Brand Name(s):

• Luvox®
• Luvox®CR

IMPORTANT WARNING

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as fluvoxamine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant.

You should know that your mental health may change in unexpected ways when you take fluvoxamine or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking fluvoxamine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

WHY is this medicine prescribed?

Fluvoxamine is used to treat obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over) and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). Fluvoxamine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

HOW should this medicine be used?

Fluvoxamine comes as a tablet and an extended-release capsule to take by mouth. The tablet usually is taken either once daily at bedtime or twice daily, once in the morning and once at bedtime. The extended-release capsule usually is taken, with or without food , once daily at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluvoxamine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release capsules whole; do not be crush or chew them.

Your doctor may start you on a low dose of fluvoxamine and gradually increase your dose, not more often than once every week, depending on how well the medication works for you and the side effects you experience.

It may take several weeks or longer for you to feel the full benefit of fluvoxamine. Continue to take fluvoxamine even if you feel well. Do not stop taking fluvoxamine without talking to your doctor. If you suddenly stop taking fluvoxamine, you may experience withdrawal symptoms such as irritability; agitation; dizziness; extreme worry; uneasiness; confusion; headache; tiredness; mood changes; difficulty falling asleep or staying asleep; or pain, burning, numbness, tingling or 'electric shock' sensations in the hands or feet. Your doctor probably will decrease your dose gradually.

Are there OTHER USES for this medicine?

Fluvoxamine is also used sometimes to treat depression. Talk with your doctor about the possible risks of using this medication for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking fluvoxamine,

• tell your doctor and pharmacist if you are allergic to fluvoxamine, any other medications, or any of the ingredients in fluvoxamine tablets and extended-release capsules. Ask your doctor or pharmacist for a list of the ingredients..
• tell your doctor if you are taking alosetron (Lotronex), astemizole (Hismanal) (not available in the U.S.), cisapride (Propulsid) (not available in the U.S.), pimozide (Orap), ramelteon (Rozerem), terfenadine (Seldane) (not available in the US), tizanidine (Zanaflex), or thioridazine. Your doctor will probably tell you not to take fluvoxamine.
• tell your doctor if you are taking the following medications or if you have stopped taking them within the past 14 days: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue; phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor will probably tell you not to take fluvoxamine. If you stop taking fluvoxamine, you should wait at least 14 days before you start to take an MAO inhibitor.
• tell your doctor and pharmacist what prescription and nonprescription medications, and vitamins you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin or aspirin-containing products and other nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); beta-blockers such as metoprolol (Lopressor, Toprol) and propranolol (Inderal, in Inderide); buspirone (BuSpar); carbamazepine (Tegretol); clopidogrel (Plavix), clozapine (Clozaril); cyclosporine (Neoral, Sandimmune); dextromethorphan (in cough medications); diazepam (Valium); diltiazem (Cardizem); diuretics ('water pills'); fentanyl (Abstral, Actiq, Fentora, Onsolis, others); haloperidol (Haldol); ketoconazole (Nizoral); lithium; medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); methadone (Dolophine, Methadose); mexiletine (Mexitil); metoclopramide; midazolam (Versed); omeprazole (Prilosec, Zegerid); other medications for anxiety, depression, or mental illness; phenytoin (Dilantin);sibutramine (Meridia); tacrine (Cognex); theophylline (Theo-Dur); tramadol (Ultram, in Ultracet); triazolam (Halcion); and quinidine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products and nutritional supplements you are taking, especially products that contain St. John's wort and tryptophan.
• tell your doctor if you drink or have ever drunk large amounts of alcohol or have used street drugs or have overused prescription medications. Also tell your doctor if you have or have ever had seizures, or heart, kidney, adrenal, or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking fluvoxamine, call your doctor. Fluvoxamine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking fluvoxamine.
• you should know that this medication may make you drowsy or affect your judgment, thinking, or motor skills. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication. You should not drink alcohol while taking fluvoxamine.
• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• enlarged pupils (black circle in center of eye)
• unsteadiness
• dizziness
• drowsiness
• nausea
• vomiting
• diarrhea
• difficulty breathing
• changes in heartbeat
• shaking of a part of the body that you cannot control
• seizure
• changes in alertness
• loss of consciousness

What OTHER INFORMATION should I know?

It is important to keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to fluvoxamine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2013.