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RISPERIDONE 1MG/ML LIQUID

Active substance(s): RISPERIDONE

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S548 LEAFLET Risperdal 20150915





Low blood pressure, Low blood pressure upon standing
(consequently, some people taking Risperdal 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





Stomach or intestinal infection, Stool incontinence, Very hard
stool, Difficulty swallowing, Excessive passing of gas or win



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



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



Abnormal posture, Joint stiffness, Joint swelling, Muscle
weakness, Neck pain



Frequent passing of urine, Inability to pass urine, Pain when
passing urine



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



S548 LEAFLET Risperdal 20150915

Very rare (may affect up to 1 in 10,000 people):

Procedural pain.



Life threatening complications of uncontrolled diabetes.



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

The following side effect has been seen with the use of another
medicine called paliperidone that is very similar to risperidone, so
these can also be expected with Risperdal: 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.

Infection



Inappropriate secretion of a hormone that controls urine volume



Sugar in the urine, Low blood sugar, High blood triglycerides (a
fat)



Lack of emotion, Inability to reach orgasm



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



Blood vessel problems in the brain



Coma due to uncontrolled diabetes



Shaking of the head



Glaucoma (increased pressure within the eyeball), Problems
with movement of your eyes, Eye rolling, Eyelid margin crusting



Eye problems during cataract surgery. During cataract surgery,
a condition called intraoperative floppy iris syndrome (IFIS) can
happen if you take or have taken Risperdal. 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,



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

How to store Risperdal
Contents of the pack and other Information

5

How to store Risperdal

1

What Risperdal is and what it is used for



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Risperdal belongs to a group of medicines called ‘anti-psychotics’.



Do not store above 30°C. Do not refrigerate. Use within 3
months of first opening.

Risperdal is used to treat the following:



Do not use after the expiry date printed on the carton or bottle
label. In addition, the liquid should not be used for longer than 3
months after the bottle has first been opened



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

Risperdal can help alleviate the symptoms of your disease and stop
your symptoms from coming back.

Contents of the pack and other information
2



Risperdal Liquid contains active ingredient risperidone. Each ml
of the oral solution contains 1mg risperidone.

Do not take Risperdal:



Risperdal Liquid also contains the following inactive ingredients:
tartaric acid, benzoic acid, sodium hydroxide and purified water.



What you need to know before you take Risperdal
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 Risperdal.

What Risperdal looks like and contents of the pack

Risperdal 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 Risperdal, your doctor should
check for signs of high blood sugar. In patients with pre-existing
diabetes mellitus blood glucose should be monitored regularly.
Risperdal commonly raises levels of a hormone called “prolactin”.
This may cause side effects such as menstrual disorders or fertility
problems in women, breast swelling in men (see Possible side
effects). If such side effects occur, evaluation of the prolactin level
in the blood is recommended.
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 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.
Before treatment is started your, or your child’s body weight may be
measured and it may be regularly monitored during treatment.
A small and inconclusive study has reported an increase in height in
children who took risperidone, but whether this is an effect of the
drug or due to some other reason is not known.



Risperdal Liquid is a clear colourless solution in an amber bottle
with tamper evident cap supplied with a dosing pipette .

Warnings and precautions
Talk to your doctor or pharmacist before taking Risperdal if:

Other medicines and Risperdal



Risperdal Liquid is available in bottles containing 100 ml.



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. Risperdal may cause
low blood pressure. Your dose may need to be adjusted

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.



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

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





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)

Medicines that may change the electrical activity of your heart,
such as medicines for malaria, heart rhythm problems, allergies
(anti-histamines), some antidepressants or other medicines for
mental problems



Medicines that cause a slow heart beat



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)

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



Medicines to treat raised blood pressure. Risperdal can lower
blood pressure



You are diabetic



Medicines for Parkinson’s disease (such as levodopa)



You have epilepsy





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

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). Risperdal taken by itself or with
furosemide, may have an increased risk of stroke or death in
elderly people with dementia.

Swollen tongue, Chapped lips, Rash on skin related to drug

Manufacturer



Dandruff



Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis)

This product is manufactured by Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium.
And



A delay in menstrual periods, Enlargement of the glands in your
breasts, Breast enlargement, Discharge from the breasts

Janssen-Cliag S.A., Paseo de Las Doce Estrellas 5-7, 28042 Marid,
Spain.

Yellowing of the skin and the eyes (jaundice).



