Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
ENTACAPONE
McDermott Laboratories Ltd t/a Gerard Laboratories
200 Milligram
Film Coated Tablet
2011-08-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Entacapone Mylan 200 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg entacapone. Excipient(s): Each tablet contains: 0.136 mg Sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Light orange, oval-shaped, biconvex, film coated tablet debossed with “EE200” on one side of the tablet and “M” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in adult patients with Parkinson’s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations. 4.2 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. POSOLOGY One 200 mg tablet is taken with each levodopa/dopa decarboxylase inhibitor dose. The maximum recommended dose is 200 mg ten times daily, i.e. 2,000 mg of entacapone. Entacapone enhances the effects of levodopa. Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment. The daily dose of levodopa should be reduced by about 10–30% by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient. If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, esp Perskaitykite visą dokumentą