Nuvigil ® tablets are prescribed for the following indications:
Active substance: armodafinil;
1 tablet contains armodafinil 50 mg or 150 mg or 250 mg;
Excipients: lactose, microcrystalline cellulose, corn starch, povidone K29 / 32, croscarmellose sodium, magnesium stearate.
Hypersensitivity to modafinil, armodafinil or to any other components of the preparation.
Pregnancy.
Nuvigil ® can be taken with or without food. However, the use of the preparation simultaneously with food intake can delay the onset of its action, as well as prolong its action.
To avoid delayed onset of action, Nuvigil® should be taken on an empty stomach.
Treatment with Nuvigil ® should be initiated and supervised by a physician with appropriate experience in the treatment of sleep disorders who has access to sleep laboratory diagnostic tools.
Pregnant
Contraindicated.
Drivers
Patients should be warned about the need to refrain from driving or operating machinery until they are confident that Nuvigil® treatment will not adversely affect their ability to do such activities.
In clinical studies of the preparation, no cases of overdose have been reported. Symptoms of a preparation overdose are likely similar to those of a modafinil overdose. Overdose symptoms in clinical trials of modafinil included excitement or agitation, insomnia, and mild to moderate hemodynamic increase.
In pre-registration controlled clinical trials, the most common adverse reactions (≥ 5%) in patients receiving Nuvigil ®, which were more common than in patients receiving placebo, were headache, nausea, dizziness and insomnia. The adverse reaction profile was similar across all studies.
The simultaneous use of modafinil and warfarin did not cause significant changes in the pharmacokinetic profiles of (R) - and (S) - warfarin. However, since only a single dose of warfarin was used in this study, interactions cannot be ruled out. Therefore, with the simultaneous use of Nuvigil ® with warfarin, more frequent monitoring of prothrombin time / INR should be considered.
Store at temperatures below 25 ° C, do not refrigerate or freeze.
Keep out of the reach of children.
Shelf life is 3 years.
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