Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Actavis Group PTC ehf
0.7 Milligram
Tablets
2010-11-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Derinik 0.7 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Derinik 0.7 mg tablets contain 0.7 mg of pramipexole base (as 1.0 mg of pramipexole dihydrochloride monohydrate). _Please note:_ Pramipexole doses as published in the literature refer to the salt form. Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round tablets, marked on one side with a “3” (three), scored on the other side with no defects and dimensions 6.0 ± 0.1 mm in diameter and 3.0 mm ± 0.2 mm in thickness. The tablets are scored so the tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Derinik is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Parkinson’s disease The daily dose is administered in equally divided doses 3 times a day. _Initial treatment_ Doses should be increased gradually from a starting dose of 0.264 mg of base (0.375 mg of salt) per day and then increased every 5-7 days. Providing patients do not experience intolerable undesirable effects, the dose should be titrated to achieve a maximal therapeutic effect. If a further dose increase is necessary the daily dose should be increased by 0.54 mg of base (0.75 mg of salt) at weekly intervals up to a maxim Leggi il documento completo