APO-GO PEN 10MG/ML SOLUTION FOR INJECTION

Active substance: APOMORPHINE HYDROCHLORIDE

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UK/H/0342/001/081-Response
Apomorphine HCL 10 mg/ml

October 2014

*

PACKAGE LEAFLET:

Information for the User

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* Abbreviated to APO-go® Pen in the text

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UK/H/0342/001/081-Response
Apomorphine HCL 10 mg/ml

October 2014

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.  hat APO-go Pen is and what it is used for
W
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
mental problems such as hallucinations
and confusion
– if you are elderly or frail.

Apomorphine hydrochloride belongs to a group
of medicines known as dopamine agonists.
UK/
APO-go Pen is used to treat Parkinson’s disease.
Apomorphine helps to reduce the amount of time
spent in an “off” or immobile state in people who
have been previously treated for Parkinson’s
disease with levodopa 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.

Tell 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.

2. Before you use APO-go Pen
Do not use APO-go Pen:

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

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.

Taking other medicines
If you use APO-go Pen with other medicines
the effect of those medicines may be altered.
This is particularly true for:
M
–  edicines such as clozapine to treat
mental disorders
– Medicines to lower your blood pressure
– Other medicines for Parkinson’s disease.

Take special care with APO-go Pen
Please inform your doctor, nurse or pharmacist:
– if you have kidney problems
– if you have lung problems
– if you have heart problems
– f you have low blood pressure or feel faint
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or dizzy when you stand
– f you are taking any medicines to treat high
i
blood pressure
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– if you feel sick or suffer from being sick

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.3 of 13
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Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicine,
including medicines obtained without a prescription.

If you experience these side effects, immediately
go to the nearest hospital casualty department.
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
T
–  he solution is cloudy or you can see
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
E
–  ach single injection should not be more than
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
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.
2

UK/H/0342/001/081-Response
Apomorphine HCL 10 mg/ml

October 2014

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
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5) protective cone 13

(f) crew the cone (see 2) clockwise onto the
S
membrane until it is tight. This securely
attaches the needle.

How to use your APO-go Pen
Read these instructions carefully
UK/H/0342/001

IMPORTANT: Do not pull the red capped
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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Injecting

Preparing for the next injection

 the red scale on the
Check
plunger (see 9) and inject only
if the line that is just visible
matches the intended dose.

(r)  there is not enough apomorphine left for
If
another injection, prepare another Pen.

(q) 
Remove the outer sleeve of the Pen and check
there is enough apomorphine left in the cartridge
for your next injection. If there is, put a new
needle in place in the same way as before.

(j) 
Once you have set the dose,
gently pull out the red capped
dosage dial as far as it will go.

Finally, replace the outer sleeve of your Pen.
(s) 

(k) 
Using a surgical wipe, clean the area of skin
where you plan to inject the medicine and
around it.
Remove the Pen’s outer sleeve
(l) 
(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

Insert the needle (see 10)
(n) 
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.

Replace the protective cone (see 5) onto the used
(p) 
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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4. Possible side effects

• Breathing difficulties
• Injection site ulceration
•  eduction in red blood cells which can make
R
the skin pale yellow and cause weakness
or breathlessness
R
•  eduction in blood platelets, which increases
the risk of bleeding or bruising

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

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 help provide13
more information on the safety of this medicine.
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What APO-go Pen looks like

5. How to store APO-go Pen

APO-go Pen is a disposable multiple dose Pen
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.

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.

Contents of the pack

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.

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
for UK and Ireland
Genus Pharmaceuticals
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.

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

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.

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

6. Further information

OR

What APO-go Pen contains

Laboratoire Aguettant
1 Rue Alexander Fleming
Boite Postale 7144
69353 Lyon, Cedex 07, France

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.

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

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

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Distributor in the UK

Iceland: 
APO-go PEN 10 mg/ml
stungulyf, lausn

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

Ireland, Malta,
UK:

Distributor in Ireland

APO-go Pen 10mg/ml
Solution for Injection

Clonmel Healthcare Ltd
Waterford Road
Clonmel
County Tipperary, Ireland

Latvia: 
APO-go PEN 10 mg/ml
šķīdums injekcijām

This medicinal product is authorised in the
Member States of the EEA under the
following names:

Luxembourg: APO-go® PEN 10 mg/ml
Solution Injectable

Lithuania: 
Britaject 10 mg/ml
injekcinis tirpalas

Poland: 
APO-go PEN, 10 mg/ml,
roztwór do wstrzykiwań

Austria, Germany, APO-go PEN 10 mg/ml
Switzerland:
Injektionslösung

Netherlands: 
APO-go PEN Oplossing
voor injectie 10 mg/ml

Belgium: 
APO-GO-PEN® 10mg/ml
oplossing voor injectie
АПО-го® ПИСАЛКА 10mg/ml
Bulgaria: 
Инжекционен разтвор

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

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

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

Czech Republic: 
BRITAJECT PEN 10 mg/ml
Injekční Roztok

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

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

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

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

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

Finland: 
Apogo PEN 10 mg/ml
injektioneste, liuos

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

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

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

Hungary: 
Britaject Pen 10mg/ml
oldatos injekció

This leaflet was last revised in

September 2014.

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

XXXXXX

UK-IRL-MT XXX / 9243356 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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