Sarafem (Oral)

Fluoxetine is used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder. It is also used with olanzapine to treat depression that is part of bipolar disorder and treatment-resistant depression in patients who have had at least 2 previous treatments that did not work well.

Fluoxetine is an antidepressant and is part of a group of medicines called selective serotonin reuptake inhibitors (SSRIs). This medicine works by increasing the activity of a chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription.

It is important for your doctor to monitor your progress during regular visits to ensure this medicine is working correctly. You may need blood tests to check for side effects.

Do not take fluoxetine with a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking fluoxetine within 2 weeks after stopping a MAO inhibitor, and wait 5 weeks after stopping fluoxetine before starting a MAO inhibitor. Taking them together or not waiting the right amount of time may lead to confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not take thioridazine (Mellaril®) with fluoxetine, and wait 5 weeks after stopping fluoxetine before starting thioridazine. Do not use pimozide (Orap®) with fluoxetine. Using these medicines together can cause very serious heart problems.

Fluoxetine may lead to a serious condition called serotonin syndrome if taken with certain medicines. Do not use fluoxetine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medications (for example, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Frova®, Imitrex®, Maxalt®, Methadose®, Relpax®, Ultram®, Zomig®). Consult your doctor before taking any other medicines with fluoxetine.

Fluoxetine may cause some teenagers and young adults to feel agitated, irritable, or show other unusual behaviors. It may also lead some individuals to have suicidal thoughts or tendencies or to feel more depressed. Some people may experience trouble sleeping, become easily upset, have a significant increase in energy, or act recklessly. If you or your caregiver notice any of these side effects, inform your doctor immediately. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has attempted suicide.

Do not stop taking this medicine suddenly without consulting your doctor first. Your doctor may advise you to gradually reduce your dosage before stopping completely. This can help reduce the risk of withdrawal symptoms, which may include agitation, breathing issues, chest pain, confusion, diarrhea, dizziness or lightheadedness, rapid heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

Tell your doctor immediately if you develop a rash or hives, swelling of the face, eyes, or mouth, or have difficulty breathing after taking this medicine.

This medicine may increase your risk of bleeding problems. Make sure your doctor knows if you are also taking other medications that thin the blood, including NSAIDs (for example, aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®) or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) can occur with this medicine. Contact your doctor immediately if you experience confusion, difficulty concentrating, headaches, memory issues, weakness, or unsteadiness.

Reach out to your doctor right away if you have dizziness, fainting, or a fast, pounding, or irregular heartbeat. Ensure your doctor is aware if you have a history of heart rhythm problems, including QT prolongation, or if you or a family member has had a heart attack, heart failure, low blood pressure, or a stroke.

Avoid alcohol while taking fluoxetine.

This medicine may affect blood sugar levels. If you have diabetes and notice any changes in your blood or urine sugar tests, consult your doctor.

Fluoxetine may cause some people to feel drowsy, have difficulty thinking clearly, or experience poor muscle control. Be aware of how fluoxetine affects you before driving, using machines, or doing anything else that requires alertness and good control of your movements.

Inform your doctor right away if you notice a decreased interest in sexual intercourse, delayed or inability to reach orgasm in women, inability to have or maintain an erection in men, or any loss of sexual ability, desire, drive, or performance. These may indicate sexual dysfunction.

Do not take other medicines without discussing them with your doctor first. This includes prescription or over-the-counter (OTC) medications and herbal (for example, St. John's wort) or vitamin supplements.

In deciding to use a drug, the chances of using the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medication or any other medicines. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific issues that would limit the usefulness of fluoxetine in children. Nevertheless, safety and efficacy have not been established to treat depression in children younger than 8 years of age, to treat obsessive-compulsive disorder in children younger than 7 years of age, and to treat depression that is part of bipolar disorder in children younger than 10 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of fluoxetine in children with bulimia nervosa, panic disorder, or treatment resistant depression. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluoxetine in the elderly. Nevertheless, elderly patients are more likely to have hyponatremia (low sodium in the blood) than younger adults, which may require caution and an adjustment in the dose for patients receiving fluoxetine.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to taking this medicine while breastfeeding.

Interactions with Medicines

Although certain medications should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially critical that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following drugs is not advised. Your doctor may decide not to treat you with this medication or change some of the other medications you take.

• Bepridil
• Bromopride
• Cisapride
• Clorgyline
• Dronedarone
• Eliglustat
• Isocarboxazid
• Levoketoconazole
• Levomethadyl
• Linezolid
• Mavacamten
• Mesoridazine
• Methylene Blue
• Nialamide
• Ozanimod
• Phenelzine
• Pimozide
• Piperaquine
• Procarbazine
• Rasagiline
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Thioridazine
• Toloxatone
• Tranylcypromine
• Ziprasidone

Using this medicine with any of the following medicines is typically not recommended, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the medicines.

