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RISPERDAL CONSTA 37.5 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INTRAMUSCULAR INJEC

Active substance(s): RISPERIDONE

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Page 1

Page 4

• Inflammation of the pancreas, a blockage in
the bowels
• Very hard stool
• Rash on skin-related to drug
• Hives (or "nettle rash"), thickening of skin,
dandruff, skin disorder, skin lesion
• Breakdown of muscle fibers and pain in
muscles (rhabdomyolysis)
• Abnormal posture
• Breast enlargement, discharge from the
breasts
• Decreased body temperature, discomfort
• Yellowing of the skin and the eyes
(jaundice)
• 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
• Increased insulin (a hormone that controls
blood sugar levels) in your blood
• Blood vessel problems in the brain
• Unresponsive to stimuli
• Coma due to uncontrolled diabetes
• Sudden loss of vision or blindness
• Glaucoma (increased pressure within the
eyeball), eyelid margin crusting
• Flushing, swollen tongue
• Chapped lips
• Priapism (a prolonged penile erection that
may require surgical treatment)
• Enlargement of the glands in your breasts
• A decrease in body temperature, coldness
in arms and legs
• Symptoms of drug withdrawal.
Very rare side effects (may affect 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 difficulty
breathing
• Lack of bowel muscle movement that
causes blockage.

What Risperdal Consta looks like and
contents of the pack
• One vial containing the powder for
prolonged–release suspension for injection
(within this powder is the active substance,
risperidone). One syringe filled with 2 ml of
clear, colourless liquid to be added to the
powder for prolonged–release suspension
for injection.
• One Alaris™ SmartSite Needle-Free Vial
for reconstitution
• Two needles for intramuscular injection
(a 21G UTW 1-inch (0.8 mm x 25 mm)
safety needle with Needle-Protection safety
device for deltoid administration and a
20G TW 2-inch (0.9 mm x 50 mm) safety
needle with Needle-protection safety device
for gluteal administration).

T06614

Risperdal® Consta® 25, 37.5 and 50 mg powder and solvent for
prolonged-release suspension for intramuscular injection
(risperidone)

Patient Information Leaflet
This medicine is available using the above name
but will be referred to as Risperdal Consta
throughout the Patient Information Leaflet.
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

Manufacturer and Product Licence Holder
This product is manufactured by Janssen
Pharmaceutica NV, Turnhoutseweg 30, B-2340,
Beerse, Belgium. It is procured from within the
EU by the Product Licence Holder: Swinghope
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS, UK.

POM

What is in this leaflet
1. What Risperdal Consta is and what it is
used for
2. What you need to know before you use
Risperdal Consta
3. How to use Risperdal Consta
4. Possible side effects
5. How to store Risperdal Consta
6. Contents of the pack and other
information

PL No:10380/1599 Risperdal Consta 25 mg
PL No:10380/1596 Risperdal Consta 37.5 mg
PL No:10380/1600 Risperdal Consta 50 mg
Leaflet revision date: 09/06/2016
Risperdal Consta is registered trademark of
Johnson & Johnson., USA.
®

1. What Risperdal Consta is and what
it is used for
Risperdal Consta belongs to a group of
medicines called ‘anti-psychotics’.
Risperdal Consta is used to maintain the
treatment of 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.

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 Consta: Rapid
heartbeat upon standing.

Risperdal Consta is intended for patients who
are currently treated with oral (e.g. tablets,
capsules) antipsychotics.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme
via
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

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

2. What you need to know before you
use Risperdal Consta

5. How to store Risperdal Consta

Do not use Risperdal Consta
• If you are allergic to risperidone or any of
the other ingredients of this medicine
(listed in section 6).

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.
Store in refrigerator (2-8°C).
Protect from light.
If refrigeration is unavailable; store at a
temperature not exceeding 25°C for no more
than 7 days prior to administration.
After reconstitution: Do not store above 25°C
and use within 6 hours.
Store in the original package.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you no
longer use. These measures will help to protect
the environment.

