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Flibanserin

Warning

Drinking alcohol close to the time that you take flibanserin can increase the risk of severe low blood pressure and fainting. If you drink one or two alcoholic drinks in the evening, you must wait at least 2 hours before taking flibanserin at bedtime. After taking flibanserin at bedtime, do not drink any alcohol until the next day. If you drink 3 or more alcoholic drinks in the evening, then you should skip your dose of flibanserin that night. Examples of an alcoholic drink could be a 12-ounce can of beer, a 5-ounce glass of wine, or a 1.5 ounce shot of distilled spirits. 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.

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, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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 this medication has been prescribed because your doctor 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.