Uses of Fluvoxamine Extended-Release Capsules:

• It is used to treat obsessive-compulsive problems.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Fluvoxamine Extended-Release Capsules?

• If you are allergic to this medicine (fluvoxamine extended-release capsules); any part of this medicine (fluvoxamine extended-release capsules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have seizures.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Alosetron, pimozide, ramelteon, thioridazine, or tizanidine.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.

This is not a list of all drugs or health problems that interact with this medicine (fluvoxamine extended-release capsules).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (fluvoxamine extended-release capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Fluvoxamine Extended-Release Capsules?

• Tell all of your health care providers that you take this medicine (fluvoxamine extended-release capsules). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (fluvoxamine extended-release capsules) affects you.
• Do not stop taking this medicine (fluvoxamine extended-release capsules) all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine (fluvoxamine extended-release capsules), you will want to slowly stop it as ordered by your doctor.
• If you smoke, talk with your doctor.
• Avoid drinking alcohol while taking this medicine (fluvoxamine extended-release capsules).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• This medicine may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
• Some people may have a higher chance of eye problems with this medicine (fluvoxamine extended-release capsules). Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
• It may take several weeks to see the full effects.
• This medicine can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death.
• If you are 65 or older, use this medicine (fluvoxamine extended-release capsules) with care. You could have more side effects.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• Taking this medicine (fluvoxamine extended-release capsules) in the third trimester of pregnancy may lead to some health problems in the newborn. Talk with the doctor.

How is this medicine (Fluvoxamine Extended-Release Capsules) best taken?

Use this medicine (fluvoxamine extended-release capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take at bedtime if you are taking once a day.
• Swallow whole. Do not chew, open, or crush.
• Keep taking this medicine (fluvoxamine extended-release capsules) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• A big weight gain or loss.
• Passing urine more often.
• Sex problems like lowered interest in sex or ejaculation problems.
• Erection that lasts more than 4 hours.
• Seizures.
• Period (menstrual) changes.
• A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.

What are some other side effects of Fluvoxamine Extended-Release Capsules?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Dry mouth.
• Trouble sleeping.
• Headache.
• Gas.
• Change in taste.
• Feeling nervous and excitable.
• Sweating a lot.
• Shakiness.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Fluvoxamine Extended-Release Capsules?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (fluvoxamine extended-release capsules) is refilled. If you have any questions about this medicine (fluvoxamine extended-release capsules), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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