Addyi is used to treat decreased sexual desire in women who have not gone through menopause and who have never had low sexual desire in the past. It 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.

Addyi is not for women who have already gone through menopause. This medicine is also not for use by men.

You should not take Addyi 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.

Before taking this medicine

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

• liver disease; or

• if you recently consumed alcohol.

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

Some medicines can cause unwanted or dangerous effects when used with Addyi. 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.

To make sure Addyi is safe for you, tell your doctor if you have:

• alcoholism (or if you currently drink alcohol);

• drug addiction;

• depression or mental illness; or

• low blood pressure.

It is not known whether this medicine 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.

Take Addyi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Addyi only at bedtime.

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

Skip your bedtime dose 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 per day at bedtime

Duration of therapy: This drug should be discontinued after 8 weeks if the patient does not report an improvement in symptoms.

Comments: This drug is not indicated to enhance sexual performance, and is not indicated for treatment in postmenopausal women or in men.

Use: Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as 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 Addyi if you are allergic to flibanserin, or if you have:

• liver disease; or

• if you recently consumed alcohol.

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

Some medicines can cause unwanted or dangerous effects when used with Addyi. 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.

To make sure Addyi is safe for you, tell your doctor if you have:

• alcoholism (or if you currently drink alcohol);

• drug addiction;

• depression or mental illness; or

• low blood pressure.

It is not known whether this medicine 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 Addyi 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.

Drinking alcohol with this medicine 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 Addyi, 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 to Addyi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe drowsiness; or

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

Common Addyi side effects 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 interact with 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.