Flibanserin Oral Tablets

What is this medication?

FLIBANSERIN (fly BAN ser in) is used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had 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 a low sexual desire that is troubling to them, and is not due to a medical or mental health problem, problems in the relationship, medicines, or drug abuse.

This medicine is not for HSDD in women who have gone through menopause. This medicine is not for men. This medicine not for use to improve sexual performance.

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

COMMON BRAND NAME(S): Addyi

What should I tell my care team before I take this medication?

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

• dehydration
• if you drink alcohol
• drug abuse or addiction
• heart disease
• history of depression or other mental health problems
• history of a drug or alcohol abuse problem
• liver disease
• low blood pressure
• an unusual or allergic reaction to flibanserin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label. This medicine should only be taken at bedtime. Do not take this medicine with grapefruit juice. If you have 1 or 2 alcohol-containing drinks, wait at least 2 hours before taking this medicine at bedtime. Do not take your bedtime dose if you have consumed 3 or more alcohol-containing drinks. After taking this medicine at bedtime, do not drink alcohol until the next day.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. It is not approved for use in children.

Overdosage: If you think you have 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 your dose at bedtime, skip the missed dose and take the next dose at bedtime the next day. Do not take this medicine the next morning or double your next dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• berotralstat
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like fluconazole, ketoconazole, itraconazole, or posaconazole
• ciprofloxacin
• clarithromycin
• conivaptan
• diltiazem
• erythromycin
• grapefruit juice
• nefazodone
• telithromycin
• verapamil

This medicine may also interact with the following medications:

• alcohol
• birth control pills
• bupropion
• certain medicines for anxiety or sleep
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• certain medicines for stomach problems like cimetidine, esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, ranitidine
• digoxin
• diphenhydramine
• etravirine
• fluoxetine
• fluvoxamine
• ginkgo biloba
• lorcaserin
• narcotic medicines for pain
• resveratrol
• rifabutin
• rifampin
• rifapentine
• sirolimus
• St. John's Wort

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 medication?

Visit your doctor or health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better after you have taken this medicine for 8 weeks.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness for at least 6 hours after your dose and until you know how this medicine affects you. Do not stand up or sit up quickly. This reduces the risk of dizzy or fainting spells.

Alcohol can increase dizziness and drowsiness, and can increase the risk of low blood pressure or fainting spells when combined with this medicine. Wait at least 2 hours after consuming 1 or 2 standard alcoholic drinks before taking this medicine at bedtime. Do not take this medicine at bedtime if you have consumed 3 or more standard alcoholic drinks that evening.

What side effects may I notice from receiving this medication?

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

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• extreme drowsiness
• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)

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

• dry mouth
• nausea
• tiredness
• trouble sleeping

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 medication?

Keep out of the reach of children and pets.

Store at 25 degrees C (77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.