apomorphine hydrochloride hemihydrate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about APOMINE Intermittent. It does not
contain all the available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
APOMINE Intermittent against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet in a safe place.
You may need to read it again.
For further information on APOMINE Intermittent please contact your doctor or pharmacist
or , your ANSSER nurse (1800 276 646).
What APOMINE Intermittent is used for
APOMINE Intermittent contains apomorphine which belongs to a group of medicines called
dopaminergic compounds.
Apomorphine is used in the treatment of Parkinson's disease to reduce the number and
severity of bouts of freezing and stiffness (or "off" periods).
This medicine works by acting on dopamine receptors. These receptors help control
movement by the body.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
Before you use APOMINE Intermittent
When you must not use it
Do not use APOMINE Intermittent if you have an allergy to:
apomorphine
sodium metabisulfite or sulfites
certain types of pain killers such as morphine or other opioid analgesics.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty breathing, swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.
The amount of sodium contained in APOMINE Intermittent solution for injection is low
(23 mg per 10 mL) and should not affect patients with sodium-restricted diets.
Do not use this medicine if you have or have had any of the following medical conditions:
certain forms of dementia eg. Alzheimer's Disease
severe kidney or liver disease
problems with circulation of blood in the brain (cerebrovascular disease)
breathing problems (respiratory depression).
Do not give this medicine to a child under the age of 18 years.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using this medicine, talk to your doctor.
Before you use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
a history of severe nausea and vomiting
heart disease
kidney disease
liver disease
lung disease
problem gambling,
any addictive behaviour (eg. sex, shopping or eating).
APOMINE can cause impulse control disorders, including addictive behaviour and cravings
for more APOMINE, even when you don’t have "off" symptoms to treat.
Before you use APOMINE Intermittent , your doctor may obtain an ECG (electrocardiogram),
do blood tests and ask for a list of all other medicines you take.
The ECG and blood tests will be repeated in the first days of your treatment and at
any point if your doctor thinks this is needed. He or she will also ask you about
other diseases you may have, in particular, concerning your heart. Some of the questions
and investigations may be repeated at each medical visit. If you experience symptoms
which may come from the heart, eg. palpitations, fainting, or near-fainting, you should
report this to your doctor immediately.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor will discuss the possible risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start
using APOMINE Intermittent.
Taking other medicines
Tell your doctor or pharmacist if you are taking or using any other medicines, including
any that you get without a prescription from your pharmacy, supermarket or health
food shop.
Some medicines and APOMINE Intermittent may interfere with each other. These include:
tetrabenazine, a medicine used to treat movement disorders
metoclopramide, a medicine used to treat nausea
medicines used to treat some psychiatric (mental) conditions (eg phenothiazines, haloperidol,
flupenthixol)
papaverine, a medicine which expands blood vessels
amphetamines.
These medicines may be affected by APOMINE Intermittent or may affect how well they
work. You may need different amounts of your medicine, or you may need to use different
medicines.
Your doctor and pharmacist have more information on medicines to be careful of or
avoid while using this medicine.
How to use APOMINE Intermittent
Follow all directions given to you by your doctor, nurse or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor, nurse or pharmacist for
help.
Do not use APOMINE Intermittent if the solution has turned green, or if the solution
is cloudy or you can see particles in it.
How much is given
Your doctor will decide what dose you will receive. This depends on your initial response
to APOMINE Intermittent.
How it is given
You will usually be in hospital when you start using APOMINE Intermittent. It is recommended
that you are given anti-nausea tablets (domperidone) for a few days before starting
APOMINE® Intermittent and that you stop all your other anti-Parkinsonian medication
before you start using APOMINE Intermittent. This medicine is given as an injection
under the skin (subcutaneously), usually into your lower abdomen or outer thigh. It
is injected several times a day using a device called the D-Mine® Pen and not with
a conventional syringe and needle that you might be familiar with.
You and/or your carers will be trained by hospital staff to recognise when and how
to give the injections.
It is advisable to change the site of injection every time you insert the needle,
to avoid getting lumps under the skin.
This medicine is for individual patient use only.
If you use too much (Overdose)
Immediately notify your doctor or nurse, or if you are not in hospital, telephone
the Poisons Information Centre 13 11 26 (Australia) or go to Accident and Emergency
at your nearest hospital, if you think that you or anyone else may have used too much
APOMINE Intermittent. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include severe nausea and vomiting, slow or troubled breathing,
restlessness, hallucinations or unconsciousness.
