Flibanserin is used to treat low sexual desire in women who have not gone through menopause and have never had low sexual desire in the past. Flibanserin is for use only when low sexual desire is NOT caused by a medical condition, a mental disorder, relationship problems, or by using drugs or other medicines.

Flibanserin is not for women who have already gone through menopause. flibanserin is also not for use by men.

Flibanserin is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Flibanserin may also be used for purposes not listed in this medication guide.

You should not take flibanserin within 2 hours after drinking alcohol.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take flibanserin only at bedtime.

Avoid drinking alcohol for at least 2 hours before taking flibanserin and until the next day. Alcohol may cause you to have dangerously low blood pressure if taken with flibanserin.

Skip your bedtime dose of flibanserin if you have consumed alcohol less than 2 hours earlier.

Flibanserin can lower your blood pressure, which can make you dizzy. If you feel light-headed after taking this medicine, lie down if you are not already in bed.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypoactive Sexual Desire Disorder:

100 mg orally once a day at bedtime

Comments:
-For patients with no improvement in hypoactive sexual desire disorder (HSDD) after 8 weeks, this drug should be discontinued.
-This drug is not indicated for the treatment of HSDD in postmenopausal women or in men.
-This drug is not indicated to enhance sexual performance.

Use: Treatment of premenopausal women with acquired, generalized HSDD characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition; problems within the relationship; or the effects of a medication or other drug substance.

You should not use flibanserin if you are allergic to it, or if you have:

• liver disease; or

• if you recently consumed alcohol.

You should not take flibanserin within 2 hours after drinking alcohol.

Some medicines can cause unwanted or dangerous effects when used with flibanserin. Your doctor may change your treatment plan if you also use:

• nefazodone;

• an antibiotic--ciprofloxacin, clarithromycin, erythromycin, telithromycin;

• antifungal medicine--fluconazole, itraconazole, ketoconazole, posaconazole;

• antiviral medicine to treat hepatitis C--boceprevir, telaprevir;

• heart or blood pressure medicine--conivaptan, diltiazem, verapamil; or

• HIV or AIDS medicine--atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

Tell your doctor if you have ever had:

• alcoholism (or if you currently drink alcohol);

• drug addiction;

• depression or mental illness; or

• low blood pressure.

It is not known whether flibanserin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using this medicine.

Flibanserin is not approved for use by anyone younger than 18 years old.

Skip the missed dose and take the medicine the following day at bedtime. Do not take flibanserin in the morning, and do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Drinking alcohol with flibanserin can cause dangerous or unwanted side effects.

Grapefruit may interact with flibanserin and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking any of the following over-the-counter or herbal products without your doctor's advice:

• cimetidine;

• gingko biloba;

• resveratrol; or

• St. John's wort.

Dizziness or low blood pressure can cause falls or other accidents. Avoid driving or operating machinery for at least 6 hours after you take flibanserin, and until you know how this medicine will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Flibanserin may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness; or

• a light-headed feeling, like you might pass out.

Common side effects of flibanserin may include:

• dizziness, drowsiness;

• tiredness;

• nausea;

• dry mouth; or

• trouble sleeping.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Taking this medicine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect flibanserin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.