A1,
A2,
B,
C1,
C2,
D,
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G-H,
I-K,
L,
M,
N,
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P1,
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Q-R,
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W-Z
Sarafem Patient, Information, Instructions - Fluoxetine Hydrochloride
Sarafem Patient, Information, Instructions - Fluoxetine Hydrochloride
INFORMATION FOR THE PATIENT
SARAFEM™
fluoxetine hydrochloride
READ THIS INFORMATION COMPLETELY BEFORE USING SARAFEM
(SAIR-a-fem). This leaflet provides a summary about SARAFEM and does not contain complete information about your medicine. This information is not meant to take the place of discussions between you and your doctor. Talk with your doctor, pharmacist or other healthcare professional if there is something you do not understand or if you want to learn more about SARAFEM. Always follow your doctor’s instructions on how to take SARAFEM.
What is SARAFEM?
SARAFEM is a prescription medicine used by women who have menstrual periods or cycles to treat the symptoms of premenstrual dysphoric disorder (PMDD).
What is PMDD?
PMDD is a medical condition that affects only women who have menstrual periods or cycles. Symptoms of PMDD are limited to the week or two before a woman’s menstrual period and commonly include mood symptoms such as irritability, mood swings, and tension as well as physical symptoms of bloating and breast tenderness. When the symptoms of PMDD appear they cause interference in day to day activities and relationships.
What is the active ingredient in SARAFEM?
SARAFEM contains fluoxetine hydrochloride, the same active ingredient found in Prozac®.
How does SARAFEM work?
While it is unknown what causes PMDD, many doctors believe it may be related to an imbalance in a natural chemical in the body called serotonin. The actions of SARAFEM on serotonin may explain its effects in improving the symptoms of this condition.
Who should not take SARAFEM?
You should not take SARAFEM if you:
x are allergic to fluoxetine hydrochloride, the active ingredient in SARAFEM.
x are taking a type of antidepressant medicine known as a monoamine oxidase inhibitor (MAOI), such as Nardil (phenelzine) or Parnate (tranylcypromine). Using an MAOI together with many prescription medicines including SARAFEM can cause serious or even life-threatening reactions. You must wait at least 14 days after you have stopped taking an MAOI before you can take SARAFEM. Also, you need to wait at least 5 weeks after you stop taking SARAFEM before you take an MAOI.
x are taking a type of antipsychotic medicine known as Mellaril (thioridazine). You need to wait at least 5 weeks after you stop taking SARAFEM before you take Mellaril.
How should I take SARAFEM?
·
Take SARAFEM exactly as directed by your doctor.
·
SARAFEM comes as a 10 mg lavender capsule and a 20 mg pink and lavender capsule. The usual dose is 20 mg a day, but your doctor will prescribe the dose that is right for you.
·
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only your regularly scheduled dose. Do not take more than the daily amount of SARAFEM that has been prescribed for you.
·
SARAFEM can be taken with or without food.
·
To help you remember to take SARAFEM, it may be best to take it at about the same time each day, such as every morning.
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Remember to get your refills before you run out of SARAFEM.
·
Talk with your doctor about how long you should keep taking SARAFEM.
·
Talk with your doctor before you stop taking SARAFEM.
What should I talk to my doctor about when taking SARAFEM?
·
If you get a rash or hives while taking SARAFEM, call your doctor right away because this can be a sign of a serious medical condition.
·
Be sure to tell your doctor if you are taking Prozac, since this contains fluoxetine, the same active ingredient found in SARAFEM.
·
Be sure to tell your doctor if you are taking or plan to take any prescription or nonprescription medicines, vitamins, natural supplements, herbal remedies or alcohol. As with most other prescription medications, SARAFEM may interact with some of these products.
·
You should tell your doctor if you are pregnant, plan to become pregnant or are breast feeding while taking SARAFEM.
·
Tell your doctor if you have diabetes. The dose of diabetes medicine you need may change when you start or stop taking SARAFEM.
·
Tell your doctor about any other medical conditions you may have, especially liver disease, or a history of seizures or mania.
What are possible side effects of SARAFEM?
All prescription medicines may cause side effects in some patients.
·
In medical studies of women taking SARAFEM for PMDD, the most common side effects likely caused by SARAFEM were tiredness, upset stomach, nervousness, dizziness, and difficulty concentrating. Other side effects were reported less frequently in those same studies. Side effects were generally mild, often disappeared after a few weeks, and most did not cause women to stop taking SARAFEM.
·
SARAFEM can cause changes in sexual desire or satisfaction.
·
Do not drive a car or operate dangerous machinery until you know what effect SARAFEM may have on you.
·
Contact your doctor or healthcare professional if you get a rash or hives, or if you get other side effects that concern you while taking SARAFEM.
What else can I do?
In addition to taking SARAFEM:
·
eat a well-balanced diet (including fruits, vegetables, and fiber) and get regular exercise.
·
drink plenty of water daily and lower the amount of caffeine and salt in your diet, especially before your menstrual period.
Talk to your doctor before you begin any diet or exercise program.
How do I store SARAFEM?
·
Store SARAFEM at room temperature.
·
Keep all medicines, including SARAFEM, out of the reach of children.
General Information
This is a summary of information about SARAFEM. Medicines are sometimes prescribed for purposes other than those listed in a patient information summary. This medicine was prescribed for your use only. Do not let anyone else use your SARAFEM.
If you have any questions or concerns, want to report any problems with the use of SARAFEM or want more information about SARAFEM, contact your doctor, pharmacist or other healthcare professional.
This patient information summary has been approved by the US Food and Drug Administration.
Literature revised July 11, 2000
Eli Lilly and Company Indianapolis, IN 46285,
USA.,PV 3281 AMP PRINTED IN USA, Copyright © 2000, Eli Lilly and
Company. All rights reserved.
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