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RISPERDAL 1MG/ML ORAL SOLUTION

Active substance(s): RISPERIDONE

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Package leaŲ
Ųet: Information for the user

© J-C 2015

GB-IE - AW_103226

1 mg/ml oral solution
Risperidone
Read all of this leaŲ
Ųet carefully
before you start taking this medicine
because it contains important
information for you.

• Keep this leaŲŲet. 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 eŮ
Ůects, talk to your doctor
or pharmacist. This includes any possible side

Ůects not listed in this leaŲet. See section 4.

What is in this leaŲ
Ųet:
1 What Risperdal is and what it is used for
2 What you need to know before you take
Risperdal
3 How to take Risperdal
4 Possible side eŮ
Ůects
5 How to store Risperdal
6 Contents of the pack and other
information

1 What Risperdal is and what it is used for
Risperdal belongs to a group of medicines
called ‘anti-psychotics’.
Risperdal 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
hyperactive.
Mania occurs in an illness called “bipolar
disorder”

• Short-term treatment (up to 6 weeks) of longterm 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 longterm 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.

2 What you need to know before you take Risperdal
Do not 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Risperdal 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. Risperdal
may cause low blood pressure. Your dose may
need to be adjusted
• You know of any factors which would favour
you having a stroke, such as high blood
pressure, cardiovascular disorder or blood
vessel problems in the brain
• You have ever experienced involuntary
movements of the tongue, mouth and face
• You have ever had a condition whose symptoms
include high temperature, muscle stiŮ
Ůness,
sweating or a lowered level of consciousness
(also known as Neuroleptic Malignant Syndrome)
• 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
• 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 possible prolactin-dependent tumour.
• You or someone else in your family has
a history of blood clots, as antipsychotics have
been associated with formation of blood clots.
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist before
using Risperdal.
As dangerously low numbers of a certain type
of white blood cell needed to Űght infection in
your blood has been seen very rarely with
patients taking Risperdal, your doctor may check
your white blood cell counts.
Risperdal may cause you to gain weight. SigniŰŰcant
weight gain may adversely aŮ
Ůect 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 eŮ
Ůects
such as menstrual disorders or fertility problems
in women, breast swelling in men (see Possible
side eŮ
Ůects). If such side eŮects 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 Ųoppy 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 diů
ůculties.
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 eŮ
Ůect of the drug or due to
some other reason is not known.

Other medicines and Risperdal

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 eŮ
Ůect 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.
Risperdal 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 Ųuid (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.

The following medicines may reduce
the eŮ
Ůect 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 diŮ
Ůerent dose of risperidone.

The following medicines may
increase the eŮ
Ůect of risperidone

• Quinidine (used for certain types of heart
disease)
• Antidepressants such as paroxetine, Ųuoxetine,
tricyclic antidepressants
• Medicines known as beta blockers (used to treat
high blood pressure)
• Phenothiazines (such as medicines used to treat
psychosis or to calm down)
• Cimetidine, ranitidine (blockers of the acidity
of stomach)
• Itraconazole and ketoconazole (medicines for
treating fungal infections)
• Certain medicines used in the treatment of
HIV/AIDS, such as ritonavir
• Verapamil, a medicine used to treat high blood
pressure and/or abnormal heart rhythm.
• Sertraline and Ųuvoxamine, medicines used to
treat depression and other psychiatric disorders.
If you start or stop taking such medicines you
may need a diŮ
Ůerent 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.

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

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 Risperdal in
the last trimester (last three months of their
pregnancy): shaking, muscle stiŮ
Ůness, and/or
weakness, sleepiness, agitation, breathing
problems, and diů
ůculty in feeding. If your baby
develops any of these symptoms you may
need to contact your doctor.
• Risperdal can raise your levels of a hormone
called “prolactin” that may impact fertility
(see Possible side eŮ
Ůects).

Driving and using machines

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 Űrst.

