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

Active substance: LEVODOPA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

In this leaflet:
1. What Duodopa is and what it is used for
2. Before you take Duodopa
3. How to take Duodopa
4. Possible side effects
5. How to store Duodopa
6. Further information
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Label Center Ludwigshafen

FOR POSITION ONLY

Read all of this leaflet carefully before you start
taking this medicine.

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. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

LCR No.:
Commodity No.: MKP-12-XXX1
Draft No.:
3
Revision date: 2. Nov. 2012
Graphic Artist: Th. Würzburger

Customer:
Fresenius Kabi
Product name/Country: Duodopa Gel, GB
Size:
85 x 120 mm
Pharma code:
Collating mark:
-

Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel
Levodopa and carbidopa monohydrate

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1.

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 signs

Carbidopa monohydrate is added to improve
the effect and reduce the undesirable effects of
levodopa.
2.

Before you take Duodopa

Do not take Duodopa if:

You are allergic (hypersensitive) to levodopa,
carbidopa monohydrate or any of the other
ingredients of Duodopa (listed in Section 6)

You have an eye problem called ‘narrow-angle
glaucoma’

You have severe liver or kidney problems

You have severe heart disease

You have a severe irregular heart beat (arrhythmia)

You have an acute stroke
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You have depression and have recently (within the
previous two weeks) been treated with either a
medicine called a ‘non-selective MAO inhibitor’
or a ‘selective MAO A inhibitor’
You have a growth in your adrenal gland
(adrenocortical tumour)
You have hormonal problems (such as overproduction of adrenocortical or thyroid hormones)

Take special care with Duodopa:
Check with your doctor before or while taking
Duodopa if:

You have a severe heart disease or have had a
heart attack

You have a lung problem (such as bronchial
asthma)

You have a hormonal problem

You have depression with suicidal tendencies or
any mental problem

You are taking medicines used to treat depression
or other mental disorders (antipsychotics)

You have an eye problem called ‘wide-angle
glaucoma’

You have ever had a stomach ulcer

You have fits (convulsions)

You experience failure to resist gambling impulses
(pathological gambling), altered sexual interest and
behaviour (increased sex drive and hypersexuality)

You have had previous upper abdominal surgery

You experience a reduced ability to handle the
device system (pump or tube connections)
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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. If you have the following symptoms,
please contact your doctor immediately: abdominal
pain, nausea and vomiting.
Duodopa should not be given to children or adolescents
under the age of 18 years. If you are not sure if any
of the above applies to you, talk to your doctor or
pharmacist before taking Duodopa.
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 known.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken 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 medicines for:

Parkinson’s disease, severe allergic reactions,
asthma, chronic bronchitis, heart diseases and
low blood pressure (such as Anticholinergics and
Sympathicomimetics)

Fits (convulsions) or epilepsy
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High blood pressure
Mental problems
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).
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before taking
Duodopa.
Pregnancy and breast-feeding
Do not use Duodopa if:

You are pregnant or are planning to become
pregnant while taking Duodopa. Unless you have
discussed it with your doctor and he or she has
clearly told you to do so.

You are breast-feeding.
Ask your doctor or pharmacist for advice before taking
any medicine, if you are pregnant or breast-feeding.
Driving and using machines
Duodopa may cause you to feel dizzy, sleepy or to
fall asleep suddenly. Do not drive or use any tools or
machines until you are sure how the medicine affects you.
3.

How to take Duodopa

Always take Duodopa exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
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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 have 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 with you. The following effects may
happen: problems opening your eye (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 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 doctor.
Suddenly stopping or lowering your Duodopa dose may
result in a serious problem called ‘Neuroleptic Malignant
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Syndrome’. The signs may include:

Fast heart beat, 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
product, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, Duodopa can cause side effects,
although not everybody gets them.
Stop taking Duodopa and tell your doctor straight
away if you notice any of the following side effects you may need urgent medical treatment:

Swelling of the face, tongue or throat which may
make it difficult to swallow or breathe; nettle type
skin rash. These may be signs of an allergic type
reaction called ‘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 also been observed with
drugs containing levodopa and carbidopa monohydrate:
Common (affects 1 to 10 users in 100)

Loss of appetite
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Seeing, hearing or feeling things that are not there
(hallucinations), confusion, nightmares, feeling
sleepy, fatigue, sleeplessness, euphoria (abnormal
elation), loss of memory, and other mental problems
such as psychotic episodes or elevated mood
Depression with very rare thoughts of suicide
Involuntary movements and muscle cramps
(dyskinesias and dystonias), slow movement
Increased, rapid or irregular heart beat (palpitations)
Feeling dizzy, especially when you stand up
(orthostatic hypotension)
Feeling like you want to faint and fainting (syncope)
Feeling sick (nausea), being sick (vomiting),
dry mouth, taste disturbance (bitter taste).

