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MADOPAR CR 100MG/25MG CAPSULES

Active substance(s): BENSERAZIDE HYDROCHLORIDE / LEVODOPA

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Package leaflet: Information for the patient

Madopar CR® 100mg/25mg Capsules
(levodopa/benserazide 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.
The name of your medicine is Madopar CR®
100mg/25mg Capsules, but it will be referred to as
Madopar CR throughout this leaflet.
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.
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.
The capsules are designed to release the
medicines into your body slowly. This is why they
are called ‘CR’ which stands for ‘controlled
release’.

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

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 CR.
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.
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.
● 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.
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.
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.
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.
If you get pregnant while taking Madopar CR, 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 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 (100mg
levodopa), three times a day with meals.
● The starting dose should not be more than 6
capsules (600mg 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.
Patients already treated with levodopa:
● Your doctor will start by giving you one
Madopar CR capsule to replace each 100mg
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.
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 the above apply to you, talk to a doctor or go to
a hospital straight away.
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.



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 side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 CR


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.



4. Possible side effects

Like all medicines Madopar CR 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.
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.

palpitations (a fluttering sensation in your
heart) and being short of breath.
Changes to your liver or blood - shown in a
blood test.

Store in the original package. Keep bottle
tightly closed
Do not store above 25 °C.
Keep out of the sight and reach of children.
Do not use 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.
If the capsules become discoloured or show
any other signs of deterioration, you should
seek the advice of your pharmacist who will
advise you what to do.

6. Contents of the pack and other
information
7.
What Madopar CR contains
Each capsule contains 100mg of levodopa and
25mg benserazide (as the hydrochloride) in a
prolonged release formulation.
Other ingredients in the capsules are mannitol
(E421), hypromellose, hydrogenated vegetable oil,
calcium hydrogen phosphate, povidone, talc,
titanium dioxide (E171), yellow iron oxide (E172),
indigo carmine (E132), gelatin and magnesium
stearate.
What Madopar CR looks like and contents of
the pack
Each capsule is marked with the name 'Roche' in
red on the dark green cap and also on the light
blue body.
Madopar CR is available as bottles of 100
capsules.
Manufactured by: F. Hoffman La Roche,
CH-4002 Basle, Switzerland.
OR
Roche Polska Sp. zo.o., ul Domaniewska 39B,
02-672 Warsaw, Poland.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Madopar CR® 100mg/25mg Capsules

Blood:
● Low numbers of red blood cells (anaemia).
The signs include feeling tired, pale skin,

PL: 18799/2707
Leaflet date: 11.11.2015

POM

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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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