RISPERDAL CONSTA INTRAMUSCULAR INJECTION Risperidone Consumer Medicine Information (CMI)
if the packaging is torn or shows signs of having
What is in this leaflet
to treat any other complaints unless your doctor
This leaflet contains important information about
RISPERDAL CONSTA. It does not contain all of the available information. It does not take the place of
Before you start to use it
RISPERDAL CONSTA should be used with caution in
If you have any concerns about using RISPERDAL
CONSTA, ask your doctor, pharmacist or nurse. Your
doctor and pharmacist have more information.
1. Tell your doctor if you have or have ever had
Keep this leaflet with your RISPERDAL CONSTA. You
any medical conditions, especially the following:
heart or blood vessel diseases, including low blood pressure.
What RISPERDAL CONSTA is used for?
Low blood pressure can result from using RISPERDAL CONSTA together with medications to treat high blood pressure. So, if you need to use
RISPERDAL CONSTA is used to treat symptoms of
both RISPERDAL CONSTA and medications to
schizophrenia and other types of related psychoses.
reduce blood pressure, consult your doctor.
These are disorders related to thought, feeling and/or
RISPERDAL CONSTA should be used with caution,
RISPERDAL CONSTA is also used to treat bipolar
and only after consultation with your doctor, if you
disorder to prevent or delay mood swings which consist
have heart problems, particularly irregular heart
of alternating periods of high (manic) or elevated mood
rhythm, abnormalities in electrical activity of the
with periods of depression. During the manic episodes
heart, or if using medications that can change the
you may feel very excited, elated, agitated,
enthusiastic, or hyperactive, or have poor judgment
including disruptive or aggressive behaviours. During the episodes of depression you may experience
sadness, low energy, lack of motivation, feelings of
parkinson's disease (a disease of the brain affecting
guilt and worthlessness, and changes in sleep or
RISPERDAL CONSTA helps to correct a chemical
imbalance in the brain associated with these
RISPERDAL CONSTA has been approved for the uses mentioned above. However, your doctor may
restlessness or difficulty sitting still
prescribe this medicine for another use. If you want
intraoperative floppy iris syndrome (a complication
that may occur during cataract extraction)
Before you use RISPERDAL
Neuroleptic Malignant Syndrome (a serious reaction to some medicines, consisting of a sudden increase in body temperature, extremely high blood pressure
When you must not use it Do not use RISPERDAL CONSTA:
tardive dyskinesia (a reaction to some medicines,
if you know you are allergic to any of its ingredients
seen as uncontrollable twitching or jerking
(signs of allergy include skin rash, itching, shortness
of breath, and/or swollen face - see the last section
of this leaflet for a list of ingredients)
2. Tell your doctor if:
• you are pregnant or are planning to become
5. Children and Adolescents
There is no experience with RISPERDAL CONSTA in
Shaking, muscle stiffness and difficulty in feeding,
all of which are reversible, may occur in newborns, if a mother used RISPERDAL CONSTA in the last
Using it for the first time
Treatment with RISPERDAL CONSTA will not be
started until it is known that you can tolerate Risperdal
Your doctor will advise you whether or not you should
treatment by mouth (tablets or oral solution)
At the start of treatment you may have a fall in blood
pressure making you feel dizzy on standing up, or your
3. Other medicines and alcohol
heart may beat faster. These should go away after a few days. Tell your doctor if they continue or worry
RISPERDAL CONSTA can increase the effect of
alcohol and other medicines which slow your reactions.
Using RISPERDAL CONSTA How to use it
RISPERDAL CONSTA should be given only after the
powder has been mixed with the diluent (liquid in the
carbamazepine, a drug mainly used for epilepsy or
trigeminal neuralgia (severe pain attacks in the face) may decrease the level of RISPERDAL
The information for your doctor or nurse on the right
way to reconstitute (make up) RISPERDAL CONSTA is included in the package.
