RISPERIDONE 1 MG/ML SUGAR FREE ORAL SOLUTION

Active substance: RISPERIDONE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperidone 1 mg/ml Sugar Free
Oral Solution
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 further questions, please ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their symptoms 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.
2.
3.
4.
5.
6.

What Risperidone Sugar Free Oral Solution is and what it is used for.
What you need to know before you take Risperidone Sugar Free Oral Solution.
How to take Risperidone Sugar Free Oral Solution.
Possible side effects.
How to store Risperidone Sugar Free Oral Solution.
Contents of the pack and other information.

1. What Risperidone Sugar Free Oral Solution is
and what it is used for:
Risperidone Sugar Free Oral Solution belongs to a group of medicines called ‘anti-psychotics’.
Risperidone Sugar Free 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.
Risperidone Sugar Free Oral Solution can help alleviate the symptoms of your disease and stop your
symptoms from coming back.

2. What you need to know before you take
Risperidone Sugar Free Oral Solution:
Do not take Risperidone Sugar Free Oral Solution if:

You are allergic (hypersensitive) 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
Sugar Free Oral Solution.
Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Sugar Free Oral Solution if:

You have Parkinson's disease or dementia

You have a heart problem. Examples include an irregular heart rhythm or if you are prone to low
blood pressure or if you are using medicines for your blood pressure. Risperidone may cause low
blood pressure. Your dose may need to be adjusted.

You have liver problems

You have kidney problems

You have epilepsy

You know of any factors which would favour you having a stroke, such as high blood pressure,
cardiovascular disorder or blood vessel problems in the brain.

You have ever experienced involuntary movements of the tongue, mouth and face

You have ever had a condition whose symptoms include high temperature, muscle stiffness,
sweating or a lowered level of consciousness (also known as Neuroleptic Malignant Syndrome)

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 an abnormally high level of the hormone prolactin in your blood or if you have a possible
prolactin-dependent tumour

You are a man and you have ever had a prolonged or painful erection

You have problems controlling your body temperature or overheating.

You or someone else in your family has a history of blood clots, as antiphychotics have been 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 Sugar Free 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 Sugar Free Oral Solution, your doctor may check
your white blood cell counts.
Risperidone Sugar Free Oral Solution may cause you to gain weight. Significant weight gain may
adversely affect your health. Your doctor should regularly measure your body weight.

Risperidone Sugar Free Oral Solution with food, drink and alcohol:
Risperidone Sugar Free Oral Solution can be taken with or without food. You should avoid drinking
alcohol when taking Risperidone Sugar Free Oral Solution.
Pregnancy breast-feeding and fertility:

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
Sugar Free Oral Solution 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 Sugar Free Oral Solution can raise your levels of a hormone called "prolactin" that
may impact fertility (see Possible side effects).
Driving and using machines:
Risperidone Sugar Free Oral Solution may cause dizziness, tiredness and vision problems. Do not drive or
use any tools or machines without talking to your doctor first.

3. How to take Risperidone Sugar Free Oral
Solution:
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
The recommended dose is as follows:
For the treatment of schizophrenia
Adults:

The usual starting dose is 2 mg per day, this may be increased to 4 mg per day on the second day.

Your dose may then be adjusted by your doctor depending on how you respond to the treatment.

Most people feel better with daily doses of 4 mg 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 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 or 2 mg twice a day.

Your doctor will tell you which is best for you.
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 mg 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.
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.
Children and adolescents:

Children and adolescents under 18 years old should not be treated with Risperidone Sugar Free
Oral Solution for schizophrenia or mania.
For the treatment of conduct disorder
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 usual 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 usual maintenance dose is 0.5 mg to 1.5 mg once a day.
Treatment duration in patients with conduct disorder should be not more than 6 weeks.
Children under 5 years old should not be treated with Risperidone Sugar Free Oral Solution for conduct
disorder.

As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking
Risperidone Sugar Free 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.

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.

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

Instructions for using the pipette with Risperidone Sugar Free Oral Solution:
The solution comes with a syringe (pipette). This should be used to help you measure the exact amount
of medicine you need.

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 notices 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.
Before treatment is started your, or your child’s body weight may be measured and it may be regularly
monitored during treatment.

