PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 100 mg

Representative sample of labeling (see HOW SUPPLIED section for complete listing)

APOTEX CORP. NDC 60505-0166-1

Fluvoxamine Maleate Tablets, USP

100 mg

Rx

100 bottle count

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RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

Warnings and Precautions (5.2, 5.10) 8/2023

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DESCRIPTION SECTION

11 DESCRIPTION

Fluvoxamine maleate, USP is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated as 5-methoxy-4′-(trifluoromethyl) valerophenone (E)-O-(2-aminoethyl) oxime maleate (1:1) and has the molecular formula C15H21O2N2 F3•C4H4O4. Its molecular weight is 434.4.

The structural formula is:


Fluvoxamine maleate, USP is a white to off-white powder which is sparingly soluble in water, freely soluble in ethanol and chloroform and practically insoluble in diethyl ether.

Fluvoxamine maleate tablets, USP are available in 25 mg, 50 mg and 100 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each tablet contains the following inactive ingredients: hydroxyethyl cellulose (25 mg and 50 mg), hydroxypropyl cellulose (100 mg), hypromellose (100 mg), iron oxide black (100 mg), iron oxide red (100 mg), iron oxide yellow (50 mg and 100 mg), magnesium stearate, mannitol, polyethylene glycol and titanium dioxide.

Meets USP Organic Impurities Test 2.

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DOSAGE & ADMINISTRATION SECTION

Highlight: * Adults: Recommended starting dose is 50 mg at bedtime, with increases of 50 mg every 4 to 7 days as tolerated to maximum effect, not to exceed 300 mg/day. Daily doses over 100 mg should be divided (2.1).

• Children and adolescents (8 to 17 years): Recommended starting dose is 25 mg at bedtime, with increases of 25 mg every 4 to 7 days as tolerated to maximum effect, not to exceed 200 mg/day (8 to 11 years) or 300 mg/day (12 to 17 years). Daily doses over 50 mg should be divided (2.2).
• Hepatically impaired: Decreased clearance may require modified dose and titration (2.3).
• Extended treatment: Adjust dose to maintain lowest effective dose; reassess patients periodically (2.6).
• Discontinuation: Gradual dose reduction is recommended (2.7, 5.9).

2 DOSAGE AND ADMINISTRATION

2.1 Adults

The recommended starting dose for fluvoxamine maleate tablets in adult patients is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of fluvoxamine maleate tablets in OCD, patients were titrated within a dose range of 100 to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day. It is advisable that a total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

2.2 Pediatric Population (children and adolescents)

The recommended starting dose for fluvoxamine maleate tablets in pediatric populations (ages 8 to 17 years) is 25 mg, administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of fluvoxamine maleate tablets in OCD, pediatric patients (ages 8 to 17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.

2.3 Elderly or Hepatically Impaired Patients

Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.

2.4 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI)

Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluvoxamine maleate tablets. Conversely, at least 14 days should be allowed after stopping fluvoxamine maleate tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4)].

2.5 Use of Fluvoxamine Maleate Tablets with Other MAOIs such as Linezolid

or Methylene Blue

Do not start fluvoxamine maleate tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4)].

In some cases, a patient already receiving fluvoxamine maleate tablets therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluvoxamine maleate tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluvoxamine maleate tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluvoxamine maleate tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].

2.6 Maintenance/Continuation Extended Treatment

It is generally agreed that obsessive compulsive disorder requires several months or longer of sustained pharmacologic therapy. The benefit of maintaining patients with OCD on fluvoxamine maleate tablets after achieving a response for an average duration of about 4 weeks in a 10-week single-blind phase during which patients were titrated to effect was demonstrated in a controlled trial [see Clinical Trials (14.2)]. The physician who elects to use fluvoxamine maleate tablets for extended periods should periodically re- evaluate the long-term usefulness of the drug for the individual patient.

