Tasmar® (tolcapone)
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Tasmar® information courtesy of Valeant Pharmaceuticals
Last updated January 2007
This section provides a summary of the drug information for Tasmar® (tolcapone). It is still important that you read the full package leaflet that accompanies the product carefully before you start to take any medication. If you have any further questions about your PD medication, or other aspects of your PD treatment, you should discuss these with your doctor or other healthcare professional.
Availability - Countries
Tasmar® is available in the following European countries:
Austria
Belgium
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Netherlands
Norway
Poland
Russia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
Tasmar®, which is available in more than 50 countries, is also available in most Latin-American countries, as well as Australia and Asia & Pacific.
Availability - Formulation
- Tasmar® is supplied as a pale to light yellow, hexagonal film-coated tablet for oral administration.
- Tasmar & 100 are engraved on one side.
- Each tablet contains 100mg of tolcapone.
Pharmaceutical Particulars
Tasmar® does not require any special storage conditions
Therapeutic Indications
Tasmar® is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other COMT inhibitors.
Because of the risk of potentially fatal, acute liver injury, Tasmar® should not be considered as first-line adjunct therapy to levodopa/benserazide or levodopa/Carbidopa.
If substantial clinical benefits are not seen within 3 weeks of the initiation of the treatment, Tasmar® should be discontinued.
How To Take Tasmar®
- Always take Tasmar® exactly as your doctor tells you. He/she will prescribe a suitable dose for you.
- The recommended dose of Tasmar® is 100mg three times daily, always as an adjunct to levodopa/benserazide or levodopa/carbidopa therapy.
- The first dose should be taken together with the first dose of the day of a levodopa preparation, and the subsequent doses should be taken approximately 6 and 12 hours later.
- Tasmar® may be taken with or without food.
- The Tasmar® tablets are film-coated and should be swallowed whole because tolcapone has a bitter taste.
- Because of the risk of rare but potentially fatal acute liver injury, your doctor should check your liver function before starting treatment with Tasmar®. Monitoring is then required every 2 weeks for the first year of treatment, every 4 weeks for the next 6 months and every 8 weeks thereafter. If your doctor increases your dose the liver tests will have to be repeated before increasing the dose and regularly afterwards.
Contra-indications (When Not To Use)
- If you have evidence of liver disease or increased liver enzymes
- If you suffer from severe dyskenesia
- If you have a previous history of Neuroleptic Malignant Syndrome Symptom Complex (NMS) and/or non-traumatic Rhabdomyolysis or Hyperthermia
- If you have phaeochromocytoma
Possible Side Effects of Tasmar®
Like all medicines, Tasmar® can have side effects.
Tell your doctor or a pharmacist as soon as possible if you do not feel well while you are taking Tasmar®.
The unwanted effects that are most likely to occur are: dyskinesia (involuntary movement), nausea, sleeping problems, decreased appetite, diarrhoea, fainting, feeling lightheaded when you stand, constipation and hallucination.
Disturbances in the way the liver works, sometimes severe hepatitis, have been observed. Therefore, if you experience symptoms such as nausea, vomiting, abdominal pain, loss of appetite, weakness, fever, darkening of urine or jaundice you should contact your doctor immediately.
Soon after beginning and during your treatment with Tasmar®, you may have symptoms caused by levodopa such as dyskinesia (involuntary movement) and nausea. Therefore, if you feel unwell, you should contact your doctor since you may need to have your levodopa dose changed.
Contact your doctor if you develop persistent or severe diarrhoea.
This medicine can cause a harmless yellow urine discoloration. However if you notice a darkening of your urine this could be a sign of muscle injury or liver injury, please inform your doctor.
Very rarely, patients develop Neuroleptic Malignant Syndrome (severe symptoms of muscle stiffening, fever or mental confusion) when antiparkinsonian treatments are abruptly reduced or withdrawn.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Product information downloads
The information on this pageprintout is a general summary of the Tasmar® medication product.
Please click on the links below to download more detailed information on the specific Tasmar® medication, its handling and use.
Links go to the electronic Medicines Compendium (eMC) website.
Further detailed information on the specific Tasmar® 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.
Further Information
For further information please contact your health care professional or Valeant Medical Information on + 44 (0) 1748 828 799
Useful Links & References
To learn more about Valeant: www.valeant.com