Follow these steps:
1. Remove the child-proof cap. Push the plastic screw cap down while turning it counter clockwise
(Figure 1).
2. Insert the syringe into the bottle.
3. While holding the bottom ring, pull the top ring up to the mark that corresponds to the number
of millilitres or mg you need to take (Figure 2).
4. Holding the bottom ring, remove the entire syringe from the bottle (Figure 3).
5. Empty the syringe into any non-alcoholic drink, except for tea. Slide the upper ring down.
6. Close the bottle.
7. Rinse the syringe with some water.
FIG 1

FIG 2

FIG 3

Other medicines and Risperidone Sugar Free Oral Solution:
Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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, medicines for allergies (some anti-histamines), some antidepressants or
other medicines for mental problems

Medicines that cause a slow heart beat

Medicines that cause low blood potassium (such as certain diuretics)

Medicines to treat 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.

If you take more Risperidone Sugar Free 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 Sugar Free 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 Sugar Free 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 you doctor or pharmacist.

The following medicines may increase the effect of risperidone:

Quinidine (used for certain types of heart disease)

Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants

Medicines known as beta blockers (used to treat high blood pressure)

Phenothiazines (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 Sugar Free Oral Solution.

LE4198_RIS_PIL_300x600_v4

02.12.14

300mm x 600mm

4. Possible side effects:
Like all medicines, Risperidone Sugar Free Oral Solution 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 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 severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue,
shortness of breath, itching, skin rash or drop in blood pressure.
The following side effects may happen:
Very common (affects more than 1 user in 10):

Parkinsonism: This condition may include: slow or impaired movement, sensation of stiffness or
tightness of the muscles (making your movements jerky), and sometimes even a sensation of
movement "freezing up" and then restarting. Other signs of parkinsonism include a slow shuffling
walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face

Feeling sleepy, or less alert

Headache,

Difficulty falling or staying asleep.
Common (affects 1 in 10 users in 100):

Sleep disorder, irritability, depression, anxiety, restlessness

Weight increased, increased appetite, decreased appetite.

Pneumonia, infection of the chest (bronchitis), common cold symptoms, sinus infection, urinary
tract infection, ear infection, feeling like you have the flu

Dystonia: This is a condition involving slow or sustained involuntary contraction of muscles. While it
can involve any part of the body (and may result in abnormal posture), dystonia often involves
muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.

Dizziness

Dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive,
spastic or writhing movements, or twitching.

Tremor (shaking)

Blurry vision, eye infection or "pink eye"

Sore throat, cough, nosebleeds, stuffy nose

Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion,
dry mouth, toothache

Rash, skin redness

Muscle spasms, bone or muscle ache, back pain, joint pain

Incontinence (lack of control) of urine

Rapid heart rate, high blood pressure, shortness of breath

Risperidone can raise your levels of a hormone called "prolactin" found on a blood test (which may
or may not cause symptoms). When symptoms of high prolactin occur, they may include in men
breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction. In women
they may include breast discomfort, leakage of milk from the breasts, missed menstrual periods,
or other problems with your cycle

Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain

Fall.

Very rare (affects less than 1 user in 10,000):

Life threatening complications of uncontrolled diabetes

Serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing

Lack of bowel muscle movement that causes blockage.
The following side effect has been seen with the use of another medicine called paliperidone that is very
similar to risperidone, so this can also be expected with risperidone: Rapid heartbeat upon standing.
Additional side effects in children and adolescents
In general, side effects in children are expected to be similar to those in adults.The following side effects
were reported more often in children and adolescents (5 to 17 years) than in adults: feeling sleepy or
less alert, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal
congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhoea, and incontinence (lack
of control) of urine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via the UK Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Risperidone Sugar Free Oral
Solution:
Keep out of the reach and sight of children.
Do not use the solution after the expiry date printed on the carton and bottle label. The expiry date
refers to the last day of that month. Once opened do not use the solution for longer than 4 months.
Store in the original package.
Do not throw away any medicines 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. Contents of the pack and other information:
What Risperidone Sugar Free Oral Solution contains
The active substance is risperidone. Risperidone Sugar Free Oral Solution contains 1 mg of risperidone
per millilitre (ml). The other ingredients are tartaric acid (E334), benzoic acid (E210), hydrochloric acid
concentrated (for pH adjustment) and water.
What Risperidone Sugar Free Oral Solution looks like and contents of the pack
Risperidone Sugar Free Oral Solution is a clear, colourless solution. It is available in bottles containing
30 ml, 60 ml, 100 ml and 120 ml; not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Chanelle Healthcare Ltd., Loughrea, Co. Galway, Ireland.
The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.
The distributor is Chanelle Medical UK Ltd.
This leaflet was last approved in 11/2014.

