WHEN TO USE PROVIGIL ?

Provigil is a prescription medicine used in the treatment of excessive daytime sleepiness narcolepsy. This medicine modulates the level of chemical messengers in the brain and exerts a stimulant effect to reduce extreme sleepiness. modafinil is a medication that promotes wakefulness. How to use Modafinil

For narcolepsy, take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Or, if your doctor directs you to, the total daily dose of modafinil may be divided into a morning dose and a noon dose. For obstructive sleep apnea, take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Continue your other treatment (such as the CPAP machine, or mouth device) unless your doctor tells you to stop.

If you are using modafinil for shift work sleep disorder, take it by mouth with or without food as directed by your doctor, usually once a day 1 hour before you start your work shift.

The dosage is based on your medical condition and response to treatment. Take this medication regularly to get the most benefit from it.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as shaking, sweating, chills, nausea, vomiting, confusion). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used modafinil for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: street drugs (such as methamphetamine, MDMA/"ecstasy").

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication and for 1 month after stopping this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Modafinil can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include axitinib, bosutinib, certain products used to treat chronic hepatitis C (asunaprevir, ombitasvir /paritaprevir/ritonavir), among others.

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).

Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.

Modafinil is very similar to armodafinil. Do not take medications containing armodafinil while using modafinil.

Overdose

Usual Adult Dose for Narcolepsy:

200 mg orally daily in the morning

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome:

200 mg orally daily in the morning

Usual Adult Dose for Shift Work Sleep Disorder:

200 mg orally daily one hour prior to the start of the work shift

Usual Pediatric Dose for Attention Deficit Disorder:

Not FDA approved.

Reports of serious dermatologic adverse effects and psychiatric events has resulted in the FDA's Pediatric Advisory Committee unanimously recommending that a specific warning against the use of modafinil in children be added to the manufacturer's labeling; use only if first- and second-line treatments have failed and the benefits outweigh the risks.

Children less than 30 kg: 200-340 mg once daily

Children more than 30 kg: 300-425 mg

Randomized, double-blind, placebo-controlled pediatric studies have utilized an 85 mg film-coated tablet (currently not commercially available) to provide these dosages. All studies utilized a titration method but varied the length of titration (3 weeks vs 7-9 days); clinical improvement was noted earlier in the shorter titration period.

SIDE EFFECTS

Headache, nausea, nervousness, dizziness, or difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood changes (such as agitation, confusion, depression, hallucinations, rare thoughts of suicide).Get medical help right away if you have any very serious side effects, including: chest pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS

Before taking modafinil, tell your doctor or pharmacist if you are allergic to it; or to armodafinil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as enlarged heart, mitral valve problem, chest pain, heart attack, irregular heartbeat), heart problems after taking stimulant drugs such as amphetamines (including chest pain, irregular heartbeat), high blood pressure, liver problems, mental/mood disorders (such as depression, mania, psychosis), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol).

Sleep disorders may reduce your ability to react quickly. Though modafinil helps keep you awake, you still may not be able to safely do things that require quick reactions (such as driving). This drug may also make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using modafinil. Modafinil may harm an unborn baby. Ask about reliable forms of non-hormonal birth control while using this medication and for 2 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.