ENCAPIA FILM COATED TABLETS 200MG

TABLET, FILM COATED

**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. Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations slightly (5–10%) more than from standard levodopa/carbidopa preparations. Hence, patients who are taking standard levodopa/benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated. If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms. _Renal impairment_: Renal insufficiency does not affect the pharmacokinetics of entacapone and there is no need for dose adjustment. However, for patients who are receiving dialysis therapy, a longer dosing interval may be considered (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment_: see section 4.3. _Elderly_: No dosage adjustment of entacapone is required for elderly patients. _Pediatric population_: The safety and efficacy of entacapone in children below age 18 have not been established. No data are available. Method of administration Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose. Entacapone can be taken with or without food (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).