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APO-GO PEN 10MG/ML SOLUTION FOR INJECTION

Active substance: APOMORPHINE HYDROCHLORIDE

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UK/H/0342/001/IB/076Apomorphine HCL 10 mg/ml

September 2013

*

PACKAGE LEAFLET:

Information for the User

mock up pen carton label
* Abbreviated to APO-go® Pen in the text

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UK/H/0342/001/IB/076Apomorphine HCL 10 mg/ml

September 2013

Read all of this leaflet carefully before you
start using this medicine.
- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your

doctor, nurse or pharmacist.
- 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.
- 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.

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

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

1. What APO-go Pen is and what it is used for

APO-go Pen contains apomorphine solution
for injection. It is injected into the area under
the skin (subcutaneously). The active ingredient
in APO-go Pen is apomorphine hydrochloride.
There is 10mg of apomorphine in each millilitre
of solution.

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 your Parkinson’s disease causes certain
if
Apomorphine hydrochloride belongs to a group
mental problems such as hallucinations
of medicines known as dopamine agonists.
UK/H/0342/001/IB/076Apomorphine HCL 10 mg/ml
September 2013
and confusion
APO-go Pen is used to treat Parkinson’s disease.
– if you are elderly or frail.
Apomorphine helps to reduce the amount of time
spent in an “off” or immobile state in people who
Tell your doctor if you or your family/carer
have been previously treated for Parkinson’s
notices that you are developing urges or cravings
disease with levodopa and/or other dopamine
to behave in ways that are unusual for you and
agonists. Your doctor or nurse will help you to
you cannot resist the impulse, drive or temptation
recognise the signs of when to use your medicine.
to carry out certain activities that could harm
Despite the name, apomorphine does not
yourself or others. These are called impulse
contain morphine.
control disorders and can include behaviours
such as addictive gambling, excessive eating
or spending, an abnormally high sex drive or
2. Before you use APO-go Pen
an increase in sexual thoughts or feelings.
Do not use APO-go Pen:
Your doctor may need to adjust or stop your dose.
– f you are under 18 years of age
i
Check with your doctor or pharmacist before
– f you have breathing difficulties
i
taking your medicine if: You are using medicines
– f you have dementia or Alzheimer’s disease
i
– f you suffer from a mental illness with
i
that are known to affect the way your heart beats.
symptoms such as hallucinations, delusions,
This includes medicines used for heart rhythm
disordered thoughts, loss of contact with reality
problems (such as quinidine and amiodarone),
– f you have liver problems
i
for depression (including tricyclic antidepressants
– f you have severe dyskinesia (involuntary
i
such as amitriptyline and imipramine) and for
movements) or severe dystonia (inability to
bacterial infections (‘macrolide’ antibiotics such
move) despite taking levodopa
as erythromycin, azithromycin and clarithromycin)
– f you are allergic to apomorphine or any of
i
and domperidone.
the other ingredients of APO-go Pen (for other
Taking other medicines
ingredients, see section 6)
If you use APO-go Pen with other medicines
– f you or someone in your family are known to
i
the effect of those medicines may be altered.
have an abnormality of electrocardiogram (ECG)
This is particularly true for:
called “long QT syndrome”. Tell your doctor.
–  edicines such as clozapine to treat
M
Take special care with APO-go Pen
mental disorders
Please inform your doctor, nurse or pharmacist:
– Medicines to lower your blood pressure
– if you have kidney problems
– Other medicines for Parkinson’s disease.
– if you have lung problems
Your doctor will tell you if you need to change
– if you have heart problems
the dose of your apomorphine or any of your
– f you have low blood pressure or feel faint
i
other medicines.
or dizzy when you stand
If you are taking levodopa (another medicine
– f you are taking any medicines to treat high
i
for Parkinson’s disease) as well as apomorphine
blood pressure
mock up or suffer from being
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your doctor should check your blood regularly.
– if you feel sick pen carton label sick
1

Please tell your doctor or pharmacist if you are
If you experience these side effects, immediately
taking or have recently taken any other medicine, HCL to the nearest hospital September 2013
casualty department.
UK/H/0342/001/IB/076Apomorphine go 10 mg/ml
including medicines obtained without a prescription.
APO-go Pen contains less than 1 mmol (23mg)
of sodium per 10ml, i.e. essentially sodium free.
Taking APO-go with food and drink
Food and drink do not affect the way APO-go Pen
will work.

3. How to use APO-go Pen
Always use APO-go Pen exactly as your doctor
has told you. You should check with your doctor,
nurse or pharmacist if you are not sure.

