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MADOPAR CR 100MG/25MG PROLONGED RELEASE HARD CAPSULES

Active substance(s): BENSERAZIDE / BENSERAZIDE HYDROCHLORIDE / LEVODOPA

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Package leaflet: Information for the patient

UK

Madopar® CR 100 mg/25 mg
Prolonged Release 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.

● 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.
● Domperidone – used to help prevent you
from feeling or being sick.

What is in this leaflet
1. What Madopar CR is and what it is used for
2. What you need to know before you take
Madopar CR
3. How to take Madopar CR
4. Possible side effects
5. How to store Madopar CR
6. Contents of the pack and other information

1. What Madopar CR is and what
it is used for
Madopar CR 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.

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

Madopar CR 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.

Tests
If you need to have tests on your blood or
urine, tell the doctor or nurse that you are
taking Madopar CR. This is because the
medicine may affect the results of some tests.

The capsules are designed to release the
medicines into your body slowly. This is why
they are called ‘CR’ which stands for
‘controlled release’.

Pregnancy and breast-feeding
Do not take Madopar CR if you are pregnant,
trying to get pregnant or breast-feeding. This
is because Madopar CR may affect your baby.
It is important for women to use contraception
while taking the medicine.

2. What you need to know before
you take Madopar CR

If you get pregnant while taking Madopar CR,
talk to your doctor straight away.

Do not take Madopar CR if:
● You are allergic (hypersensitive) to
levodopa, benserazide or any of the other
ingredients of Madopar CR (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 CR if any of the above
applies to you. If you are not sure, talk to your
doctor or pharmacist before you take Madopar
CR.

Driving and using machines
Talk to your doctor about driving and using
machines or tools, when you take Madopar
CR. This is because one of the medicines in
Madopar CR, 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 CR
Always take Madopar CR
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 without food.
Patients NOT already treated with
levodopa:
● The usual starting dose is 1 capsule
(100 mg levodopa), three times a day with
meals.
● The starting dose should not be more than
6 capsules (600 mg levodopa) a day.
● Your doctor will then increase your dose
every 2 to 3 days until they find the right
dose for you.
● Some people may also need to take another
medicine for Parkinson’s disease with their
first morning dose of Madopar CR. This is
because Madopar CR releases the
medicines slowly into the body.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Madopar CR 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.

Patients already treated with levodopa:
● Your doctor will start by giving you one
Madopar CR capsule to replace each
100 mg of levodopa you have been taking.
● Your doctor will then increase your dose
every 2 to 3 days until they find the right
dose for you. This may take up to 4 weeks.
● At the start of treatment your condition may
become worse, until the right dose is found
for you. Your doctor may want to supervise
you closely during this time.
If you forget to take Madopar CR
● 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.

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

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

Other medicines and Madopar CR
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 CR can affect the
way some medicines work. Also some other
medicines can affect the way Madopar CR works.

If you take more Madopar CR than you
should
If you take more Madopar CR 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 CR 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 CR 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, selegiline, bromocriptine,
‘anticholinergics’ called orphenadrine and
benzhexol, ‘dopamine agonists’ called
pergolide and ropinirole and a ‘COMT
inhibitor’ called entacaprone.
10164377_NP9344.indd 1

If someone else takes your Madopar CR
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.

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What Madopar CR looks like and contents
of the pack
The capsules are green and blue in colour and
have Roche printed on each end.

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

Madopar CR is supplied in amber coloured
glass bottles containing 100 capsules.

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.

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 March 2015

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 CR 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 CR 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
Website:
http://www.medicinesauthority.gov.mt/adrportal
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

5. How to store Madopar CR
● Store Madopar CR capsules in their bottle,
with the lid closed to protect the capsules
from moisture.
● Do not store Madopar CR capsules above
25°C.
● Keep out of the sight and reach of children.
● Do not use Madopar CR 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 CR contains
There are two active substances in Madopar
CR 100 mg/25 mg Prolonged Release Hard
Capsules. Each capsule contains 100 mg
levodopa and 25 mg benserazide as the
hydrochloride.
Other ingredients in the capsules are
hypromellose (E464), hydrogenated vegetable
oil, calcium hydrogen phosphate anhydrous
(E341), mannitol (E421), talc (E533b),
povidone (E1201), magnesium stearate
(E572), gelatin, indigo carmine (E132),
titanium dioxide (E171), yellow iron oxide
(E172) and red iron oxide (E172).
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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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