2.7 Discontinuation of Treatment with Fluvoxamine Maleate Tablets

Symptoms associated with discontinuation of other SSRIs or SNRIs have been reported [see Warnings and Precautions (5.9)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: * 25 mg tablets, 50 mg tablets, and 100 mg tablets (3)

3 DOSAGE FORMS AND STRENGTHS

Fluvoxamine maleate tablets, USP are available as:

Tablets 25 mg: White to off-white, round, unscored, film coated tablets, engraved “APO” on one side and “F25” on the other side.

Tablets 50 mg: Golden, round, scored, film coated tablets, engraved “APO” on one side and “F50” with a partial bisect on the other side.

Tablets 100 mg: Reddish-brown, pillow shaped, scored, film coated tablets, engraved “APO” on one side and “FLU” bisect “100” on the other side.

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BOXED WARNING SECTION

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

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CLINICAL STUDIES SECTION

14 CLINICAL STUDIES

14.1 Adult OCD Studies

The effectiveness of fluvoxamine maleate tablets for the treatment of obsessive-compulsive disorder (OCD) was demonstrated in two 10-week multicenter, parallel group studies of adult outpatients. Patients in these trials were titrated to a total daily fluvoxamine maleate dose of 150 mg/day over the first two weeks of the trial, following which the dose was adjusted within a range of 100 to 300 mg/day (on a b.i.d. schedule), on the basis of response and tolerance. Patients in these studies had moderate to severe OCD (DSM-III-R), with mean baseline ratings on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), total score of 23. Patients receiving fluvoxamine maleate experienced mean reductions of approximately 4 to 5 units on the Y-BOCS total score, compared to a 2-unit reduction for placebo patients.

Table 6 provides the outcome classification by treatment group on the Global Improvement item of the Clinical Global Impressions (CGI) scale for both studies combined.

TABLE 6 OUTCOME CLASSIFICATION (%) ON CGI-GLOBAL IMPROVEMENT ITEM FOR COMPLETERS IN POOL OF TWO ADULT OCD STUDIES

Exploratory analyses for age and gender effects on outcomes did not suggest any differential responsiveness on the basis of age or sex.

14.2 Adult OCD Maintenance Study

In a maintenance trial of adult outpatients with OCD, 114 patients meeting DSM-IV criteria for OCD and with a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score ≥18 were titrated to an effective dose of fluvoxamine maleate tablets 100 to 300 mg/day as part of an initial 10-week single-blind treatment phase. Treatment response during this single-blind phase was defined as Y-BOCS scores at least 30% lower than baseline at the end of weeks 8 and 10. Of the patients who responded, their average duration of response was 4 weeks. Patients who responded during this initial phase were randomized either to continuation of fluvoxamine maleate tablets (N=56) or to placebo (N=58) in a double-blind phase for observation of relapse. Relapse during the double-blind phase was defined as an increase in the Y-BOCS score of at least 30% over the baseline for that phase or patient refusal to continue treatment due to a substantial increase in OCD symptoms. In the double-blind phase, patients receiving continued fluvoxamine maleate tablets treatment experienced, on average, a significantly lower relapse rate than those receiving placebo.

An examination of population subgroups from this trial did not reveal any clear evidence of a differential maintenance effect on the basis of age or gender.

14.3 Pediatric OCD Study

The effectiveness of fluvoxamine maleate tablets for the treatment of OCD was also demonstrated in a 10-week multicenter, parallel group study in a pediatric outpatient population (children and adolescents, ages 8 to 17). Patients in this study were titrated to a total daily fluvoxamine dose of approximately 100 mg/day over the first two weeks of the trial, following which the dose was adjusted within a range of 50 to 200 mg/day (on a b.i.d. schedule) on the basis of response and tolerance. All patients had moderate to severe OCD (DSM-III-R) with mean baseline ratings on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) total score of 24. Patients receiving fluvoxamine maleate experienced mean reductions of approximately six units on the CY-BOCS total score, compared to a three-unit reduction for placebo patients.

