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APOMINE™ Solution for Infusion

Apomorphine (a-poe-MOR-feen) hydrochloride hemihydrate


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about APOMINE™ Solution for Infusion. 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™ Solution for Infusion 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 ™ Solution for Infusion please refer to “A guide to the use of apomorphine in the treatment of Parkinson’s Disease for patients and carers” which is available from Hospira Pty Ltd (ph: 1300 046 774).

What APOMINE™ Solution for Infusion is used for

APOMINE™ Solution for Infusion 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.

There is not enough information to recommend the use of this medicine in children under 18 years.

Before you use APOMINE™ Solution for Infusion.

When you must not use it

Do not use APOMINE™ Solution for Infusion if you have an allergy to:

  • apomorphine
  • sodium metabisulfite
  • 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.

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 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 or pharmacist 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)

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 or pharmacist about any of the above, tell them before you start using APOMINE™ Solution for Infusion.

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 ™ Solution for Infusion 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 ™ Solution for Infusion, 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 ™ Solution for Infusion

How much is given

Your doctor will decide what dose you will receive. This depends on your initial response to APOMINE™ Solution for Infusion.

How it is given

You will usually be in hospital when you start using APOMINE™ Solution for Infusion. It is recommended that you are given an anti-nausea drug (domperidone) and that you stop all your other anti-Parkinsonian medication before you start using APOMINE™ Solution for Infusion. This medicine is given as an injection under the skin (subcutaneously), usually into your lower abdomen or outer thigh. It is either injected several times a day or continuously as an infusion (ie, slow injection via a pump).

There is no need to dilute APOMINE ™ Solution for Infusion prior to use. APOMINE ™ Solution for Infusion is a pre-diluted solution in a vial, intended for use as a continuous infusion with a suitable pump/syringe driver.

You and/or your carers will be trained by hospital staff to recognise when and how to give the infusions.

If you use too much (Overdose)

Immediately notify your doctor or nurse, or if you are not in hospital, telephone the Poisons Information Centre (Australia telephone 13 11 26, New Zealand 0800 764 766) or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have used too much APOMINE™ Solution for Infusion. 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 ™ Solution for Infusion

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™ Solution for Infusion.

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 are 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™ Solution for Infusion 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™ Solution for Infusion 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™ Solution for Infusion. APOMINE™ Solution for Infusion helps most people with Parkinson’s disease, but they 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 treatment 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 this list of possible 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
  • drowsiness
  • sudden onset of sleepiness
  • dizziness or light-headedness
  • pain and sores at the injection sites
  • unpleasant metallic taste
  • runny nose
  • watery eyes
  • spontaneous penile erection
  • confusion
  • lack of impulse control
  • decreased or increased sexual arousal
  • increased need to gamble
  • compulsive eating, shopping or medication use.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

If any of the following happen tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • hallucinations
  • 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 occur in some people.

After using APOMINE™ Solution for Infusion

Storage

Store the APOMINE™ Solution for Infusion below 25°C. Keep unused vials in the outer cardboard carton.

Store in original package in order to protect from light and do not refrigerate or put in the freezer.

APOMINE™ Solution for Infusion is for single use only. Once opened, the contents of the vial should be used immediately. Discard any unused solution.

Keep it where children cannot reach it.

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™ Solution for Infusion is supplied as a clear and colourless to slightly yellow solution that comes in a 20 mL glass vial in packs of 1, 5 and 10.

Ingredients

APOMINE™ Solution for Infusion contains:

  • apomorphine hydrochloride hemihydrate
  • sodium metabisulfite
  • sodium chloride
  • hydrochloric acid
  • water for injections

APOMINE™ Solution for Infusion does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Strength
20 mL glass vial containing apomorphine hydrochloride hemihydrate 5 mg/mL

Sponsor

Australian Sponsor:

Hospira Australia Pty Ltd
ABN 58 097 064 330
Level 3, 500 Collins Street
Melbourne VIC 3000
Australia

New Zealand Sponsor:

Hospira NZ Limited
58 Richard Pearse Drive
Airport Oaks, Mangere, 2022
Auckland
New Zealand

Glass Vial
20 mL AUST R 260149

This leaflet was prepared in September 2015.

Published by MIMS June 2018

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