Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
MODAFINIL
Orchid Europe Limited
100 Milligram
Tablets
2010-05-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Modafinil 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg modafinil Contains about 51 mg of Lactose per tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off white coloured capsule shaped tablet debossed with 'M' on one side and '100 MG' on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Modafinil is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy. Excessive sleepiness is defined as difficulty maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders (see section 4.1). A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline. Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis. Posology The recommended starting daily dose is 200 mg. The total daily dose may be taken as a single dose in the morning or as two doses in the morning and at noon according to physician assessment of the patient and the patient's response. Doses of up to 400mg in one or two divided doses can be used in patients with insufficient response to the initial 200mg modafinil dose. Long-term use Physicians prescribing modafinil for an extended time should periodically re-evaluate the long-term use for the individual patients as the long-term efficacy of modafinil has not been evaluated (> 9 weeks). Patients with renal impairment There is inadequate inf Lire le document complet