APO-GO AMPOULES 10 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: APOMORPHINE HYDROCHLORIDE

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UK/H/0342/002/IB/081-Response

It is not 10 mg/ml
Apomorphine HCL Ampouleknown whether APO-go Ampoules is transferred to breast milk. Talk to 2014
October

For use in adults
PACKAGE LEAFLET: Information for the User
* Abbreviated to APO-go Ampoules in the text
Read all of this leaflet carefully before you start using this medicine.
−  this leaflet. You may need to read it again.
Keep
−  you have any further questions, ask your doctor, nurse or pharmacist.
If
− 
This medicine has been prescribed for you. Do not give it to others.
It may harm them, even if their symptoms are the same as yours.
−  any of the side effects get serious, or if you notice any side effects
If
not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What APO-go Ampoules is and what it is used for
Before you use APO-go Ampoules
How to use APO-go Ampoules
Possible side effects
How to store APO-go Ampoules
Further information

1.  hat APO-go Ampoules is and what it is used for
W
APO-go Ampoules contains apomorphine solution for injection. It is injected into the
area under the skin (subcutaneously). The active ingredient in APO-go Ampoules
is apomorphine hydrochloride. There is 10mg of apomorphine in each millilitre
of solution.
Apomorphine hydrochloride belongs to a group of medicines known as dopamine
agonists. APO-go Ampoules is used to treat Parkinson’s disease. Apomorphine helps
reduce the amount of time spent in an ‘off’ or immobile state in people who have
previously been treated for Parkinson’s disease with levodopa (another treatment for
Parkinson’s disease) and/or other dopamine agonists. 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.

2.  efore you use APO-go Ampoules
B
Do not use APO-go Ampoules

− if you are under 18 years of age
− if you have breathing difficulties
− if you have dementia or Alzheimer’s disease
−  you suffer from a mental illness with symptoms such as hallucinations,
if
delusions, disordered thoughts, loss of contact with reality
− if you have liver problems
−  you have severe dyskinesia (involuntary movements) or severe dystonia
if
(inability to move) despite taking levodopa
−  you are allergic to apomorphine or any of the other ingredients of
if
APO-go Ampoules (for other ingredients, see section 6)
−  you or someone in your family are known to have an abnormality of
if
electrocardiogram (ECG) called “long QT syndrome”. Tell your doctor.

Take special care with APO-go Ampoules:

Please inform your doctor, nurse or pharmacist:
− if you have kidney problems
− if you have lung problems
− if you have heart problems
− if you have low blood pressure or feel faint and dizzy when you stand
− if you are taking any medicines to treat high blood pressure
− if you feel sick or suffer from being sick
−  your Parkinson’s disease causes certain mental problems such as
if
hallucinations and confusion
− if you are elderly or frail.

your doctor if you are breast-feeding or intend to breast-feed. Your doctor will
explain to you, whether you should continue/discontinue breast-feeding or
continue/discontinue taking this medicine.
Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines
APO-go Ampoules can cause drowsiness and a strong desire to sleep. Do not drive
or use any tools or machinery if APO-go Ampoules affects you in this way.
This medicine can affect your ability to drive. Do not drive whilst taking this medicine
until you know how this medicine affects you. It may be an offence to drive if your
ability to drive safely is affected. There is further information for patients who are
intending to drive in Great Britain - go to https://www.gov.uk/drug-driving-law.

Information about the ingredients of APO-go Ampoules

APO-go Ampoules contains sodium metabisulphite which rarely can cause a severe
allergic reaction with symptoms such as rash or itchy skin, difficulty breathing,
puffiness of the eyelids, face or lips, swelling or redness of the tongue.
If you experience these side effects, immediately go to the nearest hospital
casualty department.
APO-go Ampoules contain less than 1 mmol (23mg) of sodium per 10ml,
i.e. essentially sodium free.

3. How to use APO-go Ampoules
Always use APO-go Ampoules exactly as your doctor has told you. You should check
with your doctor, nurse or pharmacist if you are not sure.
Domperidone should be taken at least 2 days before APO-go Ampoules is started to
stop you feeling or being sick.

Do not use APO-go Ampoules if



The solution has turned green
The solution is cloudy or you can see particles in it.

Where to inject your APO-go Ampoules



I
nject your APO-go Ampoules into an area under the skin (subcutaneously)
as shown by your doctor or nurse.
Do not inject APO-go Ampoules into a vein.