Uncommon (affects 1 to 10 users in 1,000)

Loss of weight, increased weight

Difficulty in controlling movements, increased tremor
of the hands

High blood pressure

Hoarseness, chest pain

Constipation, diarrhoea, increased saliva, difficulty
swallowing, wind (flatulence)

Swelling caused by excess fluid (oedema)

Muscle spasms

Dark urine

Feeling weak, feeling tired or generally unwell.
Rare/very rare (affects 1 to 10 users in 10,000)

Agitation, fear, reduced thinking capacity, being
disorientated, increased sex drive, headache

Numbness, pins and needles, neuroleptic malignant
syndrome (see ‘If you stop taking Duodopa’ in
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Section 3 for signs of this effect)
Change in blood values (shown in blood tests)
including agranulocytosis
Swelling in the vein (phlebitis) or inflammation of the
blood vessels
Feeling very sleepy, falling asleep suddenly. If
this happens, you should not drive or operate
machinery.
Blurred vision, double vision or other eye problems
Shortness of breath, abnormal breathing pattern
Indigestion (dyspepsia), abdominal pain, dark saliva,
hiccups, perforation or bleeding of the stomach or
bowel, burning sensation of the tongue, lockjaw,
grinding of the teeth
Skin problems such as itching, rash, facial redness,
bleeding, hair loss, dark sweat, increased sweating,
tumour of the skin (malignant melanoma)
Difficulty urinating, urinary incontinence, prolonged
and painful erection
Falling or problems walking
Fits (convulsions).

Other possible side effects (not known: frequency
cannot be estimated from the available data)
Other side-effects that have been reported are:
pathological gambling (failure to resist gambling
impulses despite serious personal or family
consequences), increased sex drive and
hypersexuality (altered sexual interest and behaviour
of significant concern to the patient or to others).
These side effects are generally reversible upon
reduction of the dose or treatment discontinuation.
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The following very common complications have been
reported for the ‘tube delivery system’:

Leaks at the connections and leakage of gastric fluid

Blockade of flow of Duodopa due to occlusion,
kinking and knotting of the tubing. Should complete
failure of the tube or pump occur see your doctor
immediately. The doctor will treat you with oral
levodopa/carbidopa until the problem is solved.

Dislocation of the tube e.g. to the stomach
(resulting in decreased treatment response)

Local infection around the site of tube entering
the stomach area (stoma), inflammation of the
abdominal cavity (peritonitis), and perforation of
adjacent organs, bleeding and abdominal pain,
especially during tube placement.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment. Used cassettes should not
be re-used but returned to your nearest pharmacy.

5.

Marketing Authorisation Holder
Abbott Products GmbH
Hans-Boeckler-Allee 20, D-30173 Hannover,
Germany

How to store Duodopa

Keep the cassettes with gel out of the reach and sight of
children.
Do not use Duodopa after the expiry date which is stated
on the carton label after EXP.
Store in a refrigerator (2 ºC–8 ºC).
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 one day (up to 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.
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6.

Further 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 white to slightly yellow.

Manufacturer
Abbott Products GmbH
Justus-von-Liebig-Strasse 33, 31535 Neustadt,
Germany
Fresenius Kabi Norge AS
P.O. Box 430, N-1753 Halden,
Norway
This medicinal product is authorised in the Member
states of the EEA under the following name:
Duodopa
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Local representative
Duodopa is distributed in the UK by
Abbott Healthcare Products Ltd,
Mansbridge Road, Southampton, SO18 3JD,
and in Ireland by
Abbott Laboratories Ireland Ltd.,
4051 Kingswood Drive,
Citywest Business Campus,
Dublin 24,
Ireland
This leaflet was last approved in October 2012
For information in large print, tape, CD or Braille,
phone 02380 467000 (UK) or 014691500 (Ireland).

FOR POSITION ONLY

MKP-12-XXX1
01-58-04-018B

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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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