Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Provigil 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 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 400 mg in one or two divided doses can be used in patients with insufficient response to the initial 200 mg modafinil dose.
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).
There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment (see section 5.2).
The dose of modafinil should be reduced by half in patients with severe hepatic impairment (see section 5.2).
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.
Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns (see section 4.4).
For oral use.
Tablets should be swallowed whole.
Death has occurred with modafinil overdose alone or in combination with other drugs. Symptoms most often accompanying modafinil overdose, alone or in combination with other drugs have included: insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, agitation, anxiety, excitation and hallucination; digestive changes such as nausea and diarrhoea; and cardiovascular changes such as tachycardia, bradycardia, hypertension and chest pain.
Induced emesis or gastric lavage should be considered. Hospitalisation and surveillance of psychomotor status; cardiovascular monitoring or surveillance until the patient’s symptoms have resolved are recommended.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
Opaque PVC/PVDC/aluminium blisters.
Packs of 10, 20, 30, 50, 60, 90, 100 or 120 tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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