Warnings and precautions
• If you have never taken any form of
Risperdal, you should begin with oral
Risperdal before beginning treatment with
Risperdal Consta.
Talk to your doctor or pharmacist before using
Risperdal Consta 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 Consta 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
circulation disorders of 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 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 have ever had a
prolonged or painful erection.
• You have difficulty controlling body
temperature or overheating
• You have kidney problems
• You have liver problems

6. Contents of the pack and other
information
What Risperdal Consta contains
Each Risperdal Consta powder and solvent for
prolonged-release suspension for injection
contains either 25 mg, 37.5 mg or 50 mg of
risperidone.
Other ingredients are:
poly-(D,1-lactide-co-glycolide).
Solvent (solution)

Fold

Polysorbate 20, carmellose sodium, sodium
phosphate dihydrate, Citric acid anhydrous,
Sodium chloride, Sodium hydroxide, Water for
injection.

• 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 medicines like
these 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 or Risperdal Consta.
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
using Risperdal Consta, your doctor may check
your white blood cell counts.
Even if you have previously tolerated oral
risperidone, rarely allergic reactions occur after
receiving injections of Risperdal Consta. Seek
medical attention right away if you experience a
rash, swelling of your throat, itching, or problems
breathing as these may be signs of a serious
allergic reaction.
Risperdal Consta 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 Consta 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 using this
medicine.
Elderly with dementia
Risperdal Consta is not for use in elderly people
with dementia.
Medical treatment should be sought straight
away if you or your carer 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.
People with kidney or liver problems
Although oral risperidone has been studied,
Risperdal Consta has not been studied in
patients with kidney or liver problems. Risperdal
Consta should be administered with caution in
this patient group.
Other medicines and Risperdal Consta
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 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

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Page 2

The following medicines may reduce the
effect of risperidone
• Rifampicin (a medicine for treating some
infections)
• Carbamazepine, phenytoin (medicines for
epilepsy)
• Phenobarbital
If you start or stop taking such medicines you
may need a different dose of risperidone.
The following medicines may increase the
effect of risperidone
• Quinidine (used for certain types of heart
disease)
• Antidepressants such as paroxetine,
fluoxetines, 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 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 Consta.
Risperdal Consta with food, drink and
alcohol
You should avoid drinking alcohol when using
Risperdal Consta.
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 using this medicine.
Your doctor will decide if you can use it.
• The following symptoms may occur in
newborn babies, of mothers that have used
Risperdal Consta 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.
• Risperdal Consta can raise your levels of a
hormone called "prolactin" that may impact
fertility (see Possible side effects).
Driving and using machines
Dizziness, tiredness, and vision problems may
occur during treatment with Risperdal Consta.
Do not drive or use any tools or machines
without talking to your doctor first.
Risperdal Consta contains less than 1 mmol
sodium (23 mg) per dose, i.e., essentially
‘sodium-free’.

3. How to use Risperdal Consta
Always use this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
Risperdal Consta is given as an intramuscular
injection either in the arm or buttock every two
weeks, administered by a health care
professional. Injections should be alternated
between the right and left sides, and should not
be given intravenously.

The recommended dose is as follows

The following side effects may happen:

Adults

Very common side effects (may affect more
than 1 in 10 people)
• Common cold symptoms
• Difficulty falling or staying asleep
• Depression, anxiety
• 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.
• Headache.

Starting dose
If your daily dose of oral (e.g. tablets)
risperidone was 4 mg or less for the last two
weeks, your starting dose should be 25 mg
Risperdal Consta.
If your daily dose of oral (e.g. tablets)
risperidone was more than 4 mg for the last two
weeks, you may be given 37.5 mg Risperdal
Consta as a starting dose.
If you are currently treated with other oral
antipsychotics than risperidone, your starting
dose of Risperdal Consta will depend on your
current treatment. Your doctor will choose
Risperdal Consta 25 mg or 37.5 mg.

