RISPERDAL CONSTA 25MG

Active substance: RISPERIDONE

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GB-IE - 33891C

GB-IE - 33891C

Package leaflet: Information for the user

If you are given more Risperdal Consta than
you should

Risperidone

®

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.

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

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
Risperdal Consta is intended for patients who are currently
treated with oral (e.g. tablets, capsules) antipsychotics.
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
Do not take Risperdal Consta

• If you are allergic (hypersensitive) to risperidone or any
of the other ingredients of this medicine (listed in
section 6).

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.

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®

Risperdal Consta

powder and solvent for
prolonged-release suspension
for intramuscular injection

Risperdal Consta

Risperdal Consta
25, 37.5 and 50 mg
®

• 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
• You have difficulty controlling 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 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 taking Risperdal Consta,
your doctor may check your white blood cell counts.
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.
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

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.

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
• 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.
The following medicines may reduce the effect of
risperidone
• Rifampicin (a medicine for treating some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital
If you start or stop taking such medicines you may need
a different dose of risperidone

The following medicines may increase the effect of
risperidone
• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants
• Medicines known as beta blockers (used to treat high
blood pressure)
• Phenothiazines (such as medicines used to treat
psychosis or to calm down)
• Cimetidine, ranitidine (blockers of the acidity of stomach)
If you start or stop taking such medicines you may need a
different dose of risperidone
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before using 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 taking 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.

3 How to use Risperdal Consta
Always take 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:

Adults
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.
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.

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. 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.
Tell your doctor immediately if you experience any of the
side effects above.
The following side effects may happen:
Very common side effects (affects more than 1 user
in 10):
• 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.
Common side effects (affects 1 to 10 users in 100):
• Pneumonia, Infection of the chest (bronchitis), Sinus
infection
• Urinary tract infection, Feeling like you have the flu
• Anemia
• Risperdal Consta can raise your levels of a hormone
called "prolactin" found on a blood test (which may or
may not cause symptoms). When symptoms of high
prolactin occur, they may include in men breast swelling,
difficulty in getting or maintaining erections, or other
sexual dysfunction. In women they may include breast
discomfort, leakage of milk from the breasts, missed
menstrual periods, or other problems with your cycle.
• 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.
Uncommon side effects (affects 1 to 10 users in 1000):
• Infection of the breathing passages, Bladder infection,
Ear infection
• Eye infection, Tonsillitis, Fungal infection of the nails,
• Infection of the skin, Infection, 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 taking taking 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 (affects 1 to 10 users in 10,000):
• 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 take or have taken
Risperdal Consta. If you need to have cataract surgery,
be sure to tell your eye doctor if you take or have taken
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
• 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 (affects less than 1 user in
10,000):
• Life-threatening complications of uncontrolled diabetes.
• Serious allergic reaction with swelling that may involve
the throat and lead to difficulty breathing.
• Lack of bowel muscle movement that causes blockage
The following side effect has been seen with the use of
another medicine called paliperidone that is very similar
to risperidone, so these can also be expected with
Risperdal Consta: Rapid heartbeat upon standing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet.
In the UK, you can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
In Ireland, reports may be made by following the links to
the online reporting option accessible from the IMB
homepage, or by completing the downloadable report
form also accessible from the IMB website, which may be
completed manually and submitted to the IMB via
freepost, to the following address:
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

5 How to store Risperdal Consta
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last day
of that month.
Store the entire dose pack in the refrigerator (2-8°C).
If refrigeration is unavailable, the pack can be stored at
room temperature (below 25°C) for a maximum of 7 days
before use.
Store in the original package.
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.

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Vial Access Device. Discard both the vial and vial
access device appropriately.

6 Contents of the pack and
other information
What Risperdal Consta contains

The active substance is risperidone.
Each Risperdal Consta powder and solvent for prolongedrelease suspension for injection contains either 25 mg,
37.5 mg or 50 mg of risperidone.
The other ingredients are:
Risperdal Consta Extended-Release Microspheres
[poly-(d,l-lactide-co-glycolide)].
Solvent (solution)
Polysorbate 20, Carmellose sodium, Disodium hydrogen
phosphate dihydrate, Citric acid anhydrous, Sodium
chloride, Sodium hydroxide, Water for injection.

