Forfivo XL (bupropion HCl) Extended-Release Tablets 450 mgForfivo XL (bupropion HCl) Extended-Release Tablets 450 mg

One Tablet Per Day.
Simple.

For your 30 mg and 60 mg
fluoxetine patients.

Download Full Prescribing Information including Boxed WARNING and Medication Guide

Medication guide
Fluoxetine tablets

Read the Medication Guide that comes with fluoxetine before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about fluoxetine?

Fluoxetine and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

  • Fluoxetine and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when fluoxetine is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

  • attempts to commit suicide
  • acting on dangerous impulses
  • acting aggressive or violent
  • thoughts about suicide or dying
  • new or worse depression
  • new or worse anxiety or panic attacks
  • feeling agitated, restless, angry, or irritable
  • trouble sleeping
  • an increase in activity or talking more than what is normal for you
  • other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Fluoxetine may be associated with these serious side effects:

2. Serotonin Syndrome. This condition can be life-threatening and may include:

  • agitation, hallucinations, coma, or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
  • dizziness
  • flushing
  • tremor
  • seizures

3. Severe allergic reactions:

  • trouble breathing
  • swelling of the face, tongue, eyes, or mouth
  • rash, itchy welts (hives) or blisters, alone or with fever or joint pain

4. Abnormal bleeding: Fluoxetine and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a nonsteroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Visual problems:

  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

6. Seizures or convulsions

7. Manic episodes:

  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating, or thinking or memory problems

10. Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsades de Pointes). This condition can be life threatening. The symptoms may include:

  • fast, slow, or irregular heartbeat
  • shortness of breath
  • dizziness or fainting

11. Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including fluoxetine, may cause sexual problems.
Symptoms in males may include:

  • Delayed ejaculation or inability to have an ejaculation
  • Decreased sex drive
  • Problems getting or keeping an erection

Symptoms in females may include:

  • Decreased sex drive
  • Delayed orgasm or inability to have an orgasm

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with fluoxetine. There may be treatments your healthcare provider can suggest.

Do not stop fluoxetine without first talking to your healthcare provider. Stopping fluoxetine too quickly may cause serious symptoms including:

  • anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
  • headache, sweating, nausea, dizziness
  • electric shock-like sensations, shaking, confusion

What is fluoxetine?

Fluoxetine is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

Fluoxetine is used to treat:

  • Major Depressive Disorder (MDD)
  • Obsessive Compulsive Disorder (OCD)
  • Bulimia Nervosa*
  • Panic Disorder*
  • Depressive episodes associated with Bipolar I Disorder, taken with olanzapine (Zyprexa)*
  • Treatment Resistant Depression (depression that has not gotten better with at least 2 other treatments), taken with olanzapine (Zyprexa)*

*Not approved for use in children.

Talk to your healthcare provider if you do not think that your condition is getting better with fluoxetine treatment.

Who should not take fluoxetine?

Do not take fluoxetine if you:

  • are allergic to fluoxetine hydrochloride or any of the ingredients in fluoxetine. See the end of this Medication Guide for a complete list of ingredients in fluoxetine.
  • take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
    • Do not take an MAOI within 5 weeks of stopping fluoxetine unless directed to do so by your physician.
    • Do not start fluoxetine if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

      People who take fluoxetine close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
    • high fever
    • uncontrolled muscle spasms
    • stiff muscles
    • rapid changes in heart rate or blood pressure
    • confusion
    • loss of consciousness (pass out)
  • take Mellaril® (thioridazine). Do not take Mellaril® within 5 weeks of stopping fluoxetine because this can cause serious heart rhythm problems or sudden death.
  • take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.

What should I tell my healthcare provider before taking fluoxetine? Ask if you are not sure.

Before starting fluoxetine, tell your healthcare provider if you:

  • are taking certain drugs or treatments such as:
    • Triptans used to treat migraine headache

    • Medicines used to treat mood, anxiety, psychotic, or thought disorders, including
      tricyclics, lithium, SSRIs, SNRIs, MAOIs, or antipsychotics

    • Tramadol and fentanyl
    • Amphetamines
    • Over-the-counter supplements such as tryptophan or St. John's Wort
    • Electroconvulsive therapy (ECT)
  • have liver problems
  • have kidney problems
  • have heart problems
  • have or had seizures or convulsions
  • have bipolar disorder or mania
  • have low sodium levels in your blood
  • have a history of a stroke
  • have high blood pressure
  • have or had bleeding problems
  • are pregnant or plan to become pregnant. It is not known if fluoxetine will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
  • are breast-feeding or plan to breast-feed. Some fluoxetine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking fluoxetine.

