SARAFEM- fluoxetine hydrochloride tablet
Allergan, Inc.
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Medication Guide
SARAFEM® (SAIR-a-fem)
(fluoxetine hydrochloride)
Tablets
Read the Medication Guide that comes with SARAFEM before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or you want to learn more about.
SARAFEM is in a class of drugs called selective serotonin reuptake inhibitors (SSRIs), which are often used for the treatment of depression and anxiety disorders. Although SARAFEM is not a treatment for depression, it contains fluoxetine hydrochloride, the same active ingredient in some antidepressants.
What is the most important information I should know about SARAFEM?
SARAFEM and other antidepressant medicines may cause serious side effects including:
1. Suicidal thoughts or actions:
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. SARAFEM may be associated with these serious side effects:
2. Serotonin Syndrome. This condition can be life-threatening and may include:
3. Severe allergic reactions:
4. Manic episodes:
5. Seizures or convulsions
6. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
7. Abnormal bleeding: SARAFEM and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID’s, like ibuprofen or naproxen), or aspirin.
8. Visual Problems
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
10. Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including SARAFEM, may cause symptoms of sexual problems
Symptoms in females may include:
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with SARAFEM. There may be treatments your healthcare provider can suggest.
Do not stop SARAFEM without first talking to your healthcare provider. Stopping SARAFEM too quickly may cause serious symptoms including:
What is SARAFEM?
SARAFEM is a prescription medicine used to treat premenstrual dysphoric disorder (PMDD).
It is not known if SARAFEM is safe and effective in children.
Talk with your healthcare provider if you do not think that your condition is getting better with SARAFEM treatment.
Who should not take SARAFEM?
Do not take SARAFEM if you:
Women who take SARAFEM close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
What should I tell my healthcare provider before taking SARAFEM? Ask if you are not sure.
Before starting SARAFEM, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. SARAFEM and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take SARAFEM with your other medicines. Do not start or stop any medicine while taking SARAFEM without talking to your healthcare provider first.
If you take SARAFEM, you should not take any other medicines that contain fluoxetine hydrochloride:
How should I take SARAFEM?
What should I avoid while taking SARAFEM?
SARAFEM can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how SARAFEM affects you. Do not drink alcohol while using SARAFEM.
What are the possible side effects of SARAFEM?
SARAFEM may cause serious side effects, including:
The most common side effects of SARAFEM include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SARAFEM. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SARAFEM?
Keep SARAFEM and all medicines out of the reach of children.
General information about SARAFEM
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SARAFEM for a condition for which it was not prescribed. Do not give SARAFEM to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about SARAFEM. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about SARAFEM that is written for healthcare professionals.
For more information about SARAFEM call 1-800-678-1605.
What are the ingredients in SARAFEM?
Active ingredient: fluoxetine hydrochloride
Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Yellow No. 6 aluminum lake (10 mg and 20 mg tablets) and D&C Yellow No. 10 aluminum lake (10 mg and 20 mg tablets)
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by:
Allergan USA, Inc.
Madison, NJ 07940
Sarafem® is a registered trademark of Allergan Pharmaceuticals International Limited
© 2021 Allergan. All rights reserved.
Rev: 09/2021
v1.0USPI0210