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

Domperidone should be taken at least 2 days
before APO-go Pen is started to stop you feeling
or being sick.

It is not known whether APO-go Pen is transferred
to breast milk. Talk to 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.

Do not use APO-go Pen if:

Ask your doctor or pharmacist for advice before
taking any medicine.

(subcutaneously) as shown by your doctor
or nurse.
• Do not inject APO-go Pen into a vein.

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

Where to inject APO-go Pen
• nject APO-go Pen into an area under the skin
I

Driving and using machines
APO-go Pen can cause drowsiness and a strong
desire to sleep. Do not drive or use any tools or
machinery if APO-go Pen affects you in this way.

How much to use
The amount of APO-go Pen you should use and
how often to use it will depend upon your personal
needs. Your doctor will discuss this with you and
tell you how much of your medicine to use. The
amount that will work best for you will have been
determined on your visit to the specialist clinic.
–  he usual daily dose is between 3mg and 30mg
T
– You may need as much as 100mg per day
–  ypically you will need between 1 and 10
T
injections per day
–  ach single injection should not be more than
E
10mg.

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 Pen
APO-go Pen contains sodium bisulphite which
rarely can cause a severe allergic reaction with
symptoms such as rash or itchy skin, difficulty
mock up pen carton label
breathing, puffiness of the eyelids, face or lips,
swelling or redness of the tongue.

Before using APO-go Pen, study the diagram below
and your Pen to familiarise yourself with your medicine.
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2

UK/H/0342/001/IB/076Apomorphine HCL 10 mg/ml

September 2013

1) Dosage dial

Instructions for Use
7)  rrow showing
A
the dosage selected

8)  umbers indicating
N
the dose per injection
(1–10mg)

9) Graduations (in mg) on
the cartridge showing
total amount of
apomorphine in the Pen.
4) Membrane

3) Outer sleeve of Pen

10) Needle*

6)  eedle
N
protector*
*This pack does NOT contain
needles for use with your Pen.
Use pen needles not more than
12mm (1⁄2”) in length and not
finer than 0.33mm (29G).
Pen needles recommended
for use with insulin pens are
compatible with APO-go® Pen.

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2)  eedle in sealed unit*
N
containing
10) needle
6) needle protector
5 of
5) protective cone 12

(f) 
Screw the cone (see 2) clockwise onto the
Read these instructions carefully
UK/H/0342/001/IB/076Apomorphine HCL membrane until it is tight. This securely
10 mg/ml
September 2013
attaches the needle.
IMPORTANT: Do not pull the red capped

How to use your APO-go Pen

dosage dial (see 1) before you have set the
dosage (see “Selecting the correct dose”).

(g)  emove the protective cone
R
(see 5), but do not throw
it away. Do not remove the
needle protector (see 6)
at this stage.

Attaching the needle
(a)  efore using APO-go Pen you will need
B
some surgical wipes and one needle in
its protective cone (see 2).

(h)  eplace the pen’s outer sleeve (see 3).
R

(b)  ake the Pen out of its box and remove
T
the outer sleeve (see 3).

Selecting the correct dose
(i)  ress the red capped
P
dosage dial (see 1) and
whilst holding it down,
turn the dial clockwise
until the arrow points to
the dose your doctor
chose for you (see 7 & 8).
Release the downward
pressure on the red capped dial. The dose
is now set and you do not need to redial for
subsequent injections.

(c)  ipe the membrane
W
of the Pen (see 4)
with a surgical wipe.



(d)  eel off the paper from
P
the needle cone (see 2).

Important: If you pass your prescribed dose
while turning the dial, just continue pressing
and turning in the same direction until the
arrow points to the dose your doctor chose
for you. Never pull and turn the red capped
dosage dial at the same time.

 your dose is 1mg, start by emptying a 1mg
If
dose onto a paper tissue and discarding it.
This is called ‘priming’ and is important because
it ensures you get a full dose the first time you
use your Pen. Then, set the dose you require
for injection and inject it in the usual way (see
“Injecting”). If the first dose required is more
than 1mg, you do not need to prime the Pen.

(e) t is important to bring the needle to the Pen
I
in a straight line, as shown above. This will
attach the needle securely. If the needle is
presented at an angle it may cause the Pen
to leak.