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:
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 to
6 mg
• This total daily dose can be divided into either
one or two doses a day. Your doctor will tell
you which is the best for you.
Elderly people
• Your starting dose will normally be 0.5 mg
twice a day
• Your dose may then be gradually increased by
your doctor to 1 mg to 2 mg twice a day
• Your doctor will tell you which is the best for
you.

For the treatment of mania

Adults
• Your starting dose will usually be 2 mg once
a day
• Your dose may then be gradually adjusted by
your doctor depending on how you respond to
the treatment
• Most people feel better with doses of 1 to 6 mg
once a day.

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.

Method of administration
For oral use.

Risperdal oral solution

The solution comes with a syringe (pipette).
This should be used to help you measure the
exact amount of medicine you need.
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.

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.

Use in children and adolescents

• Children and adolescents under 18 years old
should not be treated with Risperdal 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 Risperdal for conduct disorder.

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 Űts.

If you forget to take Risperdal

• 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 Risperdal

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.

© J-C 2015

GB-IE - AW_103226

4 Possible side eŮ
Ůects
Like all medicines, this medicine can cause side

Ůects, 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 diů
ůculty 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 stiŮ
Ůness, 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 eŮ
Ůects may happen:
Very Common (may aŮ
Ůect more than 1 in
10 people):
• Diů
ůculty falling or staying asleep
• Parkinsonism: This condition may include: slow
or impaired movement, sensation of stiŮ
Ůness
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 shuű
űing 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.
Common (may aŮ
Ůect 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 Ųu
• 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, diů
ůculty 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
• Sleep disorder, Irritability, Depression, Anxiety,
Restlessness
• 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”
• Rapid heart rate, High blood pressure,
Shortness of breath
• Sore throat, Cough, Nosebleeds, StuŮ
Ůy 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
• Fall.
Uncommon (may aŮ
Ůect up to 1 in 100 people):
• Infection of the breathing passages, Bladder
infection, ‘Eye infection, Tonsillitis, Fungal
infection of the nails, Infection of the skin,
An infection conŰŰned to a single area of skin
or part of the body, Viral infection,
Skin inŲŲammation 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 Risperdal 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 (ŰŰts), 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 Űbrillation (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 Ųuttering or
pounding feeling in your chest (palpitations)

• Low blood pressure, Low blood pressure upon
standing (consequently, some people taking
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, Diů
ůculty
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 stiŮ
Ůness, 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 gammaglutamyltransferase) in your blood, Increased
liver enzymes in your blood
• Procedural pain.
Rare (may aŮ
Ůect up to 1 in 1,000 people):
• 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 stiŮ
Ůness)
• 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 Ųoppy 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 Űght 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
• Dangerously excessive intake of water
• Irregular heart beat
• Blood clot in the legs, Blood clot in the lungs
• Trouble breathing during sleep (sleep apnea),
Fast, shallow breathing
• InŲŲammation of the pancreas, A blockage in
the bowels
• Swollen tongue, Chapped lips, Rash on skin
related to drug
• DandruŮ
• Breakdown of muscle Űbers and pain in
muscles (rhabdomyolysis)
• 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, Coldness in
arms and legs
• Symptoms of drug withdrawal
• Yellowing of the skin and the eyes (jaundice).
Very rare (may aŮ
Ůect up to 1 in 10,000 people):
• Life threatening complications of uncontrolled
diabetes.
• Serious allergic reaction with swelling that
may involve the throat and lead to diů
ůculty
breathing.
• Lack of bowel muscle movement that causes
blockage.
The following side eŮ
Ůect 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 eŮ
Ůects in children and
adolescents
In general, side eŮ
Ůects in children are expected
to be similar to those in adults.
The following side eŮ
Ůects 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 eŮ
Ůects

If you get any side eŮ
Ůects, talk to your doctor
or pharmacist. This includes any possible side

Ůects not listed in this leaŲet. You can also
report side eŮ
Ůects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
g
y
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
p
e-mail: medsafety@hpra.ie
By reporting side eŮ
Ůects you can help provide
more information on the safety of this medicine.

