Modafinil 200mg 30 tablets

Modafinil 200 mg tablets

Each tablet contains 200 mg of modafinil.

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

For the full list of excipients, see section 6.1.

Tablet

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.

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.

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 (see section 5.2).

Hepatic impairment

The dose of modafinil should be reduced by half in patients with severe hepatic impairment (see section 5.2).

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 (see section 4.4).

Method of administration

For oral use. Tablets should be swallowed whole.