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4

Injecting

Preparing for the next injection

(q) 10 mg/ml
(j) UK/H/0342/001/IB/076Apomorphine HCL Remove the outer sleeve of the Pen and check
Once you have set the dose,
September 2013
gently pull out the red capped
there is enough apomorphine left in the cartridge
dosage dial as far as it will go.
for your next injection. If there is, put a new
needle in place in the same way as before.
 the red scale on the
Check
plunger (see 9) and inject only
(r)  there is not enough apomorphine left for
If
if the line that is just visible
another injection, prepare another Pen.
matches the intended dose.
(s) 
Finally, replace the outer sleeve of your Pen.
(k) 
Using a surgical wipe, clean the area of skin
where you plan to inject the medicine and
around it.
(l) 
Remove the Pen’s outer sleeve
(see 3).

If you use more APO-go Pen than
you should

(m)  emove the needle protector
R
(see 6).

−  ell your doctor or contact your nearest
T
hospital emergency department immediately

(n) 
Insert the needle (see 10)
into the skin as shown by
your doctor.

−  ou may experience a slow heart rate,
Y
excessive sickness, excessive 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 will help you feel better.

(o)  inject, press the red capped dosage dial
To
(see 1) down as far as it will go, using your
thumb if possible. Once the red capped dosage
dial is fully depressed, count to three before
withdrawing the needle.

If you forget to use APO-go Pen
Use it when you next require it. Do not use a
double dose to make up for a forgotten dose.

(p) 
Replace the protective cone (see 5) onto the used
needle and push gently into place. Once secure,
turn the needle anti-clockwise to unscrew it.

If you stop using APO-go Pen
Do not stop using APO-go Pen without first
talking with your doctor.


Keep the needle in its protective cone and
discard it in a safe place, such as a “Sharps” bin
or an empty coffee jar.

If you have any further questions on the use of this
medicine, ask your doctor, nurse or pharmacist.

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5

4. Possible side effects

• Breathing difficulties

Like all medicines, APO-go Pen can cause side
effects, although not everybody gets them.

•  eduction in red blood cells which can make
R
the skin pale yellow and cause weakness
or breathlessness
• Reduction in blood platelets, which increases

the risk of bleeding or bruising

• 10 mg/ml
UK/H/0342/001/IB/076Apomorphine HCLInjection site ulceration September 2013

If you experience an allergic reaction stop taking
APO-go Pen 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

Rare side effects (affect less than
1 in 1000 people)
• An allergic reaction
•  osinophilia, an abnormally high amount
E
of white blood cells in the blood or in
body tissues.

APO-go Pen may sometimes cause the following:

Very common side effects (affect more than
1 in 10 people)
• Lumps under the skin at the site of injection


Side effects occurring in an unknown
number of users:

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.

•  welling of the legs, feet or fingers
S
• Inability to resist the impulse, drive or temptation
to perform an action that could be harmful to you
or others, which may include:
m  trong impulse to gamble excessively despite
S
serious personal or family consequences.
m 
Altered or increased sexual interest and
behaviour of significant concern to you or to
others, for example, an increased sexual drive.
m Uncontrollable excessive shopping or spending.
m  inge eating (eating large amounts of food in
B
a short time period) or compulsive eating
(eating more food than normal and more
than is needed to satisfy your hunger).

Common side effects (affect less than
1 in 10 people)
•  eeling sick or being sick, particularly when
F
starting APO-go Pen. 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
•  eeling tired or extremely sleepy
F
• Confusion or hallucinations
• Yawning
• Feeling dizzy or light-headed when standing up.

Tell your doctor if you experience any of these

behaviours; she or he will discuss ways of
managing or reducing the symptoms.

Uncommon side effects (affect less than
1 in 100 people)
• ncreased involuntary movements or increased
I
shakiness during ‘on’ periods
•  aemolytic anaemia, an abnormal breakdown of
H
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
mock up pen carton label
• Suddenly falling asleep
• Rashes

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
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By reporting side effects you can help8provide
more information on the safety of this medicine.
6

5. How to store APO-go Pen

What APO-go Pen looks like

Keep out of the reach and sight of children.
Do not store above 25°C. Keep the container in
the outer carton to protect from light. Store at
the same conditions after opening and between
withdrawals.

injector system with a clear glass cartridge
containing the apomorphine solution for injection.
The solution is clear, practically colourless,
odourless and free from visible particles.

Do not use APO-go Pen after the expiry date stated
on the carton and label. The expiry date refers to
the last day of that month.

Packs contain 1, 5 or 10 pens in a moulded
plastic tray in an outer cardboard carton.
Not all pack sizes may be marketed.

APO-go Pen is a
UK/H/0342/001/IB/076Apomorphine HCL 10 mg/ml disposable multiple dose Pen
September 2013

Contents of the pack

When you start using a new APO-go Pen, it can
be used for up to 48 hours. Do not re-use your
APO-go Pen after this time. Use a new Pen.

