Modafinil 200mg

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. Modafinil 200mg

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
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, one in the morning or as two doses in the morning and at one 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).

Renal impairment
There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment
The dose of modafinil should be reduced by half in patients with severe hepatic impairment
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. Tablets should be swallowed whole

Each tablet contains 200 mg of modafinil.

Excipient with known effect: Each tablet contains 227.000 mg lactose monohydrate;

White to off-white, capsule shaped, uncoated tablets, debossed with ‘4’ & ‘2’ separated by score line on one side ‘J’ on other side.