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Stalevo^®

Availability - Formulation

• Stalevo^® (levodopa/carbidopa/entacapone) is supplied as tablets for oral administration, in three different strengths:
  
  

• The film-coated tablets are brownish- or greyish-red and marked with LCE 50 (round tablet), LCE 100 (elongated ellipse-shaped tablet) or LCE 150 (oval tablet) on one side
• Do not store Stalevo^® near extreme cold or heat. It is best to store the tablets at room temperature, between 15–30°C
• Keep the tablets out of the sight and reach of children
• Do not use the tablets after the expiry date stated on the label or carton

Stalevo^® is registered for use in the following European countries

• 
  Austria
• 
  Belgium
• 
  Czech Republic
• 
  Denmark
• 
  Estonia
• 
  Finland
• 
  France
• 
  Germany
• 
  Greece
• 
  Hungary
• 
  Iceland
• 
  Ireland
• 
  Italy
• 
  Latvia
• 
  Lithuania
• 
  Luxembourg
• 
  Norway
• 
  Poland
• 
  Portugal
• 
  Russia
• 
  Slovakia
• 
  Slovenia
• 
  Spain
• 
  Sweden
• 
  Switzerland
• 
  The Netherlands
• 
  Turkey
• 
  Ukraine
• 
  United Kingdom

Therapeutic indications (When to use Stalevo^®)

• Stalevo^® is an enhanced levodopa therapy that blocks two major pathways of levodopa metabolism by dual enzyme inhibition of dopa-decarboxylase, by carbidopa, and catechol-O-methyl transferase, by entacapone
• Stalevo^® is indicated for the treatment of patients with Parkinson’s disease experiencing the signs and symptoms of end-of-dose wearing-off not stabilised on levodopa/DDCI treatment
• This means that Stalevo^® may be used as an alternative to your current levodopa therapy when you or your doctor begin to notice the re-emergence of symptoms before your next dose of levodopa is due
• In addition, if your are taking levodopa/carbidopa and entacapone as separate tablets, Stalevo^® may be used instead

How to take Stalevo^®

• Your doctor will advise you on how to take Stalevo^®. A dose schedule will be created to suit your individual needs, which may be adjusted with higher or lower doses depending on how you respond to the treatment
• You should take only one tablet each time you take Stalevo^® and according to the schedule agreed with your doctor. The tablet should be taken whole and not broken or crushed
• It is recommended that no more than 10 tablets of Stalevo^® should be taken each day
• Stalevo^® may be taken with or without food, however, a high protein diet may reduce the amount of drug that is taken up by the body

Note: You should be provided with detailed instructions on how to take Stalevo^® by your doctor. Any additional questions you may have should be discussed with your doctor

If you are not currently taking entacapone

• If you are receiving levodopa/dopa decarboxylase inhibitor (DDCI) therapy and are experiencing a re-emergence of symptoms before your next dose of levodopa is due, you can be directly transferred to Stalevo^®
• A direct switch from levodopa/DCCI to Stalevo^® is not recommended for patients who have dyskinesias or whose daily levodopa dose is above 800 mg. In such patients it is advisable to introduce entacapone treatment as a separate medication and adjust the levodopa dose if necessary, before switching to Stalevo^®
• The Stalevo^® dose and regimen is determined by your doctor

If you are currently taking entacapone

• If you are taking levodopa/carbidopa and entacapone in doses equal to those in Stalevo^® tablets, you can be directly transferred to corresponding doses of Stalevo^®
  • For example, if you are taking one tablet of 50/12.5 mg of levodopa/carbidopa with one tablet of 200 mg entacapone four-times daily, you can be transferred to one 50/12.5/200 Stalevo^® tablet four-times daily
• If you are taking levodopa/benserazide and entacapone you will be transferred to a Stalevo^® tablet that will provide either the same amount of levodopa or slightly more (5–10%)

If you take more Stalevo^® than you should

• If you have accidentally taken too many Stalevo^® tablets, talk to your doctor or pharmacist immediately

If you forget to take Stalevo^®

• If there is more than an hour until your next dose– take one tablet now, and the next tablet at the normal time
• If there is less than an hour until your next dose– take a tablet now, wait an hour, then take another tablet. After that go back to your normal schedule
• Do not take a double dose to make up for forgotten doses. Always leave at least an hour between Stalevo^® tablets, to avoid possible side effects

Stopping Stalevo^® treatment

• Do not stop taking Stalevo^® unless your doctor tells you to. In such a case, your doctor may need to adjust your other antiparkinsonian medications, especially levodopa, to give sufficient control of your symptoms
• Abrupt discontinuation of Stalevo^® and other antiparkinsonian medications may result in unwanted side effects

Note: You should be provided with detailed instructions on how to take Stalevo^® by your doctor. Any additional questions you may have should be discussed with your doctor

Contra-indications (When not to use)

• Stalevo^® should not be used in the following instances:
  • If you are allergic to levodopa, carbidopa, entacapone or any of the other ingredients of Stalevo^®
  • If you have severe liver impairment
  • If you have narrow-angle glaucoma (an eye disorder)
  • If you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure)
  • If you have ever had neuroleptic malignant syndrome, a rare reaction to medicines used to treat severe mental disorders
  • If you have ever had non-traumatic rhabdomyolysis, which is a rare muscle disorder
  • If you suspect that you might be suffering from abnormal skin lesions or have a history of melanoma

Note: Any questions you may have regarding treatment with Stalevo^® should be discussed with your doctor

