Composition
Each tablet contains: Active substance: modafinil 100 mg Excipients: monohydrated lactose, corn starch, magnesium silicate, croscarmellose sodium, povidone K90, talc and magnesium stearate.
Pharmaceutical form and content
Tablets. Box of 30 tablets of 100 mg.
Pharmacotherapeutic category
Psychostimulant and nootropic agents. The drug acts on the central nervous system to increase the level of vigilance.
Therapeutic indications
Narcolepsy. Modafinil is effective in reducing excessive diurnal drowsiness associated with this condition.
Contraindications
Known hypersensitivity to PROVIGIL or to any component of the preparation. The use of PROVIGIL is contraindicated during pregnancy and lactation (see. Special warnings).
Precautions for use
Patients suffering from anxiety should receive treatment with PROVIGIL at specialist units only. Patients should be advised to inform their doctor in case of potential pregnancy or if they are planning to become pregnant during therapy. In the light of these circumstances, treatment with modafinil should be suspended. In the hypertensive patient, blood pressure and heart rate should be monitored. PROVIGIL tablets should not be administered to patients with a history of left ventricular hypertrophy or with ischaemic ECG changes, chest pain, arrhythmia or other clinically significant manifestation of prolapse of the mitral valve associated with the use of C.N.S. stimulants.
Interactions
Oral contraceptives: because of the enzyme induction of PROVIGIL, the efficacy of oral contraceptives may be compromised. In case of the use of oral contraceptives, a product containing 50 mg or more of ethinyl oestradiol should be taken. Adequate contraception requires continuation of the oral contraceptive for two cycles after stopping PROVIGIL.
Tricyclic antidepressants: in a single dose pharmacokinetic interaction study of PROVIGIL (200 mg) and clomipramine (50 mg), no clinically important alterations were noted in the pharmacokinetic profile of PROVIGIL or clomipramine. Given the limited experience or the concomitant administration of PROVIGIL with this class of drugs, patients receiving these drugs should be carefully monitored.
Anti-convulsant therapy: no formal interaction studies of PROVIGIL have been conducted with these drugs and the concomitant administration of these drugs should therefore be undertaken with caution.
Special warnings
Whilst studies carried out with modafinil and other psychoactive agents have shown a low dependence potential, the possibility of dependence following prolonged use cannot be entirely ruled out. Since the safety and efficacy in controlled studies in children have not been established, the use of PROVIGIL is not recommended in children.
Pregnancy and lactation: PROVIGIL is contraindicated for use in pregnancy or during lactation.
Effect on the ability to drive and operate machinery: No information is available concerning the effects of PROVIGIL on the ability to drive or operate machinery.
Dose, method and time of administration
Adults: The recommended daily dose is 200-400 mg. PROVIGIL may be taken as two divided doses in the morning and at noon, or as a single dose in the morning according to physician assessment of the patient and the patient’s response.
Elderly: There is limited data available on the use of PROVIGIL in elderly patients. Since clearance tends to be reduced with advancing age, it is recommended that patients over 65 years of age should commence therapy at 100 mg daily. In the absence of renal or hepatic impairment, the dose can be subsequently increased to 400 mg/day, depending on response.
Renal and hepatic impairment
The dose in patients with hepatic or renal impairment should be halved (100-200 mg/day).
Overdose
The main symptom following massive ingestion is insomnia. Treatment: induced vomiting and gastric lavage should be considered. Hospitalisation and surveillance of psychomotor status, cardiovascular monitoring or surveillance, until the patient’s symptoms have resolved.
What to do if you forget to take one or more doses of PROVIGIL
If you forget to take a dose of PROVIGIL, take the next dose at the usual time. Never take a double dose.
Undesirable effects
Episodes of a feeling of nervousness, excitation, aggressive tendencies, insomnia, anorexia, headache, CNS stimulation, abdominal pain, dry mouth, palpitations, tachycardia and tremor. Gastrointestinal disorders (nausea, gastric discomfort) have also been reported, usually regressing when tablets are taken during meals. There have also been reports of pruritic skin rashes and, very rarely, cases of buccofacial dyskinesia. Compliance with the instructions in this leaflet will reduce the onset of undesirable effects. Inform your doctor or pharmacist if you experience any undesirable effects not described above.
EXPIRY AND STORAGE
See the expiry date indicated on the pack; this date refers to the product in its unopened and correctly stored pack.
Store the product in a safe and dry place below 25°C; protect from heat sources and sunlight.
KEEP OUT OF THE REACH OF CHILDREN
Important: do not use the medicine after the expiry date printed on the pack.
The above information is the translation of the manufacturer’s insert. It is provided under the supplying company’s terms and conditions and should not replace the advice of your personal physician.