Risperidone 1 Mg/Ml Oral Solution
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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Risperidone Oral Solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information
Risperidone Oral Solution belongs to a group of medicines called
‘anti-psychotics'.
Risperidone Oral Solution 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.
Do not take Risperidone Oral Solution:
• if you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Risperidone Oral Solution.
Warnings and precautions
Talk to 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 or someone else in your family has a history of blood clots, as medicines like this have been associated with formation of blood clots
• 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. 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 kidney problems
• You have liver problems
• 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.
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, talk to your doctor or pharmacist before using Risperidone Oral Solution.
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 Oral Solution, your doctor may check your white blood cell counts.
Risperidone Oral Solution 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 Oral Solution, your doctor should check for signs of high blood sugar.
In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
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 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 Oral Solution.
Taking Risperidone Oral Solution with food, drink and alcohol
You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone Oral Solution. Risperidone Oral Solution must not be mixed with tea.
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 who have used Risperidon in the last trimester (last three months of their pregnancy):
shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
If your baby develops any of these symptoms you may need to contact your doctor.
• Risperidone Oral Solution can raise your levels of a hormone called "prolactin" that may impact fertility (see Possible side effects).
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.
The recommended dose is
For the treatment of schizophrenia
Adults
• The usual starting dose is 2 ml oral solution (2 mg risperidone) per day, this may be increased to 4 ml oral solution (4 mg risperidone) 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 ml oral solution (4 to 6 mg risperidone).
• This total daily dose can be divided into either one or two doses a day. Your doctor will tell you which is the best dose for you.
Elderly people
• Your starting dose will normally be 0.5 ml oral solution (0.5 mg risperidone) twice a day.
• Your dose may then be gradually increased by your doctor to 1 to 2 ml oral solution (1 to 2 mg risperidone) 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 2 ml oral solution (2 mg risperidone) 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 ml oral solution (1 to 6 mg risperidone) once a day.
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 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 during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
Elderly people
• Your starting dose will usually be 0.5 ml oral solution (0.5 mg risperidone) twice a day.
• Your dose may then be gradually adjusted by your doctor to 1 to 2 ml oral solution (1 to 2 mg risperidone) 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 0.25 ml oral solution (0.25 mg risperidone) 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 ml oral solution (0.5 mg risperidone) twice a day. Some patients may need 1 ml oral solution (1 mg risperidone) twice a day.
• Treatment duration in patients with Alzheimer's dementia should be not more than 6 weeks.
For the treatment of conduct disorder in children and
adolescents
The dose will depend on your child's weight:
Other medicines and Risperidone Oral Solution
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
It is especially important to talk to your doctor or pharmacist if you
are taking any of the following:
• Medicines that work on your brain such as to help you calm down (benzodiazepines) or some medicines for pain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these
• Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (anti-histamines), 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 elevated blood pressure. Risperidone Oral Solution 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 Oral Solution taken
For children who weigh less than 50 kg
• The starting dose will normally be 0.25 ml oral solution (0.25 mg risperidone) once a day.
• The dose may be increased every other day in steps of 0.25 ml oral solution (0.25 mg risperidone) per day.
• The usual maintenance dose is 0.25 to 0.75 ml oral solution (0.25 to 0.75 mg risperidone) once a day.
For children who weigh 50 kg or more
• The starting dose will normally be 0.5 ml oral solution (0.5 mg risperidone) once a day.
• The dose may be increased every other day in steps of 0.5 ml oral solution (0.5 mg risperidone) per day.
• The usual maintenance dose is 0.5 to 1.5 ml oral solution (0.5 to 1.5 mg risperidone) 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
Oral Solution for conduct disorder.
Continued on the next page >>
draft: 5200303
o
o
o
<L>
T3
(O
3
aj
CO
o
o
o
o
o
o
o
o
o
c
to
|
Artwork Proof Box Ref: V025 - Brand alignment (includes all CDS changes) | ||
|
Proof no. |
Date prepared: |
Font size: |
|
009.0 |
29/11/2013 |
8pt |
|
Colours: |
Fonts: | |
|
| Black |
□ |
Helvetica |
|
□ |
□ | |
|
'j Dimensions: |
1 90 x 600 mm |
_y |
draft: 5200303
O
O
o
<L>
T3
(O
3
aj
CO
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.
How to take Risperidone Oral Solution
Always take this medicine exactly as your doctor 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. The amount of medicine you should take is explained under the ‘How much to take' sub-heading above.
Risperidone Oral Solution is for oral use.