How much to use
The amount of APO-go Ampoules you should use and the number of injections
required each day will depend upon your personal needs. Your doctor will discuss
this with you and tell you how much of your medicine you should inject and
how often. The amount that will work best for you will have been determined
during your visit to the specialist clinic.
• The usual daily dose is between 3mg and 30mg
• You may need as much as 100mg per day
• Typically, you will need between 1 and 10 injections each day
• Each injection should not be more than 10mg.
If your symptoms are not controlled well enough with separate injections or if you
find you are requiring more than 10 injections per day, you may require a continuous
infusion of apomorphine. Your doctor or nurse will decide if you need this.
For a continuous infusion:
• The usual dose is between 1mg and 4mg per hour
•  sually this is given to you when you are awake and stopped before
U
you go to sleep
• A different site for each infusion should be used every 12 hours.
The choice of which minipump and/or syringe driver to use will be decided by your
doctor. You should check with your doctor, nurse or pharmacist if you are not sure.

What you need to inject APO-go Ampoules
For an injection, you will need:
• One syringe and needle
•  bin called a “Sharps” bin to dispose safely of the used needles and
A
glass containers. These are available from your doctor or pharmacist.
Alternatively, use another suitable container such as an empty coffee jar.

How to open APO-go Ampoules

T
 ell your doctor if you or your family/carer notices that you are developing urges
or cravings to behave in ways that are unusual for you and you cannot resist the
impulse, drive or temptation to carry out certain activities that could harm yourself
or others. These are called impulse control disorders and can include behaviours
such as addictive gambling, excessive eating or spending, an abnormally high sex
drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust
or stop your dose.

There are 2 different types of ampoule
1) Ampoules with a single spot:

Check with your doctor or pharmacist before taking your medicine if:
You are using medicines that are known to affect the way your heart beats.
This includes medicines used for heart rhythm problems (such as quinidine and
amiodarone), for depression (including tricyclic antidepressants such as amitriptyline
and imipramine) and for bacterial infections (‘macrolide’ antibiotics such as
erythromycin, azithromycin and clarithromycin) and domperidone.

–  ocate the spot positioned directly above the short score mark on the thin part
L
of the neck. This score is the breaking point of the ampoule.
–  old the bottom of the ampoule in one hand
H
–  over the spot with your thumb and use your forefinger to grasp the neck
C
of the ampoule as shown in the diagram.
–  pply pressure with your thumb covering the spot in a backward direction.
A
–  arefully dispose of the top of the ampoule in a “Sharps” bin.
C

Taking other medicines
If you use APO-go Ampoules with other medicines the effect of those medicines
may be altered. This is especially true for:
− Medicines such as clozapine to treat some mental disorders
− Medicines to lower your blood pressure
− Other medicines for Parkinson’s disease
Your doctor will tell you if you need to change the dose of your apomorphine or
any of your other medicines.
If you are taking levodopa (another medicine for Parkinson’s disease) as well as
apomorphine your doctor should check your blood regularly.
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.

Using APO-go Ampoules with food and drink
Food and drink do not affect the way APO-go Ampoules will work.

Pregnancy and breast-feeding
APO-go Ampoules should not be used during pregnancy unless clearly necessary.
Check with your doctor or nurse before using APO-go Ampoules if you are pregnant,
think you may be pregnant or you are planning to become pregnant.
m1-3-2-leaflet-amps-UK

2) Ampoules with a complete ring(s):

–  ocate the ring(s) on the thinnest part of the neck.
L
This score is the breaking point of the ampoule.
–  old the bottom of the ampoule in one hand.
H
–  rasp the neck of the ampoule just above the ring as shown in the diagram.
G
–  pply pressure in a backward direction. This will snap off the top of
A
the ampoule.
–  arefully dispose of the top of the ampoule in a “Sharps” bin.
C
Once opened, APO-go Ampoules should be used immediately.