What Risperdal Consta looks like and
contents of the pack

• One small bottle 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 Access Device
for reconstitution
• Two needles for intramuscular injection (a 21G UTW
1-inch (0.8 mm x 25 mm) safety needle with Needle-Pro
safety device for deltoid administration and a 20G TW
2-inch (0.9 mm x 50 mm) safety needle with Needle-Pro
safety device for gluteal administration).
Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation is held by:
Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
Risperdal Consta is made by:
Janssen Pharmaceutica NV
Turnhoutseweg 30, B-2340
Beerse
Belgium
or
McGregor Cory Ltd
Middleton Close
Banbury
OX16 4RS
UK
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria:
RISPERDAL® CONSTA®
Belgium:
RISPERDAL® CONSTA®/
BELIVON® CONSTA®
Bulgaria:
РИСПОЛЕПТ КОНСТА™
Cyprus:
RISPERDAL® CONSTA®
Czech Republic: RISPERDAL® CONSTA®
Denmark:
RISPERDAL® CONSTA®
Estonia:
RISPOLEPT® CONSTA®
Finland:
RISPERDAL® CONSTA®
France:
RISPERDALCONSTA® LP
Germany:
RISPERDAL CONSTA /
Risperidon-Janssen CONSTA
Greece:
RISPERDAL® CONSTA
Hungary:
RISPERDAL CONSTA
Iceland:
RISPERDAL® CONSTA®
Ireland:
RISPERDAL® CONSTA™
Italy:
RISPERDAL®
Lithuania:
RISPOLEPT® CONSTA®
Latvia:
RISPOLEPT® CONSTA®
Liechtenstein:
RISPERDAL® CONSTA®
Luxembourg:
RISPERDAL® CONSTA® /
BELIVON® CONSTA®
Malta:
RISPERDAL® CONSTA®
Netherlands:
RISPERDAL® CONSTA®
Norway:
RISPERDAL® CONSTA®
Poland:
RISPOLEPT CONSTA®
Portugal:
RISPERDAL® CONSTA®
Romania:
RISPOLEPT CONSTA®
Slovakia:
RISPERDAL® CONSTA®
Slovenia:
RISPERDAL CONSTA®
Spain:
RISPERDAL® CONSTA
Sweden:
RISPERDAL® CONSTA®
United Kingdom: RISPERDAL® CONSTA®

Risperdal Consta extended release microspheres in the vial
must be reconstituted only in the solvent in the
syringesupplied in the dose pack, and must be administered
with only the appropriate needle supplied in the dose pack
for gluteal (2-inch (50 mm) needle) or deltoid (1-inch
(25 mm) needle) administration. Do not substitute any
components in the dose pack. To assure that the intended
dose of risperidone is delivered, the full contents from the
vial must be administered. Administration of partial contents
may not deliver the intended dose of risperidone. It is
recommended to administer immediately after reconstitution.

Remove the dose pack of Risperdal Consta from the
refrigerator and allow it to come to room temperature for
approximately 30 minutes prior to reconstitution.
Contents of the dose pack:
• One small bottle 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 Access Device
for reconstitution
• Two needles for intramuscular injection (a 21G UTW
1-inch (0.8 mm x 25 mm) safety needle with Needle-Pro
safety device for deltoid administration and a 20G TW
2-inch (0.9 mm x 50 mm) safety needle with Needle-Pro
safety device for gluteal administration).
1. Flip off the plastic colored cap from the vial. Do not
remove the grey rubber stopper. Wipe the top of the grey
rubber stopper with an alcohol wipe and allow to dry.

2. Peel back the blister pouch and remove the
SmartSite® Needle-Free Vial Access Device by
holding between the white luer cap and the skirt.
Do not touch the spike tip of the access device at any
time.

3. It is very important that the SmartSite® NeedleFree Vial Access Device be placed on the vial
correctly or the diluent could leak upon transfer
to the vial.
Place the vial on a hard surface. Hold the base of the
vial. Orient the SmartSite® Needle-Free Vial Access
Device vertically over the vial so that the spike tip is at
the center of the vial’s rubber stopper.

This leaflet was last approved in 11/2013.

IMPORTANT INFORMATION FOR
HEALTHCARE PROFESSIONALS
Instructions for Needle-Free Vial Access Device
RISPERDAL CONSTA requires close attention to
the step-by-step ‘Instructions for Use’ to help
ensure successful administration and help avoid
difficulties in the use of the kit.

With a straight downward push, press the spike tip of
the the SmartSite® Needle-Free Vial Access Device
through the center of the vial’s rubber stopper until the
device securely snaps onto the vial top.
Correct
Incorrect

4. Hold the base of the vial and swab the syringe
connection point (blue circle) of the SmartSite®
Needle-Free Vial Access Device with an alcohol wipe
and allow to dry prior to attaching the syringe to the
SmartSite® Needle-Free Vial Access Device.

5. The prefilled syringe has a white tip consisting of
2 parts: a white collar and a smooth white cap. To
open the syringe, hold the syringe by the white collar
and snap off the smooth white cap (DO NOT TWIST
OR CUT OFF THE WHITE CAP). Remove the white
cap together with the rubber tip cap inside.