What Risperdal contains



Symptoms of drug withdrawal

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.

6

Inflammation of the pancreas, A blockage in the bowels





5





You or someone else in your family has a history of blood clots,
as antipsychotics have been associated with formation of blood
clots.

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 Risperdal, your doctor may check your white
blood cell counts.

By reporting side effects you can help provide more information on
the safety of this medicine.

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

Decreased body temperature, A decrease in body temperature,
Coldness in arms and legs



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.

Possible side effects





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



How to take Risperdal

Blood clot in the legs, Blood clot in the lungs

Hardening of the skin

You have liver problems



If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperdal.

4

Irregular heart beat



You have kidney problems



If you have any further questions, ask your doctor or
pharmacist.

What you need to know before you take Risperdal

6



Keep this leaflet. You may need to read it again.

3

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.

You have problems controlling your body temperature or
overheating



What Risperdal is and what it is used for







2



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

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

1





Your medicine is known as Risperdal 1mg/ml Liquid but will be
referred to as Risperdal throughout the following leaflet.

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 at:
www.mhra.gov.uk/yellowcard.

Dangerously excessive intake of water

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

(risperidone)

Reporting of side effects





RISPERDAL 1mg/ml LIQUID

What is in this leaflet:

Rare (may affect up to 1 in 1,000 people):


Lack of bowel muscle movement that causes blockage.

PACKAGE LEAFLET: INFORMATION FOR USER

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: : S & M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.

POM

PL 19488/0548

Leaflet revision date: 15 September 2015
Risperdal is a registered trade mark of Janssen-Cilag Ltd, UK.
S548 LEAFLET Risperdal 20150915

It is especially important to talk to your doctor or pharmacist if
you are taking any of the following:

S548 LEAFLET Risperdal 20150915

The following medicines may reduce the effect of risperidone

For the treatment of mania



Feeling sleepy, or less alert



Rifampicin (a medicine for treating some infections)

Adults



Headache.



Carbamazepine, phenytoin (medicines for epilepsy)



Your starting dose will usually be 2 mg once a day

 Phenobarbital
If you start or stop taking such medicines you may need a different
dose of risperidone.



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.

The following medicines may increase the effect of risperidone

Elderly people



Quinidine (used for certain types of heart disease)



Your starting dose will usually be 0.5 mg twice a day



Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants





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

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.



Phenothiazines (such as medicines used to treat psychosis or
to calm down)



Common (may affect up to 1 in 10 people):


Pneumonia, Infection of the chest (bronchitis), Common cold
symptoms, Sinus infection Urinary tract infection Ear infection,
Feeling like you have the flu



For the treatment of long-standing aggression in people with
Alzheimer’s dementia

Raised levels of a hormone called “prolactin” found in a blood
test (which may or may not cause symptoms). Symptoms of
high prolactin occur uncommonly and may include in men
breast swelling, difficulty in getting or maintaining erections,
decreased sexual desire 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 or fertility problems.



Weight gain, Increased appetite, Decreased appetite

Cimetidine, ranitidine (blockers of the acidity of stomach)

Adults (including elderly people)



Sleep disorder, Irritability, Depression, Anxiety, Restlessness



Itraconazole and ketoconazole (medicines for treating fungal
infections)



Your starting dose will normally be 0.25 mg twice a day







Certain medicines used in the treatment of HIV/AIDS, such as
ritonavir

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





Verapamil, a medicine used to treat high blood pressure and/or
abnormal heart rhythm.

Most people feel better with 0.5 mg twice a day. Some patients
may need 1 mg twice a day

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

Treatment duration in patients with Alzheimer’s dementia
should be not more than 6 weeks.



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”



Rapid heart rate, High blood pressure, Shortness of breath



Sore throat, Cough, Nosebleeds, Stuffy nose



Abdominal pain, Abdominal discomfort, Vomiting, Nausea,
Constipation, Diarrhea, Indigestion, Dry mouth, Toothache

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



Rash, Skin redness



Muscle spasms, Bone or muscle ache, Back pain, Joint pain



Incontinence (lack of control) of urine

Do not take a double dose (two doses at the same time) to
make up for a forgotten dose



Swelling of the body, arms or legs, Fever, Chest pain,
Weakness, Fatigue (tiredness), Pain



Fall.



Sertraline and fluvoxamine, medicines used to treat depression
and other psychiatric disorders.

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 Risperdal.

Use in children and adolescents


If you take more Risperdal 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
heartbeats or fits.

