Fluvoxamine, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat OCD. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: selective serotonin reuptake inhibitor (SSRI); antidepressant

Generic and brand names: fluvoxamine, oral; Luvox CR

What is this medicine used for?

This medicine is taken by mouth to treat obsessive-compulsive disorder (OCD).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bipolar disorder
• Bleeding problems
• Glaucoma
• Heart disease or a heart attack
• High blood pressure
• Liver or kidney disease
• Low levels of sodium in the blood
• Seizures
• Thoughts of suicide

Do not take this medicine if you have taken an MAO inhibitor antidepressant in the last 2 weeks. You may have serious side effects. Talk with your healthcare provider about this.

Do not take alosetron (Lotronex), pimozide (Orap), ramelteon (Rozerem), thioridazine, or tizanidine (Zanaflex) while taking this medicine.

Tell your healthcare provider if you smoke cigarettes. Smoking may decrease the effectiveness of this medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it longer than prescribed. Taking too much can increase the risk of side effects. Do not stop taking this medicine without your healthcare provider's approval. You may need to reduce your dosage slowly to avoid withdrawal symptoms.

Check with your healthcare provider before using this medicine in children under age 18.

An adult should supervise the use of this medicine by a child.

This medicine comes in the form of immediate-release tablets and controlled-release capsules. You may take this medicine with or without food. Take it at the same time each day. If you have controlled-release capsules, do not open, break, crush, or chew them. Swallow them whole. Ask your pharmacist if you have the controlled-release capsules.

Your healthcare provider will want to see you regularly to check your response to this medicine and to see if your dosage needs to be changed. It may take some time for you to feel better. Do not stop taking the medicine until your healthcare provider tells you to do so. You may have to take this medicine for 4 weeks or more to feel its full effects.

What if I miss a dose?

Do not miss a dose. If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, dizziness, blurred vision, fast or irregular heartbeat, lack of coordination, tremors, trouble breathing, drowsiness, fainting, seizures, coma.

What should I watch out for?

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment or at times of dose changes. Call your healthcare provider right away if you or your family notice:

• New or increased thoughts of suicide
• Changes in thoughts, mood, or behavior such as becoming irritable or anxious
• Worsening of depression
• More outgoing or aggressive behavior than normal

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination
• Stiff muscles
• Fast heart beat
• Rapid changes in blood pressure or dizziness
• Increased body temperature, sweating, or flushing
• Nausea
• Vomiting
• Diarrhea

This medicine may trigger angle-closure glaucoma. Contact your provider right away if you have eye pain, vision changes, or redness and swelling in or around your eye.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may increase the effects of alcohol and interact with many other medicines. Do not drink alcohol or take any other medicine, including nonprescription products or natural remedies, unless your healthcare provider approves.

Occasionally, this medicine can cause some sexual problems. Ask your healthcare provider about this.

This medicine may cause changes in appetite or weight, or affect growth in children. Talk with your healthcare provider about this.

Adults over the age of 65 may be more sensitive to this medicine and may require a different dosage.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Seizures; thoughts of suicide or worsening of your depression; unusual changes in thoughts, mood, or behavior; severe nervousness; trouble breathing; fever; increased sweating; hallucinations; slurred speech; loss of coordination or unsteadiness; stiff muscles or uncontrolled muscle spasms; severe joint or muscle pain; confusion; severe dizziness or fainting; severe or ongoing headache; chest pain; fast, slow, or irregular heartbeat; unusual bruising or bleeding; black or tarry bowel movements; increased or heavy menstrual bleeding; blistering, peeling, or severe skin rash; memory problems or trouble concentrating; severe nausea, vomiting, or diarrhea; eye pain, vision changes, or swelling and redness around your eyes.

Other: Mild headache, loss of appetite, weight loss or gain, drowsiness, stomach pain, heartburn, weakness, nausea, vomiting, shaking, trouble sleeping, mild dizziness, dry mouth, sore throat, muscle pain, cough, runny nose, constipation, sweating, diarrhea, restlessness, rash, itching, change in sex drive or ability, increased yawning; menstrual changes; change in sense of taste.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Alosetron (Lotronex)
• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as ciprofloxacin (Cipro), isoniazid, linezolid (Zyvox), pentamidine (NebuPent, Pentam), ofloxacin, rifampin (Rifadin), and tedizolid (Sivextro)
• Antifungal medicines such as ketoconazole (Nizoral), terbinafine (Lamisil), and voriconazole (Vfend)
• Antihistamines such as brompheniramine, chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimavanserin (Nuplazid), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), and valproic acid (Depacon, Depakene, Depakote)
• Aspirin and other salicylates
• Bromocriptine (Cycloset, Parlodel)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Buspirone
• Cabergoline
• Cancer medicines such as abiraterone (Zytiga), dasatinib (Sprycel), degarelix (Firmagon), erlotinib (Tarceva), nilotinib (Tasigna), pomalidomide (Pomalyst), procarbazine (Matulane), sunitinib (Sutent), and vemurafenib (Zelboraf)
• Cinacalcet (Sensipar)
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and tolbutamide
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Gemfibrozil (Lopid)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), mexiletine, nicardipine (Cardene), propafenone (Rythmol), and quinidine
• HIV medicines such as darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and tipranavir (Aptivus)
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and omeprazole (Prilosec)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• Metoclopramide (Metozolv, Reglan)
• Metoprolol (Lopressor, Toprol)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as alfalfa, anise, bilberry, cat’s claw, garlic, ginger, ginkgo biloba, ginseng, glucosamine, gotu kola, green tea, kava, SAMe, Syrian Rue, St. John's wort, tryptophan, turmeric, and valerian
• Nausea medicines such as dolasetron (Anzemet), droperidol (Inapsine), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rasagiline (Azilect)
• Sleeping pills such as butabarbital (Butisol), phenobarbital, ramelteon (Rozerem), suvorexant (Belsomra), tasimelteon (Hetlioz), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants and diet pills such as dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)
• Theophylline

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.