Provigil

What you should know before using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatrics

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of modafinil in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of modafinil in the elderly with use in other age groups, this medicine has been used in a few elderly patients and was not shown to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Heart attack, recent or
• High blood pressure—It is not known how modafinil will affect these conditions

• Heart problems during the use of other central nervous system (CNS) stimulating medicines, history of—Similar problems may occur when you use modafinil

• Kidney disease, severe—Higher blood levels of a breakdown product of modafinil may occur. It is not known if this will cause any problems

• Liver disease, severe—Higher blood levels of modafinil may occur, increasing the chance of having unwanted effects. You will probably receive a lower dose than a patient without liver disease

• Severe mental illness, history of—Modafinil may cause the illness to return