Tasmar® (tolcapone)

Tasmar® is available in the following European countries: |
- Austria
- Belgium,
- Cyprus
- Czech Republic
- Denmark, Estonia
- Finland
- France
|
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
|
- Luxembourg
- Malta
- Netherlands
- Poland
- Portugal
- Russia
- Slovakia
|
- 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. |
This section provides a summary
of the drug information for Tasmar®. It is still important that you read the full package
leaflet carefully before you start taking any medication. If you have
any further questions about Tasmar®, (tolcapone), or other aspects
of your PD treatment, you should discuss these with your
doctor or other healthcare professional. |
Availability - Formulation
Tasmar® is available in the following formulations:
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.
Tasmar® does not require any special
storage conditions
|
Indications - When to use Tasmar
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.
|
When Tasmar® should not be used
- 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
For more information on Parkinson's Disease:
The Movement Disorder Society (MDS): http://movementdisorders.org
American Parkinson Disease Association (APDA): www.youngparkinsons.org
The Parkinson’s Disease Foundation (PDF): www.pdf.org
To
learn more about Valeant: www.valeant.com |