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DUODOPA 20MG/ML + 5MG/ML INTESTINAL GEL

Active substance(s): CARBIDOPA / LEVODOPA

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Prepared by AbbVie Graphics
Date Prepared: 30-MAY-2016

CR Number: CR-0000644-2016

Lake County

X Ludwigshafen

Commodity Number: FGG 2000 01-58-04-018J

List Number:W152

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Package leaflet: Information for the user

®

20 mg/ml + 5 mg/ml, intestinal gel
levodopa and carbidopa monohydrate
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
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Signature:

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What is in this leaflet:
1. What Duodopa is and what it is used for
2. What you need to know before you use Duodopa
3. How to use Duodopa
4. Possible side effects
5. How to store Duodopa
6. Contents of the pack and other information

1. What Duodopa is and what it is used for
Duodopa belongs to a group of medicines for Parkinson’s
disease.
Duodopa is a gel that goes through a pump and a tube
into your gut (small intestine). In the gel there are two
active substances:
• Levodopa.
• Carbidopa.
How Duodopa works
• In the body, levodopa is made into something called
‘dopamine’. This adds to the dopamine already in your
brain and spinal cord. Dopamine helps transfer signals
between nerve cells.
• Too little dopamine causes Parkinson’s disease signs
like tremor, feeling stiff, slow movement, and problems
keeping your balance.
• Treatment with levodopa increases the amount of
dopamine in your body. This means it reduces these
signs.
• Carbidopa improves the effect of levodopa. It also
reduces the side effects of levodopa.
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2. What you need to know before you use
Duodopa
Do not use Duodopa if:
• You are allergic to levodopa, carbidopa or any of the
other ingredients of this medicine (listed in section 6).
• You have an eye problem called ‘narrow-angle
glaucoma’.
• You have severe heart problems.
• You have a severe uneven heart beat (arrhythmia).
• You have had a severe stroke.
• You are taking medicines for depression called selective
MAO-A inhibitors and non-selective MAO-inhibitors
such as moclobemide or phenelzine.
• You have a tumour of the adrenal gland
(pheochromocytoma).
• You have hormone problems such as too much cortisol
(Cushing’s syndrome) or your thyroid hormone levels
are too high (hyper-thyroidism).
• You have ever had skin cancer, or you have any
unusual moles or marks on your skin which have not
been looked at by your doctor.
Do not use Duodopa if any of the above apply to you.
If you are not sure, talk to your doctor before having
Duodopa.

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Warnings and precautions:
Talk to your doctor before using Duodopa if:
• You have ever had a heart attack, blocked blood
vessels in your heart, or any other heart problems
including an uneven heart beat (arrhythmia).
• You have a lung problem – such as asthma.
• You have ever had a hormone problem.
• You have ever had depression with thoughts of suicide
or any other mental problems.
• You have an eye problem called ‘wide-angle glaucoma’.
• You have ever had a stomach ulcer.
• You have ever had fits (convulsions).
• You have ever had surgery in your upper stomach area
(upper abdominal surgery).
If any of the above apply to you (or you are not sure), talk
to your doctor before having Duodopa.
Look out for side effects
Neuroleptic Malignant Syndrome
Do not stop having Duodopa or lower your dose
unless a doctor tells you to. This is because suddenly
stopping or lowering your Duodopa dose quickly may
cause a serious problem called ‘Neuroleptic Malignant
Syndrome’ (see section 4 ‘Serious side effects’).
Feeling sleepy or dizzy
If you suddenly fall asleep (sleep attacks) or feel very
sleepy, or if you feel light-headed or dizzy:
• Do not drive or use any tools or machines until you
feel fully awake again or you no longer feel lightheaded or dizzy (see section 2 ‘Driving and using
machines’).
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Skin changes
Tell your doctor, pharmacist or nurse if you notice any
unusual marks or moles on your skin that appear or get
worse (see section 4 ‘Other side effects’).
Impulse control disorders – changes in your
behaviour
Tell your doctor if you, your family or carer notices you
are developing urges or cravings to behave in ways that
are unusual for you. Or you cannot resist the impulse,
drive or temptation to carry out certain activities that
could harm yourself or others. These behaviours are
called ‘impulse control disorders’ and can include:
• Addictive gambling.
• Excessive eating or spending.
• Abnormally high sex drive or an increase in sexual
thoughts or feelings.
Your doctor may need to review your treatments.
They will discuss ways of managing or reducing these
symptoms, with you (see section 4 ‘Impulse control
disorders – changes in your behaviour’).
Problems using the pump or tube
There may be some problems linked to using the pump
and tube:
• You become less able to handle the pump and tube,
your Parkinson’s disease symptoms get worse or it is
harder to move (bradykinesia) – The pump and tube
may not be working properly.
• You have pain in your stomach area, feel sick (nausea)
and are sick (vomit) – tell your doctor straight away if
this happens (see Section 4 ‘Serious side effects’).
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• You may get other side effects affecting your gut
(intestine) and where the tube goes in (see section 4
‘Problems using the pump or tube’).
Duodopa and cancer
In the body, carbidopa (an active substance of Duodopa)
is broken down into something called ‘hydrazine’. It
is possible that hydrazine could damage your genetic
material which could lead to cancer. However, it is not
known if the amount of hydrazine produced when taking a
normal dose of Duodopa can cause this.
Tests or checks
Your doctor may do some blood tests if you are having
this medicine.
Operations
Before you have an operation (including a dental
operation), tell the doctor (or dentist) that you are having
Duodopa.
Children and adolescents
Duodopa should not be used in children or young people
under the age of 18 years.
Other medicines and Duodopa
Tell your doctor or pharmacist if you are taking, have
recently taken, or might take any other medicines. This
includes medicines obtained without a prescription, and
herbal medicines.