LE4198

Uncommon (affects 1 to 10 users in 1000):

Stomach or intestinal infection, stool incontinence, very hard stool, difficulty swallowing, excessive
passing of gas or wind

Diabetes or worsening diabetes, high blood sugar, excessive drinking of water

Infection of the breathing passages, bladder infection, eye infection, tonsillitis, fungal infection of
the nail, infection of the skin, an infection confined to a single area of skin or part of the body,
skin infection causes by mites

Decrease in the type of white blood cells that help to protect you against infection, White blood cell
count decreased, decrease in platelets (blood cells that help you stop bleeding), anemia, decrease
in red blood cells, increase in eosinophils (a type of white blood cell) in your blood

Allergic reaction

Weight loss, loss of appetite resulting in malnutrition and low body weight

Increased cholesterol in your blood

Tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or
other parts of your body). Tell your doctor immediately if you experience involuntary rhythmic
movements of the tongue, mouth and face. Withdrawal of Risperidone Oral Solution may be needed,

Sudden loss of blood supply to brain (stroke or "mini" stroke)

Atrial fibrillation (an abnormal heart rhythm), an interruption in conduction between the upper and
lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT
interval from your heart, slow heart rate, abnormal electrical tracing of the heart (electrocardiogram
or ECG), a fluttering or pounding feeling in your chest (palpitations)

Low blood pressure, low blood pressure upon standing (consequently, some people taking
Risperidone Sugar Free Oral Solution may feel faint, dizzy, or may pass out when they stand up or
sit up suddenly, flushing

Pneumonia caused by inhaling food, lung congestion, congestion of breathing passages, crackly
lung sounds, wheezing, voice disorder, breathing passage disorder

An increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes
released with muscle breakdown

Urinary incontinence, pain when passing urine, frequent passing of urine

Confused, elated mood (mania), decreased sexual drive, nervousness, nightmares

Hives (or "nettle rash"), itching, hair loss, thickening of skin, eczema, dry skin, skin discoloration,
acne, flaky, itchy scalp or skin, skin disorder, skin lesion

Convulsions (fits), fainting

A restless urge to move parts of your body, balance disorder, abnormal coordination, dizziness
upon standing, disturbance in attention, problems with speech, loss or abnormal sense of taste,
reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or numbness skin

Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain

Oversensitivity of the eyes to light, dry eye, increased tears, redness of the eye

Sensation of spinning (vertigo), ringing in the ears, ear pain

Erectile dysfunction, ejaculation disorder

Loss of menstrual periods, missed menstrual periods or other problems with your cycle (females),

Development of breasts in men, leakage of milk from the breasts, sexual dysfunction, breast pain,
breast discomfort, vaginal discharge

Swelling of the face, mouth, eyes, or lips

Chills, an increase in body temperature

A change in the way you walk

Feeling thirsty, feeling unwell, chest discomfort, feeling "out of sorts", discomfort

Increased liver transaminases in your blood, increased GGT (a liver enzyme called
gamma-glutamyltransferase) in your blood, increased liver enzymes in your blood

Procedural pain

Unresponsive to stimuli, loss of consciousness, low level of consciousness
Rare (affects 1 to 10 users in 10,000):

Infection

Sugar in the urine, low blood sugar, high blood triglycerides (a fat)

Neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and
severe muscle stiffness)

Blood vessel problems in the brain

Dandruff

Severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of
breath, itching, skin rash and sometimes drop in blood pressure

Dangerously excessive intake of water

Irregular heart beat

Blood clot in the legs, blood clot in the lungs

Glaucoma (increased pressure within the eyeball), problems with movement of the eye, eyelid
margin crusting, eye rolling

Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative
floppy iris syndrome (IFIS) can happen if you take or have taken Risperidone Sugar Free Oral
Solution. If you need to have cataract surgery, be sure to tell your eye doctor if you take or have
taken this medicine

Dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood,

Lack of emotion, inability to reach orgasm

Trouble breathing during sleep (sleep apnea), fast, shallow breathing

Blood vessel problems in the brain

Inappropriate secretion of a hormone that controls urine volume.

Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)

Shaking of the head

Coma due to uncontrolled diabetes

Yellowing of the skin and the eyes (jaundice)

Inflammation of the pancreas, a blockage in the bowels

Swollen tongue, chapped lips, rash on skin related to drug

A delay in menstrual periods, enlargement of the glands in your breasts, breast enlargement,
discharge from the breasts

Increased insulin (a hormone that controls blood sugar levels) in your blood

Priapism (a prolonged penile erection that may require surgical treatment)

Hardening of the skin

Decreased body temperature, a decrease in body temperature, coldness in arms and legs

Symptoms of drug withdrawal.

LE4198_RIS_PIL_300x600_v4

02.12.14

300mm x 600mm

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)