• Abciximab
• Abiraterone Acetate
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Adagrasib
• Alfentanil
• Alfuzosin
• Almotriptan
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Anileridine
• Apixaban
• Apomorphine
• Aprindine
• Ardeparin
• Argatroban
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Atomoxetine
• Azithromycin
• Bedaquiline
• Belzutifan
• Bemiparin
• Benzhydrocodone
• Benzphetamine
• Betrixaban
• Bivalirudin
• Brexpiprazole
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butorphanol
• Cangrelor
• Carbamazepine
• Carvedilol
• Celecoxib
• Ceritinib
• Certoparin
• Chloral Hydrate
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Choline Salicylate
• Cilostazol
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonixin
• Clopidogrel
• Clothiapine
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Dacomitinib
• Dalteparin
• Danaparoid
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Desirudin
• Deslorelin
• Desmopressin
• Desvenlafaxine
• Deutetrabenazine
• Dexfenfluramine
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Digoxin
• Dihydrocodeine
• Diphenoxylate
• Dipyridamole
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Droxicam
• Duloxetine
• Ebastine
• Edoxaban
• Efavirenz
• Eletriptan
• Encainide
• Enclomiphene
• Encorafenib
• Enflurane
• Enoxaparin
• Entrectinib
• Epoprostenol
• Eptifibatide
• Eribulin
• Erythromycin
• Escitalopram
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluphenazine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Frovatriptan
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Gilteritinib
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Heparin
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Iloperidone
• Iloprost
• Imipramine
• Indomethacin
• Inotuzumab Ozogamicin
• Iobenguane I 123
• Iobenguane I 131
• Isoflurane
• Isradipine
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketobemidone
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Lasmiditan
• Lefamulin
• Lenvatinib
• Lepirudin
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lidoflazine
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Macimorelin
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Melitracen
• Meloxicam
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methotrimeprazine
• Methoxyphenamine
• Methylphenidate
• Metoclopramide
• Metronidazole
• Mexiletine
• Mifepristone
• Milnacipran
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nabumetone
• Nadroparin
• Nafarelin
• Nalbuphine
• Naproxen
• Naratriptan
• Nebivolol
• Nefazodone
• Nelfinavir
• Nepafenac
• Nicergoline
• Nicomorphine
• Nifedipine
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Pacritinib
• Paliperidone
• Palonosetron
• Panobinostat
• Papaveretum
• Papaverine
• Parecoxib
• Paregoric
• Parnaparin
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Perphenazine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Pimavanserin
• Pipamperone
• Piritramide
• Piroxicam
• Pitolisant
• Ponesimod
• Posaconazole
• Prajmaline
• Pranoprofen
• Prasugrel
• Pridopidine
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propranolol
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Reviparin
• Ribociclib
• Risperidone
• Ritonavir
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Rolapitant
• Salicylic Acid
• Salsalate
• Selexipag
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• St John's Wort
• Sufentanil
• Sulfamethoxazole
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Sulpiride
• Sultopride
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Tenoxicam
• Terbinafine
• Tetrabenazine
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tilidine
• Timolol
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Tolperisone
• Tolterodine
• Toremifene
• Tramadol
• Trazodone
• Treprostinil
• Triclabendazole
• Trimethoprim
• Trimipramine
• Triptorelin
• Tropisetron
• Tryptophan
• Valbenazine
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vernakalant
• Vilanterol
• Vilazodone
• Vinblastine
• Vinflunine
• Voclosporin
• Vorapaxar
• Voriconazole
• Vorinostat
• Vortioxetine
• Warfarin
• Yohimbine
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Using this medication with any of the following drugs may cause an increased risk of certain adverse effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medicines.

• Alprazolam
• Cyproheptadine
• Delavirdine
• Diazepam
• Ginkgo
• Metoprolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may as well cause interactions to occur. Discuss with your healthcare professional the use of your drug with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this drug. Make sure you inform your physician if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with mania and depression), or risk of or
• Bleeding issues or
• Diabetes or
• Glaucoma, angle-closure or
• Hyponatremia (low sodium in the blood) or
• Mania, history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• Heart attack or stroke, recent or history of or
• Heart failure or
• Heart rhythm problems (eg, QT prolongation), or history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse.

• Liver disease—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

Along with its beneficial effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical help.

