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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