eg; is a registered trademark of GlaxoSmithKline.
LUVOX CR® is a registered trademark of Abbott Products, Inc.
Distributed by:
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304
Protected by US Patent Number 7,465,462 B1
LCR-PI Rev 0714
© 2014 Jazz Pharmaceuticals, Inc.
17.11 FDA-Approved Medication Guide
Medication Guide
LUVOX CR® (LOO Vox CR)
(Fluvoxamine Maleate) Extended-Release Capsules
Read the Medication Guide that comes with LUVOX CR Capsules 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 to 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 LUVOX CR Capsules?
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 Capsules 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 Capsules 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: LUVOX |
