17.12 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:

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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.

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Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

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Watch for these changes and call your healthcare provider right away if you notice:

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New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

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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:

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attempts to commit suicide

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acting on dangerous impulses

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acting aggressive or violent

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thoughts about suicide or dying

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new or worse depression

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new or worse anxiety or panic attacks

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feeling agitated, restless, angry or irritable

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trouble sleeping

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an increase in activity or talking more than what is normal for you

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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:

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agitation, hallucinations, coma or other changes in mental status

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coordination problems or muscle twitching (overactive reflexes)

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racing heartbeat, high or low blood pressure

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sweating or fever

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nausea, vomiting, or diarrhea

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muscle rigidity

3. Visual Problems

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eye pain

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changes in vision

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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:

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trouble breathing

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swelling of the face, tongue, eyes, or mouth

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rash, itchy welts (hives) or blisters, alone or with fever or joint pain

5. Abnormal bleeding: LUVOX CR Capsules 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.

6. Seizures or convulsions

7. Manic episodes:

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greatly increased energy

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severe trouble sleeping

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racing thoughts

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reckless behavior

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unusually grand ideas

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excessive happiness or irritability

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talking more or faster than usual

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

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

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headache

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weakness or feeling unsteady

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confusion, problems concentrating or thinking, or memory problems

Do not stop taking LUVOX CR Capsules without first talking to your healthcare provider. Stopping LUVOX CR Capsules may cause serious symptoms, including:

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anxiety, irritability, high or low mood, feeling restless or changes in sleep habits

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headache, sweating, nausea, dizziness

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electric shock-like sensations, shaking, confusion

What is LUVOX CR Capsules?

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.

Who should not take LUVOX CR Capsules?

Do not take LUVOX CR Capsules if you:

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are allergic to fluvoxamine maleate or any of the ingredients in LUVOX CR Capsules. See the end of this Medication Guide for a complete list of ingredients in LUVOX CR Capsules.

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take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.

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Do not take an MAOI within 2 weeks of stopping LUVOX CR Capsules unless directed to do so by your physician.

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Do not start LUVOX CR Capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

 

People who take LUVOX CR Capsules 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:

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high fever

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uncontrolled muscle spasms

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stiff muscles

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rapid changes in heart rate or blood pressure

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confusion

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loss of consciousness (pass out)

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take Mellaril® (thioridazine). Mellaril® should not be taken with LUVOX CR Capsules because this can cause serious heart rhythm problems or sudden death.

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take 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.

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take the antipsychotic medicine Orap® (pimozide) because this can cause serious heart problems.

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Take Lotronex® (alosetron) because LUVOX CR can increase the amount of Lotronex in your body, which could increase its actions and side effects.

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take Rozerem® (ramelteon) because LUVOX CR can increase the amount of Rozerem in your body, which could increase its actions and side effects.

What should I tell my healthcare provider before taking LUVOX CR Capsules? Ask if you are not sure.

Before starting LUVOX CR Capsules, tell your healthcare provider if you:

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are taking certain drugs such as:

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Clozaril® (clozapine): used to treat schizophrenia

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Mexitil® (mexiletine): used to treat problems with heart rhythm

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Triptans: used to treat migraine headache

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Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, or antipsychotics

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Tramadol: used to reduce pain

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Benzodiazepines: used to reduce anxiety, stress, emotional upset, or seizures; helps you sleep; helps with alcohol withdrawal; reduces restlessness; and relaxes muscles

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Methadone: used to relieve pain or to help with addiction

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Theophylline used to treat swollen air passages in your lungs, to relax the muscles in your chest to ease shortness of breath, often to treat asthma

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Warfarin and other drugs that affect how your blood clots

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Diuretics to treat high blood pressure, congestive heart failure, or swelling

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Over-the-counter supplements such as tryptophan or St. John's Wort

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have liver problems

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have kidney problems

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have heart problems

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have or had seizures or convulsions

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have bipolar disorder or mania

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have low sodium levels in your blood

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have a history of a stroke

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have high blood pressure

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have or had bleeding problems

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are pregnant or plan to become pregnant. It is not known if LUVOX CR Capsules will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating obsessive compulsive disorder (OCD) during pregnancy

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are breast-feeding or plan to breast-feed. Some LUVOX CR may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking LUVOX CR Capsules.

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

If you take LUVOX CR Capsules, you should not take any other medicines that contain fluvoxamine maleate including: Fluvoxamine Maleate Immediate-Release Tablets.

How should I take LUVOX CR Capsules?

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Take LUVOX CR Capsules at night exactly as prescribed. Your healthcare provider may need to change the dose of LUVOX CR Capsules until it is the right dose for you.

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LUVOX CR Capsules may be taken with or without food.

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If you miss a dose of LUVOX CR Capsules, 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 LUVOX CR Capsules at the same time.

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If you take too much LUVOX CR, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking LUVOX CR Capsules?

LUVOX CR Capsules 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 LUVOX CR Capsules affect you. Do not drink alcohol while using LUVOX CR Capsules.

What are the possible side effects of LUVOX CR Capsules?

LUVOX CR may cause serious side effects, including all of those described in the section entitled "What is the most important information I should know about LUVOX CR?"

Common possible side effects in people who take fluvoxamine include:

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Nausea

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Sleepiness

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Weakness

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Dizziness

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Feeling anxious

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Trouble sleeping

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Sexual problems

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Sweating

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Shaking

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Not feeling hungry

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Dry mouth

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Diarrhea

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Muscle pain

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Sore throat

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Throwing up

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Upset stomach

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Yawning

Other side effects in children and adolescents taking fluvoxamine include:

 

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abnormal increase in muscle movement or agitation

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depression

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heavy menstrual periods

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flatulence (gas)

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rash

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 LUVOX CR Capsules. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO FDA AT 1-800-FDA-1088.

How should I store LUVOX CR Capsules?

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Store LUVOX CR Capsules at 59°F to 86°F (15°C to 30°C).

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Keep LUVOX CR Capsules away from high temperatures (above 86°F or 30°C) and high humidity (dampness).

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Keep the LUVOX CR Capsules bottle closed tightly.

Keep LUVOX CR Capsules and all medicines out of the reach of children.

General information about LUVOX CR Capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LUVOX CR Capsules for a condition for which it was not prescribed. Do not give LUVOX CR Capsules to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about LUVOX CR Capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about LUVOX CR Capsules that is written for healthcare professionals.

For more information about LUVOX CR Capsules, call 1-800-520-5568.

What are the ingredients in LUVOX CR Capsules?

Active ingredient: fluvoxamine maleate
Inactive ingredients:

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Extended-Release Capsules: ammonio methacrylate copolymer type B, dibutyl sebacate, colorants (FD&C Blue No. 2, Opacode Grey, red iron oxide, titanium dioxide), gelatin (porcine- or bovine-derived), sugar spheres, and talc. LUVOX CR Capsules are gluten-free.

Distributed by Jazz Pharmaceuticals, Inc. Palo Alto CA 94304

Revised 01/2017

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

LUVOX CR® is a registered trademark of Abbott Products, Inc.

LCR-MG Rev 01/2017