Modafinil (Systemic)

Brand Names : Provigil

Before Using This Medicine

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 modafinil, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to modafinil or any other central nervous system stimulating medicine, such as methylphenidate (e.g., Ritalin) or dextroamphetamine (e.g., Dexedrine). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy - Birth-control medicines, such as birth-control pills or implants, may not work properly while you are using modafinil and for 1 month after you stop using modafinil. If you do not use a different type of birth control during this time, such as condoms, you are more likely to become pregnant. If you are using a medicine for birth control, discuss this with your doctor. Modafinil has not been studied in pregnant women. However, studies in animals suggest that modafinil may cause birth defects and fewer successful pregnancies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding - It is not known whether modafinil passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking modafinil and who wish to breast-feed should discuss this with their doctor.

Children - 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.

Older adults - 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.

Other medicines - 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. When you are taking modafinil, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Appetite suppressants (diet pills) or
• Bupropion (e.g., Wellbutrin, Zyban) or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Cocaine or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet) or
• Pemoline (e.g., Cylert) - These medicines may add to the central nervous system (CNS) stimulating effects of modafinil, such as irritability, nervousness, trembling or shaking, or trouble in sleeping at night

• Cyclosporine (e.g., Sandimmune) or
• Diazepam (e.g., Valium) or
• Mephenytoin (e.g., Mesantoin) or
• Phenytoin (e.g., Dilantin) or
• Propranolol (e.g., Inderal) or
• Theophylline (e.g., Slo-Bid Gyrocaps, Theo-Dur) or
• Warfarin (e.g., Coumadin) - Higher or lower blood levels of these medicines may occur. This increases the chance that unwanted effects will occur or that these medicines will not work properly. Your doctor may need to adjust your dose of these medicines

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) - These medicines can cause very serious problems when they are used with certain other medicines. It is not known if they will cause any problems when they are used with modafinil

• Steroid contraceptives (birth control medicines, including birth control pills and implants [e.g., Norplant]) - Birth control medicines may not work properly while you are taking modafinil and for 1 month after you stop taking modafinil. It is important that you use another method of birth control to avoid pregnancy during and for 1 month after modafinil therapy. Discuss this with your doctor

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) - Higher blood levels of these medicines may occur, increasing the chance that unwanted effects will occur

Other medical problems - The presence of other medical problems may affect the use of modafinil. 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