MADOPAR 100MG/25MG DISPERSIBLE TABLETS

Active substance: LEVODOPA

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Patient Information Leaflet

Madopar
Madopar

50 mg/12.5 mg
®
100 mg/25 mg
®

Dispersible Tablets
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.

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 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 ‘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.

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

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.

1. What Madopar is and what
it is used for
Madopar dispersible tablets 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.

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.

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.
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.

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.

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.

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.

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.
1

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10142894

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

24.10.12

11.08.10

Date

Genisys-No.

Signature

1291

97.4.3524

Checked and
approved

KAU-Nr.

Signature

MMBFMM8W
MMBFMM8Z

Heck

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.

● 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
symptoms

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.
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.

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.

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’ (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 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

If the above apply to you, talk to a doctor
or go to a hospital straight away.

● Store Madopar dispersible tablets in
their bottle, with the lid closed to
protect the tablets 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 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.

6. Further information

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

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 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 ingredients in the tablets are, citric
acid anhydrous (E330), pregelatinised
starch, microcrystalline cellulose (E460)
and magnesium stearate (E572).
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.
Madopar dispersible
tablets are supplied in
amber coloured glass
bottles containing
100 tablets.

Other possible side effects:

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.

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.
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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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