FLUVOXAMINE MALEATE- fluvoxamine maleate tablet, film coated 
Barr Laboratories Inc.

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MEDICATION GUIDE

Fluvoxamine (Flu-VOX-ah-meen)

Maleate (mal-ee-eyt)

Tablets USP

Read the Medication Guide that comes with fluvoxamine maleate tablets before you start taking them 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:

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:

3. Severe allergic reactions:

4. 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).

5. Seizures or convulsions

6. Manic episodes:

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

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

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:

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:

Tell your healthcare provider about all the medicines that you take, including prescription and nonprescription 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 many 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 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:

  • 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 TEVA USA, MEDICAL AFFAIRS AT
1-866-832-8537 or 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 away from high humidity.
  • Keep fluvoxamine maleate tablets bottle closed tightly.

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 they were not prescribed. Do not give fluvoxamine maleate tablets to other people, even if they have the same condition. They 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 1-866-832-8537, MEDICAL AFFAIRS

What are the ingredients in fluvoxamine maleate tablets?

Active ingredient: fluvoxamine maleate, USP.

Inactive ingredients: corn starch, hypromellose, mannitol, methylcellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, silicon dioxide, sodium stearyl fumarate and titanium dioxide.

The 25 mg also contains FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.

The 50 mg also contains D&C yellow no. 10 aluminum lake and FD&C yellow no. 6 aluminum lake.

The 100 mg also contains synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

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

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. C 2/2013

Revised: 10/2013
 
Barr Laboratories Inc.