Special warnings and precautions for use

• Be careful with Stalevo^® and check with your doctor:
  • If you have ever had a heart attack or any other disease of the heart, blood vessels or lungs, including bronchial asthma
  • If you have a liver disorder. Your dose may need to be adjusted
  • If you have ever had a renal or endocrine disease
  • If you have ever had stomach ulcers or convulsions
  • If you have ever suffered from any form of severe mental disorder
  • If you feel depressed, have suicidal thoughts or notice unusual changes in your behaviour
  • If you have chronic wide-angle glaucoma. Your dose may need to be adjusted and the pressure in your eyes may need to be monitored
  • If you are taking other medicines that can cause low blood pressure. You should be aware that Stalevo^® (levodopa/carbidopa/entacapone) may make these reactions worse
  • If you find yourself suddenly falling asleep, or if you feel very drowsy (see also the ‘Effects on ability to drive or use machinery’ section)
  • If uncontrolled movements begin or get worse after you start taking Stalevo^®. If this happens, you should contact your doctor, because you may need to change the dose of your antiparkinsonian medications
  • If your muscles get very rigid or jerk violently, or if you suffer from tremors, agitation, confusion, fever, rapid pulse or wide fluctuations in your blood pressure. If any of this happens contact your nearest hospital immediately
  • If you feel the need to stop using Stalevo^®, please consult your doctor first. It is important to reduce the dose of Stalevo^® gradually, and make changes in your other antiparkinsonian medications in order to prevent side effects and keep your Parkinson’s disease symptoms from getting worse

Note: If you think that any of the above applies to you, contact your doctor

Interactions with other medicinal products and other forms of interaction

• Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including non-prescribed and herbal products
• Stalevo^® (levodopa/carbidopa/entacapone) may increase the effects and side effects of certain antidepressants and some other medicines. These include:
  • Monoamine oxidase-A inhibitors (e.g. moclobemide)
  • Tricyclic antidepressants (e.g. amitryptiline)
  • Noradrenaline reuptake inhibitors (e.g. desipramine, maprotiline and venlafaxine)
  • Paroxetine
  • Rimiterole
  • Isoprenaline
  • Adrenaline
  • Noradrenaline
  • Dopamine
  • Dobutamine
  • Alpha-methyldopa
  • Apomorphine
• The effects of Stalevo^® may be weakened by certain medicines. These include:
  • Dopamine antagonists used to treat mental disorders
  • Dopamine antagonists used to treat nausea and vomiting
  • Phenytoin (used to prevent convulsions)
  • Papaverine (used to relax the muscles)
• Stalevo^® may make it harder for you to digest iron. Therefore, do not take Stalevo^® and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other
• Stalevo^® may potentially interfere with drugs, such as warfarin, whose metabolism is dependent on a certain enzyme (cytochrome P450 2C9)
  • A blood clotting test (international normalised ratio) is recommended when Stalevo^®  treatment is initiated in patients receiving warfarin

Pregnancy and lactation

• If you are pregnant or think you may be pregnant, do not take Stalevo^® (levodopa/carbidopa/entacapone)  before consulting your doctor
• You should not breast-feed while under treatment with Stalevo^®

Effects on ability to drive and use machines

• Stalevo^® may lower your blood pressure, which may make you feel lightheaded or dizzy. Therefore, caution should be taken when driving or using machines
• Stalevo^® may make you feel very drowsy. If this happens, you must not drive or do anything else that requires you to be alert (e.g. using tools or machines) until you are clear of such problems

Possible undesirable effects of Stalevo^®

• Stalevo^® is generally well-tolerated. However, as with any medication some people may experience side effects as a result of treatment. Many of these side effects can be relieved by adjusting the dose. For more information, look at the information sheet that comes with each new pack of tablets. Remember that these sheets list all the possible side effects, most of which are uncommon
• The side effects most frequently reported with Stalevo^® include:
  • Uncontrolled movements
  • Nausea
  • Mental changes, including paranoia and psychotic symptoms, depression (possibly with thoughts of suicide) and problems with memory and thinking
  • Harmless urine discolouration (urine colour turns reddish-brown)

Note: If you develop any new symptoms or problems after starting on Stalevo^®, it is important to tell your doctor or pharmacist

Product information downloads

Not available

Useful links and references

• www.orion.fi

To learn more about Novartis Pharma AG:

• www.novartis.com/pharma

For the European Agency for the Evaluation of Medicinal Products Report on Stalevo^®:

• www.emea.eu.int/humandocs/Humans/EPAR/stalevo/stalevo.htm

Clinical trials with levodopa/DDCI and entacapone

1. Parkinson Study Group. Entacapone improves motor fluctuations in levodopa-treated Parkinson's disease patients. Parkinson Study Group. Ann Neurol 1997; 42(5): 747–755.
2. Rinne, U. K., J. P. Larsen, A. Siden et al. Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations. Nomecomt Study Group. Neurology 1998; 51(5): 1309–1314.
3. Poewe, W. H., G. Deuschl, A. Gordin et al. Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal levodopa response: a 6-month randomized placebo-controlled double-blind study in Germany and Austria (Celomen study). Acta Neurol Scand 2002; 105(4): 245–255.
4. Brooks, D. J. and H. Sagar. Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinson's disease: a randomised, placebo controlled, double blind, six month study. J Neurol Neurosurg Psychiatry 2003; 74(8): 1071–1079.
5. Myllyla, V., E. R. V.Kultalahti, H. Haapaniemi et al. Twelve-month safety of entacapone in patients with Parkinson's disease. Eur J Neurol 2001; 8(1): 53–60.
6. Larsen, J. P., J. Worm-Petersen, A. Siden et al. The tolerability and efficacy of entacapone over 3 years in patients with Parkinson's disease. Eur J Neurol 2003; 10(2): 137–146.

Further information

Levodopa / carbidopa / entacapone is marketed as Stalevo^® by Orion Corporation Orion Pharma and Novartis Pharma AG.