Check with your doctor right away if any of these side effects occur:

More common

• Hives, itching, skin rash
• inability to sit still
• restlessness

Less common

• Chills or fever
• joint or muscle pain

Rare

• Anxiety
• cold sweats
• confusion
• cool pale skin
• diarrhea
• difficulty with concentration
• drowsiness
• dryness of the mouth
• excessive hunger
• fast or irregular heartbeat
• headache
• increased sweating
• increased thirst
• lack of energy
• mood or behavior changes
• overactive reflexes
• purple or red spots on the skin
• racing heartbeat
• seizures
• shakiness or unsteady walk
• shivering or shaking
• talking, feeling, and acting with excitement and activity you cannot control
• trouble with breathing
• unusual or incomplete body or facial movements
• unusual tiredness or weakness

Incidence not known

• Agitation
• back or leg pains
• bleeding gums
• blindness
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bloody, black or tarry stools
• blue-yellow color blindness
• blurred vision
• chest pain, discomfort, or tightness
• clay-colored stools
• constipation
• continuing vomiting
• cough or dry cough
• dark urine
• decreased interest in sexual intercourse
• decreased urine output
• decreased vision
• delayed or inability to have an orgasm
• depression
• difficulty with swallowing
• dizziness or lightheadedness
• eye pain
• fainting
• fast, pounding, or irregular heartbeat or pulse
• general body swelling
• high fever
• hostility
• inability to have or keep an erection
• indigestion
• irregular or slow heart rate
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss in sexual ability, desire, drive, or performance
• loss of appetite
• loss of bladder control
• muscle twitching
• nausea
• nightmares
• no blood pressure or pulse
• noisy breathing
• nosebleeds
• pain in the ankles or knees
• painful, red lumps under the skin, mostly on the legs
• painful or prolonged erection of the penis
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red or irritated eyes
• red skin lesions, often with a purple center
• redness, tenderness, itching, burning, or peeling of the skin
• severe muscle stiffness
• severe sleepiness
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• stopping of heart
• sudden weakness in the arms or legs
• sudden, severe chest pain
• swelling of the face, ankles, or hands
• swollen or painful glands
• thoughts of killing oneself
• tiredness
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unconsciousness
• unpleasant breath odor
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusually pale skin
• use of extreme physical or emotional force
• vomiting of blood
• yellow eyes or skin

Some side effects may happen that usually do not need medical help. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Decreased appetite

Less common or rare

• Abnormal dreams
• breast enlargement or pain
• change in sense of taste
• changes in vision
• feeling of warmth or heat
• flushing or redness of the skin, especially on face and neck
• frequent urination
• hair loss
• increased appetite
• increased sensitivity of the skin to sunlight
• menstrual pain
• stomach cramps, gas, or pain
• unusual secretion of milk, in females
• weight loss
• yawning

Incidence not known

• Cracks in the skin
• decrease in smell
• loss of heat from the body
• loss of sense of smell
• painful or prolonged erections of the penis
• scaly skin
• swelling of the breasts or breast soreness in both females and males
• unusual milk production

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• PROzac
• PROzac Weekly
• Rapiflux
• Sarafem
• Selfemra

In Canada

• Phl-FLUoxetine

Available Dosage Forms:

• Capsule, Delayed Release
• Syrup
• Tablet
• Capsule
• Solution

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin Reuptake Inhibitor

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Follow the instructions carefully. Ask your doctor if you have any questions.

You may take the medicine with or without food.

You may have to take fluoxetine for a month or longer before you begin to feel better.

If you are using the oral liquid, shake the bottle well before measuring each dose. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup. A regular household teaspoon will not measure the proper amount of medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, delayed-release capsules, pulvules, or solution): For bulimia nervosa: Adults—60 milligrams (mg) once a day in the morning. Children—Use and dose must be determined by your doctor. For depression: Adults—At first, 20 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. If you are taking more than 20 mg per day, you may take the capsule once a day in the morning or 2 times a day (eg, morning and noon). However, the dose is usually not more than 80 mg per day. Children 8 years of age and older—At first, 10 or 20 mg once a day in the morning. Your doctor may adjust your dose as needed. Children younger than 8 years of age—Use and dose must be determined by your doctor. For depression associated with bipolar disorder (combination with olanzapine): Adults—At first, 20 milligrams (mg) of fluoxetine and 5 mg of olanzapine once a day, taken in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg of fluoxetine and 12 mg of olanzapine per day. Children 10 years of age and older—At first, 20 milligrams (mg) of fluoxetine and 2.5 mg of olanzapine once a day, taken in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg of fluoxetine and 12 mg of olanzapine per day. Children younger than 10 years of age—Use and dose must be determined by your doctor. For treatment resistant depression (combination with olanzapine): Adults—At first, 20 milligrams (mg) of fluoxetine and 5 mg of olanzapine once a day, taken in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg of fluoxetine and 20 mg of olanzapine per day. Children—Use and dose must be determined by your doctor. For obsessive-compulsive disorder: Adults—At first, 20 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day. Children 7 years of age and older—At first, 10 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day. Children younger than 7 years of age—Use and dose must be determined by your doctor. For panic disorder: Adults—At first, 10 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day. Children—Use and dose must be determined by your doctor. For premenstrual dysphoric disorder: Adults—At first, 20 milligrams (mg) once a day in the morning. Your doctor may have you take 20 mg every day of your menstrual cycle or for only 15 days of your cycle. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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