Table 7 provides the outcome classification by treatment group on the Global Improvement item of the Clinical Global Impression (CGI) scale for the pediatric study.

TABLE 7 OUTCOME CLASSIFICATION (%) ON CGI-GLOBAL IMPROVEMENT ITEM FOR COMPLETERS IN PEDIATRIC STUDY

Post hoc exploratory analyses for gender effects on outcomes did not suggest any differential responsiveness on the basis of gender. Further exploratory analyses revealed a prominent treatment effect in the 8 to 11 age group and essentially no effect in the 12 to 17 age group. While the significance of these results is not clear, the 2 to 3 fold higher steady-state plasma fluvoxamine concentrations in children compared to adolescents [see Clinical Pharmacology (12.3)] is suggestive that decreased exposure in adolescents may have been a factor, and dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit.

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OVERDOSAGE SECTION

10 OVERDOSAGE

The following have been reported with fluvoxamine tablet overdosage:

• Seizures, which may be delayed, and altered mental status including coma.
• Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol.
• Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk).

Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a fluvoxamine overdose.

Consider contacting a poison center (1-800-221-2222) or a medical toxicologist for overdosage management recommendations.

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INFORMATION FOR PATIENTS SECTION

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluvoxamine maleate tablets and should counsel them in the appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for fluvoxamine maleate tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluvoxamine maleate tablets.

Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate the need for very close monitoring and possibly changes in the medication [see Boxed Warning, Warnings and Precautions (5.1)].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome particularly with the concomitant use of fluvoxamine with other serotonergic agents (including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John's Wort) [see Warnings and Precautions (5.2)].

** Angle Closure Glaucoma**

Patients should be advised that taking Fluvoxamine Maleate Tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.3)].

Interference with Cognitive or Motor Performance

Since any psychoactive drug may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain that fluvoxamine maleate tablets therapy does not adversely affect their ability to engage in such activities.

Pregnancy

• Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Fluvoxamine Maleate Tablets.
• Advise patients that Fluvoxamine Maleate Tablets use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).
• Advise women that there is a risk of relapse with discontinuation of antidepressants.
• Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Fluvoxamine Maleate Tablets during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise breastfeeding women using Fluvoxamine Maleate Tablets to monitor infants for diarrhea, vomiting, decreased sleep, and agitation and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].

Concomitant Medication

Patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for clinically important interactions with fluvoxamine maleate tablets.

Patients should be cautioned about the concomitant use of fluvoxamine and NSAIDs, aspirin, or other drugs that affect coagulation since the combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions (5.8)].

Because of the potential for the increased risk of serious adverse reactions including severe lowering of blood pressure and sedation when fluvoxamine and tizanidine are used together, fluvoxamine should not be used with tizanidine [see Warnings and Precautions (5.5)].

Because of the potential for the increased risk of serious adverse reactions when fluvoxamine and alosetron are used together, fluvoxamine should not be used with LotronexTM (alosetron) [see Warnings and Precautions (5.7)].

Sexual Dysfunction

Advise patients that use of fluvoxamine maleate tablets may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.16)].

** Alcohol**

As with other psychotropic medications, patients should be advised to avoid alcohol while taking fluvoxamine maleate tablets.

Allergic Reactions

Patients should be advised to notify their physicians if they develop a rash, hives, or a related allergic phenomenon during therapy with fluvoxamine maleate tablets.

All registered trademarks in this document are the property of their respective owners.

Dispense with Medication Guide available at https://www.apotex.com/products/us/mg.asp

APOTEX INC.

FLUVOXAMINE MALEATE TABLETS, USP

25 mg, 50 mg and 100 mg

Revision: 17

SPL MEDGUIDE SECTION

MEDICATION GUIDE

Fluvoxamine (Flu VOX ah meen) Maleate Tablets, USP

Medication Guide available at https://www.apotex.com/products/us/mg.asp

Read the Medication Guide that comes with fluvoxamine maleate tablets 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 fluvoxamine maleate tablets?