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Injecting APO-go Ampoules
UK/H/0342/002/IB/081-Response

Used syringes, needles
Apomorphine HCL Ampoule 10 mg/ml and ampoules should be discarded in a “Sharps” bin or2014
October




Place the needle firmly on the end of the syringe
W
 ithdraw the volume you require for your dose as advised by your
doctor or nurse
•  ou may need to dilute APO-go Ampoules before use. Your doctor or
Y
nurse will have told you if you need to do this and how to do it
• nject your medicine as shown by your doctor or nurse into an area
I
under the skin (subcutaneously)
•  iscard used syringes, needles and ampoules in a “Sharps” bin
D
(available from your doctor or pharmacist) or other suitable container,
such as an empty coffee jar
•  ake care not to splash any of the solution onto yourself or the carpet
T
as it may stain green.
If you have any further questions about the use of this medicine, ask your
doctor or nurse.

If you use more APO-go Ampoules than you should

−  your doctor or contact your nearest hospital emergency
Tell
department immediately
−  may experience a slow heart rate, excessive sickness, excessive
You
sleepiness and/or difficulty breathing. You may also feel faint or dizzy
particularly when you stand up, due to low blood pressure.
Lying down and raising your feet may help you to feel better.

If you forget to use APO-go Ampoules

Take it when you next require it. Do not take a double dose to make up
for a forgotten dose.

If you stop using APO-go Ampoules

Do not stop using APO-go Ampoules without first talking with your doctor.
If you have any further questions on the use of this medicine, ask your doctor,
nurse or pharmacist.

4. Possible side effects
Like all medicines, APO-go Ampoules can cause side effects, although not
everybody gets them.
If you experience an allergic reaction stop taking APO-go Ampoules and contact
a doctor or your nearest hospital emergency department immediately.
The signs of an allergic reaction may include:
• Rash
• Breathing difficulties
• Swelling of the face, lips, throat or tongue
APO-go Ampoules may sometimes cause the following:

Very common side effects (more than 1 user in 10):


L
 umps under the skin at the site of injection which are sore, troublesome and
may be red and itchy. In order to avoid getting these lumps, it is advisable to
change the site of injection every time you insert the needle.

Common side effects (1 to 10 users in 100):






F
 eeling sick or being sick, particularly when starting APO-go Ampoules.
If you are taking domperidone and still feel sick, or if you are not taking
domperidone and you feel sick, tell your doctor or nurse as soon as possible
Feeling tired or extremely sleepy
Confusion or hallucinations
Yawning
Feeling dizzy or light-headed when standing up.

Uncommon side effects (1 to 10 users in 1,000):










I
ncreased involuntary movements or increased shakiness during ‘on’ periods
H
 aemolytic anaemia, an abnormal breakdown of red blood cells in the blood
vessels or elsewhere in the body. This is an uncommon side effect that can
occur in patients also taking levodopa
Suddenly falling asleep
Rashes
Breathing difficulties
Injection site ulceration
R
 eduction in red blood cells which can make the skin pale yellow and
cause weakness or breathlessness
Reduction in blood platelets, which increases the risk of bleeding or bruising.

Rare side effects (1 to 10 users in 10,000):



An allergic reaction
E
 osinophilia, an abnormally high amount of white blood cells in the blood
or in body tissues.

Side effects with unknown frequency (frequency cannot be estimated
from the available data):

•  welling of the legs, feet or fingers
S
• nability to resist the impulse, drive or temptation to perform an action that
I
could be harmful to you or others, which may include:
S
m  trong impulse to gamble excessively despite serious personal
or family consequences.
Altered or increased sexual interest and behaviour of significant
m 
concern to you or to others, for example, an increased sexual drive.
m Uncontrollable excessive shopping or spending.
B
m  inge eating (eating large amounts of food in a short time period)
or compulsive eating (eating more food than normal and more than
is needed to satisfy your hunger).
T
 ell your doctor if you experience any of these behaviours; she or he will
discuss ways of managing or reducing the symptoms.
If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor, nurse or pharmacist.

5. How to Store APO-go Ampoules
Keep out of the reach and sight of children.
Do not use APO-go Ampoules after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in original carton to protect from light.
Once opened, APO-go Ampoules should be used immediately.
Do not use if the solution has turned green. It should only be used if the solution
is clear and colourless.
m1-3-2-leaflet-amps-UK

other suitable container, such as an empty coffee jar. When your “Sharps” bin or
container is full, please give it to your doctor or pharmacist for safe disposal.
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.

