In the U.S.—

In Canada—

• Antiobsessional agent
• antidepressant

Fluvoxamine (floo-VOX-a-meen ) is used to treat obsessive-compulsive disorder.

This medicine may also be used for other conditions as determined by your doctor.

Fluvoxamine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluvoxamine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fluvoxamine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Fluvoxamine has not been studied in pregnant women. However, studies in animals have shown that fluvoxamine may cause lower survival rates in offspring when given to the mother in doses less than the maximum recommended human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Fluvoxamine passes into breast milk. However, the effects of this medicine in nursing babies are not known.

Children—This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. Because fluvoxamine may cause weight loss or a decrease in appetite, children who will be taking fluvoxamine for a long time should have their weight and growth measured by the doctor regularly.

Fluvoxamine must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure fluvoxamine is safe and effective in children.

Older adults—Fluvoxamine has been tested in a limited number of older adults and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, fluvoxamine may be removed from the body more slowly in older adults and an older adult may receive a lower dose than a younger adult.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluvoxamine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alprazolam (e.g., Xanax) or
• Bromazepam (e.g., Lectopam) or
• Clozapine (e.g., Clozaril) or
• Metoprolol (e.g., Lopressor) or
• Midazolam (e.g., Versed) or
• Propranolol (e.g., Inderal) or
• Theophylline (e.g., Theo-Dur) or
• Triazolam (e.g., Halcion) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) or
• Warfarin (e.g., Coumadin)—Higher blood levels of these medicines may occur, causing unwanted effects. Your doctor may want to see you more often if you are taking one of these medicines with fluvoxamine. Your doctor may also change the dose of these medicines or may change you to a different medicine.

• Astemizole (e.g., Hismanal) or
• Cisapride (e.g., Propulsid) or
• Terfenadine (e.g., Seldane)— Do not take any of these medicines while you are taking fluvoxamine or a very serious heart problem may occur.

• Buspirone (e.g., BuSpar) or
• Bromocriptine (e.g., Parlodel) or
• Dexfenfluramine (e.g., Redux) or
• Dextromethorphan (e.g., Robitussin DM) or
• Dihydroergotamine (e.g., D.H.E. 45) or
• Fenfluramine (e.g., Pondimin) or
• Levodopa (e.g., Sinemet) or
• Lithium (e.g., Eskalith) or
• Meperidine (e.g., Demerol) or
• Moclobemide (e.g., Manerex) or
• Nefazodone (e.g., Serzone) or
• Pentazocine (e.g., Talwin) or
• Selective serotonin reuptake inhibitors, other (fluoxetine [e.g., Prozac], paroxetine [e.g., Paxil], sertraline [e.g., Zoloft]) or
• Street drugs (LSD, MDMA [e.g., ecstasy], marijuana) or
• Sumatriptan (e.g., Imitrex) or
• Tramadol (e.g., Ultram) or
• Trazodone (e.g., Desyrel) or
• Tryptophan or
• Venlafaxine (e.g., Effexor)—Using these medicines with fluvoxamine may increase the chance of developing a rare, but very serious, unwanted effect known as the serotonin syndrome. Symptoms of this syndrome include agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching. If you develop these symptoms (usually three or more occur together) check with your doctor as soon as possible

• Diazepam (e.g., Valium)—Higher blood levels of diazepam may occur, causing unwanted effects. Taking diazepam while you are taking fluvoxamine is not recommended

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Do not take fluvoxamine while you are taking or within 2 weeks of taking an MAO inhibitor, or you may develop agitation, coma, severe muscle stiffness, sudden high body temperature, or extremely high blood pressure. At least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other

• Brain disease or mental retardation or
• Seizures, history of—The risk of seizures may be increased

• Liver disease—Higher blood levels of fluvoxamine may occur, increasing the chance of side effects

• Mania or hypomania, history of—The condition may be activated

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Fluvoxamine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are taking fluvoxamine for obsessive-compulsive disorder, you may have to take it for up to 10 or 12 weeks before you begin to feel better. Your doctor should check your progress at regular visits during this time.

