Label Center Ludwigshafen
CR No.:
CR-0000567-2014
Commodity No.: FGG 2000 01-58-04-018F
Draft No.:
3
Revision date: 23. June 2014
Graphic Artist: S. Gradinger
Min. text size: 8 pt
Colors:
Black
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.
code
FGG 2000 01-58-04-018F.indd 1
Customer:
Fresenius Kabi
Product name/Country: Duodopa 20mg/ml + 5mg/ml / UK/IE
Size:
85mm x 120mm
Pharma code:
3
Collating mark:
N/A
What is in this leaﬂet:
1. What Duodopa is and what it is used for
2. What you need to know before you take Duodopa
3. How to take Duodopa
4. Possible side effects
5. How to store Duodopa
6. Contents of the pack and other information
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 2
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. 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).
2
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 3
• 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:
3
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 4
• 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 treatments.
• If you notice any unusual marks or moles on your
skin that 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
4
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 5
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 vomiting.
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.
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,
5
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 6
•
•
•
•
•
•
•
•
•
chronic bronchitis, heart diseases and low
blood pressure (such as Anticholinergics and
Sympathomimetics)
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.
6
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 7
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.
3.
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 daytime. 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
7
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 8
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 doctor.
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.
8
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 9
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.
4.
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;
9
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 10
• 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;
• Reduced 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.
10
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 11
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
bleeding;
• 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.
11
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 12
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
behaviours; 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
12
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 13
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.
13
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 14
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).
14
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 15
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
Website: www.mhra.gov.uk/yellowcard
Ireland
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: [email protected]
15
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 16
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 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.
16
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 17
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.
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.
17
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 18
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
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
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 (Ireland).
18
23.06.14 15:54
FGG 2000 01-58-04-018F.indd 19
19
23.06.14 15:54
code
FGG 2000 01-58-04-018F.indd 20
FGG 2000 01-58-04-018F
23.06.14 15:54