Children and adolescents under 18 years old should not be
treated with Risperdal for schizophrenia or mania.

Risperdal with food, drink and alcohol

For the treatment of conduct disorder
The dose will depend on your child’s weight:

If you forget to take Risperdal

You can take this medicine with or without food. You should avoid
drinking alcohol when taking Risperdal.

For children who weigh less than 50 kg



Pregnancy, breast-feeding and fertility








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.



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 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

If you stop taking Risperdal

The following symptoms may occur in newborn babies, of
mothers that have used Risperdal 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.



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.

Risperdal can raise your levels of a hormone called “prolactin”
that may impact fertility (see Possible side effects).

Children under 5 years old should not be treated with Risperdal for
conduct disorder.

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.

Treatment duration in patients with conduct disorder should be not
more than 6 weeks.

4
Driving and using machines

People with kidney or liver problems

Dizziness, tiredness, and vision problems may occur during
treatment with Risperdal. Do not drive or use any tools or machines
without talking to your doctor first.

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.

3

How to take Risperdal

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:

Risperdal oral solution

For the treatment of schizophrenia

The solution comes with a syringe (pipette).

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 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.





This should be used to help you measure the exact amount of
medicine you need.
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)

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

6. Close the bottle
7. Rinse the syringe with some water.

Your doctor will tell you which is the best for you.



Infection of the breathing passages, Bladder infection, ‘Eye
infection, Tonsillitis, Fungal infection of the nails, Infection of the
skin, An infection confined to a single area of skin or part of the
body, Viral infection, Skin inflammation caused 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



Diabetes or worsening of diabetes, High blood sugar, Excessive
drinking of water

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



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



Increased cholesterol in your blood



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

Elated mood (mania), Confusion, Decreased sexual drive,
Nervousness, Nightmares



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 Risperdal may be needed,



Experience fever, muscle stiffness, sweating or a lowered level
of consciousness (a disorder called “Neuroleptic Malignant
Syndrome”). Immediate medical treatment may be needed



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



Are a man and experience prolonged or painful erection. This is
called priapism. Immediate medical treatment may be needed



Unresponsive to stimuli, Loss of consciousness, Low level of
consciousness



Experience involuntary rhythmic movements of the tongue,
mouth and face. Withdrawal of risperidone may be needed



Convulsion (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



Oversensitivity of the eyes to light, Dry eye, Increased tears,
Redness of the eyes



Sensation of spinning (vertigo), Ringing in the ears, Ear pain



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)

Follow these steps:

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

Elderly people

Tell your doctor immediately if you:

Method of administration
For oral use.



Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



Uncommon (may affect up to 1 in 100 people):



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 (may affect more than 1 in 10 people):



Difficulty falling or staying asleep
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.

S548 LEAFLET Risperidone 20150915





Low blood pressure, Low blood pressure upon standing
(consequently, some people taking Risperidone Liquid 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





Stomach or intestinal infection, Stool incontinence, Very hard
stool, Difficulty swallowing, Excessive passing of gas or win



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



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



Abnormal posture, Joint stiffness, Joint swelling, Muscle
weakness, Neck pain



Frequent passing of urine, Inability to pass urine, Pain when
passing urine



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



S548 LEAFLET Risperidone 20150915

Very rare (may affect up to 1 in 10,000 people):

Procedural pain.



Life threatening complications of uncontrolled diabetes.



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

The following side effect has been seen with the use of another
medicine called paliperidone that is very similar to risperidone, so
these can also be expected with Risperidone Liquid: 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.

Infection



Inappropriate secretion of a hormone that controls urine volume



Sugar in the urine, Low blood sugar, High blood triglycerides (a
fat)



Lack of emotion, Inability to reach orgasm



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



Blood vessel problems in the brain



Coma due to uncontrolled diabetes



Shaking of the head



Glaucoma (increased pressure within the eyeball), Problems
with movement of your eyes, Eye rolling, Eyelid margin crusting



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 Liquid. If you
need to have cataract surgery, be sure to tell your eye doctor if
you take or have taken this medicine.

RISPERIDONE 1mg/ml LIQUID
(risperidone)
Your medicine is known as Risperidone 1mg/ml Liquid but will be
referred to as Risperidone throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



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.

How to take Risperidone Liquid

4

Possible side effects

By reporting side effects you can help provide more information on
the safety of this medicine.

