Warner Chilcott
sarafem® fluoxetine hydrochloride
Medication Guide
Important Safety Information

US Full Prescribing Information

Sarafem® is an FDA-approved prescription treatment that relieves both the mood and physical symptoms of PMDD (Premenstrual Dysphoric Disorder). Many physicians believe that Sarafem helps to correct the imbalance of serotonin that could contribute to PMDD.

Why do you feel so bad before your period?
You could feel this way if you have PMDD, the intense mood and physical symptoms that happen the week or two before your period, month after month.

PMDD is a distinct medical condition. Common symptoms include irritability, sadness, sudden mood changes, tension, bloating, and breast tenderness. The many symptoms of PMDD can markedly interfere with your daily activities and relationships and can make you feel out of control. Some women describe PMDD as frustrating, surprising, tiring, or even isolating. It can take away your enjoyment of family, friends, or work. Some think it's part of being a woman or PMS (Premenstrual Syndrome). But for millions it is PMDD.

While PMDD is not fully understood, many doctors believe it may be caused by an imbalance of a chemical in the body called serotonin. The normal cyclical changes in female hormones may interact with serotonin and other chemicals, and the changes may result in the mood and physical symptoms of PMDD.

With PMDD, it may seem like you only suffer a few days a month, but those days add up. In fact, you can spend up to 25 percent of your childbearing years dealing with these symptoms. You may have even noticed that your symptoms are more bothersome now than when you were younger. It's not your imagination – if left untreated PMDD symptoms can worsen with age.

How to take Sarafem
Take Sarafem as prescribed by your doctor. It's usually taken in a single daily dose in the morning, either every day of the month or only during a certain part of the month.

You can take Sarafem with or without food.

In clinical studies, Sarafem helped relieve PMDD symptoms of most women. It's important to take Sarafem as prescribed to help control your symptoms.

What to expect from Sarafem
With treatment, you should begin to feel relief from both your mood and physical PMDD symptoms. In clinical studies, symptom relief included decreases in irritability, mood swings, tiredness, tension, and breast tenderness. Many women also reported an improved interest in social activities.

Even though you may start to feel better, your doctor may continue treatment to keep your PMDD symptoms under control. Stopping treatment may cause your symptoms to return. Talk to your doctor before you stop treatment. You should also talk to him or her about how long you should continue treatment.

Important Safety Information
Sarafem is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adult women (18 years and older).

Although Sarafem is not a treatment for depression, it contains fluoxetine hydrochloride, the same active ingredient in some antidepressants.

In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults with depression and other psychiatric disorders. Anyone considering the use of Sarafem or any other antidepressant must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidal thinking or behavior with antidepressants in adults older than 24; there was a reduction in risk with antidepressants in adults 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely. Families and caregivers should discuss with the healthcare provider right away any observations of worsening depression symptoms, suicidal thinking and behavior, or unusual changes in behavior. Sarafem is not approved for use in patients under age 18.

For further information, a Medication Guide: Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions is available from your physician or pharmacist, or by clicking here.

Patients taking antidepressants and their families or caregivers should watch for worsening depression symptoms, unusual changes in behavior and thoughts of suicide.  Call the doctor if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly.  Be especially observant within the first few months of treatment or whenever there is a change in dose. You should not stop taking Sarafem abruptly.   Talk to your doctor before you stop taking Sarafem.  

You should not take Sarafem if you are allergic to fluoxetine, the active ingredient in Sarafem.

You should not take Sarafem at the same time as or within two weeks of stopping an MAO inhibitor (MAOI). Don't take an MAOI for at least 5 weeks after stopping Sarafem. Also, you should not take thioridazine or pimozide at the same time as taking Sarafem.  You need to wait at least 5 weeks after stopping Sarafem before you may use thioridazine.

Some women may experience side effects such as headache, upset stomach, tiredness, insomnia, nervousness, dizziness and difficulty concentrating. Side effects are usually mild and tend to go away within a few weeks.

If you develop a rash or hives while taking Sarafem, call your doctor right away because this can be a sign of a serious medical condition.

Tell your doctor about all the nonprescription and prescription medicines you are taking, including those for migraine, to avoid a potentially life-threatening condition. Also, tell your doctor if you are taking or plan to take any vitamins, herbal supplements or alcohol.

Be sure to tell your doctor if you are pregnant or nursing, or planning on becoming pregnant, as you should not need Sarafem during pregnancy. Some newborns exposed to fluoxetine late in the mother's third trimester have needed special care.

What else you can do
In addition to taking Sarafem, a well-balanced diet and regular exercise can be elements in relieving both the mood and physical symptoms of PMDD. By eating fruits and vegetables, drinking more water, and decreasing your caffeine, alcohol, and salt intake, especially on days before your monthly period, you’ll benefit all month long. Aerobic exercise is also a great way to maintain physical fitness. As with any diet or exercise program, consult your doctor before starting.

Your doctor may also suggest that you keep track of how you feel throughout the month, so you can better manage your PMDD symptoms.

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The product information provided in this site is intended only for residents of the United States.
The products discussed herein may have different product labeling in different countries.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider.
Decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.