TASMAR Film-coated tablet Ref.[9760] Active ingredients: Tolcapone

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Meda AB, Pipers väg 2A, S-170 09, Solna, Sweden

Product name and form

Tasmar 100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pale to light yellow, hexagonal, biconvex, film-coated tablet. “TASMAR” and “100” are engraved on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 100 mg tolcapone.

Excipients with known effect: Each tablet contains 7.5 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tolcapone

Tolcapone is an orally active, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. Administered concomitantly with levodopa and an aromatic amino acid decarboxylase inhibitor (AADC-I), it leads to more stable plasma levels of levodopa by reducing metabolism of levodopa to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD). High levels of plasma 3-OMD have been associated with poor response to levodopa in Parkinson’s disease patients.
List of Excipients

Tablet core:

Calcium hydrogen phosphate
Microcrystalline cellulose
Povidone K30
Sodium starch glycollate
Lactose
Talc
Magnesium stearate

Film-coat:

Hydroxypropylmethylcellulose
Talc
Yellow iron oxide
Ethylcellulose
Titanium dioxide
Triacetin
Sodium lauril sulfate

Pack sizes and marketing

Tasmar is available in PVC/PE/PVDC blisters (pack sizes of 30 and 60 film-coated tablets) and in amber glass bottles without desiccant (pack sizes of 30, 60,100 and 200 film-coated tablets).

Not all pack sizes may be marketed.

Marketing authorization holder

Meda AB, Pipers väg 2A, S-170 09, Solna, Sweden

Marketing authorization dates and numbers

EU/1/97/044/001-3, 7, 8, 10

Date of first authorisation: 27 August 1997
Renewal of the authorisation: 31 August 2004
Date of latest renewal: 21 July2014

Drugs

Drug Countries
TASMAR Austria, Brazil, Cyprus, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Turkey, United Kingdom, United States, South Africa
 
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