Flibanserin Tablets

What is this medication?

FLIBANSERIN (fly BAN ser in) treats hypoactive sexual desire disorder (HSDD). It works by balancing substances in the brain that help regulate mood and increase sex drive.

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
• Frequently drink alcohol
• Heart disease
• History of depression or other mental health conditions
• Liver disease
• Low blood pressure
• Substance use disorder
• An unusual or allergic reaction to flibanserin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label. This medication should only be taken at bedtime. Do not take this medication with grapefruit juice. If you have 1 or 2 alcohol-containing drinks, wait at least 2 hours before taking this medication at bedtime. Do not take your bedtime dose if you have consumed 3 or more alcohol-containing drinks. After taking this medication 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 care team about the use of this medication 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 medication the next morning or double your next dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Adagrasib
• Aprepitant, fosaprepitant
• Berotralstat
• Ceritinib
• Certain antibiotics, such as chloramphenicol, ciprofloxacin, clarithromycin, erythromycin, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as fluconazole, ketoconazole, isavuconazonium, itraconazole, posaconazole
• Conivaptan
• Crizotinib
• Cyclosporine
• Diltiazem
• Dronedarone
• Duvelisib
• Fedratinib
• Grapefruit juice
• Idelalisib
• Imatinib
• Lefamulin
• Letermovir
• Lonafarnib
• Mifepristone
• Nefazodone
• Netupitant
• Nilotinib
• Ribociclib
• Tucatinib
• Verapamil
• Voxelotor

This medication may also interact with the following:

• Alcohol
• Certain medications for anxiety or sleep
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Certain medications for stomach problems, such as cimetidine, esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, ranitidine
• Digoxin
• Diphenhydramine
• Estrogen or progestin hormones
• Etravirine
• Fluoxetine
• Fluvoxamine
• Ginkgo biloba
• Opioids for pain or cough
• 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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better after you have taken this medication 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 medication 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 medication. Wait at least 2 hours after consuming 1 or 2 standard alcoholic drinks before taking this medication at bedtime. Do not take this medication 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 care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

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

• Dizziness
• Dry mouth
• Falling asleep during daily activities
• Fatigue
• Nausea
• 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 medication after the expiration date.

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

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication 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.