Tell your healthcare provider about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Fluoxetine and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take fluoxetine with your other medicines. Do not start or stop any medicine while taking fluoxetine without talking to your healthcare provider first.

If you take fluoxetine, you should not take any other medicines that contain fluoxetine hydrochloride including:

  • Symbyax® (olanzapine and fluoxetine hydrochloride)
  • Sarafem® (fluoxetine)
  • Prozac®
  • Prozac® Weekly™

How should I take fluoxetine?

  • Take fluoxetine exactly as prescribed. Your healthcare provider may need to change the dose of fluoxetine until it is the right dose for you. Each tablet can be broken in half (along the functional score).
  • Fluoxetine may be taken with or without food.
  • If you miss a dose of fluoxetine, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluoxetine at the same time.
  • If you take too much fluoxetine, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking fluoxetine?

Fluoxetine can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how fluoxetine affects you. Do not drink alcohol while using fluoxetine.

What are the possible side effects of fluoxetine?

Fluoxetine may cause serious side effects, including:

  • See “What is the most important information I should know about fluoxetine?”
  • Problems with blood sugar control. People who have diabetes and take fluoxetine may have problems with low blood sugar while taking fluoxetine. High blood sugar can happen when fluoxetine is stopped. Your healthcare provider may need to change the dose of your diabetes medicines when you start or stop taking fluoxetine.
  • Feeling anxious or trouble sleeping

Common possible side effects in people who take fluoxetine include:

  • unusual dreams
  • sexual problems
  • loss of appetite, diarrhea, indigestion, nausea or vomiting, weakness, or dry mouth
  • flu symptoms
  • feeling tired or fatigued
  • change in sleep habits
  • yawning
  • sinus infection or sore throat
  • tremor or shaking
  • sweating
  • feeling anxious or nervous
  • hot flashes
  • rash

Other side effects in children and adolescents include:

  • increased thirst
  • abnormal increase in muscle movement or agitation
  • nose bleed
  • urinating more often
  • heavy menstrual periods
  • possible slowed growth rate and weight change. Your child's height and weight should be monitored during treatment with fluoxetine.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of fluoxetine. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store fluoxetine?

  • Store fluoxetine at room temperature between 68°F and 77°F (20°C to 25°C).
  • Keep fluoxetine away from light.
  • Keep fluoxetine bottle closed tightly.

Keep fluoxetine and all medicines out of the reach of children.

General information about fluoxetine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine for a condition for which it was not prescribed. Do not give fluoxetine to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about fluoxetine. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluoxetine that is written for healthcare professionals.

For more information about fluoxetine call 1-877-447-7979.

What are the ingredients in fluoxetine tablets, 60 mg?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: mannitol, microcrystalline cellulose, maize starch, povidone, hypromellose, magnesium stearate, titanium dioxide, sucrose, glycerol, and polysorbate.

This Medication Guide has been approved by the US Food and Drug Administration.

Symbyax and Prozac are registered trademarks of Eli Lilly and Company.
Prozac Weekly is a registered trademark of Eli Lilly and Company.
Sarafem is a registered trademark of Warner Chilcott.
Mellaril is a registered trademark of Novartis AG Corporation.
Orap is a registered trademark of Teva Pharmaceuticals USA.
Coumadin is a registered trademark of Bristol Myers Squibb.
Jantoven is a registered trademark of Upsher-Smith Laboratories Inc.

Manufactured by:
Orion Pharmaceuticals
FN-02200
Espoo, Finland

Distributed by:
Almatica Pharma, Inc.
Pine Brook, NJ 07058 USA

Product of Finland

Revised June 2021
PL576-02

Download Full Prescribing Information including Boxed WARNING and Medication Guide

Important safety information

Important drug warning

Download Full Prescribing Information including Boxed WARNING and Medication Guide

Indications:

Fluoxetine is indicated for the treatment of Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Bulimia Nervosa (BN), and Panic Disorder (with or without agoraphobia) in adults. Fluoxetine is also indicated for the treatment of MDD in children and adolescents 8 to 18 years of age and OCD in children and adolescents 7 to 17 years of age.

Use another fluoxetine product for initial doses of 10 mg to 20 mg/day or for doses other than 30 mg or 60 mg.

Important safety information for fluoxetine tablets, 60 mg

Contraindications

  • Do not use monoamine oxidase inhibitors (MAOIs) intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine due to risk of serotonin syndrome. Do not use fluoxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue due to risk of serotonin syndrome.
  • Do not use fluoxetine with pimozide due to risk of QT interval prolongation and drug interaction.
  • Do not use fluoxetine with thioridazine due to risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine.
  • Do not use this fluoxetine product in patients with known hypersensitivity to fluoxetine due to risk of anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria.