Common side effects (may affect up to 1 in
10 people)
• Pneumonia, infection of the chest
(bronchitis), sinus infection
• Urinary tract infection, feeling like you have
the flu, anemia
• 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.
• High blood sugar, weight gain, increased
appetite, weight loss, decreased appetite
• Sleep disorder, irritability, decreased sexual
drive, restlessness, feeling sleepy, or less
alert
• 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
• Rapid heart rate
• Low blood pressure, chest pain, high blood
pressure
• Shortness of breath, sore throat, cough,
stuffy nose
• Abdominal pain, abdominal discomfort,
vomiting, nausea, stomach or intestinal
infection,
constipation,
diarrhea,
indigestion, dry mouth, toothache
• Rash
• Muscle spasms, bone or muscle ache,
back pain, joint pain
• Incontinence (lack of control) of urine
• Erectile dysfunction
• Loss of menstrual periods
• Leakage of milk from the breasts
• Swelling of the body, arms or legs, fever,
weakness, fatigue (tiredness)
• Pain
• A reaction at the injection site, including
itching, pain or swelling
• Increased liver transaminases in your blood,
increased GGT (a liver enzyme called
gamma-glutamyltransferase) in your blood
• Fall.

Your doctor will decide on the dose of Risperdal
Consta that is right for you.
Maintenance dose
• The usual dose is 25 mg every two weeks
as an injection.
• A higher dose of 37.5 or 50 mg may be
necessary. Your doctor will decide on the
dose of Risperdal Consta that is right for
you.
• Your doctor may prescribe oral Risperdal for
the first three weeks following your first
injection.
If you are given more Risperdal Consta than
you should
• People who have been given more
Risperdal Consta than they should have
experienced the following symptoms:
sleepiness, tiredness, abnormal body
movements, problems with standing and
walking, dizziness from low blood pressure,
and abnormal heart beats. Cases of
abnormal electrical conduction in the heart
and convulsion have been reported.
• See a doctor right away.
If you stop using Risperdal Consta
You will lose the effects of the medicine.
You should not stop this medicine unless told to
do so by your doctor as your symptoms may
return. Be sure not to miss your appointments
when you are supposed to receive your
injections every two weeks. If you cannot keep
your appointment, be sure to contact your doctor
right away to discuss another date when you
can come in for your injection. If you have any
further questions on the use of this medicine,
ask your doctor or pharmacist.
Use in children and adolescents
Risperdal Consta is not for people who are
under 18 years old.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately if you:
• Experience blood clots in the veins,
especially in the legs (symptoms include
swelling, pain, and redness in the leg),
which may travel through blood vessels to
the lungs causing chest pain and difficulty
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.
Even if you have previously tolerated oral
risperidone, rarely allergic reactions occur
after receiving injections of Risperdal
Consta.

