MEDAPIA Film-coated tablet Ref.[51150] Active ingredients: Entacapone

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, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.

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.

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).

Hepatic impairment

See section 4.3.

Elderly (≥65 years)

No dosage adjustment of entacapone is required for older people.

Paediatric 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).

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, decreased activity, somnolence, hypotonia, skin discolouration and urticaria. Management of acute overdose is symptomatic.

24 months.

Brown amber glass bottles (hydrolytic class III) with white LDPE closures: This medicinal product does not require any special storage conditions.

PVC/PVDC-Alu blisters opaque: Store below 30°C.

The tablets are packed in:

• Brown amber glass bottles (hydrolytic class III) containing 30 or 60 tablets, with white LDPE closures and with one white cylindrical silica gel desiccant pill. Each bottle also includes one piece of white polyurethane foam.
• PVC/PVDC-Alu opaque blisters containing 30, 60, 100 or 500 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.