral Solution 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 Oral Solution
Always take Risperidone Oral Solution exactly as your doctor has told you. You should 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. The amount of medicine you should take is explained under the ‘How much to take’ sub-heading above.
Instructions for using the dispenser and adaptor with Risperidone Oral Solution:
a) Remove the child-resistant cap from the bottle by pushing down on the cap while turning it anti-clockwise. See Fig 1.
b) Press the bottle adaptor firmly into the bottle neck.
c) Hold the empty dispenser and draw out the plunger to the required dose mark. See Fig 2.
d) Fit the dispenser into the bottle adaptor and turn the entire unit (bottle and oral dispenser)
Fig 2
e) To ensure the correct dose is obtained push the plunger in and then draw out medicine SLOWLY until the mark that matches the number of mg or ml to be taken is just visible. See Fig 3. If there are bubbles in the dispenser, repeat step d) until the bubbles are eliminated,
f) Place the bottle upright on a flat surface and remove the dispenser.
g) Make sure the patient is sitting or is held upright before giving the medicine.
h) Direct the dispenser towards the inside of the cheek. Push the plunger in slowly to give time to swallow; rapid squirting of the medicine may cause choking, The solution may also be emptied into a drink of mineral water, orange juice or black coffee,
i) Remove the dispenser from the adaptor and rinse the dispenser with some warm, soapy water,
j) Remove the bottle adaptor and replace the child-resistant cap on the bottle by screwing it down clockwise until it locks fully,
Fig 1
if you take more Risperidone Oral Solution 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 Oral Solution
• 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 Oral Solution
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 Oral Solution 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, If you notice any of these symptoms seek medical advice immediately,
Side effects that are very common (affecting more than one person in every 10 people):
• 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
Side effects that are common (affecting one to ten people in every 100 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 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.
Side effects that are uncommon (affecting one to 10 people in one thousand people):
• 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
• 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), involuntary movements of face, arms, or legs, ringing in ears, face edema,
Side effects that are rare (affecting one to 10 people in 10 thousand people):
• 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 fibres and pain in muscles (rhabdomyolysis), movement disorder
• Coma due to uncontrolled diabetes
• Yellowing of the skin and the eyes (jaundice)
• Inflammation of the pancreas.
Side effects that are very rare (affecting less than one person in 10 thousand people):
• Life threatening complications of uncontrolled diabetes,
Side effects with unknown frequency of occurrence (frequency cannot be estimated from available data):
• Severe allergic reaction resulting in difficulty in breathing and shock
• 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 Earisforf 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 oral solution
Keep out of the reach and sight of children,
This medicinal product does not require any special storage conditions,
Do not use Risperidone Oral Solution after the expiry date which is stated on the bottle and the carton. The expiry date refers to the last day of the month. The solution should not be used for longer than three months after the bottle has been opened,
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 Oral Solution contains
The active substance is risperidone. The solution contains Img of risperidone per millilitre (ml) The solution also contains:
Malic acid, hydroxypropylbetadex, sodium methylparaben (E219), saccharin sodium, disodium edetate, potassium hydroxide and purified water.
What Risperidone Oral Solution looks like and contents of the pack
Risperidone Oral Solution is a clear, colourless oral solution, It is available in bottles containing 100ml. Each bottle is supplied with a press-in bottle adaptor and an oral dispenser. Risperidone Oral solution - PIL information
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Product Name |
Reference Number |
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Risperidone lmg/ml Oral Solution |
29831/0349 |
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For the Republic of Ireland please call UK +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 medicinal product is authorised in the Member States of the EEA under the following names:
Ireland - Risperidone 1mg/ml Oral Solution This leaflet was last revised in 11/2015