Flibanserin

IMPORTANT WARNING:

Flibanserin may cause very low blood pressure resulting in dizziness, lightheadedness, and fainting. Tell your doctor if you have or have ever had liver disease or if you drink or have ever drunk large amounts of alcohol. Drinking alcohol around the same time as taking flibanserin can increase the risk of having very low blood pressure. Wait at least 2 hours after drinking 1 or 2 alcoholic drinks before taking flibanserin at bedtime. If you drink 3 or more alcoholic drinks in the evening, skip your flibanserin dose on that evening. After taking flibanserin at bedtime, do not drink any alcohol until the following day. Your doctor will probably tell you not to take flibanserin. Tell your doctor and pharmacist if you are taking any of the following medications or have taken them in the last 2 weeks: amprenavir (Agenerase; no longer available in the U.S.), atazanavir (Reyataz, in Evotaz), boceprevir (Victrelis), ciprofloxacin (Cipro), clarithromycin (Biaxin, in Prevpac), conivaptan (Vaprisol), diltiazem (Cartia XT, Diltzac, Tiazac, others), erythromycin (E.E.S., Erytab, Erythrocin), fluconazole (Diflucan), fosamprenavir (Lexiva), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), nefazodone, nelfinavir (Viracept), posaconazole (Noxafil), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), telaprevir (Incivek; no longer available in the U.S.), telithromycin (Ketek), and verapamil (Calan, Covera, Verelan, in Tarka). Your doctor may tell you not to take flibanserin, change your medications during your treatment with flibanserin, or monitor you carefully for side effects. Do not eat grapefruit or drink grapefruit juice while taking flibanserin. If you have any of the following symptoms, call your doctor immediately and lie down: lightheadedness, fainting, or dizziness.

Keep all appointments with your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with flibanserin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Flibanserin is used to treat women with hypoactive sexual desire disorder (HSDD; a low sexual desire that causes distress or interpersonal difficulty) who have not experienced menopause (change of life; the end of monthly menstrual periods). Flibanserin should not be used for the treatment of HSDD in women who have gone through menopause or in men or to improve sexual performance. Flibanserin is in a class of medications called a serotonin receptor 1A agonist/serotonin receptor 2A antagonist. It works by changing the activity of serotonin and other natural substances in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Flibanserin comes as a tablet to take by mouth. It is usually taken once daily at bedtime. Take flibanserin at bedtime every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take flibanserin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If your symptoms do not improve after 8 weeks of treatment, call your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking flibanserin,

• tell your doctor and pharmacist if you are allergic to flibanserin, any other medications, or any of the ingredients in flibanserin tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antidepressants such as fluoxetine (Prozac, Sarafem); antifungals; cimetidine (Tagamet); digoxin (Lanoxin); diphenhydramine (Benadryl); medications for anxiety or mental illness; medications for seizures such as carbamazepine (Epitol, Tegretol, Teril, others), phenobarbital, and phenytoin (Dilantin, Phenytek); opiate (narcotic) medications for pain control; oral contraceptives; proton pump inhibitors including dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex); ranitidine (Zantac); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sirolimus (Rapamune); sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking, especially ginkgo, resveratrol, and St. John's wort.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking flibanserin, call your doctor. Do not breastfeed while taking flibanserin.

• you should know that flibanserin may make you drowsy. Do not drive a car or operate machinery until at least 6 hours after your dose of flibanserin and until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If a dose is missed at bedtime, take the next dose at bedtime the following day. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Flibanserin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• tiredness
• difficulty falling asleep or staying asleep
• dry mouth
• constipation

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING and SPECIAL PRECAUTIONS sections, call your doctor immediately:

• excessive sleepiness
• hoarseness; difficulty breathing or swallowing
• hives; itching
• swelling of the face, lips, or mouth

Flibanserin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.