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Do not use Duodopa if you are taking:
• Medicines for depression called selective MAO-A
inhibitors and non-selective MAO inhibitors such as
moclobemide or phenelzine.
Talk to your doctor or pharmacist before starting Duodopa
if you are taking other medicines for:
• Anaemia – such as iron tablets.
• Tuberculosis – such as isoniazid.
• Anxiety – such as benzodiazepines.
• Sickness – such as metoclopramide.
• High blood pressure – such as anti-hypertensives.
• Spasms in the blood vessels – such as papaverine.
• Fits (convulsions) or epilepsy – such as phenytoin.
• Parkinson’s disease – such as tolcapone, entacapone,
amantadine.
• Mental problems – such as anti-psychotics including
phenothiazines, butyrophenones and risperidone.
• Severe allergic reactions, asthma, chronic bronchitis,
heart disease and low blood pressure – such as anticholinergics and sympatho-mimetics.
• You are taking a medicine which may cause low
blood pressure. This could cause something called
‘orthostatic hypotension’ – this can make you dizzy
when getting up from a chair or bed. Duodopa can
make this worse. Always change positions slowly.
Duodopa with food and drink
For some patients, Duodopa may not work well if it is
taken with, or shortly after eating protein-rich food – such
as meats, fish, dairy products, seeds and nuts. Talk to
your doctor if you think this applies to you.
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Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor for advice before starting treatment with
Duodopa.
• Do not use Duodopa if you are breast-feeding.
Driving and using machines
Do not drive or use any tools or machines until you are
sure how Duodopa affects you.
• Duodopa may make you feel very sleepy, or you may
sometimes find yourself suddenly falling asleep (sleep
attacks).
• Duodopa may lower your blood pressure, which can
make you feel light-headed or dizzy.
Do not drive or use any tools or machines until you feel
fully awake again or you no longer feel light-headed or
dizzy.

