Fluvoxamine Maleate (Page 10 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 68151-0637

NDC: 68151-0637-1 1 TABLET, COATED in a BLISTER PACK

17 PATIENT COUNSELING INFORMATION

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.

17.1 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 and WARNINGS AND PRECAUTIONS (5.1)].

17.2 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, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) [see WARNINGS AND PRECAUTIONS-Serotonin Syndrome (5.2)].

17.3 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)]

17.4 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.

17.5 Pregnancy

Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy with Fluvoxamine Maleate Tablets [see USE IN SPECIFIC POPULATIONS (8.1)].

17.6 Nursing

Patients receiving Fluvoxamine Maleate Tablets should be advised to notify their physicians if they are breast-feeding an infant. [See USE IN SPECIFIC POPULATIONS — Nursing Mothers (8.3)].

17.7 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-Warfarin and Other Drugs That Interfere With Hemostasis (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 Lotronex^TM (alosetron) [see WARNINGS AND PRECAUTIONS (5.7)].

17.8 Alcohol

As with other psychotropic medications, patients should be advised to avoid alcohol while taking Fluvoxamine Maleate Tablets.

17.9 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.

Lotronex^TM is a registered trademark of GlaxoSmithKline.

Manufactured by

ANI Pharmaceuticals, Inc.

Baudette, MN 56623

9212 Rev 01/17

17.10 FDA-Approved Medication Guide

MEDICATION GUIDE

Fluvoxamine (Flu VOX ah meen) Tablets

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:

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Fluvoxamine Maleate Tablets and 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.

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Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

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Watch for these changes and call your healthcare provider right away if you notice:

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New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

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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:

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attempts to commit suicide

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acting on dangerous impulses

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acting aggressive or violent

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thoughts about suicide or dying

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new or worse depression

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new or worse anxiety or panic attacks

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feeling agitated, restless, angry or irritable

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trouble sleeping

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an increase in activity or talking more than what is normal for you

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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:

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agitation, hallucinations, coma or other changes in mental status

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coordination problems or muscle twitching (overactive reflexes)

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racing heartbeat, high or low blood pressure

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sweating or fever

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nausea, vomiting, or diarrhea

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muscle rigidity

3. Visual problems

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eye pain

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changes in vision

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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:

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trouble breathing

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swelling of the face, tongue, eyes, or mouth

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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:

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greatly increased energy

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severe trouble sleeping

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racing thoughts

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reckless behavior

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unusually grand ideas

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excessive happiness or irritability

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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:

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headache

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weakness or feeling unsteady

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confusion, problems concentrating or thinking or memory problems

Do not stop Fluvoxamine Maleate Tablets without first talking to your healthcare provider.

Stopping Fluvoxamine Maleate Tablets too quickly may cause serious symptoms including:

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anxiety, irritability, high or low mood, feeling restless or changes in sleep habits

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headache, sweating, nausea, dizziness

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electric shock-like sensations, shaking, confusion

What is Fluvoxamine Maleate Tablets?

Fluvoxamine Maleate Tablets is 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:

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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.

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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.

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Do not take an MAOI within 2 weeks of stopping Fluvoxamine Maleate Tablets unless directed to do so by your physician.

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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:

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high fever

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uncontrolled muscle spasms

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stiff muscles

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rapid changes in heart rate or blood pressure

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confusion

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loss of consciousness (pass out)

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take Mellaril^® (thioridazine). Do not take Mellaril^® within 2 weeks of stopping FLUVOXAMINE MALEATE TABLETS because this can cause serious heart rhythm problems or sudden death.

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take Orap^® (pimozide) because taking this drug with fluvoxamine maleate tablets can cause serious heart rhythm problems or sudden death.

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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.

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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:

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Are taking certain drugs such as:

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Monoamine oxidase inhibitors (MAOIs) such as Emsam® (selegiline), Nardil® (phenelzine), or Parnate® (tranylcypromine)

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Mellaril ^® (thioridazine): used to treat mental or mood problems

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Zanaflex^® (tizanidine): used to treat spasticity (a condition in which muscles keep tightening and cramping)

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Orap^® (pimozide): used to treat Tourette Syndrome (a brain condition causing tics)

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Lotronex^® (alosetron): used to treat a condition with diarrhea, continuing stomach pain, cramps, and bloating

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Triptans: used to treat migraine headache

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

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Tramadol: used to reduce pain

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

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Methadone: used to relieve pain or to help with addiction

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Clozapine: used to treat mental disorders

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Mexiletine: used to treat abnormalities in heart rhythm

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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

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Warfarin and other drugs that affect how your blood clots

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

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

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have liver problems

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have kidney problems

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have heart problems

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have or had seizures or convulsions

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have bipolar disorder or mania

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have low sodium levels in your blood

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have a history of a stroke

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have high blood pressure

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have or had bleeding problems

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are pregnant or plan to become pregnant. It is not known if Fluvoxamine Maleate Tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating OCD during pregnancy.

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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?

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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.

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Fluvoxamine Maleate Tablets may be taken with or without food.

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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.

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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:

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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:

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nausea

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sleepiness

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weakness

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indigestion

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sweating

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loss of appetite

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shaking

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vomiting

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delayed ejaculation

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inability to have an orgasm

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decreased sex drive

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dry mouth

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stuffy nose

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unusual taste

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frequent urination

Other side effects in children and adolescents include:

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agitation or abnormal increase in activity

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feeling depressed or sad

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excessive gas

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heavy menstrual periods

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rash

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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.