Flibanserin Oral tablet

What is this medicine?

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.

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

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 medicine?

Take this medicine by mouth with a glass of water. Do not take with alcohol. Do not take with grapefruit juice. Follow the directions on the prescription label. This medicine should only be taken at bedtime. Taking it at a time other than bedtime can increase your risk of low blood pressure, fainting, accidental injury, and daytime drowsiness. Take your medicine at regular intervals. 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. This medicine is not 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 medicine?

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

• alcohol

• amprenavir

• atazanavir

• boceprevir

• ciprofloxacin

• clarithromycin

• conivaptan

• diltiazem

• erythromycin

• fluconazole

• fosamprenavir

• grapefruit juice

• indinavir

• itraconazole

• ketoconazole

• nefazodone

• nelfinavir

• posaconazole

• ritonavir

• saquinavir

• telaprevir

• telithromycin

• verapamil

This medicine may also interact with the following medications:

• 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

• nefazodone

• resveratrol

• rifabutin

• rifampin

• rifapentine

• simvastatin

• 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 medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor if your symptoms have not improved after you have taken this medicine for 8 weeks.

You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness for at least 6 hours after you take your dose and until you know how this medicine affects you. The risk of severe drowsiness is increased if you are also taking other medicines that cause drowsiness, or if you take this medicine during waking hours. Only take this medicine at bedtime.

Alcohol can increase dizziness and drowsiness, and can increase the risk of low blood pressure or fainting spells when combined with this medicine. Do not drink any alcoholic beverages while using this medicine.

Do not stand or sit up quickly. This reduces the risk of dizzy or fainting spells. This medicine can cause low blood pressure, sometimes with dizziness and fainting spells. If you begin to feel dizzy or lightheaded, lie down and call for help if the symptoms don't go away.

Check with your doctor or health care professional if you get an attack of severe diarrhea or vomiting, or if you sweat a lot. The loss of too much body fluid may increase your risk for low blood pressure, dizziness, or fainting.

This medicine is only available through a restricted program called the ADDYI REMS Program, and can only be obtained through certified pharmacies participating in the program. For more information about the Program and a list of pharmacies that are enrolled in the Program, go to www.AddyiREMS.com or call 1-844-PINK-PILL (1-844-746-5745).

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

• extreme drowsiness

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

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

• constipation

• drowsiness

• dry mouth

• 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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). 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.