APO-GO PEN 10MG/ML SOLUTION FOR INJECTION

Active substance: APOMORPHINE HYDROCHLORIDE

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PACKAGE LEAFLET: Information for the User
APO-go® PEN
10 mg/ml Solution for Injection *
Apomorphine hydrochloride
* Abbreviated to APO-go® Pen in the text
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. What APO-go Pen is and what it is used for
2. Before you use APO-go Pen
3. How to use APO-go Pen
4. Possible side effects
5. How to store APO-go Pen
6. 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 10 mg of apomorphine in each millilitre of solution.
Apomorphine hydrochloride belongs to a group of medicines known as dopamine agonists.
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.
2. Before you use APO-go Pen
Do not use APO-go Pen:
- if you are under 18 years of age
- if you have breathing difficulties
- if you have dementia or Alzheimer’s disease
- if you suffer from a mental illness with symptoms such as hallucinations, delusions,
disordered thoughts, loss of contact with reality
- if you have liver problems
- if you have severe dyskinesia (involuntary movements) or severe dystonia (inability to move)
despite taking levodopa
- if you are allergic to apomorphine or any of the other ingredients of APO-go Pen (for other
ingredients, see section 6).
- If you or someone in your family are known to have an abnormality of electrocardiogram
(ECG) called “long QT syndrome”. Tell your doctor.

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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
- if you have low blood pressure or feel faint or dizzy when you stand
- if you are taking any medicines to treat high blood pressure
- if you feel sick or suffer from being sick
- if your Parkinson’s disease causes certain mental problems such as hallucinations and
confusion
- if you are elderly or frail.
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.
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:




Medicines such as clozapine to treat 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 medicine,
including medicines obtained without a prescription.
Taking APO-go with food and drink
Food and drink do not affect the way APO-go Pen will work.
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.
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.

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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 taking any medicine.
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.
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.
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.
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.
Domperidone should be taken at least 2 days before APO-go Pen is started to stop you feeling
or being sick.
Do not use APO-go Pen if:
- The solution has turned green
- The solution is cloudy or you can see particles in it
Where to inject APO-go Pen
• Inject APO-go Pen into an area under the skin (subcutaneously) as shown by your doctor
or nurse.
• Do not inject APO-go Pen into a vein.
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.
-

The usual daily dose is between 3 mg and 30 mg
You may need as much as 100 mg per day
Typically you will need between 1 and 10 injections per day
Each single injection should not be more than 10 mg.

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

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1) Dosage dial
7) Arrow showing the dosage selected
8) Numbers indicating the dose per injection (1-10 mg)

9) Graduations (in mg) on the cartridge showing total
amount of apomorphine in the Pen.
4) Membrane
10) Needle*
6) Needle protector*

3) Outer sleeve of Pen

2) Needle in sealed unit* containing
10) needle,
6) needle protector
5) protective cone

* This pack does NOT contain needles for use with your Pen.
Use pen needles not more than 12mm (½”) in length and not finer than 0.33mm (29 G). Pen
needles recommended for use with insulin pens are compatible with APO-go® Pen.
IMPORTANT: Do not pull the red capped dosage dial (see 1) before you have set the
dosage (see ‘Selecting the correct dosage’).
Attaching the needle
(a) Before using APO-go Pen you will need some surgical wipes and one needle in its protective
cone (see 2).
(b) Take the Pen out of its box and remove the outer sleeve (see 3).

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

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

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

(f) Screw the cone (see 2) clockwise onto the membrane until it is tight. This securely attaches
the needle.
(g) Remove the protective cone (see 5), but do not throw it away. Do not remove the needle
protector (see 6) at this stage.

(h) Replace the Pen’s outer sleeve (see 3).
Selecting the correct dose
(i) Press the red capped 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

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pressure on the red capped dial. The dose is now set and you do not need to redial for
subsequent injections.

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.
If your dose is 1 mg, start by emptying a 1 mg 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 1 mg, you do not need to prime the Pen.
Injecting
(j) Once you have set the dose, gently pull out the red capped dosage dial as far as it will go.
Check the red scale on the plunger (see 9) and inject only if the line that is just visible matches
the intended dose.