Dosing—

The dose of fluvoxamine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fluvoxamine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage form (tablets):
  • For treatment of obsessive-compulsive disorder:
    • Adults—At first, 50 milligrams (mg) once a day at bedtime. Your doctor may increase your dose if needed. However, the dose usually is not more than 300 mg a day. If your daily dose is higher than 100 mg, your doctor may want you to take it in two divided doses.
    • Children younger than 8 years of age—Use and dose must be determined by your doctor.
    • Children 8 to 17 years of age—At first, 25 mg once a day at bedtime. Your doctor may increase your dose if needed. However, the dose usually is not more than 200 mg a day. If your daily dose is higher than 50 mg, your doctor may want you to take it in two divided doses.

Missed dose—

If you miss a dose of fluvoxamine and your dosing schedule is:

• One time a day—Take the missed dose as soon as possible if remembered the same day and go back to your regular dosing schedule. Do not double doses.
• Two times a day—Skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects.

Do not take astemizole, cisapride, or terfenadine while you are taking fluvoxamine. If you do, you may develop a very serious heart problem.

Do not take fluvoxamine if you have taken a monoamine oxidase (MAO) inhibitor in the past 14 days. Do not start taking an MAO inhibitor within 14 days of stopping fluvoxamine. If you do, you may develop agitation, coma, extreme muscle stiffness, sudden high body temperature, or other severe unwanted effects.

Avoid drinking alcohol while taking fluvoxamine.

Check with your doctor as soon as possible if you develop a skin rash, hives, or itching while you are taking fluvoxamine.

Fluvoxamine may cause some people to become drowsy or less able to think clearly, or to have blurred vision or poor muscle control. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, able to see clearly, or able to control your movements well.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This is to decrease the chance of having discontinuation symptoms.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Change in sexual performance or desire 
  
  

• Less common
  • Behavior, mood, or mental changes;  trouble in breathing;  trouble in urinating;  twitching 
  
  

• Rare
  • Absence of or decrease in body movements;  blurred vision;  clumsiness or unsteadiness;  convulsions (seizures);  inability to move eyes;  increase in body movements;  menstrual changes;  nose bleeds;  red or irritated eyes;  redness, tenderness, itching, burning or peeling of skin;  skin rash;  sore throat, fever, and chills;  unusual bruising;  unusual, incomplete, or sudden body or facial movements;  unusual secretion of milk, in females ;  weakness 
  
  

• Rare--Symptoms of serotonin syndrome (usually three or more occur together)
  • Agitation;  confusion;  diarrhea;  fever;  overactive reflexes;  poor coordination;  restlessness;  shivering;  sweating;  talking or acting with excitement you cannot control;  trembling or shaking;  twitching 
  
  

• Symptoms of overdose--may be more severe than usual side effects, or two or more may occur together
  • Coma;  convulsions (seizures);  diarrhea;  dizziness;  drowsiness;  dryness of mouth;  fast or slow heartbeat ;  large pupils;  low blood pressure;  nausea;  trembling or shaking;  trouble in urinating;  twitching;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Constipation;  dizziness;  drowsiness;  headache;  nausea;  trouble in sleeping;  unusual tiredness;  vomiting 
  
  

• Less common
  • Abdominal pain;  change in sense of taste ;  decreased appetite;  diarrhea ;  dryness of mouth;  feeling of constant movement of self or surroundings;  feeling of fast or irregular heartbeat;  frequent urination ;  heartburn;  increased sweating ;  trembling or shaking;  unusual weight gain or loss 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Confusion;  decreased energy;  dizziness;  headache;  irritability;  nausea;  problems with memory;  weakness 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, fluvoxamine is used in certain patients with the following medical condition:

• Mental depression

If you are taking fluvoxamine for mental depression, you may have to take it for 3 weeks or longer before you begin to feel better . Your doctor should check your progress at regular visits during this time.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.