MADOPAR 50MG/12.5MG DISPERSIBLE TABLET

Active substance: LEVODOPA

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Package leaflet: Information for the patient

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

Levodopa and benserazide (as hydrochloride)

Please 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. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Madopar is and what it is used for
2. What you need to know before you take
Madopar
3. How to take Madopar
4. Possible side effects
5. How to store Madopar
6. Contents of the pack and other
information

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. What you need to know 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:
Contents of the pack and other 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 ‘Other
medicines and
Madopar’.
● 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.
Warnings and precautions
Talk to your doctor or pharmacist before
taking 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.
If any of the above apply to you, or if you
are not sure, talk to your doctor or
pharmacist before you take Madopar.
Other medicines and Madopar
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 ‘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.
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● Ferrous sulfate (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.
● Strong painkillers – such as codeine or
morphine.
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.

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.
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.
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.
If you stop taking 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 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 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.
If someone else takes your Madopar tablets
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.
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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 or have
nose bleeds.

Madopar dispersible tablets are supplied in
amber coloured glass bottles containing
100 tablets.
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 February 2014

Other possible side effects:
Not known (frequency cannot be estimated
from the available data)
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.
● A change in the colour of your saliva,
tongue, teeth or inside of your mouth.
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 symptoms
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.
● You may experience 'on-off' effects. This
is where you can switch quite suddenly
between being 'on' and able to move, and
being 'off' and immobile.
● An irresistible urge to move the legs and
sometimes the arms.
● 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.
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 via
the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Madopar
● 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 sight and reach of children.
● Do not use Madopar after the expiry date
printed on the pack.
● Do not throw away any medicines via
household waste. Ask your pharmacist
how to throw away medicines you no
longer use. These measures will help
protect the environment.

6. Contents of the pack and
other 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.
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.
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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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