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MADOPAR CR 100 MG/ 25 MG PROLONGED RELEASE HARD CAPSULES

Active substance(s): BENSERAZIDE / LEVODOPA

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Madopar® CR 100 mg/ 25 mg
prolonged released hard capsules

2738
15.12.15[3]

(levodopa/benserazide hydrochloride)
PATIENT INFORMATION LEAFLET
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.
Your medicine is available using the above name but 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 CR’.
- 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 (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.
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.

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

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

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.

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.

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.

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

5. HOW TO STORE MADOPAR CR
- Do not store above 25°C. Store in the original package. Keep bottle tightly
closed in order to protect from moisture.
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date printed on the pack.
- If your capsules become discoloured or shown any other signs of
deterioration, please contact your doctor or pharmacist before taking your
medicine.
- 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.

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 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.
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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Madopar CR contains
There are two active substances in Madopar CR.
Each prolonged released hard capsule contains 100 mg levodopa and 25mg
benserazide (as hydrochloride).
The inactive ingredients are hypromellose, hydrogenated vegetable oil,
calcium hydrogen phosphate anhydrous, mannitol, povidone, talc,
magnesium stearate, gelatin and the colours indigo carmine (E132), titanium
dioxide (E171) and iron oxide (E172).
What Madopar CR capsules look like and contents of the pack
Madopar CR are hard gelatin capsules with light blue opaque body and dark
green opaque cap and imprinted with ROCHE in red.
Madopar CR is supplied in amber coloured glass bottles containing 100
capsules. Dessicant enclosed.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by F. Hoffmann-La Roche AG, Basel, Switzerland. Procured
from within the EU by Product Licence holder Star Pharmaceuticals Ltd.,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL 20636/2738

Leaflet revision and issue date (Ref.) 15.12.15[3]
Madopar is a trademark of Roche Products Limited.

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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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