After it has been made up, RISPERDAL CONSTA
should be injected in the arm or buttock every two
Tell your doctor if you have ever taken medicines for
weeks. Next time the injection will be given into the
depression. In particular, fluoxetine and paroxetine
other arm or buttock, and so on. Injection is not to be
may increase the level of RISPERDAL in your blood.
So tell your doctor if you start and/or stop taking
The usual dose of RISPERDAL CONSTA is 25mg
once every two weeks. However, your doctor might
decide to administer a higher dose of 37.5mg or 50mg.
The following medicines do not have an effect on
Your doctor will decide on the dose of RISPERDAL
RISPERDAL: eryrthromycin (antibiotic), galantamine
and donepezil (used to treat dementia), lithium or
Because risperidone is released gradually into your
valproate (used to treat mania), digoxin (a heart drug),
body, you will need an injection only every two weeks.
topiramate (used to treat epilepsy or migraine),
During the first three weeks of treatment additional
cimetidine and ranitidine (used to reduce stomach
risperidone tablets or liquid, which can be taken by
mouth, must be used, because the first injection will not
start to work straight away. Your doctor will explain this to you.
Tell your doctor if you are taking medicines for: •
Later, depending on how well the treatment is working,
your doctor may decide to further adjust the dose of
RISPERDAL CONSTA or to add oral RISPERDAL
• other medicines for your heart or blood pressure.
Do not stop your treatment just because you feel better. If you have to stop RISPERDAL CONSTA on
the advice of your doctor, it is best to do it gradually.
You should not drink alcohol while using RISPERDAL
Stopping treatment suddenly may cause effects such
as feeling sick, vomiting, sweating, sleeplessness,
muscle stiffness, or jerky movements, or your original
Your doctor or pharmacist has more information on the
medicines to avoid, or to be careful of, while you are
Elderly people should receive the lowest dose (25mg) Patients with impaired kidney and liver function. 4. Elderly People
Elderly people should receive the lowest dose (25mg) of RISPERDAL CONSTA (see “How to use it”).
RISPERDAL CONSTA has not been studied in
patients whose kidney or liver is not working properly.
Be careful driving or operating machinery until you
Use in such patients should be with caution, a starting
dose of 0.5mg twice-daily oral risperidone is
recommended during the first week. In the second
light-headedness in some people, especially after
week 1mg twice daily or 2mg once daily can be given.
the first dose. Make sure you know how you react
If a daily total oral dose of at least 2mg is well tolerated
to RISPERDAL CONSTA before you drive a car,
(i.e. the drug does not upset you), an injection of
operate machinery, or do anything else that could
RISPERDAL CONSTA can be administered every 2
• Avoid excessive eating as there is a possibility of
weight gain when using RISPERDAL CONSTA.
If you forget to use RISPERDAL CONSTA
• If you forget to use RISPERDAL CONSTA, contact
Side Effects
your doctor or nurse as soon as possible.
Overdose
All medicines can have side effects. Sometimes they are serious, but most of the time they are not.
If you think you or anybody else has taken too
RISPERDAL CONSTA is generally well tolerated and
much RISPERDAL CONSTA, contact your doctor,
side effects are often hard to distinguish from the
pharmacist or the Poisons Information Centre who
disease symptoms. You may need medical treatment
will advise you what to do.
if you get some of the side effects. Tell your doctor
You can contact the Poisons Information Centre by
as soon as possible if you do not feel well while
dialling 13 11 26 in Australia, or 0800 POISONS or you are using RISPERDAL CONSTA. 0800 764 766 in New Zealand.
Below is a list of possible side effects you could get
Signs of overdose may include drowsiness, sleepiness,
excessive trembling, excessive muscle stiffness,
increased heart rate, very low blood pressure causing fainting or unconsciousness.
While you are using RISPERDAL Things you must do
• Always follow your doctor's instructions carefully,
and seek your doctor's advice before changing or
stopping treatment. Your doctor will be happy to
• fall in blood pressure, particularly on standing. This
discuss any questions you may have with your
will be apparent to you as light-headedness or
treatment. Remember, this medicine has been
dizziness that passes after a few seconds or after
• Tell all doctors, dentists and pharmacists who are
treating you, that you are using RISPERDAL CONSTA.