3. How to use Duodopa
Always take this medicine exactly as your doctor,
pharmacist or nurse has told you. Check with your doctor
or pharmacist if you are not sure.
About Duodopa gel and the pump
• Duodopa is a gel that goes through a pump and a tube
into your gut (small intestine).
• The gel comes in a plastic cassette. The cassette is
connected to a pump.
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• The pump is connected to a tube which is placed into
your gut (small intestine).
• The pump gives you a small dose throughout the day.
This means that the level of the medicine in your blood
stays the same. It also means some of the movement
side effects are lower.
How much to use
• Your doctor will decide how much Duodopa you should
use and for how long.
• Usually, a larger morning dose (called the ‘bolus dose’)
is given. This allows you to quickly get the right amount
of medicine in your blood. After that dose, a steady
(‘maintenance’) dose is given.
• If needed, you may have extra doses – this will be
decided by your doctor.
If you use more Duodopa than you should
If you have used more Duodopa than you should, talk
to your doctor or go to a hospital straight away. Take
the medicine pack with you. The following effects may
happen:
• Problems opening your eyes.
• Muscle spasms you cannot control in your eyes, head,
neck and body (dystonia).
• Movement you make without wanting to (dyskinesia).
• Unusual fast, slow or uneven heart beats (arrhythmia).
If you forget to use Duodopa
• Start your pump, with your normal dose, as soon as
possible.
• Do not increase your dose to make up for a forgotten
dose.
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If you stop or lower your dose of Duodopa
Do not stop having Duodopa or lower your dose unless a
doctor tells you to. This is because suddenly stopping or
lowering your Duodopa dose quickly may cause a serious
problem called ‘Neuroleptic Malignant Syndrome’. This
problem is more likely to happen if you are also taking a
medicine called an ‘anti-psychotic’ (see section 4 ‘Serious
side effects’).
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious side effects from Duodopa
Stop having Duodopa and tell your doctor straight away,
if you notice any of the following serious side effects. You
might need urgent medical treatment:
• Swelling of the face, tongue or throat which may make
it difficult to swallow or breathe, or nettle type skin
rash. These may be signs of a severe allergic reaction
(anaphylactic reaction). Frequency not known. Cannot
be estimated from available data.
• Fever, sore throat or mouth, or trouble passing water.
These may be signs of a white blood cell problem called
‘agranulocytosis’. Your doctor will take a blood sample
to check for this. Very rare: may affect up to 1 in 10,000
people.
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Tell your doctor straight away if you notice any of the
following serious side effects:
• Neuroleptic Malignant Syndrome – the signs may
include:
- Fast heartbeat, changing blood pressure and
sweating, followed by fever.
- Faster breathing, muscle stiffness, lower
consciousness and coma.
- Higher levels of a protein in your blood (an enzyme
called ‘creatine phosphokinase’). This is measured
by your doctor. Rare: may affect up to 1 in 1,000
people.
See section 3 ‘If you stop or lower your dose of
Duodopa’ for more information on Neuroleptic
Malignant Syndrome.
Other side effects from Duodopa
Tell your doctor, pharmacist or nurse if you notice any of
the following side effects:
Very common: may affect more than 1 in 10 people
• Falling.
• Weight loss.
• Feeling sick (nausea), constipation.
• Anxiety, depression, not being able to sleep (insomnia).
• Movement you make without wanting to (dyskinesia),
worsening of Parkinson’s disease symptoms.
• Feeling dizzy when you stand up or change positions
(orthostatic hypotension) – this is from low blood
pressure. Always change positions slowly – do not
stand up quickly.
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Common: may affect up to 1 in 10 people
• Weight gain.
• Uneven heartbeat.
• Not wanting to eat.
• Feeling tired, weak.
• High or low blood pressure.
• Anaemia – low levels of iron in the blood.
• Having pain, neck pain, muscle cramps, muscle
weakness.
• Suddenly falling asleep (sleep attacks), feeling very
sleepy, sleep disorders.
• Pain when breathing, feeling short of breath, chest
infections (pneumonia).
• Having higher levels of amino acids or homo-cysteine in
the blood, having too little vitamin B6 and B12.
• Feeling dizzy or like you are going to faint, or fainting
(syncope).
• Difficulty swallowing or dry mouth, change in taste
(bitter taste).
• Headache, a feeling of prickling or numbness of the
skin.
• Rashes, itching, increased sweating, swelling caused by
too much fluid (oedema).
• Difficulty passing water (retention of urine) or unable to
control water flow (incontinence).
• Seeing, hearing or feeling things that are not there
(hallucinations), confusion, abnormal dreams, feeling
agitated, impulsive behaviour, psychotic disorder.
• Having a swollen stomach, diarrhoea, wind (flatulence),
indigestion (dyspepsia), being sick (vomiting).
• Parkinson’s disease symptoms coming back quickly
or when not expected – this is called the ‘on and off
phenomenon’.
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• Reduced sense of touch, muscle spasms you cannot
control – affecting your eyes, head, neck and body
(dystonia), shaking.
Impulse control disorders – changes in your
behavior. These are common, may affect up to 1 in
10 people.
Some people are unable to resist the impulse to do
something that could be harmful to themselves or others.
This may include:
• A strong impulse to gamble too much, despite serious
effects on you or your family.
• A change or increase in sexual thoughts and behaviour
of significant concern to you or to others. This could
include an increased sexual drive.
• Excessive shopping or spending too much which
cannot be controlled.
• Binge eating – eating large amounts of food in a short
time, or compulsive eating – eating more food than
normal and more than your body needs.
Tell your doctor if you, your family or carer notice any of
these behaviors. Your doctor may need to review your
treatment. They will discuss ways of managing or reducing
these symptoms with you.
Uncommon: may affect up to 1 in 100 people
• Dark urine.
• Hoarse voice, chest pain.
• Hair loss, red skin, hives.
• Having more saliva than usual.
• Swelling in your veins (phlebitis).
• A change in the way you walk.
• Trying to end your own life – suicide.
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• Feeling tired or generally unwell.
• Fast and uneven beats of the heart (palpitations).
• Low number of white blood cells or changes in blood
cell counts which may cause bleeding.
• Confusion, elevated mood (euphoric mood), increased
sexual interest, nightmares, dementia, feeling of fear.
• Problems in controlling movements, and making strong
movements you cannot control.
• Problems opening your eyes, double vision, blurred
vision, optic nerve damage (optic ischaemic
neuropathy).
Rare: may affect up to 1 in 1,000 people
• Abnormal thinking.
• Uneven breathing pattern.
• Painful erection that will not go away.
• Unusual marks or moles on your skin that appear or get
worse, or tumour of the skin (malignant melanoma).
• Dark saliva or sweat, burning feeling on your tongue,
grinding of your teeth, hiccups.
Tell your doctor, pharmacist or nurse if you notice any of
the side effects listed above.
Side effects from the pump or tube
The following side effects have been reported for the
pump and tube, ‘tube delivery system’. Tell your doctor or
nurse if you notice any of these.
• If you become less able to handle the pump and tube,
your Parkinson’s disease symptoms get worse or it is
harder to move (bradykinesia) – the pump and tube may
not be working properly.
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• If you have pain in your stomach area, feel sick (nausea)
and are sick (vomit), tell your doctor straight away – you
might have a problem with the pump or tube.
Very Common: may affect more than 1 in 10 people
• Stomach pain.
• Infection where the tube goes into your stomach –
caused by surgery.
• Thick scarring where the tube goes in your stomach.
• Problems from having the tube put in – pain or swelling
in the mouth or throat, difficulty swallowing, stomach
discomfort, pain or swelling, injury to the throat, mouth
or stomach, bleeding, being sick (vomiting), wind
(flatulence), anxiety.
• Problems around where the tube goes into your
stomach – red or raw skin, sores, discharge, pain or
irritation.
Common: may affect up to 1 in 10 people
• Incision site infection, post procedural infection after the
tube is placed in the intestine.
• Inflamed wall of stomach.
• Infection in the gut (intestine) or where the tube goes
into your stomach.
• The tube moves around in the gut or gets blocked –
which could cause lower amounts of medicine to be
absorbed.
Uncommon: may affect up to 1 in 100 people
• Inflamed colon (colitis).
• Inflamed pancreas (pancreatitis).
• The tube goes through the wall of the large intestine.
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• Blockage (obstruction), bleeding or ulcer in the gut.
• Sliding of one part of the gut into an adjacent part of the
gut (intussusception).
• Food getting stuck around the tube causing it to block.
• Pocket of infection (abscess) – this could happen after
the tube is placed in your stomach.
Not Known: it is not known how often these happen
• Reduced blood flow in the small intestine.
• The tube goes through the wall of the stomach or small
intestine.
Side effects when levodopa and carbidopa are
taken by mouth
The following side effects have been reported with
levodopa and carbidopa (the same active substances as
in Duodopa) when taken by mouth. These side effects
could also occur with Duodopa:
Rare: may affect up to 1 in 1,000 people
• Anaemia – low iron in the blood.
• An eye problem called ‘Horner's syndrome’.
• Not being able to open your mouth all the way (trismus).
• Red or purple skin rash that looks like small bruises
(Henoch-Schönlein purpura).
• Neuroleptic malignant syndrome (see section 4 ‘Serious
side effects’).
• Widening of the pupil in your eye for a long period of
time (mydriasis), decreased eye movement.
Very rare: may affect up to 1 in 10,000 people
• Changes in blood tests.
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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 (see details
below). By reporting side effects you can help provide
more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

