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Tasmar^® (tolcapone)

Availability - Countries

Tasmar^® is available in the following European countries:

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" is engraved on one side, "100" on the other.
• 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 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 given 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.

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 Undesirable Effects of Tasmar^®

These are the most commonly reported undesirable effects with Tasmar®, however, it does not necessarily mean that you will experience some or all of them. For full information about possible undesirable effects we kindly ask you to read the package information or talk to your doctor.

• Dyskinesia, nausea and other levodopa-associated undesirable effects - You may experience an increase in levodopa-associated adverse reactions. Often times reducing the dose of levodopa mitigates these effects.
• Diarrhoea - Some patients experience diarrhoea while taking Tasmar. Many patients experience this effect 2-4 months after initiation of therapy
• Occasional reports of orthostatic hypotension.
• Psychiatric problems are common in Parkinsonian patients, including those being treated with levodopa. They include feeling in confusion, insomnia, drowsiness, depression, dizziness, hallucinations. Sleep disturbances, excessive dreaming, somnolence (excessive drowsiness), and other psychiatric reactions may occur.
• Sometimes your urine may be coloured red and turn dark if left to stand. The changes are the result of the action of the drug and are no cause for concern
• Rare cases of severe hepatocellular injury resulting in death have been reported during marketed use.

Useful Links & References

To learn more about Valeant: www.valeant.com

Further Information

Tasmar^® Website

• www.tasmar.com