• If you become pregnant while using RISPERDAL
• Pre-menopausal women should tell their doctor if
Although these effects are generally not harmful,
they do not have a period for more than six months
contact your doctor if they bother you too much.
while using RISPERDAL CONSTA, even if they are
• drowsiness, tiredness, difficulty in concentrating,
Things to be careful of
somnolence, usually mild and short lasting may
occur more often in children than in adults
Do not drink alcohol. RISPERDAL CONSTA can
Ask your doctor before taking any other medicines.
RISPERDAL CONSTA can increase the effects of
• indigestion, nausea, abdominal pain, constipation
medicines which slow your reactions. Always ask
• sexual function disturbances – erectile dysfunction,
your doctor or pharmacist before taking other
problems with ejaculation, decreased sexual drive
medicines. These include herbal treatments and
those bought in a pharmacy or supermarket.
• During a long treatment, twitching of the tongue,
Disposal
face, mouth and jaws can occur. Should this
Once you have finished using RISPERDAL CONSTA,
ask your pharmacist what to do with any unused
• In the early stages of treatment, in some people,
blood pressure may decrease slightly and the heart beat increase resulting in dizziness. This usually goes away after a few days. (See "Using it for the
Product Description
• After using RISPERDAL CONSTA for a long time,
What it looks like
somewomen may experience breast enlargement
RISPERDAL CONSTA is available in vials (small
or get a discharge from the breasts. They may also
bottles) which contain different amounts of risperidone.
experience irregular or heavy periods or absence of
The package contains everything required to
their periods. In men, breasts may enlarge slightly.
reconstitute and administer the product.
• A vial with white powder contains the
• Oversensitivity (allergy). (See “When you must not
• A syringe with diluent, with which the powder is
• In extremely rare cases, significant changes in body
temperature may occur. This rise or fall in
temperature is caused by a combination of several
factors such as extreme cold or heat. Call your doctor if this happens.
Ingredients
• In elderly patients with dementia, sudden weakness
The active ingredient in RISPERDAL CONSTA is
or numbness of the face, arms or legs, especially
risperidone, which is present in amounts of either
on one side, instances of slurred speech and stroke
25mg, 37.5mg or 50mg in an injection of RISPERDAL
have been seen. If any of these should occur, even
for a short period of time, seek medical attention
The powder is made from a 7525 DL JN1 poly-(d/l-
lactide-co-glycolide) polymer called polyglactin. A
In very rare cases, high blood sugar has been
polymer is a small particle made up of many smaller,
reported. The symptoms of high blood sugar may
similar particles bound together. Risperidone is
be the need to urinate more often or feeling thirsty
attached to this polymer and then slowly released from
all the time. Contact your doctor if you experience
it once it has been injected into the body. The diluent
contains polysorbate 20, carmellose sodium, sodium
phosphate-dibasic dihydrate, citric acid anhydrous, sodium chloride, sodium hydroxide and water for
IMPORTANT: If you experience high fever, stiff muscles, fast breathing, abnormal sweating or decreased mental alertness, contact your doctor Sponsor immediately. Your body may not be reacting properly to the medicine. Do not hesitate to report any other side effects to your doctor or pharmacist.
NZ Office: Auckland, New Zealand Telephone: 0800 800 806
After using RISPERDAL CONSTA Registration Numbers Storage
Keep the entire pack of RISPERDAL CONSTA in a
This leaflet was prepared in February 2013
Do not store it or any medicines in the bathroom or
near a sink. Heat and dampness can destroy some
® RISPERDAL CONSTA is a registered trademark of
• Keep it where young children cannot reach it.
• Do not use RISPERDAL CONSTA beyond the date
(month and year) printed on the pack after the letters "EXP", even if it has been stored properly. Medicines cannot be stored indefinitely.