Fluoxetine (Premenstrual), Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat a severe form of premenstrual syndrome (PMS). Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: selective serotonin reuptake inhibitor (SSRI)

Generic and brand names: fluoxetine (premenstrual), oral; Sarafem

What is this medicine used for?

This medicine is taken by mouth to treat premenstrual dysphoric disorder (PMDD). PMDD is a severe form of premenstrual syndrome (PMS).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bipolar disorder, depression, or thoughts of suicide
• Bleeding problems
• Diabetes
• Glaucoma
• Heart disease or a heart attack
• High blood pressure
• Kidney or liver disease
• Problems with low levels of sodium in the blood
• Seizures

Do not take this medicine if you have taken an MAO inhibitor in the last 2 weeks. Do not take pimozide (Orap) or thioridazine while taking this medicine. Do not take other medicines that contain fluoxetine such as Prozac or Symbyax. Also, do not start taking any of these medicines within 5 weeks after stopping this medicine. Taking these medicines can cause life-threatening side effects. Talk with your healthcare provider about this.

Females of childbearing age: This medicine is not usually given to pregnant women. If you are pregnant, tell your healthcare provider. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Usually you take it once a day. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. You may need to reduce your dosage slowly to avoid serious side effects.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Take the medicine at the same time each day to help you remember to take it.

What if I miss a dose?

If you miss a dose one day, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses the next day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, fever, drowsiness, tremors, fast irregular heartbeat, confusion, dizziness, fainting, nervousness, seizures, coma.

What should I watch out for?

Even though you are not taking this medicine for depression, it is a medicine that can be used for depression. Sometimes antidepressants may cause unusual changes in mood or behavior or make you think about harming yourself. Contact your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.

Contact your healthcare provider if your condition does not improve or if it gets worse.

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination
• Fast heart beat
• Rapid changes in blood pressure
• Increased body temperature, sweating, or flushing
• Nausea, vomiting, or diarrhea
• Muscle stiffness

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may increase the effects of alcohol and interact with many other medicines. Do not drink alcohol or take any other medicine, including nonprescription products or natural remedies, unless your healthcare provider approves.

Do not give this medicine to others, even if they seem to have similar symptoms.

This medicine may cause severe weight loss. Talk to your healthcare provider about this.

Occasionally, this medicine may cause some sexual problems. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Seizures; trouble breathing; new or worsening depression; thoughts of suicide; unusual changes in thoughts, mood, or behavior; severe nervousness or confusion; hallucinations; severe loss of appetite; sudden or severe weight loss; fever; stiff muscles; fast heartbeat; chest pain; ringing in the ears; unusual bruising or bleeding; black or tarry bowel movements; blistering, peeling, or severe skin rash; severe dizziness or fainting; joint or muscle pain; memory problems or trouble concentrating; eye pain, vision changes, or swelling and redness around your eyes.

Other: Dizziness, drowsiness, increased yawning, nausea, diarrhea, constipation, dry mouth, stomach pain, vomiting, sweating, shaking, trouble sleeping, abnormal dreams, headache, decreased appetite, sexual problems, nervousness, runny nose, sore throat.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Alfuzosin (Uroxatral)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifampin (Rifadin), rifapentine (Priftin), tedizolid (Sivextro), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), mirtazapine (Remeron), nefazodone, sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), perphenazine, pimavanserin (Nuplazid), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Apomorphine (Apokyn)
• Aspirin and other salicylates
• Beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol), nebivolol (Bystolic), and timolol
• Bromocriptine (Cycloset, Parlodel)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cabergoline
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), crizotinib (Xalkori), degarelix (Firmagon), nilotinib (Tasigna), procarbazine (Matulane), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and tolbutamide
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), furosemide (Lasix), and hydrochlorothiazide (Microzide)
• Doxepin (Silenor)
• Gemfibrozil (Lopid)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, mexiletine, nicardipine (Cardene), procainamide, propafenone (Rythmol), ranolazine (Ranexa), and quinidine
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Ivabradine (Corlanor)
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not start taking this medicine if you have taken an MAO inhibitor in the last 14 days; Do not start an MAO inhibitor within 5 weeks after stopping this medicine.)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana) and formoterol (Perforomist)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), ticagrelor (Brilinta), and warfarin (Coumadin)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as alfalfa, anise, bilberry, cat's claw, garlic, ginger, ginkgo biloba, ginseng, glucosamine, gotu kola, kava, SAMe, St. John's wort, tryptophan, turmeric, and valerian
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rasagiline (Azilect)
• Sleeping pills such as butabarbital (Butisol), ramelteon (Rozerem), suvorexant (Belsomra), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants and diet pills such as dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)
• Tacrolimus (Astagraf, Prograf, Protopic)
• Tricyclic antidepressants such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), and nortriptyline (Pamelor)

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.