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Active substance: LEVODOPA

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Package leaflet: Information for the user
Duodopa, 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 or pharmacist.

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.
What is in this leaflet:
What Duodopa is and what it is used for
What you need to know before you take Duodopa
How to take Duodopa
Possible side effects
How to store Duodopa
Contents of the pack and other information

What Duodopa is and what it is used for

What Duodopa is used for
Duodopa belongs to a group of medicines for treatment of Parkinson’s disease. Duodopa contains two
medicines in a gel: levodopa and carbidopa monohydrate.
How Duodopa works
• Levodopa is made into dopamine in the body. Dopamine is present in your brain and in your
spinal cord. It helps transfer signals between nerve cells. Too little dopamine causes Parkinson’s
disease signs like tremor, feeling rigid, slow movements, and problems keeping your balance.
• Treatment with levodopa increases the amount of dopamine in your body and so reduces these
• Carbidopa monohydrate is added to improve the effect and reduce the undesirable effects of

What you need to know before you take Duodopa

Do not take Duodopa:
• If you are allergic to levodopa, carbidopa monohydrate or any of the other ingredients of this
medicine (listed in section 6).
• If you have an eye problem called ‘narrow-angle glaucoma’.
• You have severe heart disease.
• You have a severe irregular heart beat (arrhythmia).
• You have an acute stroke.
• If you are taking certain medicines for treating depression (selective MAO-A inhibitors and nonselective MAO-inhibitors).
• If you have a tumour of the adrenal gland (pheochromocytoma), over-production of cortisol
(Cushing’s syndrome) or over-production of thyroid hormones.
• If you have ever had skin cancer or you have any unusual moles or marks on your skin which have
not been examined by your doctor.


Warnings and precautions:
Talk to your doctor before taking Duodopa:
• If you have ever had a heart attack or any other diseases of the heart including cardiac
arrhythmias, or blockage of the blood vessels.
• If you have a lung problem (such as bronchial asthma).
• If you have ever had a hormone-related disease. If you have ever had depression with suicidal
tendencies or any other mental disorders.
• If you are taking anti-psychotic medications.
• If you have an eye problem called ‘wide-angle glaucoma’.
• If you are taking a medicine which may cause low blood pressure when rising from a chair or bed
(orthostatic hypotension). You should be aware that Duodopa may make these reactions worse.
• If you have ever had a stomach ulcer.
• If you have fits (convulsions).
• If you have had previous upper abdominal surgery.
It is important to be aware of the following information and side effects that can occur with Duodopa.
You should contact your doctor or pharmacist or nurse if you experience any of them:

If you find yourself suddenly falling asleep, or if you feel very drowsy, you should not drive or
use any tools or machines (see also section 'Driving and using machines').
If you notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation,
confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this happens,
contact your doctor immediately.
If you or your family/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, an abnormally high
sex drive or an increase in sexual thoughts or feelings. Your doctor may need to review your
If you notice any unusual marks or moles on your skin could get appear or get worse.
If you experience a reduced ability to handle the device system (pump or tube connections).
If you experience worsening of execution of movements (bradykinesia) which may indicate a
malfunction of the device system. Having a PEG-J tube in your intestine may result in the risk of
undigested food getting stuck around the tube, or other complications such as blocking of the
intestine or stomach, sores or irritation at the place where the tube goes into your stomach,
bleeding in your stomach or intestines, inflammation of the pancreas or of the stomach, or an
infection which occurs after the operation to put the tube into your intestine. If you have the
following symptoms, please contact your doctor immediately: abdominal pain, nausea and

Duodopa contains a substance called hydrazine, a breakdown product of one of the ingredients
(carbidopa). This substance can cause damage to the genetic material which could theoretically lead to
cancer. The risk for humans when exposed to hydrazine at recommended doses of Duodopa is not
Your doctor may take some regular laboratory tests during a long term treatment with Duodopa.
If you must undergo surgery, please tell your doctor that you are using Duodopa.
Children and adolescents
Duodopa should not be given to children or adolescents 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, including herbal medicines.

