FLUVOXAMINE MALEATE- fluvoxamine maleate tablet, film coated 
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MEDICATION GUIDE

Fluvoxamine (Flu VOX ah meen) Maleate 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:

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:

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 or Neuroleptic Malignant Syndrome-like reactions. 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®), a non-steroidal anti-inflammatory drug (NSAID’s, 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 healthcase provider.

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

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:

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:

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.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 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 Sandoz Inc. at 1-800-525-8747 or go to www.us.sandoz.com

What are the ingredients in Fluvoxamine Maleate Tablets?

Active ingredient: Fluvoxamine maleate

Inactive ingredients: carnauba wax, corn starch, hypromellose, magnesium stearate, mannitol, methylcellulose, polyethylene glycol, polysorbate, pregelatinized starch, sodium starch glycolate, titanium dioxide and yellow iron oxide.

The 100 mg tablets also contain red iron oxide.

Sandoz Inc.

Princeton, NJ 08540

OS8653

Rev. 07/11

MF0157REV07/11

MG #24851

Revised: 01/2013
 
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