FLUVOXAMINE MALEATE- fluvoxamine maleate tablet, coated 
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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:

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 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

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 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:

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 stopping FLUVOXAMINE MALEATE TABLETS because 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: used to reduce pain
Benzodiazepines: used to reduce anxiety, stress, emotional upset, or seizures; helps you sleep; helps with alcohol withdrawal; reduces restlessness; and relaxes muscles
Methadone: used to relieve pain or to help with addiction
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. 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.
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.

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?

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.

Revised: 6/2019
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