Opening the bottle and handling the dosing pipette
A dosing pipette is supplied with each bottle. The bottle has a
child-proof screw cap.
1. Open the screw cap by pressing it firmly downwards and turning it anticlockwise as shown in Figure 1.
2. Insert the pipette into the bottle. In order to measure the dose hold the pipette tightly with one hand by the lower ring and with the other hand pull the upper ring of the pipette until the correct quantity of the medicine is visible from the barrel of the pipette (ml or mg for example) as shown in Figure 2.
3. Draw the pipette carefully from the bottle holding it tightly by the lower ring as shown in Figure 3. Transfer the quantity of medicine drawn into the pipette into a glass containing a drink (not alcohol or tea) by pressing the upper ring of the pipette. Drink the contents of the glass.
4. Close the bottle and rinse the empty pipette with water.
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 medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can 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 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.
• 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.
The following side effects may happen:
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 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, a tremor while at rest, persistent blinking in response to tapping of the forehead (an abnormal reflex)
• Feeling sleepy, or less alert
• Headache, difficulty falling or staying asleep.
Common (affects 1 to 10 users in 100):
• Drowsiness, fatigue, restlessness, inability to sit still, irritability, depression, anxiety, sleepiness, dizziness, poor attention, feeling exhausted, sleep disorder
• Vomiting, diarrhoea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth, toothache
• Weight increased, 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
• 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, high blood pressure, chest pain
• Blood prolactin hormone level increased
• Fall.
Uncommon (affects 1 to 10 users in 1,000):
• Excessive drinking of water, stool incontinence, thirsty, very hard faeces, excessive passing of gas, 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, a restless urge to move parts of the body, low level of consciousness, excessive sleep, nervousness, nightmares, 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
• Hives (or “nettle rash”), eczema, 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, sensation of tingling, pricking, or numbness of the skin, 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, convulsions (fits), gait disturbance, sluggishness, decreased appetite resulting in malnutrition and low body weight, weight-loss, feeling ‘out of sorts', balance disorder, allergy, oedema (swelling in body tissues), 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
• 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, sensation of spinning (vertigo), face edema
• Inability to urinate or incomplete emptying of the bladder
• Increase in body temperature.
Rare (affects 1 to 10 users in 10,000):
• Infection
• Inability to reach orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip inflammation, swollen tongue
• Glaucoma, problems with movement of the eyes, reduced visual clarity, eyelid margin crusting, eye rolling
• Eye problems during cataract surgery - a so called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Risperidone Oral Solution. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine.
• 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
• Irregular heart beat
• Blood clot in the legs, blood clot in the lungs
• 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
• Tremor of the head
• Coma due to uncontrolled diabetes
• Yellowing of the skin and the eyes (jaundice)
• Inflammation of the pancreas
• Increased insulin (a hormone that controls blood sugar levels) in the blood
• Sugar in the urine, low blood sugar
• Hardening of the skin
Very rare (affects less than 1 user in 10,000):
• Life threatening complications of uncontrolled diabetes.
Unknown frequency of occurrence (frequency cannot be estimated from the 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 (see beginning of this section under “Tell your doctor immediately if you”)
• Dangerously excessive intake of water
• Blood clots in the veins especially in the legs (see beginning of this section under “Tell your doctor immediately if you”).
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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the bottle. The expiry date refers to the last day of that month.
Do not freeze.
Do not use Risperidone Oral Solution after 6 months have elapsed from first opening of the bottle.
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 to protect the environment.
What Risperidone Oral Solution contains
- The active substance is risperidone. Each 1 ml of Oral Solution contains 1 mg risperidone.
- The other ingredients are benzoic acid (E 210); water, purified.
What Risperidone Oral Solution looks like and contents of the pack
Risperidone 1 mg/ml Oral Solution is a clear, colourless Oral Solution.
It is available in amber glass bottles with a white plastic child resistant closure containing 30 ml, 60 ml, 100 ml or 120 ml Oral Solution.
A dosing pipette including pipette holder is enclosed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or
LEK Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia.
This leaflet was last revised in 11/2013.
SZ00000LT000
o
o
o
o
o
o
o
o
o
c
to
|
Artwork Proof Box Ref: V025 - Brand alignment (includes all CDS changes) | ||
|
Proof no. |
Date prepared: |
Font size: |
|
009.0 |
29/11/2013 |
8pt |
|
Colours: |
Fonts: | |
|
| Black |
□ |
Helvetica |
|
□ |
□ | |
|
'j Dimensions: |
1 90 x 600 mm |
_y |
E