flibanserin 100 mg tablet

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Medication name

Generic name:
Flibanserin - oral

Pronunciation
(flib-AN-ser-in)

Brand name(s)
Addyi

Warning

If you drink alcohol, you must wait at least 2 hours before taking this medication. After taking flibanserin at bedtime, do not drink any alcohol until the next day. Alcohol increases the risk of severe low blood pressure and fainting. To decrease your risk, if you drink alcohol in the evening, you may skip your dose of flibanserin that night. Flibanserin is available only through a restricted program from certified prescribers and pharmacies called the Addyi Risk Evaluation and Mitigation Strategy (REMS) Program. Consult your doctor and pharmacist for more details and to discuss the risks and benefits of using flibanserin.

Do not take flibanserin if you have liver problems or if you take certain medications that may interact with flibanserin because your risk for severe low blood pressure or fainting will increase. See the Drug Interactions section. Before using flibanserin, tell your doctor and pharmacist if you have liver problems and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Also, before you start using any new product, ask your doctor and pharmacist if it could interact with flibanserin.

Uses

This medication is used to treat women who have not gone through menopause who have low sexual desire and are concerned about it.

Flibanserin should not be used to treat low sexual desire caused by: a medical or mental/mood disorder, problems in the relationship, or the effects of other drugs. This medication should not be used by women who have gone through menopause, or by men. Flibanserin is not used to enhance sexual performance.

How to use

Read the Medication Guide provided by your pharmacist before you start taking flibanserin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily at bedtime. Take flibanserin only at bedtime to reduce your risk of low blood pressure, fainting, and drowsiness while you are awake.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not get better after 8 weeks of treatment.

Side effects

See also Warning and How to Use sections.

Drowsiness, dizziness, nausea, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Low blood pressure and fainting may occur even if you take flibanserin by itself. The risk of these side effects is greater if you take this medication with or less than 2 hours after alcohol, or at a time of day other than at bedtime, or if you take more of it than prescribed. If you feel dizzy or lightheaded, lie down right away. Get medical help right away or have someone get medical help for you right away if symptoms last or if you faint.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking flibanserin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • alcohol use
  • regular use/abuse of drugs/alcohol
  • liver problems
  • low blood pressure

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until at least 6 hours after taking flibanserin and until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of flibanserin from your body, which may affect how flibanserin works. Examples include azole antifungals (such as fluconazole, ketoconazole), certain calcium channel blockers (such as diltiazem, verapamil), macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, rifamycins (such as rifabutin, rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, severe dizziness, fainting.

Notes

Do not share this medication with others.

Missed dose

If you miss a dose, skip the missed dose. Take your next dose at bedtime the next day. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised April 2019.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.