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5. How to store Duodopa
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date which is
stated on the carton label after EXP. The expiry date
refers to the last day of that month.
• Store the cassettes in a refrigerator (2ºC to 8ºC). They
should be stored in the outer carton in order to protect
from sunlight.
• A cassette of the gel may be used for up to 16 hours
once it is out of the refrigerator.
• The drug cassettes are for single use only and should
not be used for longer than 16 hours even if some gel
remains.
• Do not re-use an opened cassette.
• The gel might become slightly yellow – this does not
affect the medicine.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment. Return used cassettes
to your nearest pharmacy – do not re-use.

6. Contents of the pack and other information
What Duodopa contains
• The active substances are levodopa and carbidopa
monohydrate. 1 ml of gel contains 20 mg levodopa and
5 mg carbidopa monohydrate.
• The other ingredients are carmellose sodium and
purified water.
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What Duodopa looks like and contents of the pack
Duodopa is available in cassettes (bags of PVC with a
protective hard plastic cover) containing 100 ml with
7 cassettes in each pack. The gel is off-white to slightly
yellow.
Marketing Authorisation Holder
AbbVie Ltd., Maidenhead, SL6 4UB, UK
AbbVie Limited, Citywest Business Campus, Dublin 24,
Ireland
Manufacturer
Fresenius Kabi Norge AS
Svinesundsveien 80
NO-1788 Halden
Norway
This medicinal product is authorised in the Member
States of the EEA under the following name:
Duodopa
This leaflet was last revised in May 2016
For information in large print, tape, CD or Braille, phone
01628 774920 (UK) or 01 428 7900 (Ireland).

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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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