Package leaflet: Information for the patient

Madopar® 50 mg/12.5 mg
Madopar® 100 mg/25 mg
Madopar® 200 mg/50 mg
Hard Capsules

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 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. 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.

● 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.
● 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.
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.
If you stop taking 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 malignantlike 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.

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.

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

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 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).

4. Possible side effects

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

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).
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● 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.
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.

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 February 2014

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 (see details below).
By reporting side effects you can help provide
more information on the safety of this medicine.
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

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 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
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.