IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ADDYI?
Your risk of severe low blood pressure and fainting (loss of consciousness) is increased:

• if you drink alcohol close to the time you take your ADDYI dose,
• if you take ADDYI with certain medicines, or
• if you have liver problems and you take ADDYI.

To lower your risk of low blood pressure and fainting (loss of consciousness):

• Do not drink alcohol close to the time you take your ADDYI dose
  • Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking ADDYI at bedtime.
  • Skip your ADDYI dose if you drink 3 or more standard alcoholic drinks that evening.
• After taking ADDYI at bedtime do not drink alcohol until the following day.

Tell your doctor about other medicines you take. Do not take or start taking any prescription or over-the-counter medicines, or herbal supplements without first talking to your doctor.
Do not take ADDYI if you have liver problems.
If you take Addyi and feel lightheaded or dizzy, lie down right away. Call for help if the symptoms do not go away.

Who should not take ADDYI?
Do not take ADDYI if you:

• take certain medicines. Taking ADDYI with certain other medicines can increase the amount of ADDYI in your blood and cause severe low blood pressure, fainting (loss of consciousness), and sleepiness.
• Do not take ADDYI if you are taking any of the following: certain medicines to treat HIV-1 infection, fungal infections, antibiotics, Hepatitis C infection, high blood pressure, chest pain (angina), or other heart problems, nefazodone used to treat depression.
• have liver problems

What should I tell my doctor before taking ADDYI?
Before you take ADDYI, tell your doctor about all of your medical conditions, including if you:

• drink alcohol, use drugs, or have a history of alcohol or drug abuse
• have ever had depression or other mental health problems
• have low blood pressure or a medical condition that can cause low blood pressure
• are pregnant or plan to become pregnant. It is not known if ADDYI will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ADDYI passes into your breast milk. You and your doctor should decide if you will take ADDYI or breastfeed. You should not do both.

Tell your doctor if you have had an allergic reaction such as hives, itching, or trouble breathing during or after receiving a dose of ADDYI.
Tell your doctor about all of the medicines you take, ADDYI can affect the way other medicines work, and other medicines can affect the way ADDYI works, and can cause serious side effects.

What should I avoid while taking ADDYI?

• Do not drink alcohol close to the time you take your ADDYI dose.
• Do not drive, operate machinery, or do things that require clear thinking until at least 6 hours after you take ADDYI and until you know how ADDYI affects you.
• Do not drink grapefruit juice if you take ADDYI. Drinking grapefruit juice during your treatment with ADDYI increases your risk of severe low blood pressure and fainting (loss of consciousness).
• You should not take the herbal supplements St. John’s Wort, ginkgo, or resveratrol or certain over-the-counter medicines such as cimetidine until you talk to your doctor. Taking with ADDYI may increase your risk of low blood pressure, fainting (loss of consciousness), and sleepiness.

What are the possible side effects of ADDYI?
ADDYI can cause serious side effects, including:

• Sleepiness is a common side effect of ADDYI and can be serious.
• Low blood pressure and fainting (loss of consciousness) can happen when you take ADDYI even if you do not drink alcohol or take other medicines or herbal supplements.

Your risk of sleepiness, low blood pressure and fainting is increased if ADDYI is taken during waking hours, if you drink alcohol (risk of low blood pressure and fainting is increased within 2 hours of taking ADDYI), or take certain medicines or herbal supplements.

The most common side effects of ADDYI include:

Dizziness Difficulty falling asleep or staying asleep

Nausea Dry mouth

Tiredness

These are not all of the possible side effects of ADDYI. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information, including Boxed Warning regarding severe low blood pressure and fainting in certain settings, and Medication Guide at addyi.com/pi.