5

How to store Risperidone Liquid

6

Contents of the pack and other Information

5

How to store Risperidone Liquid

1

What Risperidone Liquid is and what it is used for



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Do not refrigerate. Use within 3
months of first opening.

Risperidone Liquid belongs to a group of medicines called ‘antipsychotics’.
Risperidone Liquid is used to treat the following:



Do not use after the expiry date printed on the carton or bottle
label. In addition, the liquid should not be used for longer than 3
months after the bottle has first been opened



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



Risperidone Liquid contains active ingredient risperidone. Each
ml of the oral solution contains 1mg risperidone.



Risperidone Liquid also contains the following inactive
ingredients: tartaric acid, benzoic acid, sodium hydroxide and
purified water.



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



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

What Risperidone Liquid looks like and contents of the pack




Risperidone Liquid is a clear colourless solution in an amber
bottle with tamper evident cap supplied with a dosing pipette.

Dangerously excessive intake of water





Risperidone Liquid is available in bottles containing 100 ml.

Irregular heart beat



Blood clot in the legs, Blood clot in the lungs

Product Licence holder



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



Inflammation of the pancreas, A blockage in the bowels

Procured from within the EU and repackaged by the Product
Licence holder: : S & M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.



Swollen tongue, Chapped lips, Rash on skin related to drug



Dandruff

Manufacturer



Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis)



A delay in menstrual periods, Enlargement of the glands in your
breasts, Breast enlargement, Discharge from the breasts



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 Liquid 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 Liquid

Do not take Risperidone Liquid:


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 Liquid.

Talk to your doctor or pharmacist before taking Risperidone Liquid
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 Liquid
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

This product is manufactured by Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium.



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

And



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)

Janssen-Cliag S.A., Paseo de Las Doce Estrellas 5-7, 28042 Marid,
Spain.

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



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

POM



Hardening of the skin

Leaflet revision date: 15 September 2015



Decreased body temperature, A decrease in body temperature,
Coldness in arms and legs



Symptoms of drug withdrawal



Yellowing of the skin and the eyes (jaundice).

PL 19488/0548

S548 LEAFLET Risperidone Liquid 20150915

Risperidone Liquid 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 Liquid, your doctor
should check for signs of high blood sugar. In patients with preexisting diabetes mellitus blood glucose should be monitored
regularly.
Risperidone Liquid commonly raises levels of a hormo ne called
“prolactin”. This may cause side effects such as menstrual
disorders or fertility problems in women, breast swelling in men (see
Possible side effects). If such side effects occur, evaluation of the
prolactin level in the blood is recommended.
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 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.
Before treatment is started your, or your child’s body weight may be
measured and it may be regularly monitored during treatment.
A small and inconclusive study has reported an increase in height in
children who took risperidone, but whether this is an effect of the
drug or due to some other reason is not known.

Warnings and precautions





You or someone else in your family has a history of blood clots,
as antipsychotics have been associated with formation of blood
clots.

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 Liquid, your doctor may check your
white blood cell counts.

What you need to know before you take Risperidone Liquid

What Risperidone Liquid contains



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.

3

Contents of the pack and other information

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



What Risperidone Liquid is and what it is used for

6

You have liver problems



If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Risperidone Liquid.

2

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.

You have kidney problems



If you have any further questions, ask your doctor or
pharmacist.

1





Keep this leaflet. You may need to read it again.

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 at:
www.mhra.gov.uk/yellowcard.

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

You have problems controlling your body temperature or
overheating



Reporting of side effects







What is in this leaflet:

Rare (may affect up to 1 in 1,000 people):


Lack of bowel muscle movement that causes blockage.

PACKAGE LEAFLET: INFORMATION FOR USER



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

Other medicines and Risperidone Liquid
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, allergies
(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 raised blood pressure. Risperidone Liquid
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 Liquid taken by itself
or with furosemide, may have an increased risk of stroke or
death in elderly people with dementia.

S548 LEAFLET Risperidone 20150915

The following medicines may reduce the effect of risperidone

For the treatment of mania



Feeling sleepy, or less alert



Rifampicin (a medicine for treating some infections)

Adults



Headache.



Carbamazepine, phenytoin (medicines for epilepsy)



Your starting dose will usually be 2 mg once a day

 Phenobarbital
If you start or stop taking such medicines you may need a different
dose of risperidone.



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.

The following medicines may increase the effect of risperidone

Elderly people



Quinidine (used for certain types of heart disease)



Your starting dose will usually be 0.5 mg twice a day



Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants





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

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.



