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MADOPAR 200MG/50MG HARD CAPSULES

Active substance(s): BENSERAZIDE HYDROCHLORIDE / LEVODOPA

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Madopar Test 3_GB

04.12.2007

14:08 Uhr

Seite 1

Madopar Test 3 GB 0712.10 75

Patient Information Leaflet

Tests
If you need to have
tests on your blood
or urine, tell the doctor
or nurse that you are
taking Madopar. This
is because the medicine
may affect the results
of some tests.
Pregnancy and breast-feeding
Do not take Madopar if you are pregnant,
trying to get pregnant or breast-feeding.
This is because Madopar may affect
your baby. It is important for women
to use contraception while taking
the medicine.
If you get pregnant while taking
Madopar, talk to your doctor straight
away.
Driving and using machines
Talk to your doctor about driving
and using machines or tools, when you
take Madopar. This is because one
of the medicines in Madopar, levodopa,
can make you feel very sleepy. This can
happen very quickly, even during the day.
You must not drive or use machines
if this happens to you. If you are in any
doubt about whether you can do a
particular activity, talk to your doctor.

Do not take Madopar if any of the
above applies to you. If you are not sure,
talk to your doctor or pharmacist before
you take Madopar.

3. How to take Madopar
Always take Madopar exactly as
your doctor has told you. You should
check with your doctor if you are not sure.
How much you take and when you take
it is different for different people.
• Either swallow the tablets whole
with a little water or
• Dissolve in a little water or orange
squash (not fresh orange juice).
Use at least 25 ml liquid for each
tablet.
• Take them with or just after food.

Take special care with Madopar
Check with your doctor or pharmacist
before you take Madopar if:
• You have a problem with the pressure
in your eyes called ‘wide-angle
glaucoma’.
• You have problems with your
hormones, kidneys, lungs or liver.
• You have diabetes (high blood sugar).
• You have heart problems, particularly
an uneven heart beat (arrhythmia)
or you have had a heart attack.
• You have any mental illness,
such as depression.
• You have a ‘peptic ulcer’, an ulcer
in your stomach, or in the tube leading
from it (‘duodenal ulcer’).
• You have something called
‘osteomalacia’ which causes problems
with the strength of your bones.
If any of the above apply to you,
or if you are not sure, talk to your doctor
or pharmacist before you take Madopar.

Patients NOT already treated
with levodopa:
• The usual starting dose is one 50 mg/
12.5 mg tablet (50 mg levodopa),
three or four times a day.
• Your doctor will then increase your
dose every 2 to 3 days until they find
the right dose for you.
Patients already treated
with levodopa:
• Your starting dose of Madopar will
be one less 100 mg/25 mg tablet than
the number of levodopa 500 mg
capsules or tablets you take each day.
For example if you take four levodopa
tablets (2000 mg levodopa) each day,
your doctor will start by giving you
three Madopar 100 mg/25 mg tablets
daily.
• After one week your doctor may then
start to increase your dose every
2 to 3 days until they find the right
dose for you.

Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines. This includes
medicines that you buy without
a prescription and herbal medicines.
This is because Madopar can affect the
way some medicines work. Also some
other medicines can affect the way
Madopar works.

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Do not take Madopar if:
• You are allergic (hypersensitive)
to levodopa, benserazide or any of the
other ingredients of Madopar (listed
in Section 6: Further information).
• You have a problem
with the pressure
in your eyes called
‘narrow-angle
glaucoma’.
• You have serious
problems with
your kidneys, liver
or heart.
• You have a serious problem with your
hormones, such as an overactive
thyroid gland.
• You have a severe mental problem
which may make you distressed and
anxious, or may make you lose contact
with reality and become unable
to think and judge clearly.
• You have depression and have taken
a medicine called a ‘non-selective
monoamine oxidase inhibitor’ (MAOI)
in the last 14 days. These medicines
include isocarboxazid and phenelzine.
See the section on ‘Taking other
medicines’.
• You are pregnant or trying to
become pregnant. See the section on
‘Pregnancy and breast-feeding’.
• You are under 25 years of age.
This is because your bones may not
have finished developing.
• You have ever had skin cancer.

