Flibanserin (flib-AN-ser-in)

Treats low sexual desire disorder in women who have not gone through menopause.

Brand Name(s):

Addyi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine only at bedtime.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and just take the next regular dose at the regular time. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with amprenavir, atazanavir, boceprevir, ciprofloxacin, clarithromycin, conivaptan, diltiazem, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, or verapamil.
• Some foods and medicines can affect how flibanserin works. Tell your doctor if you are using any of the following:
  • Carbamazepine, digoxin, diltiazem, diphenhydramine, etravirine, ginkgo, phenobarbital, phenytoin, resveratrol, rifabutin, rifampin, rifapentine, sirolimus, St John's wort
  • Birth control pills
  • Medicine to treat depression (including fluoxetine)
  • Medicine to treat a fungus infection
  • Stomach medicine (including cimetidine, ranitidine, or a proton pump inhibitor)
• Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks (including one 12-ounce regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits or shot) before taking flibanserin at bedtime, or you may skip your dose if you drink 3 or more standard alcoholic drinks in the evening. If you have taken flibanserin at bedtime, do not drink alcohol until the following day.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have low blood pressure or a history of depression, mental problems, or alcohol or drug abuse.
• Do not breastfeed while you are using this medicine.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you or for 6 hours after you take a dose. Sit or lie down if you feel dizzy or lightheaded. Tell your doctor if you continue to feel dizzy or lightheaded after you have been using this medicine for awhile.
• Call your doctor if your symptoms do not improve within 8 weeks, or if they get worse.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

If you notice these less serious side effects, talk with your doctor:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fainting, dizziness, or lightheadedness

Call your doctor right away if you notice any of these side effects:

• Dry mouth
• Nausea
• Sleepiness or unusual drowsiness
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088