Nefazodone Hydrochloride Oral tablet

What is this medicine?

NEFAZODONE (nef AY zoe done) is used to treat depression.

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:

• attempted suicide or thinking about it
• bipolar disorder or mania
• heart disease, previous heart attack or stroke
• liver disease or a history of liver disease
• seizures
• an unusual or allergic reaction to nefazodone, other medicines, food, 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 may take this medicine with or without food. Take your medicine 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:

• carbamazepine
• cisapride
• duloxetine
• eplerenone
• ergot alkaloids like dihydroergotamine, ergotamine, methysergide
• lovastatin
• medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
• pimozide
• ranolazine
• simvastatin
• SSRIs like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline
• trazodone
• triazolam
• venlafaxine
• red yeast rice

This medicine may also interact with the following medications:

• atorvastatin
• buspirone
• cyclosporine
• desipramine
• digoxin
• erythromycin
• general anesthetics
• haloperidol
• ketoconazole
• lithium
• medicines for anxiety or sleeping problems, such as alprazolam, diazepam, or clonazepam
• phenytoin
• tacrolimus
• warfarin

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.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

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
• changes in vision
• dark urine
• feeling faint or lightheaded, falls
• flu-like symptoms like fever, chills, cough, muscle or joint aches and pains
• irregular heartbeat
• loss of appetite for several days
• prolonged or painful erection
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• seizures
• suicidal thoughts or other mood changes
• trouble passing urine or change in the amount of urine
• unusually tired or weak
• yellowing of the eyes or skin

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

• constipation
• nausea or stomach upset

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 below 40 degrees C (104 degrees F). Keep container tightly closed. Throw away any unused medicine 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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.