Änderungen

Operations
If you are going to have an operation,
tell the doctor that you are taking
Madopar. This is because you may need
to stop taking it before you have
a general anaesthetic.

2. Before you take Madopar

Sängergasse 19
Tel. 061 307 92 00
Fax 061 307 92 05
ISDN 061 303 00 93
www.stauffer-febel.ch
E-Mail: info@stauffer-febel.ch

Madopar works like this:
• In your body the levodopa is changed
into dopamine. Dopamine is the
active medicine that is needed in your
brain to help Parkinson’s disease.
• The benserazide allows more of
the levodopa you take to get into your
brain, before it is changed into
dopamine.

Neusatz

People with Parkinson’s disease
do not have enough dopamine in certain
parts of their brains. This can result
in slow movements, stiff muscles
and tremor.

OK for Printing

Madopar dispersible tablets contain
two medicines called levodopa
and benserazide. They are used to treat
Parkinson’s disease.

. Abzug

1. What Madopar is
and what it is used for

Corrections

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

PREPRESSINFORMATION
Madopar Dispersible Tablets
Madopar Test 3 GB 0712.10 75
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Format: 148 × 594 mm (NF4 NEU)
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Font-size: Lauftext: 10 Pkt

In particular, tell your doctor or
pharmacist if you are taking the following
medicines:
• Other medicines for Parkinson’s
disease, such as amantadine,
‘anticholinergics’ called orphenadrine
and benzhexol, ‘dopamine agonists’
called pergolide and ropinirole and
a ‘COMT inhibitor’ called entacaprone.
• Ferrous sulphate (used to treat low
levels of iron in the blood).
• Antacids (used for stomach acid if you
have indigestion).
• Metoclopramide (used to treat
problems with digestion).
• Phenothiazines – such as
chlorpromazine, promazine and
prochloroperazine (used to treat
mental illness).
• Thioxanthenes – such as flupentixol
and zuclopenthixol (used to treat
mental illness).
• Butyrophenones – such as haloperidol
and benperidol (used to treat mental
illness).
• Diazepam (used to treat anxiety
and insomnia).
• Tetrabenazine (used to help problems
controlling your muscle movement).
• Papaverine (used to improve blood flow
around the body).
• Treatment for high blood pressure
(hypertension), in particular reserpine.
• ‘Sympathomimetics’ – such as
epinephrine, norepinephrine and
isoproterenol (used to treat problems
with your heart or asthma).
• Amphetamines – medicines used
for attention deficit disorder, feeling
sleepy during the day (narcolepsy)
or to help control appetite and weight
gain.

Date: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Do not take Madopar if you have
taken a medicine for depression called
a ‘non-selective monoamine oxidase
inhibitor’ (MAOI) in the last 14 days.
These medicines include isocarboxazid
and phenelzine. If this applies to you,
do not take Madopar and ask your doctor
or pharmacist for advice.

Please 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 become
serious or troublesome, or if you notice
any side effects not listed in this
leaflet, please tell your doctor
or pharmacist.

Date: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Levodopa and benserazide (as hydrochloride)

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s
r

Signature: . . . . . . . . . . . . . . . . . . . . . . . . . .

50 mg/12.5 mg
100 mg/25 mg
Dispersible Tablets
®

Printed Name: . . . . . . . . . . . . . . . . . . . . . . .

®

Printed Name: . . . . . . . . . . . . . . . . . . . . . . .

Madopar
Madopar

CUSTOMERS
RELEASE

Madopar Test 3_GB

04.12.2007

14:08 Uhr

Seite 2

Patients already treated with
a combined levodopa/decarboxylase
inhibitor:
• The usual starting dose is one 50 mg/
12.5 mg tablet (50 mg levodopa),
three or four times a day.
• Your doctor will then increase your
dose every 2 to 3 days until they find
the right dose for you.

5. How to store Madopar
• Store Madopar dispersible tablets in
their bottle, with the lid closed to
protect the capsules from moisture.
• Do not store Madopar tablets above
25 °C.
• Keep out of the reach and sight
of children.
• Do not use Madopar after the expiry
date printed on the pack.
• Do not throw away any left over
tablets. Instead, return them to your
pharmacist so that they can be
disposed of carefully. Only keep them
if your doctor tells you to.