(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).
(m) Remove the needle protector (see 6).

(n) Insert the needle (see 10) into the skin as shown by your doctor.
(o) To inject, press the red capped dosage dial (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.

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

Preparing for the next injection
(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.
(r) If there is not enough apomorphine left for another injection, prepare another pen.
(s) Finally, replace the outer sleeve of your Pen.

If you use more APO-go Pen than you should
− Tell your doctor or contact your nearest hospital emergency department immediately
− You may experience a slow heart rate, 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.
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.
If you stop using APO-go Pen
Do not stop using APO-go Pen 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 Pen can cause side effects, although not everybody gets them.

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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
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 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 (affect less than 1 in 10 people)
• Feeling sick or being sick, particularly when 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
• Feeling tired or extremely sleepy
• Confusion or hallucinations.
• Yawning
• Dizziness or light-headedness when standing up
Uncommon side effects (affect less than 1 in 100 people)
• Increased involuntary movements or increased shakiness during ‘on’ periods
• Haemolytic 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
• Reduction 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 (affect less than 1 in 1000 people)
• An allergic reaction
• Eosinophilia, an abnormally high amount of white blood cells in the blood or in body tissues.
Side effects occuring in an unknown number of users:
• Swelling of the legs, feet or fingers.
• Inability to resist the impulse, drive or temptation to perform an action that could be harmful
to you or others, which may include:
o Strong impulse to gamble excessively despite serious personal or family
consequences.
o Altered or increased sexual interest and behaviour of significant concern to you or
to others, for example, an increased sexual drive.
o Uncontrollable excessive shopping or spending.
o Binge 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).

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Tell your doctor if you experience any of these behaviors; she or he will discuss ways
of managing or reducing the symptoms.
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 {to be completed
nationally: the national reporting system listed in Appendix V}. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store APO-go Pen
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.
Do not use APO-go Pen after the expiry date stated on the label and carton. The expiry date
refers to the last day of that month.
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.
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.
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.
6. Further information
What APO-go Pen contains
The active substance is apomorphine hydrochloride. Each milliliter of APO-go Pen contains 10
mg of apomorphine hydrochloride. Each APO-go Pen contains 3 ml of solution for injection.
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.
What APO-go Pen looks like
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.
Contents of the pack
Packs contain 1, 5 or 10 pens in a moulded plastic tray in an outer cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
To be completed nationally.

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

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OR

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

OR
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Distributor in 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:
APO-go Pen 10mg/ml – Injektionslösung
Belgium:
Britaject PEN 10 mg/ml Solution injectable
Bulgaria:
APO-go PEN 10mg/ml Разтвор за инжектиране
Cyprus:
APO-go Στυλεοφόρος συσκευή 10mg/ml
Czech Republic:
Britaject PEN 10 mg/ml injekční roztok
Denmark:
APO-go Pen 10mg/ml Injektionsvǽske, oplǿsning
Estonia:
APO-go, 10 mg/ml süstelahus pen-süstlis
Finland:
Apogo PEN 10 mg/ml injektioneste, liuos
Greece:
APO-go Σνσκενή Τνπον Στνλό (Pen)
Hungary:
Britaject PEN 10 mg/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 10mg/ml Solution Injectable
Poland:
APO-go PEN, 10 mg/ml, roztwór do wstrzykiwań
Netherlands:
APO-go Pen, Oplossing Voor injectie 10mg/ml
Norway:
Britaject 10 mg/ml injeksjonsvæske, oppløsning i ferdigfylt penn
Portugal:
APO-go Pen 10 mg/ml Solução injectável
Romania:
APO-go 10 mg/ml soluţie injectabilă în pen multidoză
Slovak Republic:
APO-go 10 mg/ml injekčný roztok naplnený v pere
Slovenia:
APO-go 10 mg/ml raztopina za injiciranje v peresniku
Spain:
APO-go Pen 10 mg/ml Solución inyectable
Sweden:
APO-go Pen 10 mg/ml Injektionsvätska, lösning
This leaflet was last revised in June 2013.

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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.

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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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