Phenothiazines (such as medicines used to treat psychosis or
to calm down)



Common (may affect up to 1 in 10 people):


Pneumonia, Infection of the chest (bronchitis), Common cold
symptoms, Sinus infection Urinary tract infection Ear infection,
Feeling like you have the flu



For the treatment of long-standing aggression in people with
Alzheimer’s dementia

Raised levels of a hormone called “prolactin” found in a blood
test (which may or may not cause symptoms). Symptoms of
high prolactin occur uncommonly and may include in men
breast swelling, difficulty in getting or maintaining erections,
decreased sexual desire 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 or fertility problems.



Weight gain, Increased appetite, Decreased appetite

Cimetidine, ranitidine (blockers of the acidity of stomach)

Adults (including elderly people)



Sleep disorder, Irritability, Depression, Anxiety, Restlessness



Itraconazole and ketoconazole (medicines for treating fungal
infections)



Your starting dose will normally be 0.25 mg twice a day







Certain medicines used in the treatment of HIV/AIDS, such as
ritonavir

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





Verapamil, a medicine used to treat high blood pressure and/or
abnormal heart rhythm.

Most people feel better with 0.5 mg twice a day. Some patients
may need 1 mg twice a day

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

Treatment duration in patients with Alzheimer’s dementia
should be not more than 6 weeks.



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”



Rapid heart rate, High blood pressure, Shortness of breath



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



Swelling of the body, arms or legs, Fever, Chest pain,
Weakness, Fatigue (tiredness), Pain

If you stop taking Risperidone Liquid



Fall.

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.

Uncommon (may affect up to 1 in 100 people):



Sertraline and fluvoxamine, medicines used to treat depression
and other psychiatric disorders.

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 Liquid.

Use in children and adolescents


Risperidone Liquid with food, drink and alcohol
You can take this medicine with or without food. You should avoid
drinking alcohol when taking Risperidone Liquid.

For children who weigh less than 50 kg





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
heartbeats or fits.

Children and adolescents under 18 years old should not be
treated with Risperidone Liquid for schizophrenia or mania.

For the treatment of conduct disorder
The dose will depend on your child’s weight:

Pregnancy, breast-feeding and fertility

If you take more Risperidone Liquid than you should



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.

If you forget to take Risperidone Liquid




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 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 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 following symptoms may occur in newborn babies, of
mothers that have used Risperidone Liquid 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.



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.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Risperidone Liquid can raise your levels of a hormone called
“prolactin” that may impact fertility (see Possible side effects).

Children under 5 years old should not be treated with Risperidone
Liquid for conduct disorder.

4

Driving and using machines

People with kidney or liver problems

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Dizziness, tiredness, and vision problems may occur during
treatment with Risperidone Liquid. Do not drive or use any tools or
machines without talking to your doctor first.

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.





3

How to take Risperidone Liquid

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Method of administration
For oral use.

The recommended dose is as follows:

Risperidone Liquid oral solution

For the treatment of schizophrenia

The solution comes with a syringe (pipette).

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 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.




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

1. Remove the child-proof cap. Push the plastic screw cap down
while turning it counter clockwise (Figure 1)



Are a man and experience prolonged or painful erection. This is
called priapism. Immediate medical treatment may be needed

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)

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.

Follow these steps:

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

6. Close the bottle
7. Rinse the syringe with some water.

Your doctor will tell you which is the best for 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



This should be used to help you measure the exact amount of
medicine you need.

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

Elderly people




Infection of the breathing passages, Bladder infection, ‘Eye
infection, Tonsillitis, Fungal infection of the nails, Infection of the
skin, An infection confined to a single area of skin or part of the
body, Viral infection, Skin inflammation caused 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



Diabetes or worsening of diabetes, High blood sugar, Excessive
drinking of water



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



Increased cholesterol in your blood



Elated mood (mania), Confusion, Decreased sexual drive,
Nervousness, Nightmares



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 Liquid may be needed,



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



Unresponsive to stimuli, Loss of consciousness, Low level of
consciousness



Convulsion (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



Oversensitivity of the eyes to light, Dry eye, Increased tears,
Redness of the eyes



Sensation of spinning (vertigo), Ringing in the ears, Ear pain



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)

Possible side effects

Tell your doctor immediately if you:




The following side effects may happen:
Very Common (may affect more than 1 in 10 people):


Difficulty falling or staying asleep



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.

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.

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