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The eMC  

Last Updated 06 Jan 2014

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Stalevo 50mg/12.5mg/200mg tablets

Stalevo (Stal-lee-voh) is a medicine which is used in Parkinson's disease. Stalevo contains carbidopa/entacapone/levodopa. It is supplied by Orion Pharma (UK) Limited.

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

There are 7 preparations of Stalevo available. If Stalevo 50mg/12.5mg/200mg tablets is not the preparation you are looking for, please select from the drop down list below.

Select your preparation (type) of Stalevo

Stalevo 50mg/12.5mg/200mg tablets

Information specific to Stalevo 50mg/12.5mg/200mg tablets when used in Parkinson's disease

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Your medicine

Stalevo contains three medicines - levodopa, carbidopa and entacapone. They work together to increase the levels of dopamine in the brain. Stalevo is used to treat Parkinson's disease.

Other information about Stalevo:

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 Stalevo:

  • do not take preparations containing iron at the same time as Stalevo. You should take Stalevo and these preparations at least two to three hours apart
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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. 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 Stalevo:

If you are having problems taking this medicine, 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 medicines 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 NHS Direct on 0845 46 47 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 Stalevo abruptly. This is because, in some instances, stopping Stalevo abruptly can cause withdrawal symptoms or cause your original condition to return. In these instances, reducing the dose of Stalevo gradually over time may reduce the chances of having these problems.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

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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 Stalevo:

  • there are no special instructions on how to look after your medicine

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

Stalevo 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:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone under 18 years of age.

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

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

Over time it is possible that Stalevo can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Stalevo 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.

Very common: More than 1 in 10 people who take Stalevo:

  • abnormal muscle movements or problems controlling muscle movement
  • connective tissue problems
  • diarrhoea - seek medical advice if you have diarrhoea
  • muscle or bone pain
  • nausea
  • reddish-brown discoloration of urine

Common: More than 1 in 100 people who take Stalevo:

Uncommon: More than 1 in 1000 people who take Stalevo:

Rare: More than 1 in 10,000 people who take Stalevo:

The frequency of these side-effects is unknown:

  • 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
  • convulsions
  • liver problems
  • may affect the result of a urine test for detecting ketones
  • mental changes - you or your carer should seek medical advice if you are depressed, have thoughts of committing suicide or there are changes to your mental state
  • neuroleptic malignant syndrome - this may occur when Stalevo is stopped abruptly or if doses of Stalevo are reduced too quickly. You or your carer should seek medical advice if you get these symptoms: abnormally high body temperature, faster heart rate, mental changes such as confusion or agitation, tremors, muscle rigidity or sudden jerks
  • rhabdomyolysis
  • urticaria

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 NHS Direct on 0845 46 47.

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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 Stalevo:

The following types of medicine may interact with Stalevo:

If you are taking Stalevo 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.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Stalevo:

If you have been prescribed Stalevo you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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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 Stalevo:

  • 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 Stalevo.

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 Stalevo:

  • the medicine levodopa interacts with protein. A diet that is high in protein may affect the absorption of Stalevo and stop it from working as well as normal

For more advice speak to your prescriber, nutritionist or pharmacist.

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Alcohol

Alcohol can interact with certain medicines.

In the case of Stalevo:

  • there are no known interactions between alcohol and Stalevo
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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 Stalevo:

  • the use of this medicine during pregnancy is not recommended. You should only take this medicine during pregnancy if your doctor thinks that you need it

You should discuss your personal circumstances with your doctor if you are pregnant or want to become pregnant. This is so that together you can make a decision about what treatment you may need during your pregnancy.

You should discuss whether there are any other medicines which you could take during pregnancy which would treat your condition.

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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 Stalevo:

  • women who are taking Stalevo should not breast-feed

Before you have Stalevo 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.

Stalevo contains:

  • carbidopa, entacapone and levodopa
  • croscarmellose sodium
  • glycerol 85% (E422)
  • hypromellose
  • magnesium stearate
  • maize starch
  • mannitol (E421)
  • polysorbate 80
  • povidone K 30 (E1201)
  • red iron oxide (E172)
  • sucrose
  • titanium dioxide (E171)
  • yellow iron oxide (E172)

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 Stalevo before, do not take Stalevo. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Stalevo, Version 10, last updated 06 Jan 2014