While you are using APOMINE Intermittent
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using APOMINE Intermittent.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
using this medicine.
If you plan to have surgery, tell the surgeon or anaesthetist that you are using this
medicine.
It may affect other medicines used during surgery.
If you become pregnant while using this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Things you must not do
Do not use APOMINE Intermittent to treat any other complaints unless your doctor tells
you to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Things to be careful of
Be careful driving or operating machinery until you know how APOMINE Intermittent
affects you.
This medicine may cause drowsiness, sudden onset of sleepiness, dizziness or light-headedness
in some people. If you have any of these symptoms, do not drive, operate machinery
or do anything else that could be dangerous.
Side effects
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
while you are using APOMINE Intermittent.
APOMINE Intermittent helps most people with Parkinson's Disease but may have unwanted
side effects in a few people. All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may need medical attention if you
get some of the side effects.
If you are over 65 years of age you may have an increased chance of experiencing side
effects.
Do not be alarmed by the following lists of side effects.
You may not experience any of them.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
Tell your doctor, nurse or pharmacist if you notice any of the following and they
worry you:
nausea or vomiting, particularly when starting this medicine
lumps under the skin, rashes or ulcers at the site of injection, which are sore, troublesome
and may be red and itchy
drowsiness, yawning or suddenly falling asleep, weight loss
confusion
dizziness or light-headedness when standing up, fainting
headache
unpleasant metallic taste, sore mouth
runny nose, watery eyes
reduced facial hair growth
spontaneous penile erection
decreased sex drive
infertility, or inability to get pregnant
absent, irregular or infrequence periods
breast milk leakage in people who are not pregnant
loss of interest in sex, painful or uncomfortable intercourse, or vaginal dryness
acne or excess body and facial hair growth
hot flashes.
The above list includes the more common side effects of your medicine. They are usually
mild and short-lived.
Tell your doctor as soon as possible if you notice any of the following:
increased involuntary movements or increased shakiness during ‘on’ periods
aggression and agitation
swelling of your arms and hands, or legs and ankles (peripheral oedema)
pale or yellow skin, yellow eyes or mouth, dark coloured urine
fever, weakness, dizziness, confusion, breathlessness, inability to handle physical
activity, increased heart rate
pain in the upper abdomen and bloating, or feeling full in the stomach early after
eating, loss of appetite, unexplained weight loss
bleeding or bruising
lack of impulse control - an inability to resist the impulse, drive or temptation
to perform an action that could be harmful to you or others, which can include an
increased need to gamble, compulsive eating, shopping or medication use, or a highly
increased sex drive.
The above list includes serious side effects that may require medical attention. Serious
side effects are rare or uncommon.
If any of the following happen tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
hallucinations (seeing, hearing or feeling things that are not there)
severe nausea and vomiting
The above list includes serious side effects which may require medical attention.
These side effects are rare.
Tell your doctor, nurse or pharmacist if you notice anything that is making you feel
unwell.
Other side effects not listed above may also occur in some people.
Some of these side effects can only be found when your doctor does tests from time
to time to check your progress.
After using APOMINE Intermittent
Storage
Store the APOMINE Intermittent below 25°C until it is time to use it. Do not refrigerate
or freeze. Keep the container in the outer carton and protect from light.
APOMINE Intermittent is for single use only. After the first injection, the contents
of the cartridge should be used within 72 hours. Any solution remaining after this
time should be discarded.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Do not throw out the D-Mine Pen.
You can keep it to use with the other cartridges.
Disposal
If your doctor tells you to stop using this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
APOMINE Intermittent is supplied as a clear, colourless to slightly yellow, sterile
solution that comes in 3 mL glass cartridges, in packs of 5.
Do not use APOMINE Intermittent if it looks cloudy or develops a green colour.
Ingredients
APOMINE Intermittent contains:
apomorphine hydrochloride hemihydrate
sodium metabisulfite (E223)
hydrochloric acid
sodium chloride
water for injections
APOMINE Intermittent does not contain lactose, sucrose, gluten, tartrazine or any
other azo dyes.
Strength
3 mL cartridge containing apomorphine hydrochloride hemihydrate 10 mg/mL
Sponsor
Pfizer Australia Pty Ltd
Level 17, 151 Clarence Street
Sydney NSW 2000
Glass cartridges - AUST R 296520
This leaflet was prepared in July 2022.