Uncommon side effects (may affect up to 1 in
100 people)
• Infection of the breathing passages,
bladder infection, ear 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, abscess under the skin
• White blood cell count decreased, decrease
in platelets (blood cells that help you stop
bleeding), decrease in red blood cells
• Allergic reaction
• Sugar in the urine, diabetes or worsening of
diabetes
• Loss of appetite resulting in malnutrition and
low body weight
• High blood triglycerides (a fat), increased
cholesterol in your blood
• Elated mood (mania), confusion, Inability to
reach orgasm, 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 Consta may be
needed.
• Sudden loss of blood supply to brain (stroke
or "mini" stroke)
• Loss 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 of skin
• Eye infection or "pink eye", 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)
• Low blood pressure upon standing
(consequently,
some
people
using
Risperdal Consta may feel faint, dizzy, or
may pass out when they stand up or sit up
suddenly)
• Fast, shallow breathing, congestion of
breathing passages, wheezing, nosebleeds
• Stool incontinence, difficulty swallowing,
excessive passing of gas or wind
• Itching, hair loss, eczema, dry skin, skin
redness, skin discoloration, acne, flaky,
itchy scalp or skin
• An
increase
of
CPK
(creatine
phosphokinase) in your blood, an enzyme
which is sometimes released with muscle
breakdown
• Joint stiffness, joint swelling, muscle
weakness, neck pain
• Frequent passing of urine, inability to pass
urine, pain when passing urine
• Ejaculation disorder, a delay in menstrual
periods, missed menstrual periods or other
problems with your cycle (females),
development of breasts in men, 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"
• Hardening of the skin
• Increased liver enzymes in your blood
• Procedural pain.
Rare side effects (may affect up to 1 in 1,000
people)
• Decrease in the type of white blood cells
that help to protect you against infection
• Inappropriate secretion of a hormone that
controls urine volume
• Low blood sugar
• Excessive drinking of water
• Lack of emotion
• Neuroleptic
malignant
syndrome
(confusion,
reduced
or
loss
of
consciousness, high fever, and severe
muscle stiffness)
• Low level of consciousness
• Shaking of the head
• Problems with movement of your eyes,
eye rolling, oversensitivity of the eyes to
light
• Eye problems during cataract surgery.
During cataract surgery, a condition called
intraoperative floppy iris syndrome (IFIS)
can happen if you use or have used
Risperdal Consta. If you need to have
cataract surgery, be sure to tell your eye
doctor if you use or have used this
medicine.
• Irregular heart beat
• Dangerously low numbers of a certain type
of white blood cell needed to fight infection
in your blood, increase in eosinophils
(a type of white blood cell) in your blood,
blood clot in the legs, blood clot in the lungs
• Trouble
breathing
during
sleep
(sleep apnea)
• Pneumonia caused by inhaling food, lung
congestion, crackly lung sounds, voice
disorder breathing passage disorder
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Fold

• Medicines that cause low blood potassium
(such as certain diuretics)
• Medicines for Parkinson's disease (such as
levodopa)
• Medicines to treat raised blood pressure.
Risperdal Consta can lower blood pressure
• 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
Consta taken by itself or with furosemide,
may have an increased risk of stroke or
death in elderly people with dementia.

FRONT PAGE
T06615

IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS

Risperdal® Consta® 25, 37.5 and 50 mg powder and solvent
for prolonged-release suspension for intramuscular
injection
(risperidone)

Important information

Connect vial adapter to vial
Place vial on a hard surface and hold by the base.
Center vial adapter over the grey rubber stopper.
Push vial adapter straight down onto vial top until it
snaps securely into place.
Do not place vial adapter on at an angle or diluent
may leak upon transfer to the vial.

RISPERDAL® CONSTA® requires close attention to these step-by-step Instructions for Use
to help ensure successful administration.
Use components provided
The components in this dose pack are specifically designed for use with RISPERDAL®
CONSTA®. RISPERDAL® CONSTA® must be reconstituted only in the diluent supplied in
the dose pack.
Do not substitute ANY components of the dose pack.
Do not store suspension after reconstitution
Administer dose as soon as possible after reconstitution to avoid settling.
Proper dosing
The entire contents of the vial must be administered to ensure intended dose of
RISPERDAL® CONSTA® is delivered.

SINGLE-USE DEVICE
Do not reuse. Medical devices require specific material characteristics to perform as
intended. These characteristics have been verified for single use only. Any attempt to
re-process the device for subsequent re-use may adversely affect the integrity of the
device or lead to deterioration in performance.
Dose pack contents

Connect prefilled syringe to vial adapter
Remove sterile blister
Remove vial adaptor from sterile blister only when
you are ready to remove the white cap from the
prefilled syringe.
Keep vial vertical to prevent leakage.
Hold base of vial and pull up on the sterile blister to
remove.
Do not shake.
Do not touch exposed luer opening on vial adapter.
This will result in contamination.
Use proper grip
Hold by white collar at the tip of the syringe.
Do not hold syringe by the glass barrel during
assembly.

Step 1. Assemble componets
Take out dose pack
Wait 30 minutes
Remove dose pack from the refrigerator and allow to
sit at room temperature for at least 30 minutes
before reconstituting.
Do not warm any other way.

Connect vial adapter to vial
Remove cap from vial
Flip off coloured cap from vial.
Wipe top of the grey stopper with an alcohol swab.
Allow to air dry.
Do not remove grey rubber stopper.