In particular, talk to your doctor or pharmacist before starting Duodopa if you are taking other
medicines for:

Parkinson’s disease (such as tolcapone, entacapone, amantadine), severe allergic reactions,
asthma, chronic bronchitis, heart diseases and low blood pressure (such as Anticholinergics and
Fits (convulsions) or epilepsy (such as phenytoin)
High blood pressure (Antihypertensives)
Mental problems (Antipsychotics such as phenothiazines, butyrophenons and risperidone)
Depression (such as ‘tricyclic antidepressants’ or ‘non-selective monoamine oxidase inhibitors’)
Tuberculosis (such as isoniazide)
Anxiety (such as benzodiazepines)
Anaemia (such as iron tablets)
Sickness (such as metoclopramide)
Spasms in the blood vessels (such as papaverine).

Duodopa with food and drink
Duodopa may be taken with or without food. For some patients, Duodopa may not be well absorbed if
it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and
nuts). Consult your doctor if you think this applies to you.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for
advice before having the tube inserted into your intestine and taking this medicine.
Do not use Duodopa if you are breast-feeding.
Driving and using machines
Duodopa may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore,
be particularly careful when you drive or when you use any tools or machines.
Do not drive or do anything that requires you to be alert if you feel very drowsy, or if you
sometimes find yourself suddenly falling asleep. Wait until you feel fully awake again before driving
or doing anything else that requires you to be alert.
How to take Duodopa
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
How Duodopa is given
• Duodopa is a gel which comes in a plastic cassette. These are connected to a pump.
• The pump is connected to a tube which is placed into the small intestine.
• You are given a small dose continuously during day-time. This means that the level of the
medicines in your blood is more constant and also some of the movement side effects are lower.
How much Duodopa is given
• Your doctor will decide how much Duodopa you should be given and for how long.
• Usually, a larger morning dose is given using the pump (bolus dose) to quickly reach the correct
blood level. After that dose, a continuous (maintenance) dose is given.
• If needed, extra doses may be given.
If you take more Duodopa than you should
If you have had more Duodopa than you should, talk to your doctor or go to a hospital straight away.
Take the medicine pack (the carton) with you. The following effects may happen: problems opening
your eyes (blepharospasm), uncontrollable muscle spasms affecting your eyes, head, neck and body
(dystonia), involuntary movements (dyskinesia), unusual fast, slow or uneven heart beats (arrhythmia).

If you forget to take Duodopa
Start your pump, as prescribed, as soon as possible.
Do not increase your dose to make up for a forgotten dose.
If you stop or lower your dose of Duodopa
It is important that you do not stop having Duodopa or lower your dose until told to do so by your
Suddenly stopping or lowering your Duodopa dose may result in a serious problem called ‘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.
This problem is more likely to happen if you are also taking a medicine called an ‘antipsychotic’.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Duodopa and tell your doctor straight away if you notice the following side effects - you
may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)
• Allergic reaction, the signs may include swelling of the face, tongue or throat which may make it
difficult to swallow or breathe; nettle type skin rash (angioedema).
• 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 the levels of your
white blood cells.
The following side effects have been observed with Duodopa:
Very Common: may affect more than 1 in 10 people
• Uncontrolled movements (dyskinesia), worsening of Parkinson’s disease;
• Feeling sick (nausea), constipation;
• Decreased weight;
• Anxiety, depression, insomnia;
• Feeling dizzy, especially when you stand up due to low blood pressure;
• Fall.
Common: may affect up to 1 in 10 people
• Anaemia;
• Increased weight, increased levels of amino acids, loss of appetite, vitamin B6 and B12 deficiency,
increased homocysteine in the blood;
• Hallucinations, confusion, abnormal dreams, sleep attacks, sleep disorder, agitation, impulsive
behaviour, psychotic disorder;
• Reduce sense of touch, dizziness, uncontrollable muscle spasms affecting your eyes, head, neck
and body (dystonia), headache, on and off phenomenon, a sensation of prickling or numbness,
muscle weakness, sleepiness, feeling like you want to faint and fainting (syncope), shaking;
• Irregular heart beat;
• High blood pressure, low blood pressure;
• Respiratory pain, shortness of breath, pneumonia;

