Tasimelteon Oral capsule

What is this medicine?

TASIMELTEON (ta si MEL tee on) is used to treat sleep-wake cycle disruptions in people who are blind.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cigarette smoker

• history of an alcohol abuse problem

• liver disease

• an unusual or allergic reaction to tasimelteon, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not take with food. Do not cut, crush or chew this medicine; swallow whole. Take this medicine before bedtime at the same time every night. After taking this medicine, limit your activities to those needed to prepare for bed. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss taking your dose at the usual time on a given night, skip that dose. Then, take the next dose at your regular time the following night. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

• alcohol

• beta-blockers like metoprolol and propranolol

• certain medicines for fungal infections like ketoconazole

• certain medicines for sleep

• fluvoxamine

• melatonin

• ramelteon

• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Because of individual differences in circadian rhythms, daily use for several weeks or months may be needed before the benefit of this medicine occurs.

You may get drowsy or dizzy. Do not do anything that requires mental alertness after taking your dose. Limit your activities to preparing for bed after taking this medicine. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

If you smoke, tell your doctor if you notice this medicine is not working well for you. Talk to your doctor if you are a smoker or if you decide to stop smoking.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• cough

• dark urine

• fever or chills

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite, nausea

• pain when urinating

• right upper belly pain

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• drowsiness

• headache

• unusual dreams or nightmares

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture and light. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.