Marketing Authorisation Holder
and Manufacturer
Britannia Pharmaceuticals Ltd.
Park View House, 65 London Road
Newbury, Berkshire RG14 1JN, United Kingdom

To dispose of your Pens safely, always remove
the needle from the Pen before discarding it in a
“Sharps” bin or other suitable container such as
an empty coffee jar.

Manufacturer(s)
Laboratoire Aguettant
1 Rue Alexander Fleming
Boite Postale 7144
69353 Lyon, Cedex 07, France

When your “Sharps” bin or container is full,
please give it to your doctor or pharmacist for
safe disposal. If the Pen is completely empty you
may dispose of it in your household waste. If the
Pen contains some apomorphine, please return it
to your pharmacist.

OR

6. Further information

STADA Arzneimittel AG
Stadastraße 2 – 18
61118 Bad Vilbel, Germany

What APO-go Pen contains

Distributor in the UK

The active substance is apomorphine
hydrochloride. Each millilitre of APO-go Pen
contains 10mg of apomorphine hydrochloride.
Each APO-go Pen contains 3ml of solution for
injection.

Distributor in Ireland

Britannia Pharmaceuticals Ltd.
Park View House, 65 London Road
Newbury, Berkshire RG14 1JN, United Kingdom
Clonmel Healthcare Ltd.
Waterford Road
Clonmel
County Tipperary, Ireland

Each APO-go Pen also contains:
− Sodium bisulphite (E222)
− Hydrochloric acid (37%)
− Water for Injections.
Refer to ‘Section 2: Information about the ingredients
mock up pen carton label
of APO-go Pen’ regarding sodium bisulphite.

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7



This medicinal product is authorised in the
Poland: 
APO-go PEN, 10 mg/ml,
Member States of the EEA under the
UK/H/0342/001/IB/076Apomorphine HCL 10 mg/ml roztwór do wstrzykiwań
September 2013
following names:
Netherlands: 
APO-go PEN Oplossing
voor injectie 10 mg/ml

Austria, Germany, APO-go PEN 10 mg/ml
Switzerland:
Injektionslösung
Belgium: 
APO-GO-PEN® 10mg/ml
oplossing voor injectie

Norway: 
Britaject 10mg/ml
injeksjonsvæske,
oppløsning i ferdigfylt penn

Bulgaria: 
АПО-го® ПИСАЛКА 10mg/ml
Инжекционен разтвор

Portugal: 
APO-go Pen 10 mg/ml
Solução injectável

Cyprus: APO-go Στυλεοφόρος συσκευή
10 mg/ml Ενέσιμο Διάλυμα

Romania: APO-go 10 mg/ml soluţie
injecţabilă în pen multidoză

Czech Republic: 
BRITAJECT PEN 10 mg/ml
Injekční Roztok

Slovak Republic: 
APO-go 10 mg/ml injekčný
roztok naplnený v pere

Denmark: 
APO-go PEN 10 mg/ml
injektionsvæske, opløsning

Slovenia: 
APO-go 10 mg/ml raztopina
za injiciranje v peresniku

Estonia: 
APO-go 10 mg/ml
süstelahus pen-süstlis

Spain: 
APO-go PEN 10 mg/ml
Solución inyectable

Finland: 
Apogo PEN 10 mg/ml
injektioneste, liuos

Sweden: 
APO-go PEN 10 mg/ml
injektionsvätska, lösning

Greece: APO-go Στυλεοφόρος συσκευή
10 mg/ml Ενέσιμο Διάλυμα
Hungary: 
Britaject Pen 10mg/ml
oldatos injekció
Iceland: 
APO-go PEN 10 mg/ml
stungulyf, lausn
Ireland, Malta,
UK:

APO-go Pen 10mg/ml
Solution for Injection

Latvia: 
APO-go PEN 10 mg/ml
šķīdums injekcijām
Lithuania: 
Britaject 10 mg/ml
injekcinis tirpalas
Luxembourg: APO-go® PEN 10 mg/ml
Solution Injectable

This leaflet was last revised in
December 2014.

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8

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UK/H/0342/001/IB/076Apomorphine HCL 10 mg/ml

September 2013

If this leaflet is difficult to see or
read and you would like it in a
different format, please contact
Britannia Pharmaceuticals Ltd.

mock up pen carton label
XXXXXX

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UK-IRL-MT 017 / 9243356 XXXX

UK/H/0342/001/IB/076Apomorphine HCL 10 mg/ml

mock up pen carton label

September 2013

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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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