Addyi

The recommended dose of Addyi (Flibanserin) is 100 mg taken by mouth, once daily at bedtime.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Addyi (Flibanserin) exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Addyi (Flibanserin) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause dryness of the mouth; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may cause either drowsiness or excitability - use caution until you know how you will react; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each pink, oval, film-coated tablet debossed on one side with "fl100" and blank on the other side contains 100 mg of Addyi (Flibanserin). Nonmedicinal ingredients: croscarmellose sodium, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, macrogol, microcrystalline cellulose, talc and titanium dioxide.

Do not take Addyi (Flibanserin) if you:

• are allergic to Addyi (Flibanserin) or any ingredients of the medication
• have decreased liver function
• are pregnant
• are breast-feeding
• are going through or have gone through menopause
• have Low Blood Pressure and drink alcohol
• are taking any of the following medications:
  • "azole" antifungal medications (e.g., fluconazole, itraconazole, Voriconazole)
  • Carbamazepine
  • Diltiazem
  • HIV protease inhibitors (e.g., ritonavir, saquinavir)
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • Phenobarbital
  • Phenytoin
  • rifampin
  • St. John's wort
  • Verapamil

There may be an interaction between Addyi (Flibanserin) and any of the following:

• alcohol
• Aliskiren
• antiarrythmics (e.g., Amiodarone, Dronedarone, quinidine)
• anticancer medications (e.g., Docetaxel, Doxorubicin, Paclitaxel, quinidine, Topotecan, trabectedin, Venetoclax, Vincristine)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• Bosentan
• brimonidine
• Buspirone
• calcium channel blockers (e.g., Amlodipine, diltiazem, Nifedipine, verapamil)
• Carvedilol
• chloral hydrate
• Cimetidine
• Clonidine
• Colchicine
• conivaptan
• corticosteroids (e.g., Dexamethasone, Hydrocortisone)
• Cyclosporine
• Danazol
• dabigatran
• Digoxin
• Edoxaban
• Entacapone
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• Guanfacine
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• isoniazid
• ivermectin
• Lomitapide
• Loperamide
• lumacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• Methotrexate
• mifepristone
• Mirtazapine
• Moclobemide
• Modafinil
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• Nadolol
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Olopatadine
• Ondansetron
• protein kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• Pramipexole
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin)
• rifabutin
• rifampin
• Romidepsin
• St. John's wort
• scopolamine
• seizure medications (e.g., carbamazepine. Clobazam, , Levetiracetam, phenobarbital, phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• sildosin
• Sirolimus
• sodium oxybate
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Stiripentol
• Tacrolimus
• thalidomide
• Tocilizumab
• Tolvaptan
• Tramadol
• tricyclic antidepressants (e.g., Clomipramine, Desipramine, Imipramine)
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Addyi (Flibanserin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Addyi (Flibanserin).

Alcohol and other medications that cause drowsiness: Taking Addyi (Flibanserin) at the same time as alcohol and other medications that cause drowsiness (e.g., antidepressants, sleeping pills, anxiety medications) can cause increased drowsiness, severe low blood pressure and fainting. If you have low blood pressure you should never drink alcohol while taking Addyi (Flibanserin).

Drowsiness/dizziness: Addyi (Flibanserin) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks for at least 6 hours after taking Addyi (Flibanserin). And until you have determined how you are affected by Addyi (Flibanserin).

Heart problems: Addyi (Flibanserin) may cause decreased blood pressure, fainting, increased heart rate or irregular heartbeat. Any of these can cause symptoms of heart problems to worsen. If you have heart disease such as Angina, Congestive Heart Failure, or arrhythmia, discuss with your doctor how Addyi (Flibanserin) may affect the medical condition, how the medical condition may affect the dosing and effectiveness of Addyi (Flibanserin), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Addyi (Flibanserin) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Addyi (Flibanserin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Addyi (Flibanserin), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Addyi (Flibanserin).

Pregnancy: Addyi (Flibanserin) should not be used during pregnancy. If you become pregnant while taking Addyi (Flibanserin), contact your doctor immediately.

Breast-feeding: It is not known if Addyi (Flibanserin) passes into breast milk. If you are a breast-feeding mother and are taking Addyi (Flibanserin), it may affect your baby. Breastfeeding is not recommended while taking Addyi (Flibanserin).

Children: Addyi (Flibanserin) is not intended for use by children

Seniors: Addyi (Flibanserin) is not intended to be used by women who are experiencing menopause or those who are post-menopausal. The safety and effectiveness of Addyi (Flibanserin) have not been determined for women who are older than 55 years of age.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. You must wait at least 6 hours after taking this drug before driving or engaging in other activities requiring full mental alertness. If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time. This medication may be taken with or without food. Avoid grapefruit and grapefruit juice during your treatment. Grapefruit can seriously affect how this medication works. Consuming alcohol may intensify the toxicity of this product. Avoid or limit alcohol consumption. If you have low blood pressure, never drink alcohol during treatment.