Important Safety Information

Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of obsessive compulsive disorder (OCD).

Suicidality and Antidepressant Medications

LUVOX CR Capsules and other antidepressant medicines may increase suicidal thoughts and actions in some children, teenagers, and young adults within the first few months of treatment or when the dose is changed.

Depression and other serious mental illnesses are the most important causes of suicidal thoughts and 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 LUVOX CR 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.

Please see the Medication Guide on this website for additional information on the risk of suicidal thoughts or actions.

WHO SHOULD NOT TAKE LUVOX CR?

Do not take LUVOX CR Capsules if you:

• Are allergic to fluvoxamine maleate or any of the ingredients in LUVOX CR Capsules (see the end of the Medication Guide in the full Prescribing Information for a complete list of ingredients in LUVOX CR Capsules).
• Take a monoamine oxidase inhibitor (MAOI). Do not take an MAOI within 2 weeks of stopping LUVOX CR Capsules and do not start LUVOX CR Capsules if you stopped taking an MAOI in the last 14 days (2 weeks). People who take LUVOX CR Capsules close in time to an MAOI may have serious, 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, or loss of consciousness (pass out).
• Take any of the following:
  • Mellaril^® (thioridazine). Mellaril^® should not be taken with LUVOX CR Capsules because this can cause serious heart rhythm problems or sudden death
  • Zanaflex^® (tizanidine) because LUVOX CR can increase the amount of Zanaflex in your body, which could increase its actions and side effects. This could include causing drowsiness and a drop in blood pressure and affecting how well you do things that require alertness.
  • The antipsychotic medicine Orap^® (pimozide) because this can cause serious heart problems
  • Lotronex^® (alosetron) because LUVOX CR can increase the amount of Lotronex in your body, which could increase its actions and side effects.
  • Rozerem^® (ramelteon) because LUVOX CR can increase the amount of Rozerem in your body, which could increase its actions and side effects.

Talk to your doctor if you have any questions.

Always talk with your doctor and pharmacist about any medicines you are taking, including herbal remedies and over-the-counter medicines, for example, aspirin and ibuprofen.

Side Effects

LUVOX CR may cause side effects. In studies, common side effects were nausea, sleepiness, weakness, dizziness, feeling anxious, trouble sleeping, sexual problems, sweating, shaking, not feeling hungry, dry mouth, diarrhea, muscle pain, sore throat, throwing up, upset stomach and yawning. These effects were seen in at least 5% of patients on LUVOX CR and reported twice as often with LUVOX CR as with a sugar pill. In studies, 19% (or nearly one-fifth) of 124 patients with OCD and 26% (more than one-quarter) of 279 patients with another illness left the study early because of side effects.

We encourage you to discuss side effects and any questions regarding LUVOX CR with your doctor.

What should I tell my healthcare provider before taking LUVOX CR?

You should tell your healthcare provider about all of your medical conditions (See Medication Guide on this website), whether you are pregnant, planning to become pregnant or are breastfeeding. Also to avoid a serious and potentially life-threatening condition, tell your healthcare provider if you are taking any of the following:

• Other SSRIs or SNRIs, certain migraine or headache medications (triptans)
• NSAID pain relievers, aspirin, warfarin, or blood thinners

Do not stop taking LUVOX CR abruptly without first discussing it with your healthcare provider.

LUVOX CR is a registered trademark of Abbott Products, Inc.
CT STEPS is a registered trademark of Jazz Pharmaceuticals, Inc.
SODAS^® is a registered trademark of Elan Pharma International Ltd. (EPIL). US Patent no 7,465,462.