For all syringe assembly steps, hold the syringe only
by the white collar located at the tip of the syringe.
Be careful not to overtighten components when
assembling. Holding the white collar will help to
prevent the white collar from getting detached
and ensure a good connection to the syringe.
Overtightening connections may cause syringe
component parts to loosen from the syringe body.
6. While holding the white collar of the syringe, insert
and press the syringe tip into the blue circle of the
SmartSite® Needle-Free Vial Access Device and
twist in a clockwise motion to secure the connection
of the syringe to the SmartSite® Needle-Free Vial
Access Device (avoid over tightening).
Hold the skirt of the vial access
device during attachment to prevent it
from spinning.
Keep the syringe and the SmartSite®
Needle-Free Vial Access Device aligned.
7. Inject the entire contents of the syringe containing the
solvent into the vial.

8. Shake the vial VIGOROUSLY while holding the
plunger rod down with the thumb for a minimum of
10 seconds to ensure a homogeneous suspension.
When properly mixed, the suspension appears
uniform, thick, and milky in colour. The microspheres
will be visible in liquid, but no dry microspheres remain.

DO NOT STORE THE VIAL AFTER
RECONSTITUTION OR THE SUSPENSION
MAY SETTLE.
9. Invert the vial completely and SLOWLY
withdraw the entire contents of the
suspension from the vial into the syringe.
Tear the section of the vial label at the
perforation and apply the detached label
to the syringe for identification purposes.
10. While holding the white collar of the syringe,
unscrew the syringe from the SmartSite® Needle-Free

11. Open the needle pack and select the appropriate
needle provided with the kit. Do NOT touch the
connection part of the needle, only touch the
transparent sheath of the needle.
For GLUTEAL injection, select the 20G
TW 2-inch (0.9 mm x 50 mm) needle
(longer needle with yellow coloured hub).
For DELTOID injection, select the
21G UTW 1-inch (0.8 mm x 25 mm)
needle (shorter needle with green
coloured hub).
12. To prevent contamination, be
careful not to touch the orange
Needle-Pro safety device’s luer
connector. While holding the white
collar of the syringe, attach the luer
connection of the orange NeedlePro safety device to the syringe with
an easy clockwise twisting motion.
13. While continuing to hold the white collar of the syringe,
grasp the transparent needle sheath and seat the
needle firmly on the orange Needle-Pro safety device
with a push and a clockwise twist. Seating the needle
will help ensure a secure connection between the
needle and the orange Needle-Pro safety device
while conducting the following steps.

14. RESUSPENSION OF RISPERDAL CONSTA WILL
BE NECESSARY PRIOR TO ADMINISTRATION,
AS SETTLING WILL OCCUR OVER TIME ONCE
PRODUCT IS RECONSTITUTED. RESUSPEND
THE MICROSPHERES IN THE SYRINGE BY
SHAKING VIGOROUSLY.
15. While holding the white collar of the syringe, pull the
transparent needle sheath straight away from the
needle. DO NOT TWIST the sheath as the luer
connections may be loosened.

16. Tap the syringe gently to make any air bubbles rise to
the top.
Remove air in syringe by depressing the plunger rod,
carefully and slowly, while holding the needle in an
upright position.
Inject the entire contents of the syringe
intramuscularly into the selected gluteal
or deltoid muscle of the patient
immediately. Gluteal injection should
be made into the upper-outer
quadrant of the gluteal area.
DO NOT ADMINISTER
INTRAVENOUSLY.
WARNING: To avoid a needle stick injury with a
contaminated needle:
• Do not use free hand to press the Needle-Pro safety
device over the needle.
• Do not intentionally disengage the Needle-Pro safety device.
• Do not attempt to straighten the needle or engage NeedlePro safety device if the needle is bent or damaged.
• Do not mishandle the Needle-Pro safety device as it
may cause the needle to protrude from the Needle-Pro
safety device.
17. After injection is complete, press the needle into the
orange Needle-Pro safety device using a one-handed
technique. Perform a one-handed technique by GENTLY
pressing the orange Needle-Pro safety device against a
flat surface. AS THE ORANGE NEEDLE-PRO SAFETY
DEVICE IS PRESSED, THE NEEDLE WILL FIRMLY
ENGAGE INTO THE ORANGE NEEDLE-PRO SAFETY
DEVICE. Visually confirm that the needle is fully engaged
into the Orange Needle-Pro safety device before
discarding. Discard needle appropriately. Also discard the
other (unused) needle provided in the dose pack.

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.
© J-C 2013

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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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