• Important Safety Information
• Prescribing Information
• Medication Guide

What is LUVOX CR?

LUVOX CR Capsules is a prescription medicine used to treat obsessive compulsive disorder (OCD). It is the same kind of drug that is used to treat depression. 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 LUVOX CR treatment.

What is the most important information I should know about LUVOX CR?

LUVOX CR is the same kind of medicine as those used to treat depression. These medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

• LUVOX CR and other 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 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.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 in 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

Call your healthcare provider right away if you have any of the following symptoms, or call 911 in an emergency. LUVOX CR 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. 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

4. Abnormal bleeding: LUVOX CR and other 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 (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Seizures or convulsions

6. 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

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:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking, or memory problems

Do not stop taking LUVOX CR without first talking to your healthcare provider.
Stopping LUVOX CR 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

WHO SHOULD NOT TAKE LUVOX CR?

Do not take LUVOX CR if you:

• Are allergic to fluvoxamine maleate or any of the ingredients in LUVOX CR (see the end of the Medication Guide in the full Prescribing Information for a complete list of ingredients in LUVOX CR).
• Take a monoamine oxidase inhibitor (MAOI). Do not take an MAOI within 2 weeks of stopping LUVOX CR unless directed to do so by your physician. Do not start LUVOX CR if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
• Take any of the following: Mellaril® (thioridazine), Zanaflex® (tizanidine), Orap® (pimozide), Lotronex® (alosetron), Rozerem® (ramelteon). Please see Medication Guide.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herb supplements. LUVOX CR 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 LUVOX CR with your other medicines. Do not start or stop any medicine while taking LUVOX CR without talking to your healthcare provider first.

WHAT ARE THE COMMON SIDE EFFECTS WITH LUVOX CR?

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.

Other side effects in children and adolescents taking LUVOX CR were abnormal increase in muscle movement and agitation, depression, heavy menstrual periods, flatulence (gas) and rash.

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