Fluvoxamine Extended-Release Capsules

What is this medication?

FLUVOXAMINE (floo VOX a meen) treats obsessive-compulsive disorder (OCD). It increases the amount of serotonin in the brain, a substance that helps regulate mood. It belongs to a group of medications called SSRIs.

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

COMMON BRAND NAME(S): Luvox CR

What should I tell my care team before I take this medication?

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

• Bipolar disorder or a family history of bipolar disorder
• Bleeding disorders
• Glaucoma
• Heart disease
• Liver disease
• Low levels of sodium in the blood
• Seizures
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• Take MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Take medications that treat or prevent blood clots
• Thyroid disease
• An unusual or allergic reaction to fluvoxamine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

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

Do not take this medication with any of the following:

• Alosetron
• Cisapride
• Linezolid
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)
• Pimozide
• Thioridazine
• Tizanidine

This medication may also interact with the following:

• Alcohol
• Amphetamines
• Aspirin and aspirin-like medications
• Certain medications for depression, anxiety, or psychotic disturbances
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for seizures like carbamazepine and phenytoin
• Clozapine
• Diltiazem
• Diuretics
• Fentanyl
• Furazolidone
• Isoniazid
• Lithium
• Medications that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• Medications for sleep
• Methadone
• Metoprolol
• Mexiletine
• NSAIDS, medications 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 medication?

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

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 care team.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication 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 care team 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 care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Prolonged or painful erection
• Seizures
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

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

• Change in sex drive or performance
• Diarrhea
• Drowsiness
• Loss of appetite
• Nausea
• Sweating
• Tremors or shaking

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 medication?

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 medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.