Reference ID: 4504090 MEDICATION GUIDE ADDYI ® (add-ee) (flibanserin) Tablets Read this Medication Guide before you start taking ADDYI ® and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor. 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 take ADDYI and: • drink alcohol close to the time you take your ADDYI dose. o Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking ADDYI at bedtime. Examples of 1 standard alcoholic drink include: ▪ one 12-ounce regular beer ▪ 5 ounces of wine ▪ 1.5 ounces of distilled spirits or shot o If you drink 3 or more standard alcoholic drinks in the evening, skip your ADDYI dose at bedtime. o After you have taken your ADDYI at bedtime do not drink alcohol until the following day. • take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over-the-counter medicines, or herbal supplements while taking ADDYI until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI. • have liver problems. Do not take ADDYI if you have liver problems. If you take ADDYI and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you feel like you could faint (lose consciousness). If you faint (lose consciousness), tell your doctor as soon as you can. What is ADDYI? ADDYI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to: • a medical or mental health problem • problems in the relationship • medicine or other drug use ADDYI is not for use for the treatment of HSDD in women who have gone through menopause or in men. ADDYI is not for use to improve sexual performance. ADDYI is not for use in children.