Fluvoxamine Maleate Oral capsule, extended-release

What is this medicine?

FLUVOXAMINE (floo VOX a meen) is an antidepressant. It is used to treat obsessive-compulsive disorder.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bipolar disorder

• glaucoma

• liver disease

• seizures

• suicidal thoughts

• an unusual or allergic reaction to fluvoxamine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alosetron

• cisapride

• linezolid

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methylene blue (injected into a vein)

• pimozide

• thioridazine

• tizanidine

This medicine may also interact with the following medications:

• alcohol

• aspirin and aspirin-like medicines

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• certain medicines for seizures like carbamazepine and phenytoin

• clozapine

• diltiazem

• diuretics

• fentanyl

• furazolidone

• isoniazid

• lithium

• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

• medicines for sleep

• methadone

• metoprolol

• mexiletine

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

• omeprazole

• procarbazine

• propranolol

• quinidine

• ramelteon

• rasagiline

• supplements like St. John's wort, kava kava, valerian

• tacrine

• theophylline

• tramadol

• tryptophan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Continue to take your medicine even if you do not immediately feel better. It can take several weeks before you feel the full effect of this medicine.

Patients and their families should watch out for depression or thoughts of suicide that get worse. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your doctor.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fast talking and excited feelings or actions that are out of control

• hallucination, loss of contact with reality

• irregular, pounding heartbeat

• muscle spasms or weakness

• seizures

• suicidal thoughts or other mood changes

• unusual bleeding or bruising

• unusually tired or weak

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance

• diarrhea or constipation

• difficulty sleeping

• headache

• increased sweating

• loss of appetite

• tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from humidity. Keep container tightly closed. Throw away any unused medicine after the expiration date.

Fluvoxamine Maleate Oral tablet

What is this medicine?

FLUVOXAMINE (floo VOX a meen) is an antidepressant. It is used to treat obsessive-compulsive disorder.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bipolar disorder

• glaucoma

• liver disease

• seizures (convulsions)

• suicidal thoughts

• an unusual or allergic reaction to fluvoxamine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 8 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alosetron

• cisapride

• linezolid

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methylene blue (injected into a vein)

• pimozide

• thioridazine

• tizanidine

This medicine may also interact with the following medications:

• alcohol

• aspirin and aspirin-like medicines

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• certain medicines for seizures like carbamazepine and phenytoin

• clozapine

• diltiazem

• diuretics

• fentanyl

• furazolidone

• isoniazid

• lithium

• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

• medicines for sleep

• methadone

• metoprolol

• mexiletine

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

• omeprazole

• procarbazine

• propranolol

• quinidine

• ramelteon

• rasagiline

• supplements like St. John's wort, kava kava, valerian

• tacrine

• theophylline

• tramadol

• tryptophan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor if your symptoms do not get better or if they get worse. Visit your doctor or health care professional for regular checks on your progress. Because it may take several weeks to see the full effects of this medicine, it is important to continue your treatment as prescribed by your doctor.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fast talking and excited feelings or actions that are out of control

• hallucination, loss of contact with reality

• irregular, pounding heartbeat

• muscle spasms or weakness

• seizures

• suicidal thoughts or other mood changes

• unusual bleeding or bruising

• unusually tired or weak

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance

• diarrhea or constipation

• difficulty sleeping

• headache

• increased sweating

• loss of appetite

• tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from humidity. Keep container tightly closed. Throw away any unused medicine after the expiration date.