When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to fluvoxamine.

How to Use This Medicine:
Long Acting Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at bedtime, unless your doctor tells you otherwise.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use fluvoxamine with alosetron, pimozide, ramelteon, thioridazine, or tizanidine. Do not use fluvoxamine and an MAO inhibitor within 14 days of each other.
• Some medicines can affect how fluvoxamine works. Tell your doctor if you are using the following:
  
  • Buspirone, carbamazepine, clozapine, diazepam, fentanyl, lithium, methadone, metoprolol, mexiletine, omeprazole, phenytoin, propranolol, St John's wort, tacrine, theophylline, tramadol, or tryptophan supplements
  • A sedative, other medicine to treat depression, triptan medicine to treat migraine headaches, a diuretic (water pill), an NSAID pain or arthritis medicine (such as aspirin, celecoxib, diclofenac, ibuprofen, naproxen), or a blood thinner (such as warfarin)
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, bleeding problems, glaucoma, epilepsy or seizures, heart disease, or you had a heart attack. Tell your doctor if you smoke.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  
  • Serotonin syndrome (may be life-threatening when used with certain other medicines)
  • Higher risk of bleeding problems
  • Low sodium levels in the blood
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• This medicine may cause decreased appetite and weight loss. Your child's height and weight will be measured to make sure your child is growing properly.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, sweating, muscle spasms, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Confusion, weakness, and muscle twitching
• Eye pain, vision changes, seeing halos around lights
• Fast, pounding, or uneven heartbeat
• Feeling more excited or energetic than usual
• Headache, trouble concentrating, memory problems, unsteadiness
• Seizures
• Unusual behavior, thoughts of hurting yourself or others, panic, trouble sleeping
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Constipation, stomach upset
• Dizziness, unusual drowsiness or sleepiness
• Loss of appetite, weight loss
• Sexual problems

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088