FLUVOXAMINE MALEATE- fluvoxamine maleate tablet, film coated 
Upsher-Smith Laboratories, LLC

----------

MEDICATION GUIDE

Fluvoxamine (Flu-VOX-ah-meen) Maleate Tablets, USP

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 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 fluvoxamine maleate tablets are 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

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

Stopping fluvoxamine maleate tablets too quickly may cause serious symptoms including:

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:

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:

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:

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:

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.

If you take fluvoxamine maleate tablets, you should not take any other medicines that contain fluvoxamine including: LUVOX CR®

How should I take fluvoxamine maleate tablets?

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 affect 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:

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

Other side effects in children and adolescents include:

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 FDA at 1-800-FDA-1088.

How should I store fluvoxamine maleate tablets?

Store fluvoxamine maleate tablets at room temperature between 20° to 25°C (68° to 77°F).

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 Upsher-Smith Laboratories, LLC at 1-888-650-3789 or go to www.upsher-smith.com

What are the ingredients in fluvoxamine maleate tablets?

Active ingredient: fluvoxamine maleate

Inactive ingredients: carnauba wax, corn starch, magnesium stearate, mannitol, methylcellulose, pregelatinized starch (corn) and sodium starch glycolate (potato). The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. The 100 mg tablets also contain red iron oxide.

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

All trademarks are property of their respective owners.

For Medication Guides, please visit www.upsher-smith.com or call 1-888-650-3789.

Manufactured by
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369

Revised: 10/2021

Revised: 11/2021
Upsher-Smith Laboratories, LLC