5 How to store Risperdal
Keep this medicine out of the sight and reach
of children.
Do
not use
usethis
thismedicine
medicineafter
afterthe
the
expiry
date
Do not
expiry
date
which
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orfoil,
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The expiry
or
bottle.
expiry
dateofrefers
to the last day
date
refersThe
to the
last day
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of
Dothat
not month.
store above 30°C.
Do
not freeze.
store above 30°C.
Do not
Do
not
Store
infreeze.
the original package in order to protect
Store in the original package in order to protect
from light and moisture.
from light and moisture.

Once the bottle is opened, any unused portion
of Risperdal oral solution should be discarded
after 3 months.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6 Contents of the pack and other information
What Risperdal contains

The active substance is risperidone
1 ml oral solution contains 1 mg risperidone.
The other ingredients are:
Tartaric acid, Benzoic acid, Sodium hydroxide,
PuriŰŰed water

What Risperdal looks like and contents
of the pack
Risperdal oral solution is supplied in an amber
bottle with a child-resistant cap containing 30 ml,
60 ml, 100 ml or 120 ml of a clear, colourless
liquid. A dosing pipette is also provided.
The pipette supplied with the bottle size of 30 ml,
60 ml and 100 ml is graduated in milligrams and
milliliters with a minimum volume of 0.25 ml and
a maximum volume of 3 ml. Graduation marks in
0.25 ml (equals 0.25 mg oral solution)
increments up to 3 ml (equals 3 mg oral solution)
are printed on this pipette.
The pipette supplied with the bottle size of 120 ml
is graduated in milligrams and milliliters with
a minimum volume of 0.25 ml and a maximum
volume of 4 ml. Graduation marks in 0.25 ml
(equals 0.25 mg oral solution) increments up to
4 ml (equals 4 mg oral solution) are printed on
this pipette.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The marketing authorization is held by:
Janssen-Cilag Ltd., 50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire, HP12 4EG,
UK
Risperdal 1 mg/ml oral solution is made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Road, Banbury,
OX16 4RS, UK

This medicinal product is authorised in the
Member States of the EEA under the
following names:
Risperdal / Risperdal® Quicklet
RISPERDAL / RISPERDAL
Instasolv
Cyprus:
RISPERDAL
Czech Republic: RISPERDAL
Denmark:
RISPERDAL
Estonia:
RISPOLEPT
Finland:
RISPERDAL / RISPERDAL
INSTASOLV
France:
RISPERDAL /
RISPERDALORO
Germany:
RISPERDAL 1mg; 2mg; 3mg;
4mg / Risperdal Filmtabletten
0,5mg; 6mg / RISPERDAL
QUICKLET 0,5 mg
Schmelztabletten / RISPERDAL
QUICKLET 1mg; 2mg, 3mg;
4mg/ Risperdal Lösung 1mg/ml
Greece:
RISPERDAL / RISPERDAL
QUICKLET
Hungary:
RISPERDAL
Iceland:
RISPERDAL
Ireland:
RISPERDAL / RISPERDAL
Quicklet
Italy:
RISPERDAL
Lithuania:
RISPOLEPT
Latvia:
RISPOLEPT / RISPERDAL
Quicklet
Luxembourg:
RISPERDAL RISPERDAL
Instasolv
Malta:
RISPERDAL
Netherlands:
RISPERDAL / RISPERDAL
Quicklet
Norway:
RISPERDAL / RISPERDAL
smeltetabletter
Poland:
RISPOLEPT
Portugal:
RISPERDAL / RISPERDAL
QUICKLET
Romania:
RISPOLEPT
Slovenia:
RISPERDAL
Spain:
RISPERDAL / RISPERDAL
FLAS
Sweden:
RISPERDAL
United Kingdom: RISPERDAL / RISPERDAL
Quicklet
Austria:
Belgium:

This leaŲ
Ųet was last revised in 05/2015

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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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