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The precautions listed here pertain to the use of Modalert as a treatment for narcolepsy. Since modafinil has not been approved by the FDA for use in multiple sclerosis, there are no precautions specific to MS-related uses of the drug.

The Food and Drug Administration (FDA) has added a warning to the labeling of Provigill. During the clinical trials of Modalert for daytime sleepiness, serious rashes requiring hospitalization were reported in children taking Modalert; no serious rashes were reported in adults. Following those trials, rare cases of serious or life-threatening rashes have been reported in children and adults. In addition, multi-organ sensitivity (allergic) reactions have also been reported, as well as psychiatric reactions, including mania, delusions, hallucinations, and suicidal thoughts. While it is difficult to determine from these post-marketing reports what the exact relationship is between Modalert and these problems, you are advised to contact your physician if you experience a rash, chest pain, depression, anxiety, or signs of psychosis or mania.

Tell your physician if you have ever had an unusual or allergic reaction to any other nervous system stimulant such as Ritalin® or Dexedrine®.

This medication may cause some people to become dizzy or confused, or to have blurred vision or difficulty controlling movements. Make sure you know how you react to this medication before driving a car or engaging in any other potentially dangerous activity.

If you think that the Modalert is not working properly after you have taken it for a few weeks, speak to your physician. Do not increase the dose.

If you are using a medication for birth control such as birth control pills or implants, it may not work effectively in combination with Modalert or for one month after you have stopped taking Modalert. During this time, an additional form of birth control should be used.

Studies of the effects of Modalert in pregnancy have not been done in humans. Studies in animals, however, suggest that the use of Modalert may result in unsuccessful pregnancies or cause birth defects. Before taking this medication, make sure your physician knows if you are pregnant or planning to become pregnant.

It is not known whether Modalert passes into breast milk. If you are taking Modalert and wish to breastfeed, you should discuss this with your physician.

When taking Modalert, it is especially important for your physician to know if you are taking any of the following medications that may add to the stimulating effects of Modalert such as irritability, nervousness, trembling or shaking, insomnia:

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