Prepare vial adapter
Hold sterile blister as shown.
Peel back and remove paper backing.
Do not remove vial adapter from blister.
Do not touch spike tip at any time. This will result in
contamination.

Remove cap
Holding the white collar, snap off the white cap.
Do not twist or cut off the white cap.
Do not touch syringe tip. This will result in
contamination.
The broken-off cap can be discarded.

BACK PAGE

Connect syringe to vial adapter
Hold vial adapter by skirt to keep stationary.
Hold syringe by white collar then insert tip into the
luer opening of the vial adapter.
Do not hold the glass syringe barrel.
This may cause the white collar to loosen or detach.
Attach the syringe to the vial adapter with a firm
clockwise twisting motion until it feels snug.
Do not over-tighten. Over-tightening may cause the
syringe tip to break.

Step 2. Reconstitute microspheres

Resuspend microspheres
Fully remove the blister pouch.
Just before injection, shake syringe vigorously
again, as some settling will have occurred.

Step 4. Inject dose

Inject diluent
Inject entire amount of diluent from syringe into the
vial.

Remove transparent needle protector
Move the needle safety device back towards the
syringe, as shown. Then hold white collar on syringe
and carefully pull the transparent needle protector
straight off.

Vial contents will now be under pressure.
Keep holding the plunger rod down with thumb.

Do not twist transparent needle protector, as the luer
connection may loosen.

Remove air bubbles
Hold syringe upright and tap gently to make any air
bubbles rise to the top.
Slowly and carefully press plunger rod upward
to remove air.

Suspend microspheres in diluent
Continuing to hold down the plunger rod, shake
vigorously for at least 10 seconds, as shown.
Check the suspension. When properly mixed, the
suspension appears uniform, thick and milky in
colour.
Microspheres will be visible in the liquid. Immediately
proceed to the next step so suspension does not
settle.

Inject
Immediately inject entire contents of syringe
intramuscularly (IM) into the gluteal or deltoid muscle
of the patient.
Gluteal injection should be made into the
upper-outer quadrant of the gluteal area.

Transfer suspension to syringe
Invert vial completely. Slowly pull plunger rod down
to withdraw entire contents from the vial into the
syringe.

Do not administer intravenously.

Secure needle in safety device
Using one hand, place needle safety device at a
45 degree angle on a hard, flat surface. Press down
with a firm, quick motion until needle is fully engaged
in safety device.
Avoid needle stick injury:
Do not use two hands.
Do not intentionally disengage or mishandle the
needle safety device.
Do not attempt to straighten the needle or engage
the safety device if the needle is bent or damaged.

Remove vial adapter
Hold white collar on the syringe and unscrew from
vial adapter.
Tear section of the vial label at the perforation.
Apply detached label to the syringe for identification
purposes.
Discard both vial and vial adapter appropriately.

Properly dispose of needles
Check to confirm needle safety device is fully
engaged.
Discard in an approved sharps container.
Also discard the unused needle provided in the dose
pack.

Step 3. Attach needle
Select appropriate needle
Choose needle based on injection location
(gluteal or deltoid).

Attach needle
Peel blister pouch open part way and use to grasp
the base of the needle, as shown.
Holding the white collar on the syringe, attach
syringe to needle luer connection with a firm
clockwise twisting motion until snug.
Do not touch needle luer opening. This will result in
contamination.

Manufacturer and Product Licence Holder
This product is manufactured by Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340,
Beerse, Belgium. It is procured from within the EU by the Product Licence Holder:
Swinghope Limited, Brandon House, Marlowe Way, Croydon CR0 4XS, UK.
POM
PL No: 10380/1599
PL No: 10380/1596
PL No: 10380/1600

Risperdal Consta 25 mg
Risperdal Consta 37.5 mg
Risperdal Consta 50 mg

Leaflet revision date: 09/06/2016
Risperdal Consta® is registered trademark of Johnson & Johnson., USA.

T06615

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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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