*Abreviated to APO-go® PFS in text
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Patient Information Leaflet

Please read this leaflet carefully before you use APO-go® PFS. If you have any questions or are unsure about anything, ask your doctor, nurse or pharmacist

What does your medicine contain?
APO-go® PFS is available in 10ml pre-filled syringes containing a solution for subcutaneous infusion. The active ingredient of APO-go® PFS is apomorphine hydrochloride 5mg/ml. It also contains sodium metabisulphite (E223), hydrochloric acid and water for injections. Apomorphine hydrochloride is one of several medicines known as dopamine agonists, used to treat Parkinson’s disease. It helps reduce that amount of time spent in an ‘off’ or immobile state. Your doctor or nurse will help you to recognise the signs of when to use your medicine. Despite the name, apomorphine does not contain morphine.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Forum Products Ltd
41-51 Brighton Road
Redhill
Surrey RH1 6YS
United Kingdom

Manufacturer:
Federa S.C
Avenue Jean Jaurèslaan
71, B-1030
Brussels
Belgium

Distributor in the UK:
Britannia Pharmaceuticals Ltd
41-51 Brighton Road
Redhill
Surrey RH1 6YS
United Kingdom

Before you use your medicine
– Are you pregnant, think you may be pregnant or intending to become pregnant?
– Are you breast-feeding?
– Do you have heart disease?
– Do you have liver disease?
– Do you have kidney problems?
– Do you have breathing difficulties or suffer from asthma?
– Do you have low blood pressure (feel faint or dizzy upon standing)?
– Do you suffer from nausea and vomiting?
– Do you have dementia or Alzheimer’s disease?
– Are you allergic to sulphites, metabisulphites or any of the ingredients of APO-go®?
– Do you have neuropsychiatric problems (confusion, hallucinations) or other mental disturbances?
– Do you have severe dyskinesia (involuntary movements) or dystonia (inability to move)?
– Are you taking any medicines to treat high blood pressure?
– Are you taking neuroleptic medicines (e.g. Clozapine)?
– Are you under 18 years of age?
– Are you taking any other medicines?

If the answer is YES to any of these questions, tell your doctor before using APO-go® PFS.

Dosage
The dosage for each infusion, and the duration of infusions required each day will be determined by your personal needs. Your doctor will tell you how much of your medicine you should administer.

The dose that will work for you will have been determined during your initiation treatment in a specialist clinic.

The average infusion rate is between 1mg and 4mg per hour, usually during waking hours, but should not exceed 100mg under the skin (subcutaneously) daily. Your doctor or nurse will decide which dose is best for you.

This medicine should not be administered into a vein.

Side Effects
All medicines sometimes cause side effects. Tell your doctor if you think your medicine is making you feel unwell or if you get any of the following:

  • feeling sick or being sick*
  • confusion or hallucinations
  • feeling tired or somnolence (excessive drowsiness)**
  • low blood pressure (feeling faint or dizzy upon standing up)
  • lumps under the skin at the site of injection which are sore, troublesome and may be itchy. It is advisable not to inject yourself everytime in exactly the same place on your skin, but to vary the site of injection
  • increased involuntary movements or worsening tremors during 'on' periods
  • anaemia or blood disorders***
  • an allergic reaction**** such as:
    - skin rash or itchy skin
    - difficulty breathing or tightness of the chest
    - puffiness of the eyelids, face or lips
    - swelling or redness of the tongue
  *

Most patients take domperidone to stop them feeling or being sick. If you are taking domperidone and still have sickness, or if you are not taking domperidone and have sickness, tell your doctor or nurse as soon as possible.
     
  ** APO-go® PFS can cause excessive drowsiness. Take special care when you drive or operate machinery. You must refrain from driving or any activity (e.g. operating machinery) where impaired alertness may put yourself or others at risk of serious injury.
     
  *** Anaemia (or blood disorders) is an uncommon side effect which can occur in patients taking levodopa (another medicine for the treatment of Parkinson’s disease). If you are taking levodopa as well as APO-go®, your doctor should arrange for you to have blood tests at regular intervals.
     
  **** Sodium metabisulphite may rarely cause hypersensitivity reactions and bronchospasm. Tell your doctor if you suddenly have difficulty in breathing, or if you think you have an allergic reaction.

What to do if you use too much medicine
It is important not to administer more than the prescribed dose since this may cause low blood pressure, excess sickness or excess sleepiness. If you administer too much medicine tell your doctor or contact your nearest hospital emergency department, immediately.

Storage of your medicine

  • Do not store APO-go® PFS above 25°C. Do not store in direct heat or sunlight (keep unused pre-filled syringes in the outer cardboard carton).
  • Do not use if the solution has turned green. Use APO-go® PFS only if the solution is clear, colourless and free of any visible particles.
  • Withdraw contents immediately after opening and discard the pre-filled syringe.
  • At the end of use, if the pre-filled syringe contains some apomorphine, please empty it into your toilet and flush away. Take care not to splash any of the solution onto yourself, carpet or toilet seat since it may stain green.
  • Always use your medicine before the expiry date on the label. Do not use any medicine after this date.
  • Do not use after 24 hours from first infusion.
  • Discard the glass pre-filled syringe, any used plastic syringes and the adaptor in a “Sharps” bin.
  • KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

Remember:
This medicine is for you. Never give it to others, even if they have the same symptoms as you.

Further information
This leaflet does not contain all the information about your medicine. If you are unsure of anything or have any questions, ask your doctor, nurse or pharmacist

There is no need to dilute APO-go® PFS prior to use.

The APO-go® PFS has been designed for continuous infusion of apomorphine therapy via a syringe driver. It is not intended to be used for intermittent injection.

APO-go® PFS can be used with suitable pumps/syringe drivers, e.g. APO-go pump or Graseby syringe driver. Detailed explanations will be provided by the Distributor.

Do not throw this leaflet away as you may want to read it again.

Date of preparation: October 2005

UK 007

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