White to off-white, capsule shaped, uncoated tablets, debossed with ‘4’ & ‘2’ separated by score line on one side ‘J’ on other side. The tablet can be divided into equal doses
Each tablet contains 200 mg of modafinil. Excipient with known effect: Each tablet contains 227.000 mg lactose monohydrate.
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.
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.
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.