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This safety information provides critical guidance for the use of flibanserin (Addyi), highlighting potential risks and necessary precautions. If you have any questions or concerns, please consult your healthcare provider.

• Alcohol Interaction: Taking flibanserin close to alcohol consumption can lead to serious low blood pressure and fainting. If you consume 1 or 2 alcoholic drinks, wait at least 2 hours before taking your dose at bedtime. If you consume 3 or more drinks, skip the dose that night. Avoid drinking alcohol after taking flibanserin until the following day.

• Drug and Food Interactions: Flibanserin can interact with certain medications, supplements, and foods, such as ciprofloxacin, fluconazole, birth control pills, and grapefruit, which may result in dangerously low blood pressure and fainting. Discuss with your healthcare provider all products you use to avoid these interactions.

• Liver Problems: Individuals with liver issues should not take flibanserin, as it can cause severe low blood pressure and fainting. Notify your healthcare provider about any liver conditions before starting this medication to explore alternative treatments.

• Drowsiness and Concentration: Flibanserin may cause drowsiness and impair concentration, particularly if taken during the day or combined with alcohol or other sedatives. This can affect your ability to think clearly and focus.

• Allergic Reactions: If you experience allergic symptoms such as swelling of the face, lips, or mouth, itching, hives, or difficulty breathing, discontinue use immediately and seek medical attention.

• Contraindications: Do not take flibanserin if you are on medications that interact with it, consume grapefruit, or have liver damage, as these can increase the risk of severe health issues.

In case of overdose, contact emergency services or seek immediate medical assistance. Always inform your doctor and pharmacist about your complete medical history and any new products you plan to use to ensure safe and effective use of flibanserin.

When taking this medication, some individuals may experience common side effects such as dizziness, sleepiness, nausea, or tiredness. These effects are typically mild, but if they persist or worsen, it’s advisable to consult your healthcare provider. Trouble sleeping may also occur in some cases.

Other side effects reported include dry mouth, constipation, stomach pain, anxiety, or a rash. While these are generally manageable, you should reach out to a healthcare provider if they are bothersome.

More serious side effects, although rare, require immediate medical attention. These include symptoms of an allergic reaction such as swelling of the face, lips, or mouth, itchiness, hives, and trouble breathing. Low blood pressure and fainting can also occur, especially if the medication is taken with alcohol, at a time other than bedtime, or in excessive amounts. If you feel faint or lightheaded, lying down immediately and seeking medical help is crucial. Always be vigilant for these symptoms to ensure timely intervention if necessary.

Flibanserin can be affected by other medications, which may change how it works in your body. Some drugs that can influence the processing of flibanserin include azole antifungals like Fluconazole and Ketoconazole, calcium channel blockers such as diltiazem and Verapamil, macrolide antibiotics including Clarithromycin and Erythromycin, as well as Nefazodone, rifamycins like Rifabutin and Rifampin, Ritonavir, and St. John's wort. Additionally, medications used for seizures, such as Carbamazepine and Phenytoin, can also interact with flibanserin.

It is important to inform your healthcare provider if you are taking other medications that may cause drowsiness. These include opioid pain or cough relievers like codeine and hydrocodone, marijuana (cannabis), sleep or anxiety medications such as Alprazolam, Lorazepam, and Zolpidem, muscle relaxants like Carisoprodol and Cyclobenzaprine, as well as antihistamines such as Cetirizine and diphenhydramine.

Always check the labels of all your medications, especially those for allergies or cough-and-cold, as they may contain ingredients that cause drowsiness. Consult your pharmacist to ensure you are using these products safely.