Fluvoxamine is the same kind of medicine as those used to treat depression and may cause serious side effects, including:

1.** Suicidal thoughts or actions:**

Fluvoxamine maleate tablets and antidepressant medicines may increase suicidal thoughts or actionsin 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 fluvoxamine maleate tablets 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

Tell your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Fluvoxamine maleate tablets 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

**3.**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.

4. 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

**5.**Abnormal bleeding: fluvoxamine maleate tablets and antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), or a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen, naproxen, or aspirin).

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.****Sexual problems (dysfunction).**Taking selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine maleate tablets, 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 fluvoxamine maleate tablets. There may be treatments your healthcare provider can suggest.

Do not stop fluvoxamine maleate tablets without first talking to your healthcare provider.

Stopping fluvoxamine maleate tablets 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 are fluvoxamine maleate tablets?

Fluvoxamine maleate tablets are a prescription medicine used to treat obsessive compulsive disorder (OCD). It is important to talk with your healthcare provider about the risks of treating OCD and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

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

Who should not take fluvoxamine maleate tablets?

Do not take fluvoxamine maleate tablets if you:

• are allergic to fluvoxamine maleate or any of the ingredients in fluvoxamine maleate tablets. See the end of this Medication Guide for a complete list of ingredients in fluvoxamine maleate tablets.
• 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 2 weeks of stopping fluvoxamine maleate tablets unless directed to do so by your physician.
• Do not start fluvoxamine maleate tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take fluvoxamine maleate tablets 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 2 weeks of stoppingFluvoxamine Maleate Tabletsbecause this can cause serious heart rhythm problems or sudden death.** take Orap*®(pimozide) because taking this drug with Fluvoxamine Maleate Tablets can cause serious heart rhythm problems or sudden death.** take Zanaflex®** (tizanidine).Fluvoxamine maleate tablets could increase the amount of Zanaflex in your body, which could increase its actions and side effects. This could include drowsiness and a drop in blood pressure and affecting how well you do things that require alertness. Take Lotronex®** (alosetron).**Fluvoxamine maleate tablets may increase the amount of Lotronex in your body, which could increase its actions and side effects.

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

Before starting fluvoxamine maleate tablets, tell your healthcare provider if you:

• Are taking certain drugs such as: Monoamine oxidase inhibitors (MAOIs) such as Emsam*®**** (selegiline), Nardil****®**** (phenelzine), or Parnate****®**** (tranylcypromine)** Mellaril*®**** (thioridazine): used to treat mental or mood problems** Zanaflex*®**** (tizanidine): used to treat spasticity (a condition in which muscles keep tightening and cramping)** Orap*®**** (pimozide): used to treat Tourette Syndrome (a brain condition causing tics)** Lotronex*®**** (alosetron): used to treat a condition with diarrhea, continuing stomach pain, cramps, and bloating**

• Triptans: used to treat migraine headache

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

• Tramadol, fentanyl, meperidine, methadone, or other opioids

• Benzodiazepines: used to reduce anxiety, stress, emotional upset, or seizures; helps you sleep; helps with alcohol withdrawal; reduces restlessness; and relaxes muscles

• Clozapine: used to treat mental disorders

• Mexiletine: used to treat abnormalities in heart rhythm

• Theophylline: used to treat swollen air passages in your lungs, to relax the muscles in your chest to ease shortness of breath, often to treat asthma

• Warfarin and other drugs that affect how your blood clots

• Diuretics to treat high blood pressure, congestive heart failure, or swelling

• Over-the-counter supplements such as tryptophan or St. John’s Wort

• 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. Talk to your healthcare provider about the risk to your unborn baby if you take Fluvoxamine Maleate Tablets.

• Talk to your healthcare provider about the benefits and risks of treating OCD during pregnancy.

• If you become pregnant during treatment with Fluvoxamine Maleate Tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-­844-405-6185.

