TASMAR Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Tasmar 100 mg film-coated tablets.
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.
Pharmaceutical form
Film-coated tablet. Pale to light yellow, hexagonal, biconvex, film-coated tablet. TASMAR and 100 are engraved on one side.
Therapeutic indications
Tasmar is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinsons disease and motor fluctuations, who failed to respond ...
Posology and method of administration
Posology Paediatric population Tasmar is not recommended for use in children below the age of 18 due to insufficient data on safety or efficacy. There is no relevant indication for use in children and ...
Contraindications
Hypersensitivity to tolcapone or any of its other ingredients listed in section 6.1. Evidence of liver disease or increased liver enzymes. Severe dyskinesia. A previous history of Neuroleptic Malignant ...
Special warnings and precautions for use
Tasmar therapy should only be initiated by physicians experienced in the management of advanced Parkinsons disease, to ensure an appropriate risk-benefit assessment. Tasmar should not be prescribed until ...
Interaction with other medicinal products and other forms of interaction
Tasmar, as a COMT inhibitor, is known to increase the bioavailability of the co-adminstered levodopa. The consequent increase in dopaminergic stimulation can lead to the dopaminergic adverse reactions ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of tolcapone in pregnant women. Therefore, Tasmar should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. ...
Effects on ability to drive and use machines
No studies on the effects of Tasmar on the ability to drive and use machines have been performed. There is no evidence from clinical studies that Tasmar adversely influences a patients ability to drive ...
Undesirable effects
The most commonly observed adverse reactions associated with the use of Tasmar, occurring more frequently than in placebo-treated patients are listed in the table below. However, Tasmar, as a COMT inhibitor, ...
Overdose
Isolated cases of either accidental or intentional overdose with tolcapone tablets have been reported. However clinical circumstances of these cases were so diverse, that no general conclusions can be ...
Pharmacodynamic properties
Pharmaco-therapeutic group: Anti-Parkinson drugs, other dopaminergic agents ATC code: NO4BX01 Mechanism of action Tolcapone is an orally active, selective and reversible catechol-O-methyltransferase (COMT) ...
Pharmacokinetic properties
In the therapeutic range, tolcapone pharmacokinetics are linear and independent of levodopa/AADC-I (benserazide or carbidopa) coadministration. Absorption Tolcapone is rapidly absorbed with a t<sub>max ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. Carcinogenesis, ...
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 ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Meda AB, Pipers väg 2A, S-170 09, Solna, Sweden
Marketing authorization number(s)
EU/1/97/044/001-3, 7, 8, 10
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 August 1997 Renewal of the authorisation: 31 August 2004 Date of latest renewal: 21 July2014
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