If you forget to take Madopar
• If you forget to take a dose, skip the
missed dose. Then take the next dose
when it is due.
• Do not take a double dose (two doses
at the same time) to make up for
a forgotten dose.
Stopping Madopar
You must not stop taking your tablets
without talking to your doctor first.
This is because if you stop taking the
tablets suddenly it can cause something
called ‘neuroleptic malignant-like
syndrome’. This can be life threatening.

6. Further information
What Madopar contains
There are two active substances in
Madopar dispersible tablets, and there
are two different strengths of tablet
available
• Each Madopar 50 mg/12.5 mg
Dispersible Tablet contains 50 mg
levodopa and 12.5 mg benserazide
as the hydrochloride.
• Each Madopar 100 mg/25 mg
Dispersible Tablet contains 100 mg
levodopa and 25 mg benserazide
as the hydrochloride.

If you take more Madopar than
you should
If you take more Madopar than you
should, talk to a doctor or go to a hospital
straight away. Take the medicine pack
with you. The following effects may
happen if you have taken more tablets
than you should: changes in your heart
beat, confusion, difficulty sleeping, feeling
or being sick and unusual movements
of different parts of the body that
you cannot control.

Other ingredients in the tablets are, citric
acid anhydrous (E 330), pregelatinised
starch, microcrystalline cellulose (E 460)
and magnesium stearate (E 572).

If someone else takes your Madopar
tablets by mistake, they should talk to
a doctor or go to a hospital straight
away.

What Madopar dispersible tablets
look like and contents of the pack
Madopar 50 mg/12.5 mg Dispersible
Tablets are round and white in colour,
have Roche 62.5 marked one side
and a score line on the other. Madopar
100 mg/25 mg Dispersible Tablets
are round and white in colour, have
Roche 125 marked one side and a score
line on the other.

If you have any further questions on
the use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Madopar dispersible tablets are
supplied in amber coloured glass bottles
containing 100 tablets.

Like all medicines Madopar can cause
side effects, although not everyone
will get them.

Marketing Authorisation Holder
and Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

Stomach and gut:
• Loss of appetite, feeling sick or being
sick or diarrhoea, particularly at
the start of your treatment. To help
with this, your doctor may tell you
to take Madopar with some food
or drink or increase your dose more
slowly.
• Bleeding in your stomach
or intestines. You may see blood
in your stools (they may look black
and tarry) or blood when you
are sick (this may look like coffee
grounds).

This leaflet was last approved in
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Skin:
• Allergic reactions.
The signs include
a rash and feeling
itchy.
Heart and circulation:
• Heart beat may be uneven or go faster
or slower.
• Feeling dizzy when you stand up.
This usually gets better if your dose
is lowered.
Blood:
• Low numbers of red blood cells
(anaemia). The signs include feeling
tired, pale skin, palpitations
(a fluttering sensation in your heart)
and being short of breath.
• Low numbers of all types of white
blood cells. The signs include infections
of your mouth, gums, throat and
lungs.
• Low numbers of platelets in your
blood. The signs include bruising easily
and nose bleeds.
• Changes to your liver or blood –
shown in a blood test.
Mental problems:
• Feeling excited, anxious, agitated,
depressed, aggressive or disorientated
(the feeling of being lost).
• Believing things which are not true,
hallucinations (seeing and possibly
hearing things that are not really
there) or losing contact with reality.
• Feeling sleepy, sometimes during
the daytime.
• Falling asleep suddenly.
• Having difficulty sleeping.
• Being unable to stop gambling even
if this causes serious personal
or family problems.
• An increase in your levels of sexual
desire or sex drive (libido) which may
be worrying to you or to others.
Others:
• Unusual movements of different
parts of your body which you cannot
control. This may affect your hands,
feet, face or tongue. Your doctor
may change your dose of Madopar
to help with these effects.
• Changes to how things taste or a loss
of taste.
• Redness of the face or neck.
• Sweating.
• Your urine (water) may become
slightly red. This is not a cause for
concern. It is caused by your body
getting rid of the medicine.
If any of the side effects become serious
or troublesome, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.

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Madopar Test 3 GB 0712.10 75

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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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