Comtess^®/Comtan^® (entacapone)

Quick links Availability - formulation Therapeutic Indications Contra-indications (When not to use) Special warnings & precautions for use Interactions with other medicinal products Pregnancy and lactation Effects on ability to drive & use machines Possible undesirable effects How To Take Product information downloads Useful links & references Further information

Availability

Entacapone is provided by Orion Corporation Orion Pharma as Comtess^®, and is provided by Novartis Pharma AG as Comtan^®, depending on the country you live in.

Comtess^® / Comtan^® are available for use in the following European countries:

Availability - Formulation

• Comtess^®/Comtan^® (entacapone) is supplied as tablets for oral administration. Each tablet contains 200 mg of entacapone
• The oval-shaped, film-coated tablets are brownish-orange with COMT engraved on one side
• Do not store Comtess^®/Comtan^® near extreme cold or heat
  • It is best to store the tablets at room temperature, between 15–30°C
• Keep out of the sight and reach of children
• Do not use tablets after the expiry date stated on the label or carton

Therapeutic indications (When to use)

• Comtess^®/Comtan^® (entacapone) is used together with levodopa to treat Parkinson’s disease. Comtess^®/Comtan^® improves the efficacy of levodopa therapy in relieving the symptoms of Parkinson's disease. Comtess^®/Comtan^® has no antiparkinsonian activity without levodopa

How to take Comtan^®/Comtess^®

• It is recommended that you take one tablet of Comtess^®/Comtan^® (entacapone) every time you take your usual dose of levodopa medicine
• Comtess^®/Comtan^® should always be taken at the same time as your levodopa therapy
• Comtess^®/Comtan^® may be taken with or without food; however, since it should always be given with levodopa the restrictions on taking levodopa (as prescribed by your doctor) will apply
• The drug maximum recommended dose is 10 Comtess^®/Comtan^® tablets each day, i.e. 2000 mg of entacapone per day. Your doctor will provide you with specific instructions

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

If you take more Comtess^®/Comtan^® than you should

• If you have accidentally taken too many Comtess^®/Comtan^® tablets talk to your doctor or pharmacist immediately

If you forget to take Comtess^®/Comtan^®

• If you forget to take the Comtess^®/Comtan^® tablet with your levodopa dose, you should continue your treatment by taking the next Comtess^®/Comtan^® tablet exactly as prescribed by your doctor. Do not take a double dose to make up for the forgotten tablet

Stopping Comtess^®/Comtan^® treatment

• Do not stop taking Comtess^®/Comtan^® unless your doctor tells you to. In such a case, your doctor may need to re-adjust the dosage of your other antiparkinsonian medication. Abrupt discontinuation of both Comtess^®/Comtan^® and other antiparkinsonian medication may result in unwanted side effects. If you have any further questions on the use of this product, ask your doctor or pharmacist

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

Contra-indications (When not to use)

• Comtess^®/Comtan^® (entacapone) should not be used in the following instances:
  • If you are allergic (hypersensitive) to entacapone or any of the other ingredients of Comtess^®/Comtan^®
  • If you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure)
  • If you are taking certain antidepressant medications called non-selective monoamine oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine). Concomitant use of a selective MAO-A inhibitor and selective MAO-B inhibitor with entacapone is also contraindicated. Ask your doctor or pharmacist whether your antidepressive medication can be taken together with Comtess^®/ Comtan^®
  • If you have liver impairment
  • If you have ever had neuroleptic malignant syndrome, a rare reaction to medicines used to treat severe mental disorders
  • If you ever had non-traumatic rhabdomyolysis, which is a rare muscle disorders
  • If you are not taking levodopa

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

Special warnings and precautions for use

• Be careful with Comtess^®/Comtan^® and check with your doctor:
  • If you suffer from levodopa-induced orthostatic hypertension, or are taking medicinal products which may cause orthostatic hypertension (low blood pressure when standing)
  • 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)

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
• Comtess^®/Comtan^® (entacapone) may increase the effects of other medicinal products such as those containing:
  • Rimiterole
  • Isoprenaline
  • Adrenaline
  • Noradrenaline
  • Dopamine
  • Dobutamine
  • Alpha-methyldopa
  • Apomorphine
  • Paroxetine
• Comtess^®/Comtan^® may affect the absorption of iron. Comtess^®/Comtan^® and iron preparations should be taken at least 2 to 3 hours apart
• Comtess^®/Comtan^® 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 entacapone treatment is initiated in patients receiving warfarin

Pregnancy and lactation

• Do not take Comtess^®/ Comtan^® (entacapone) during pregnancy or if you are breast-feeding

Effects on ability to drive and use machines

• Comtess^®/Comtan^® (entacapone) taken with levodopa 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 Comtan^®/Comtess^® (entacapone)

• Most people take Comtess^®/Comtan^® (entacapone) with no adverse effects; however, as with any medication some people do experience undesirable side effects as a result of entacapone treatment. 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 Comtess^®/Comtan^® include:
• Uncontrolled movements (dyskinesias, hyperkinesias)
• Nausea and/or vomiting
• Worsening of parkinsonian symptoms
• Harmless reddish-brown discolouration of urine
• Mental changes: insomnia, hallucinations, confusion and paroniria
• Diarrhoea/constipation
• Dryness of the mouth

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

Product information downloads

The information on this pageprintout is a general summary of the Comtess^®/Comtan^® medication product.

Please click on the links below to download more detailed information on the specific Comtess^®/Comtan^® medication, its handling and use. Links go to the electronic Medicines Compendium (eMC) website.

Further detailed information on the specific Neupro^® medication, its handling and use can be downloaded via the electronic Medicines Compendium (eMC) website (http://emc.medicines.org.uk/):

UK Patient Information Leaflets (PIL)

UK Summary of Product Characteristics (SPC)

Please note that SPCs are designed for healthcare professionals.

European Public Assessment Report

Further detailed information can also be downloaded via the European Medicines Agency (EMEA) website (www.emea.europa.eu):

Links below go to the The European Medicines Agency (EMEA) website.

Useful links and references

To learn more about Orion Corporation Orion Pharma:

• www.orion.fi

To learn more about Novartis Pharma AG:

• www.novartis.com/pharma

European Agency for the Evaluation of Medicinal Products Report on Entacapone

• www.emea.europa.eu/humandocs/Humans/EPAR/comtess/comtess.htm
• www.emea.europa.eu/humandocs/Humans/EPAR/comtan/comtan.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

Entacapone is known as Comtess^®, provided by Orion Corporation Orion Pharma or Comtan^®, provided by Novartis Pharma AG depending on the country you live in.