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SPC: COMTAN Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Comtan 200 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg entacapone. Excipient with known effect: Each tablet contains 1.82 mg sucrose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Brownish-orange, oval, biconvex film-coated tablet with Comtan engraved on one side.

Therapeutic indications

Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in adult patients with Parkinsons disease and end-of-dose motor fluctuations, who cannot ...

Posology and method of administration

Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa. The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic impairment. Phaeochromocytoma. Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A ...

Special warnings and precautions for use

Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinsons disease. NMS, including rhabdomyolysis and hyperthermia, is characterised ...

Interaction with other medicinal products and other forms of interaction

No interaction of entacapone with carbidopa has been observed with the recommended treatment schedule. Pharmacokinetic interaction with benserazide has not been studied. In single-dose studies in healthy ...

Pregnancy and lactation

Pregnancy No overt teratogenic or primary foetotoxic effects were observed in animal studies in which the exposure levels of entacapone were markedly higher than the therapeutic exposure levels. As there ...

Effects on ability to drive and use machines

Comtan in association with levodopa may have a major influence on the ability to drive and use machines. Entacapone may, together with levodopa, cause dizziness and symptomatic orthostatism. Therefore, ...

Undesirable effects

Summary of the safety profile The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of treatment. Reduction of ...

Overdose

The post-marketing data include isolated cases of overdose in which the reported highest daily dose of entacapone has been 16,000 mg. The acute symptoms and signs in these cases of overdose included confusion, ...

Pharmacodynamic properties

Pharmacotherapeutic group: other dopaminergic agents ATC code: N04BX02 Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors. It is a reversible, specific, and ...

Pharmacokinetic properties

General characteristics of the active substance Absorption There are large intra- and interindividual variations in the absorption of entacapone. The peak concentration (C<sub>max</sub>) in plasma is usually ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In repeated dose toxicity studies, ...

List of excipients

Tablet core: Microcrystalline cellulose Mannitol Croscarmellose sodium Hydrogenated vegetable oil Magnesium stearate Film-coating: Hypromellose Polysorbate 80 Glycerol 85% Sucrose Yellow iron oxide (E172) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Amber glass bottles (hydrolytic class III) with white tamper-resistant polypropylene closures containing 30, 60 or 100 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization number(s)

EU/1/98/081/001-003

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 September 1998 Date of latest renewal: 03 September 2008

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