Patient Information Sheet
Fluoxetine hydrochloride

This is a summary of the most important information about fluoxetine. For details, talk to your healthcare professional.

FDA ALERT [07/2006] � Possible Life- Threatening Serotonin Syndrome When Used With Triptan Medicines

A life-threatening condition called serotonin syndrome can happen when medicines called selective serotonin reuptake inhibitors (SSRIs), such as Fluoxetine, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are used together.� Signs and symptoms of serotonin syndrome include the following:

• restlessness
• hallucinations
• loss of coordination
• fast heart beat
• increased body temperature
• fast changes in blood pressure
• overactive reflexes
• diarrhea
• coma
• nausea
• vomiting

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan.� This information comes from reports sent to FDA and knowledge of how these medicines work.� If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

Before you take Fluoxetine and a triptan together, talk to your healthcare professional.� If you must take these medicines together, be aware of the possibility of serotonin syndrome, and get medical care right away if you think serotonin syndrome is happening to you.

This information reflects FDA�s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

FDA ALERT [07/2006] � Infant Persistent Pulmonary Hypertension
The results of a study that looked at the use of antidepressant medicines during pregnancy in� mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) were recently published in a medical journal.
Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies.� Babies with PPHN can be very sick and may die.

The study results showed that:

• babies born to mothers who took selective serotonin reuptake inhibitors (SSRIs), the family of medicines Fluoxetine belongs to,
• 20 weeks or later in their pregnancies,
• had a higher chance (were 6 times as likely) to have persistent pulmonary hypertension (PPHN),
• than babies born to mothers who did not take antidepressants during pregnancy.

The FDA plans to further look at the role of SSRIs in babies with PPHN.

Talk to your doctor if you are taking Fluoxetine and are pregnant or are planning to have a baby.� You and your doctor will need to talk about the best way to treat your depression during pregnancy.

This information reflects FDA�s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

What is Fluoxetine?

Fluoxetine is in a class of medicines called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine is used to treat Depression, Obsessive-Compulsive Disorder (OCD), Bulemia Nervosa, and Panic Disorder.

Who Should Not Take Fluoxetine?

Never take Fluoxetine if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking Fluoxetine close in time to an MAOI can result in serious, sometimes fatal, reactions, including:

• High body temperature
• Coma
• Seizures (convulsions)

Do not take a MAOI within 5 weeks of stopping Fluoxetine.� MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.

Never take Fluoxetine if you are taking Mellaril (thioridazine), used to treat schizophrenia. Also, do not take Mellaril within 5 weeks of stopping Fluoxetine. Taking Fluoxetine close in time to Mellaril can result in serious heart beat problems.

What Are The Risks?

The following are the major potential risks and side ffects of Fluoxetine therapy.� However, this list is not complete.

• Possible life-threatening serotonin syndrome when used with triptan medicines:� See FDA Alert [07/2006] above.
  
  
• Infant persistent pulmonary hypertension:� See FDA Alert [07/2006] above.
  
  
• Suicidal thoughts or actions: Persons taking Fluoxetine may be more likely to think about killing themselves or actually try to do so, especially when Fluoxetine is first started or the dose is changed.� People close to persons taking Fluoxetine can help by paying attention to changes in user�s moods or actions.�� Contact your healthcare professional right away if someone using Fluoxetine talks about or shows signs of killing him or herself.� If you are taking Fluoxetine yourself and you start thinking about killing yourself, tell your healthcare professional about this side effect right away.
  
  
• Stopping Fluoxetine: Do not stop taking Fluoxetine suddenly because you could get side effects. Your healthcare professional will slowly decrease your dose.
  
  
• Rash and possible allergic reactions: Fluoxetine may cause serious skin, lung and allergic-type reactions. Contact your healthcare professional right away if you get a skin rash or hives, have problems breathing, or get swelling of your tongue, lips, or throat.
  
  
• Bleeding problems: Fluoxetine may cause bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen and naproxen), or other drugs that affect bleeding.
  
  
• Mania: You may become unusually hyperactive, excitable or elated.
  
  
• Seizures: You may experience a seizure (convulsion), even if you are not taking Fluoxetine close in time with an MAOI.
  
  
• Weight loss: Fluoxetine can cause weight loss. Children who take it for a long time should have their growth and body weight measured regularly.
  
  
• Pregnancy: Tell your healthcare professional if you are or may be pregnant (see FDA Alert [07/2006] above).� In addition to the issue described in the alert,� babies delivered to mothers taking Fluoxetine late in pregnancy have developed problems, such as difficulty breathing and feeding.
  
  
• Sexual problems: You may have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire).
  
  
• Other side effects include nausea, difficulty sleeping, anxiety, nervousness, and sleepiness.
  
  
• Tell your healthcare professional about all your medical conditions, especially if you have liver or heart disease, or diabetes. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby.

Are There Any Interactions With Drugs or Foods?

• Do not take Fluoxetine with Sarafem (Fluoxetine hydrochloride), a drug used to treat PreMenstrual Dysphoric Disorder (PMDD), because they are very similar and you could get an overdose.
  
  
• Fluoxetine may interact with medicines other than the ones already mentioned in this information sheet, causing serious side effects. Tell your healthcare professional about all medicines, vitamins, and herbal supplements you take, especially:
  
  
• Those that affect bleeding
• Those used to treat diabetes, seizures, anxiety, mental illness, or depression
  
  
• If you plan to drink alcohol, talk to your healthcare professional.

How Do I Take Fluoxetine?

• Fluoxetine is taken by mouth, with or without food, exactly as prescribed by your healthcare professional.
  
  
• Take the weekly version of Fluoxetine only once a week. Do not start until 7 days after you�ve taken the last dose of the daily Fluoxetine.