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FLUOXETINE DRUG INFORMATION, ABOUT FLUOXETINE HCL

GENERIC PROZAC®: Fluoxetine (flew-OX-eh-teen)

WHAT IS FLUOXETINE?

Fluoxetine is used to treat:

• depression
• obsessive compulsive disorders (OCD)
• bulimia (an eating disorder)
• severe symptoms of PMS (premenstrual dysphoric disorder-PMDD)

Fluoxetine works by helping restore the balance of certain natural chemicals in the brain.

OTHER FLUOXETINE USES

Fluoxetine has also been used to treat

• panic attacks
• obesity
• alcoholism

HOW TO USE FLUOXETINE HYDROCHLORIDE

Take fluoxetine by mouth usually once a day in the morning, with or without food; or as directed by your doctor.

The dosage is based on your medical condition and your response to therapy. Some medical conditions may require different dosing schedules (e.g., twice a day in the morning and at noon) as determined by your doctor.

Take fluoxetine exactly as prescribed. It is important to continue taking it even if you feel better.

Do not stop taking fluoxetine without consulting your doctor.

It may take up to four weeks before the full benefit of fluoxetine takes effect.

FLUOXETINE SIDE EFFECTS

If any of these fluoxetine side effects persist or worsen, notify your doctor promptly:

• nausea
• upset stomach
• headache
• trouble sleeping
• drowsiness
• dry mouth
• sweating

Tell your doctor immediately if any of these serious fluoxetine side effects occur:

• decreased interest in sex
• flu-like symptoms (e.g., chills, fever, muscle aches, weakness)
• loss of appetite
• unusual weight loss
• unusual or severe mental or mood changes
• uncontrolled movements (tremor)

Tell your doctor immediately if any of these serious (although, unlikely) fluoxetine side effects occur:

• changes in sexual ability
• painful and/or prolonged erection
• swelling or white spots on the mouth and/or tongue
• trouble swallowing
• vision changes

Tell your doctor immediately if any of these highly unlikely but very serious fluoxetine side affects occur:

• fainting
• irregular heartbeat
• rapid heartbeat

An allergic reaction to fluoxetine is unlikely, but if it occurs, seek immediate medical attention. Symptoms of an allergic reaction include:

• dizziness
• itching
• rash
• swelling
• trouble breathing

If you notice other side effects not listed above, contact your doctor.

FLUOXETINE PRECAUTIONS

Tell your doctor your medical history, especially:

• any allergies
• kidney disease
• liver problems
• heart problems
• seizures
• diabetes

Fluoxetine may make you dizzy or drowsy. Use caution when engaging in activities requiring alertness (driving, using machinery, etc.).

Limit alcoholic beverages.

Liquid preparations of fluoxetine may contain sugar and/or small amounts of alcohol. This is important to take into consideration if you have diabetes, alcohol dependence or liver disease.

Caution is advised when using fluoxetine in the elderly. They may be more sensitive to the effects of the drug.

FLUOXETINE and PREGNANCY

Fluoxetine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your physician.

FLUOXETINE and BREAST FEEDING

Fluoxetine passes into breast milk. Because of the potential risk to the infant, breast-feeding while using fluoxetine is not recommended. Consult your doctor before breast-feeding.

FLUOXETINE DRUG INTERACTIONS

Certain medications taken with fluoxetine could result in serious, even fatal, drug interactions.

Before or after treatment with fluoxetine:

• Avoid taking MAO inhibitors within 2 weeks, e.g.:
  • furazolidone
  • linezolid
  • isocarboxazid
  • moclobemide
  • procarbazine
  • phenelzine
  • tranylcypromine
  • selegiline
• Avoid taking thioridazine within 5 weeks.

Consult your physician or pharmacist for additional information.

Fluoxetine is not recommended for use with:

• astemizole
• weight loss medicine (e.g., sibutramine, phentermine)
• thioridazine
• terfenadine

Tell your physician about all prescription and nonprescription medicines you use, especially:

• other SSRI antidepressants (e.g., citalopram, sertraline)
• anti-seizure drugs (e.g., carbamazepine, phenytoin/hydantoins)
• "blood thinners" (e.g., warfarin)
• nefazodone
• clozapine
• flecainide
• haloperidol
• herbal/natural products (e.g., St John's wort, ayahuasca)
• lithium
• propafenone
• trazodone
• "triptan" migraine drugs (e.g., sumatriptan, zolmitriptan)
• tramadol
• tricyclic antidepressants (e.g., amitriptyline, nortriptyline)
• tryptophan
• venlafaxine

Tell your physician if you take any medications that cause drowsiness such as:

• anti-anxiety drugs (e.g., alprazolam)
• certain antihistamines (e.g., diphenhydramine)
• medicine for sleep
• muscle relaxants
• narcotic pain relievers (e.g., codeine)
• psychiatric medicine (e.g., phenothiazines such as chlorpromazine)
• tranquilizers

Check the labels on all your medications because they may contain drowsiness-causing ingredients (e.g., cough-and-cold products).

Tell your physician about other medicines you take which affect the heart rhythm (QTc prolongation), such as:

• dofetilide
• pimozide
• procainamide
• quinidine
• sotalol
• sparfloxacin
• "water pills" (diuretics such as furosemide or hydrochlorothiazide)

Fluoxetine may affect the amount of sugar in your blood. If you take any medication for diabetes (e.g., glipizide, glyburide, metformin), your dosage of these drugs may need to be adjusted when fluoxetine is started or discontinued.

Consult your doctor. Do not start or stop fluoxetine or any medicine without doctor or pharmacist approval.

FLUOXETINE OVERDOSE

If an overdose is suspected, immediately call the poison control center at (1-800-222-1222). Or call emergency services at (911).

Symptoms of an overdose may include:

• fainting
• irregular heartbeat
• lightheadedness
• severe dizziness

NOTES

Do not share your fluoxetine with others.

Laboratory or other medical tests may be performed to monitor your progress.

MISSED DOSES

If you miss a fluoxetine dose, take it as soon as you remember. If it is near the time of the next dose, skip the dose that was missed. Continue with your usual dosing schedule. Do not take a double dose to catch up.

STORAGE

Store fluoxetine at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.

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