Warnings and precautions

  • All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.
  • The development of a potentially life-threatening serotonin syndrome has been reported with serotonin-norepinephrine or selective serotonin reuptake inhibitors (SNRIs or SSRIs), including fluoxetine, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Patients should be monitored for emergence of serotonin syndrome. The concomitant use of fluoxetine with MAOIs intended to treat psychiatric disorders is contraindicated. Fluoxetine should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. Treatment with fluoxetine and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur, and supportive symptomatic treatment should be initiated.
  • Systemic reactions with rash, possibly related to vasculitis and including lupus-like syndrome, have developed in patients treated with fluoxetine. Although these reactions are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic reactions. Anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria alone and in combination, have been reported. Pulmonary reactions, including inflammatory processes of varying histopathology and/or fibrosis, have been reported rarely. These reactions have occurred with dyspnea as the only preceding symptom. Upon the appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified, fluoxetine should be discontinued.
  • A major depressive episode may be the initial presentation of Bipolar Disorder. Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disorder and monitored for mania/hypomania. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
  • The percentage of patients experiencing convulsions in all US fluoxetine clinical trials appears to be similar to that associated with other marketed drugs effective in the treatment of MDD. Fluoxetine should be introduced with care in patients with a history of seizures. There have been rare reports of prolonged seizures in patients taking fluoxetine who are also receiving electroconvulsive therapy treatment.
  • Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with fluoxetine. Rarely have patients discontinued treatment with fluoxetine because of anorexia or weight loss. Weight change should be monitored during therapy.
  • SNRIs and SSRIs, including fluoxetine, may increase the risk of bleeding reactions. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk.
  • The pupillary dilation that occurs following use of many antidepressant drugs including fluoxetine may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
  • Hyponatremia has been reported during treatment with SNRIs and SSRIs, including fluoxetine. Elderly patients and patients taking diuretics or who are otherwise volume-depleted may be at greater risk. Discontinuation of fluoxetine should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.
  • In US placebo-controlled clinical trials, among the most common adverse reactions associated with discontinuation (incidence at least twice that for placebo and at least 1% for fluoxetine in trials collecting only a primary reaction associated with discontinuation) were anxiety (2% in OCD), insomnia (1% in combined indications and 2% in BN), and nervousness (1% in MDD).
  • Postmarketing cases of QT interval prolongation and ventricular arrhythmia including Torsades de Pointes have been reported in patients treated with fluoxetine. Fluoxetine should be used with caution in patients with congenital long QT syndrome; a previous history of QT prolongation; a family history of long QT syndrome or sudden cardiac death; and other conditions that predispose to QT prolongation and ventricular arrhythmia. Such conditions include concomitant use of drugs that prolong the QT interval; hypokalemia or hypomagnesemia; recent myocardial infarction, uncompensated heart failure, bradyarrhythmias, and other significant arrhythmias; and conditions that predispose to increased fluoxetine exposure. Consider ECG assessment and periodic ECG monitoring if initiating treatment with fluoxetine in patients with risk factors for QT prolongation and ventricular arrhythmia. Consider discontinuing fluoxetine and obtaining a cardiac evaluation if patients develop signs or symptoms consistent with ventricular arrhythmia.
  • In patients with diabetes, hypoglycemia has occurred during therapy with fluoxetine, and hyperglycemia has developed following discontinuation of the drug. As is true with many other types of medication when taken concurrently by patients with diabetes, insulin and/or oral hypoglycemic, dosage may need to be adjusted when therapy with fluoxetine is instituted or discontinued.
  • Fluoxetine has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.
  • Because of the long elimination half-lives of the parent drug and its major active metabolite, changes in dose will not be fully reflected in plasma for several weeks, affecting both strategies for titration to final dose and withdrawal from treatment.
  • During marketing of fluoxetine, SNRIs, and SSRIs, there have been spontaneous reports of adverse reactions occurring, some of which have been serious, upon discontinuation of these drugs, particularly when abrupt. Patients should be monitored for these symptoms when discontinuing treatment with fluoxetine. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.

Adverse reactions

  • Most common adverse reactions associated with the use of fluoxetine (incidence of at least 5% and at least twice that for placebo, within at least 1 of the indications) for the treatment of MDD, OCD, and BN in US controlled clinical trials and Panic Disorder in US plus non-US controlled trials: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn.

You are encouraged to report negative side effects of prescription drugs to Almatica at 1-877-447-7979 or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

FORFIVO XL is a registered trademark of IntelGenx Corporation.

Download Full Prescribing Information including Boxed WARNING and Medication Guide