MADOPAR 125 DISPERSIBLE TABLETS

Active substance: LEVODOPA

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MADOPAR 125 DISPERSIBLE TABLETS
(Levodopa/Benserazide)
Your medicine is known by the above name but will be referred to as
Madopar throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions about your illness or your medicine,
ask your doctor, nurse or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1) What Madopar is and what it is used for
2) Before you take Madopar
3) How to take Madopar
4) Possible side effects
5) How to store Madopar
6) Further 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) 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: Further 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 ‘Taking other
medicines’.
 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.
Take special care with Madopar
Check with your doctor or pharmacist before you take 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.

Taking other medicines
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
‘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.
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 sulphate (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.
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 breastfeeding. 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.
Stopping 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.

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.
 Low numbers of platelets in your blood. The signs include bruising easily
and nose bleeds.

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.
 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 any of the side effects become serious or troublesome, or if you notice any
side effects not listed in this leaflet, please tell your doctor or pharmacist.

5) How to store Madopar
 Do not use after the expiry date printed on the carton label or or container
label.
 Keep all medicines out of the sight and reach of children.
 Madopar should be stored below 25°C, and should be protected from
moisture.
 If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will tell you what to do.
 If your doctor tells you to stop taking the tablets, please take them back to
the pharmacist for safe disposal. Only keep the tablets if your doctor tells
you to.

6) Further information
What Madopar contains
Each tablet contains the active ingredients, levodopa 100mg and
benserazide 25mg (as 28.5mg benserazide hydrochloride)
Madopar also contain the following inactive ingredients: pregelatinised maize
starch, anhydrous citric acid, microcrystalline cellulose and magnesium
stearate.
What Madopar looks like and contents of the pack
Madopar is a white, round tablet, marked ROCHE 125 on one side and a
breakline on the reverse.
Madopar Tablets are available in an amber glass bottle containing 30 tablets.
PL 10383/0417

POM

Other possible side effects:
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.

Who makes and repackages your medicine?
Your medicine is manufactured by Roche SpA. – Officina Di Segrate – Via
Morelli 2 Italy Procured from within the EU and repackaged by the Product
Licence Holder: Primecrown Ltd., Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.

Heart and circulation:
 Feeling dizzy when you stand up. This usually gets better if your dose is
lowered.

Leaflet date: 11.12.2012

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.

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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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