• are breast-feeding or plan to breast-feed. Some fluvoxamine maleate tablets may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking fluvoxamine maleate tablets.

**Tell your healthcare provider about all the medicines that you take, **including prescription and non-prescription medicines, vitamins, and herbal supplements. fluvoxamine maleate tablets 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 fluvoxamine maleate tablets with your other medicines. Do not start or stop any medicine while taking fluvoxamine maleate tablets without talking to your healthcare provider first.

How should I take fluvoxamine maleate tablets?

• Take fluvoxamine maleate tablets exactly as prescribed. Your healthcare provider may need to change the dose of fluvoxamine maleate tablets until it is the right dose for you.
• Fluvoxamine maleate tablets may be taken with or without food.
• If you miss a dose of fluvoxamine maleate tablets, 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 fluvoxamine maleate tablets at the same time.
• If you take too much fluvoxamine maleate tablets, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking fluvoxamine maleate tablets?

Fluvoxamine maleate tablets 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 fluvoxamine maleate tablets affects you. Do not drink alcohol while using fluvoxamine maleate tablets.

What are the possible side effects of fluvoxamine maleate tablets?

Fluvoxamine maleate tablets may cause serious side effects, including:

• See “What is the most important information I should know about fluvoxamine maleate tablets?” *Feeling anxious or trouble sleeping

Common possible side effects in people who take fluvoxamine maleate Tablets include:

• nausea
• sleepiness
• weakness
• indigestion
• sweating
• loss of appetite
• shaking
• vomiting
• delayed ejaculation
• inability to have an orgasm
• decreased sex drive
• dry mouth
• stuffy nose
• unusual taste
• frequent urination

Other side effects in children and adolescents include:

• agitation or abnormal increase in activity
• feeling depressed or sad
• excessive gas
• heavy menstrual periods
• rash
• possible slowed growth rate and weight change.

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 fluvoxamine maleate tablets. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO APOTEX AT 1-800-706-5575 OR FDA AT 1-800-FDA-1088.

How should I store fluvoxamine maleate tablets?

Store fluvoxamine maleate tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

• Keep Fluvoxamine Maleate Tablets away from high humidity.
• Keep Fluvoxamine Maleate Tablets in a tight, light-resistant container.

Keep fluvoxamine maleate tablets and all medicines out of the reach of children.

General information about fluvoxamine maleate Tablets

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

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

For more information about Fluvoxamine Maleate Tablets call toll free at 1-800-706-5575 or go to www.apotex.com

What are the ingredients in fluvoxamine maleate tablets?

Active ingredient: Fluvoxamine maleate

Inactive ingredients:
hydroxyethyl cellulose (25 mg and 50 mg), hydroxypropyl cellulose (100 mg), hypromellose (100 mg), iron oxide black (100 mg), iron oxide red (100 mg), iron oxide yellow (50 mg and 100 mg), magnesium stearate, mannitol, polyethylene glycol and titanium dioxide.

All registered trademarks in this document are the property of their respective owners.

APOTEX INC.

FLUVOXAMINE MALEATE TABLETS, USP

25 mg, 50 mg and 100 mg

Revised: February 2024

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

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

Fluvoxamine maleate tablets, USP are available in the following strengths, colors, imprints, and presentations:****

Tablets 25 mg: White to off-white, round, unscored, film coated tablets, engraved “APO” on one side and “F25” on the other side.

Bottles of 100...........................................................................NDC 60505-0164-1

Tablets 50 mg: Golden, round, scored, film coated tablets, engraved “APO” on one side and “F50” with a partial bisect on the other side.

Bottles of 100...........................................................................NDC 60505-0165-1

Tablets 100 mg: Reddish-brown, pillow shaped, scored, film coated tablets, engraved “APO” on one side and “FLU” bisect “100” on the other side.

Bottles of 100...........................................................................NDC 60505-0166-1

Keep out of reach of children.****

Fluvoxamine maleate tablets, USP should be protected from high humidity and stored at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container.

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