MADOPAR 50MG/12.5MG HARD CAPSULES

Active substance: LEVODOPA

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29.10.12

11.08.10

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Patient Information Leaflet

Madopar
Madopar
Madopar

50 mg/12.5 mg
100 mg/25 mg
®
200 mg/50 mg
®
®

Hard Capsules
Levodopa and benserazide (as hydrochloride)

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.

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.
Do not take Madopar if you have taken
a medicine for depression called a ‘nonselective 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.
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.

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

1. What Madopar is and what
it is used for
Madopar capsules contain two medicines
called levodopa and benserazide. They are
used to treat Parkinson’s disease.
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.
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.

2. Before you take Madopar
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.
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.

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.
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.

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.
Tell your doctor 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.

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.
● Swallow the capsules whole with
a little water (do not crush or chew
them).
● Take them with or just after food.
Patients NOT already treated
with levodopa:
● The usual starting dose is one
50 mg/12.5 mg capsule (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 capsule 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 capsules
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.

If any of the above apply to you, or if you
are not sure, talk to your doctor or
pharmacist before you take Madopar.
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
1

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10142875

Printing Colour:

Pantone Black

Format:

148x594 mm

Folding Format:

148x297 mm

Type Size

11 pt

Drawing Norm

NP9344

make-up code

GB

Good To Print

Version

Date

1

29.10.12

11.08.10

Date

Genisys-No.

Signature

1324

97.4.3524

Checked and
approved

KAU-Nr.

Signature

MMBFMM8W
MMBFMM8Z

Heck

Patients already treated with a
combined levodopa/decarboxylase
inhibitor:
● The usual starting dose is one
50 mg/12.5 mg capsule (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.
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 capsules
without talking to your doctor first.
This is because if you stop taking the
capsules suddenly it can cause something
called ‘neuroleptic malignant-like
syndrome’ (NMLS). Early signs include
increased shaking, sudden high body
temperature and muscle problems
including stiffness and trouble with
balance and keeping upright (postural
instability) especially if seen with
sweating, paleness and fast heart beat.
NMLS can be life threatening.
If the above apply to you, talk to a doctor
or go to a hospital straight away.
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 capsules
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.
If someone else takes your Madopar
capsules by mistake, they should talk to
a doctor or go to a hospital straight
away.
If you have any further questions on
the use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines Madopar can cause
side effects, although not everyone will
get them.
See your doctor as soon as possible
if you get the following side effects:
● Allergic reactions. The signs include
a rash and feeling itchy.
● Heart beat that is uneven or is faster
or slower than normal.
● 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).
● Low numbers of all types of white
blood cells. The signs include
infections of your mouth, gums,
throat and lungs.
● Reduced numbers of red blood cells,
white blood cells and platelets in your
blood. This may make you feel tired,
get infections more easily, or bruise
more easily.
● Low numbers of platelets in your
blood. The signs include bruising easily
and nose bleeds.
Other possible side effects:
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.

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.

5. How to store Madopar
● Store Madopar capsules in their
bottle, with the lid closed to protect
the capsules from moisture.
● Do not store Madopar capsules 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
capsules. Instead, return them to your
pharmacist so that they can be
disposed of carefully. Only keep them
if your doctor tells you to.

6. Further information
What Madopar contains
There are two active substances in
Madopar hard capsules, and there are
three different strengths of capsules
available.
● Each Madopar 50 mg/12.5 mg Hard
Capsule contains 50 mg levodopa and
12.5 mg benserazide as the
hydrochloride.
● Each Madopar 100 mg/25 mg Hard
Capsule contains 100 mg levodopa and
25 mg benserazide as the
hydrochloride.
● Each Madopar 200 mg/50 mg Hard
Capsule contains 200 mg levodopa and
50 mg benserazide as the
hydrochloride.
Other ingredients in the capsules
are Microcrystalline cellulose (E460),
povidone K90 (E1201), talc (E553b),
magnesium stearate (E572), gelatin,
indigo carmine (E132), titanium dioxide
(E171), iron oxide (E172), black iron
oxide (E172). Madopar 50 mg/12.5 mg
Hard Capsules also contain mannitol
(E421).
What Madopar capsules look like
and contents of the pack
Madopar 50 mg/12.5 mg Hard Capsules
are grey in colour at one end and pale
blue at the other, with
Roche printed in black
ink on both ends.
Madopar
100 mg/25 mg Hard
Capsules are pale pink
in colour at one end and pale blue at the
other, with Roche printed in black ink
on both ends.
Madopar 200 mg/50 mg Hard Capsules
are brown in colour at one end and pale
blue at the other, with Roche printed in
black ink on both ends.
Madopar capsules are supplied in
amber coloured glass bottles containing
100 capsules.
Marketing Authorisation Holder
and Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom
This leaflet was last revised
in October 2012

Heart and circulation:
● 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.
● 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.
Impulse Control Disorders:
You may experience an inability to resist
the impulse to perform an action that
could be harmful, which may include:
● Strong impulse to gamble excessively
despite serious personal or family
consequences.
● Altered or increased sexual interest
and behaviour of significant concern
to you or to others, for example an
increased sexual drive.
● Uncontrollable excessive shopping or
spending
● 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
2
symptoms
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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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