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The eMC  

Last Updated 31 Jul 2014

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Madopar 50mg/12.5mg capsules

Madopar (Mad-oh-par) is a medicine which is used in Parkinson's disease. Madopar contains benserazide hydrochloride/levodopa. It is supplied by Roche Products Limited.

The information in this Medicine Guide for Madopar varies according to the condition being treated and the particular preparation used.

There are 6 preparations of Madopar available. If Madopar 50mg/12.5mg capsules is not the preparation you are looking for, please select from the drop down list below.

Select your preparation (type) of Madopar

Madopar 50mg/12.5mg capsules

Information specific to Madopar 50mg/12.5mg capsules when used in Parkinson's disease

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Your medicine

Madopar contains two medicines – Benserazide and levodopa. They both work together to increase the levels of dopamine in the brain. Madopar is used to treat Parkinson's disease and its associated symptoms which may help you to become more active. You should take care to increase your level of activity gradually as a sudden increase in your level of daily activity may increase your chances of having an accident.

Other information about Madopar:

  • your doctor may start you on a low dose of this medicine and then increase the dose depending on how you respond to treatment

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Madopar:

  • this medicine should be taken with or immediately after a meal
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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Madopar:

If you are having problems taking this form of Madopar, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or call 111 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

If you are not having any problems taking this medicine then do not stop taking it, even if you feel better, unless advised to do so by your prescriber. If, however, you find that this medicine is causing you problems then you should talk to your prescriber about your concerns.

If your medical team decides that it is best that you do not take this medicine any more, they may advise that you do not stop Madopar abruptly. This is because, in some instances, stopping Madopar abruptly can cause withdrawal symptoms or cause your original condition to return. In these instances, reducing the dose of Madopar gradually over time may reduce the chances of having these problems.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or call 111.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Madopar:

  • do not store in temperatures above 25°C
  • keep the tablets in the original bottle. The bottle contains a drying agent - do not remove or eat the drying agent
  • make sure the bottle is closed tightly

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Madopar is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Madopar is not used in children.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to check that this medicine is having the desired effect
  • to check that this medicine is not having any undesired effects

Over time it is possible that Madopar can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Madopar has become unsuitable, it is important that the prescriber is contacted immediately.

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Side-effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

The frequency of these side-effects is unknown:

  • a drop in blood pressure on standing or sitting up
  • abnormal laboratory test results
  • abnormal muscle movements or problems controlling muscle movement - this may affect the arms, legs, face or other body parts
  • aggressive behaviour
  • behavioural changes such as an urge to gamble, to buy or to shop, increased libido, hypersexuality, an unusual increase in appetite or binge eating. You or your carer should seek medical advice if there are any changes to your behaviour
  • blood problems
  • delusions
  • depression
  • difficulty sleeping
  • dopamine dysregulation syndrome - this may lead to excessive use of Madopar
  • dose tolerance when Madopar has been taken for a long time - this may lead to periods of time where movement suddenly becomes difficult, where your symptoms return before you take your next dose of Madopar or sudden changes from good symptom control to poor symptom control
  • euphoria
  • feeling agitated
  • feeling anxious
  • feeling drowsy
  • feelings of disorientation
  • flushing
  • gastrointestinal bleeding
  • gastrointestinal problems such as nausea, vomiting, diarrhoea or a loss of appetite - you may reduce the chances of these side-effects from happening by taking Madopar with some food or liquid
  • hallucinations
  • heart problems
  • hypersensitivity reactions
  • itching
  • loss of taste or taste changes
  • may affect the results for certain tests
  • mouth colour changes including the tongue, tooth or saliva
  • neuroleptic malignant syndrome may occur when this medicine is stopped abruptly - seek immediate medical advice if you have fever, muscle rigidity or psychological changes
  • psychiatric problems
  • psychosis or psychotic-like behaviour
  • restless legs syndrome - this may happen if Madopar is taken for a long period of time
  • skin rash or rashes
  • sleepiness - this may be excessive or occur very suddenly at any time of the day. If this happens you must seek medical advice
  • sweating
  • urine colour changes - this may include the urine becoming red in colour

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call 111.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Madopar:

The following types of medicine may interact with Madopar:

If you are taking Madopar and one of the above medicines or types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Madopar.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

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Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Madopar:

  • this medicine could affect your ability to drive or operate machinery

Some people who take this medicine may have sudden attacks of sleepiness. You must not drive if you have had any sudden attacks of sleepiness caused by Madopar.

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery.

If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

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Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Madopar:

  • protein-rich meals may decrease the effect of Madopar

If your diet includes any of the above, speak to your prescriber or pharmacist for further advice.

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Alcohol

Alcohol can interact with certain medicines.

In the case of Madopar:

  • there are no known interactions between alcohol and Madopar
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Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Madopar:

  • you must not take Madopar during pregnancy. If you could become pregnant, you must use effective contraception or abstain from penetrative sex. You must contact your prescriber if you become pregnant, or think you have become pregnant, while taking Madopar

This medicine is not suitable during pregnancy. It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

If you are planning to become pregnant, you should discuss your personal circumstances with your doctor so that together you can make a decision about what treatment you may need during your pregnancy.

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Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Madopar:

  • women who are taking Madopar should not breast-feed
  • it is not known whether this medicine passes into breast milk

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Madopar contains:

  • benserazide hydrochloride and levodopa
  • black iron oxide (E172)
  • indigo carmine (E132)
  • iron oxide (E172)
  • magnesium stearate (E572)
  • mannitol (E421)
  • microcrystalline cellulose E460
  • povidone K90 (E1201)
  • talc (E553b)
  • titanium dioxide (E171)

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Madopar before, do not take Madopar. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Madopar, Version 7, last updated 31 Jul 2014