Posology : מינונים

2. DOSAGE AND ADMINISTRATION
Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders.
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, one in the morning and one 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 information to determine safety and efficacy of dosing in patients with renal impairment.
Patients with hepatic impairment
The dose of modafinil should be reduced by half in patients with severe hepatic impairment.

Elderly
There are limited data available on the use of modafinil in elderly patients. In view of the potential for lower clearance and increased systemic exposure, it is recommended that patients over 65 years of age commence therapy at 100 mg daily.
Paediatric population
Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns.
Method of administration
For oral use. Caplets should be swallowed whole.


3. DOSAGE FORMS AND STRENGTHS
The caplets are white to off-white, capsule-shaped and debossed with '100' on one side.