Http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=50573

These highlights do not include all the information needed to use Fluvoxamine Maleate T. Page 1 of 7 Read the Medication Guide that comes with Fluvoxamine Maleate Tablets before you start taking it and each time you get a refil . 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 Fluvoxamine is the same kind of medicine as those used to treat depression and may cause Depression or other serious mental il nesses 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, especial y if severe. Pay particular at ention to such changes when Fluvoxamine Maleate Tablets is Keep all fol ow-up visits with your healthcare provider and call between visits if you are worried at empts 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 http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=50573 These highlights do not include all the information needed to use Fluvoxamine Maleate T. Page 2 of 7 other unusual changes in behavior or mood 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 trouble breathing swel ing of the face, tongue, eyes, or mouth rash, itchy welts (hives) or blisters, alone or with fever or joint pain g Fluvoxamine Maleate Tablets and antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin ® , a non-steroidal anti-inflammatory drug (NSAID’s, like ibuprofen, greatly increased energy severe trouble sleeping racing thoughts reckless behavior unusually grand ideas excessive happiness or irritability talking more or faster than usual h . Children and adolescents should have height and weight d Elderly people may be at greater risk for this. http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=50573 These highlights do not include all the information needed to use Fluvoxamine Maleate T. Page 3 of 7 weakness or feeling unsteady confusion, problems concentrating or thinking or memory problems Stopping Fluvoxamine Maleate Tablets too quickly 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 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 al treatment choices with your healthcare provider. Talk to your healthcare provider if you do not think that your condition is get ing bet er with Fluvoxamine Maleate Tablets treatment. Wh Do not take Fluvoxamine Maleate Tablets if you: are al ergic to fluvoxamine maleate or any of the ingredients in Fluvoxamine Maleate Tablets. See the end of this Medication Guide for a complete list of ingredients in Fluvoxamine Maleate Tablets. 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. Do not take an MAOI within 2 weeks of stopping Fluvoxamine Maleate Tablets. Do not start Fluvoxamine Maleate Tablets if you stopped taking an MAOI in the last high fever uncontrolled muscle spasms stif muscles rapid changes in heart rate or blood pressure confusion loss of consciousness (pass out) http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=50573 These highlights do not include all the information needed to use Fluvoxamine Maleate T. Page 4 of 7 e .) Fluvoxamine maleate tablets could increase the amount of Zanaflex in your body, which could increase its actions and side effects. This could include drowsiness and a drop in blood pressure and affecting how wel you do things n . Fluvoxamine maleate tablets may increase the amount of Lotronex in your body, which could increase its actions and side effects. Before starting Fluvoxamine Maleate Tablets, tel your healthcare provider if you: Triptans: used to treat migraine headache Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, or antipsychotics Tramadol: used to reduce pain Benzodiazepines: used to reduce anxiety, stress, emotional upset, or seizures; helps you sleep; helps with alcohol withdrawal; reduces restlessness; and relaxes muscles Methadone: used to relieve pain or to help with addiction Clozapine: used to treat mental disorders. Mexiletine: used to treat abnormalities in heart rhythm. Theophylline used to treat swol en air passages in your lungs, to relax the muscles in your chest to ease shortness of breath, often to treat asthma Warfarin and other drugs that affect how your blood clots Diuretics to treat high blood pressure, congestive heart failure, or swelling http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=50573 These highlights do not include all the information needed to use Fluvoxamine Maleate T. Page 5 of 7 Over-the-counter supplements such as tryptophan or St. John’s Wort have liver problems have kidney problems have heart problems have or had seizures or convulsions have bipolar disorder or mania have low sodium levels in your blood have a history of a stroke have high blood pressure have or had bleeding problems are pregnant or plan to become pregnant. It is not known if Fluvoxamine Maleate Tablets wil harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating OCD during pregnancy. are breast-feeding or plan to breast-feed. Some Fluvoxamine Maleate Tablets may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Fluvoxamine Maleate Tablets. 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 ef ects. 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® 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. http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=50573 These highlights do not include all the information needed to use Fluvoxamine Maleate T. Page 6 of 7 Fluvoxamine Maleate Tablets can cause sleepiness or may af ect 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. Wh Fluvoxamine Maleate Tablets may cause serious side ef ects, including: See “What is the most important information I should know about Fluvoxamine Maleate 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 ef ects 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. Tel your healthcare provider if you have any side ef ect that bothers you or that does not go away. These are not al the possible side effects of Fluvoxamine Maleate Tablets. For more information, ask your healthcare provider or pharmacist. http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=50573 These highlights do not include all the information needed to use Fluvoxamine Maleate T. Page 7 of 7 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. 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 writ en for healthcare professionals. For more information about Fluvoxamine Maleate Tablets call Sandoz Inc. at 1-800-525-8747 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: 08/2011 http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=50573

Source: http://www.clinicalpharmacology.com/Medguides/fluvoxaminesandoz201108.pdf