6. Further Information
What APO-go Ampoules contains
The active substance is apomorphine hydrochloride. Each millilitre of
APO-go Ampoules contains 10mg of apomorphine hydrochloride.
APO-go Ampoules is available in either 2ml ampoules containing 20mg of apomorphine
hydrochloride or 5ml ampoules containing 50mg of apomorphine hydrochloride.
APO-go Ampoules also contain:
− Sodium metabisulphite (E223)
− Hydrochloric acid, concentrated (or sodium hydroxide)
− Water for Injections
Refer to ‘Section 2: Information about the ingredients of APO-go Ampoules’ regarding
sodium metabisulphite.

What APO-go Ampoules looks like and contents of the pack
APO-go Ampoules is a solution for injection or infusion. The solution is clear
and colourless.
Glass ampoules containing 2ml Solution for Injection or Infusion, in packs of 5 ampoules.
Glass ampoules containing 5ml Solution for Injection or Infusion, in packs of 5 ampoules.
The ampoules are contained in a plastic tray within a cardboard carton.
There are two types of ampoules:
An ampoule with a coloured spot (partially scored)
An ampoule with a ring around the thinnest part of the neck (fully scored).
Bundle packs of 25 and 50 ampoules are available in some territories.
The 25 ampoule bundle pack consists of 5 packs each containing 5 ampoules.
The 50 ampoule bundle pack consists of 10 packs each containing 5 ampoules.
Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Genus Pharmaceuticals
Park View House, 65 London Road, Newbury, Berkshire RG14 1JN, United Kingdom.

Manufacturer(s)
Kern Pharma S.L., Pol. Ind. Colon II, E-08228, Terrassa (Barcelona), Spain
or Laboratoire Aguettant,
1 Rue Alexander Fleming, BP 7144, 69353 Lyon, Cedex 07, France
or Britannia Pharmaceuticals Ltd,
Park View House, 65 London Road, Newbury, Berkshire RG14 1JN, United Kingdom
or  TADA Arzneimittel AG,
S
Stadastraße 2 – 18, 61118 Bad Vilbel, Germany

Distributor in the UK

Genus Pharmaceuticals
Park View House, 65 London Road, Newbury, Berkshire RG14 1JN, United Kingdom

Distributor in Ireland

Clonmel Healthcare Ltd, Waterford Road , Clonmel, County Tipperary, Ireland

This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria, Germany,
Switzerland:
Belgium:

APO-go® Ampullen 10 mg/ml
Injektions-/Infusionslösung


APO-GO-AMP® 10mg/ml oplossing voor injectie of infusie

Bulgaria:



А
 ПО-го® Ампули 10mg/ml
инжекционен или инфузионен разтвор

Czech Republic:  RITAJECT Ampule 10mg/ml Injekční/infuzní roztok
B
Denmark:


Apo-go Ampul injektionsvæske, opløsning 10mg/ml

Estonia: 
APO-go 10 MG/ML, süste-või infusioonilahus
France: 
APOGO 10mg/ml solution injectable/pour perfusion
Hungary:

B
 RITAJECT 10mg/ml oldatos injekció vagy infúzió

Ireland, UK:  PO-go Ampoules 10mg/ml Solution for Injection or Infusion
A
Lithuania:

Britaject 10 mg/ml injekcinis/infuzinis tirpalas

Luxembourg: 
APO-go® Ampoules 10mg/ml
Solution Injectable/ pour Perfusion
Netherlands: 
APO-go Ampullen 10mg/ml Oplossing voor injectie of infusie
Poland: 
APO-go Ampoules, 10 mg/ml,
roztwór do wstrzykiwań lub infuzji
Portugal:

A
 po-go 10mg/ml Solução injectável ou para perfusão

Romania:

APO-go 10 mg/ml soluţie injectabilă/perfuzabilă

Slovak Republic:

APO-go® 10 mg/ml injekčný alebo infúzny roztok

Slovenia:

A
 PO-go 10 mg/ml raztopina za injiciranje
ali infundiranje v ampuli

Spain:

A
 PO-go 10 mg/ml
Solución Inyectable o para Perfusión en Ampollas

Sweden:

APO-go 10mg/ml injetionsvätska, lösning

This leaflet was last revised in 09/2014
I
f this leaflet is difficult to see or read and you would like it in a different format,
please contact Genus Pharmaceuticals, Park View House, 65 London Road,
Newbury, Berkshire RG14 1JN, United Kingdom.

UK-IRL XXX.H / 9244195 XXXX

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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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