Flibanserin

Warning

Do not drink alcohol if you take this medication. Alcohol increases the risk of severe low blood pressure and fainting. Because of this risk, 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.

Also, 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.

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. Do not drive, use machinery, or do any activity that requires alertness until at least 6 hours after taking flibanserin and until you are sure you can perform such activities safely. Avoid alcoholic beverages. (See also Warning section.)

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.

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 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.

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RxAnswers™ is a copyrighted combined product from Healthnotes and First DataBank, Inc.

Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

This information is intended only for residents of the United States. Products sold under the same brand names in other countries may contain different ingredients.

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Information expires December 2017.

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