• Swollen stomach, diarrhoea, dry mouth, taste disturbance (bitter taste), indigestion (dyspepsia),
wind (flatulence), being sick (vomiting), difficulty swallowing;
• Rashes, increased sweating, swelling caused by excess fluid (oedema), itching;
• Muscle cramps, neck pain;
• Difficulty passing urine or incontinence (inability to control urine flow), retention of urine;
• Tiredness, pain, feeling weak.
Uncommon: may affect up to 1 in 100 people
• Abnormally low number of white blood cells, changes in the blood cell count which may result in
• Disorientation, euphoric mood, increased sexual interest, nightmare, have tried to end their own
lives (suicide attempt), suicide, dementia, fear;
• Difficulty in controlling movements, gait disturbance, abnormal violent and involuntary contraction
or series of contractions of the muscles;
• Problems opening eyes (blepharospasm), double vision, vision blurred, optic nerve damage (optic
ischaemic neuropathy);
• Rapid and irregular beating of the heart (palpitations);
• Swelling in the vein (phlebitis);
• Hoarseness, chest pain;
• Increased saliva;
• Loss of hair, redness of skin (erythema), hives (urticaria);
• Dark urine;
• Feeling tired or generally unwell.
Rare: may affect up to 1 in 1,000 people
• Abnormal thinking;
• Abnormal breathing pattern;
• Dark saliva, hiccups, burning sensation of the tongue, grinding of the teeth;
• Dark sweat, tumour of the skin (malignant melanoma);
• Prolonged and painful erection.
Not known: frequency cannot be estimated from the available data
• Severe allergic reaction (anaphylactic reaction).
You may experience the following common (may affect up to 1 in 10 people) side effects:
• Inability to resist the impulse to perform an action that could be harmful, which may include:
o Strong impulse to gamble excessively despite serious personal or family consequences.
o Altered or increased sexual interest and behavior 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).
Tell your doctor if you experience any of these behaviors; they will discuss ways of managing or
reducing the symptoms.
The following side effects have been observed with the ‘tube delivery system’:
Very Common: may affect more than 1 in 10 people
• Infection in the wound from the surgery;
• Stomach pain;
• Thickened scarring after surgery;
• Complications of device insertion like pain in the mouth and throat, swollen stomach, stomach
discomfort, pain, throat irritation, injury to the digestive tract, internal bleeding, anxiety, difficulty
in swallowing, vomiting, wind (flatulence), or gas;
• Redness of incision site, post procedural discharge, procedural pain, procedural site reaction.

Common: may affect up to 1 in 10 people
• Incision site infection, post procedural infection after the tube is placed in the intestine;
• Inflammation in wall of stomach;
• Movement of the tube out of the intestine for example to the stomach (resulting in decreased
treatment response), blocking of the tubing (device occlusion);
Uncommon: may affect up to 1 in 100 people
• Abscess (blocked off infection) after the procedure to place the tube that goes into the intestine;
• Blockage of the tube due to undigested food getting stuck around the tube, colitis (inflammation in
the colon), obstruction of the intestines, inflammation in pancreas, bleeding in small intestine,
ulcer in small intestine, penetration of the wall of the large intestine.
Not Known: frequency cannot be estimated from the available data
• Penetration of the wall of the stomach or small intestine by the tube that goes into the intestines,
reduced blood flow in the small intestine.
The following side effects have been observed with oral medicinal products containing
levodopa/carbidopa and could occur with Duodopa:
Rare: may affect up to 1 in 1,000 people
• Anaemia;
• Being unable to open the mouth completely (trismus), neuroleptic malignant syndrome (see
Section 3, If you stop or lower your dose of Duodopa);
• Activation of a pre-existing Horner's syndrome (an eye disorder), excessive or prolonged dilation
of the pupil of the eye (mydriasis), a deterioration in eye movements;
• Henoch-Schönlein purpura.
Very rare: may affect up to 1 in 10,000 people
• Change in blood values (shown in blood tests).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517

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 in a refrigerator (2ºC-8ºC). A cassette of the gel may be used for up to 16 hours once it is out of
the refrigerator.
Keep the cassettes in the outer carton in order to protect from light.
The drug cassettes are for single use only and should not be used for longer than 16 hours even if some
intestinal gel remains. By the end of the storage time the gel might become slightly yellow. This does
not influence the treatment with Duodopa.
Do not re-use an opened cassette.
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. Used
cassettes should not be re-used but returned to your nearest pharmacy.

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.
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
In the UK; AbbVie Ltd, Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead,
Berkshire, SL6 4XE, UK
In Ireland; AbbVie Limited, Block B, Liffey Valley Office Campus, Quarryvale, Co. Dublin, Ireland
Abbott Products GmbH
Justus-von-Liebig-Strasse 33
31535 Neustadt
Fresenius Kabi Norge AS
P.O. Box 430
N-1753 Halden
This medicinal product is authorised in the Member States of the EEA under the following
This leaflet was last revised in May 2014
For information in large print, tape, CD or Braille, phone 01628 774920 (UK) or 01 428 7900


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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.