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Addyi (Generic Flibanserin)

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WARNING

Flibanserin may produce extremely low blood pressure, which can lead to fainting, dizziness, and lightheadedness. Inform your doctor if you currently or in the past have liver disease, consume a lot of alcohol, or both. When taking flibanserin, the chance of having very low blood pressure can increase if alcohol is consumed at the same time. If you have had one or two alcoholic beverages, wait at least two hours before taking flibanserin before bed. Skip the flibanserin dose that evening if you consume three or more alcoholic beverages. Avoid drinking alcohol until the day after taking flibanserin at night. Most likely, your doctor will advise against taking flibanserin. Inform your physician and pharmacist if you are taking any of the following drugs, or have taken any of them within the previous two weeks: amprenavir (Agenerase; no longer available in the United States), atazanavir (Reyataz, in Evotaz), boceprevir (Victrelis), ciprofloxacin (Cipro), clarithromycin (Biaxin, in Prevpac), and conivaptan (Vaprisol), Erythromycin (E.E.S., Erytab, Erythrocin), diltiazem (Cartia XT, Diltzac, Tiazac, others), fluconazole (Diflucan), fosamprenavir (Lexiva), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), nefazodone (Calan, Covera, Verelan, in Tarka). When you are receiving therapy with flibanserin, your doctor may advise you not to take it, adjust your prescription regimen, or closely monitor you for side effects. When taking flibanserin, avoid consuming grapefruit or grapefruit juice. Call your doctor right away and lie down if you experience any of the following symptoms: lightheadedness, fainting, or dizziness.

Keep all of your doctor’s appointments.

The manufacturer’s patient information sheet (Medication Guide) will be provided to you by your doctor or pharmacist when you start treatment with flibanserin as well as each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

Flibanserin is used to treat women who have not gone through menopause and have hypoactive sexual desire disorder (HSDD; a low sexual desire that causes unhappiness or interpersonal problems) (change of life; the end of monthly menstrual periods). Flibanserin shouldn’t be used to treat menopausal women who have HSDD, for men, or to enhance sexual performance. A serotonin receptor 1A agonist/serotonin receptor 2A antagonist is a class of drugs that includes flobanserin. It affects how serotonin and other naturally occurring chemicals in the brain function.

How should this medicine be used?

Flibanserin is available as an oral tablet. Typically, one dose is given at bedtime each day. Take flibanserin every night before bed. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take flibanserin as prescribed by your doctor. Never take it in larger or less amounts or more frequently than directed by your doctor.

Call your doctor if your symptoms do not go away after 8 weeks of treatment.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking flibanserin,

  • If you have an allergy to flibanserin, any other drugs, or any of the ingredients in flibanserin tablets, tell your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, herbal products, vitamins, and nutritional supplements you are now taking or intend to take. Mention any of the following as well as the medications specified in the IMPORTANT WARNING section. Antifungals, cimetidine (Tagamet), digoxin (Lanoxin), diphenhydramine (Benadryl), antidepressants like fluoxetine (Prozac, Sarafem), benzodiazepines such carbamazepine, as well as antidepressants like fluoxetine (Prozac, Sarafem) (Epitol, Tegretol, Teril, others), phenobarbital, phenytoin (Dilantin, Phenytek), opiate (narcotic) painkillers, oral contraceptives, proton pump inhibitors such as dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabe, sirolimus (Rapamune), sedatives, sleeping medications, tranquillizers, and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • Please let your doctor know if you are taking any herbal supplements, notably ginkgo, resveratrol, and St. John’s wort.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you become pregnant while taking flibanserin. Flibanserin should not be taken while nursing a baby.
  • You need to be aware that flibanserin might make you sleepy. After taking flibanserin, wait at least six hours before operating machinery or driving a car to see how this drug affects you.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Take the next dose at bedtime the next day if a dose is missed at bedtime. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There could be adverse consequences from libanserin. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Tiredness
  • Having trouble falling or staying asleep
  • Mouth ache
  • Constipation

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those detailed in the IMPORTANT WARNING and SPECIAL PRECAUTIONS sections:

  • Extreme drowsiness
  • Trouble breathing or swallowing; hoarseness
  • Itching and hives
  • Swelling of the lips, mouth, or face

Other negative effects of libanserin are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Addyi®
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