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Fluoxetine HCl
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CONSUMER INFORMATION
Fluoxetine HCl
CAS number 54910-89-3
WARNING: Antidepressant medications are used to treat a variety of
conditions, including depression and other mental/mood disorders. These
medications can help prevent suicidal thoughts/attempts and provide other
important benefits. However, studies have shown that a small number of
people (especially people younger than 25) who take antidepressants for any
condition may experience worsening depression, other mental/mood symptoms,
or suicidal thoughts/attempts. Therefore, it is very important to talk with
the doctor about the risks and benefits of antidepressant medication
(especially for people younger than 25), even if treatment is not for a
mental/mood condition.
USES: Fluoxetine is a selective serotonin reuptake inhibitor (SSRI)
used to treat depression, anxiety disorders (panic attacks),
obsessive-compulsive disorder (OCD), a certain eating disorder (bulimia),
and a severe form of premenstrual syndrome (premenstrual dysphoric
disorder). SSRIs work by helping to restore the balance of certain natural
substances in the brain (neurotransmitters such as serotonin). Fluoxetine
may improve your mood, sleep, appetite, and energy level and may help
restore your interest in daily living. It may decrease anxiety/unreasonable
fears, persistent/troubling thoughts (obsessions), and unwanted urges that
keep returning (compulsions). It may decrease the number and severity of
panic attacks. Fluoxetine may lessen premenstrual symptoms such as
irritability, increased appetite, and depression. It may decrease bingeing
and purging behaviors in bulimia.
HOW TO USE: Take this medication by mouth with or without
food, usually once daily or as directed by your doctor. This medication may
make you either sleepy or wakeful. Therefore, depending on how this
medication affects you, your doctor may direct you to take the entire dose
once daily in either the morning or evening. If you are taking this
medication twice a day, your doctor may direct you to take it in the morning
and at noon. If you are taking fluoxetine for premenstrual problems, your
doctor may direct you to take it every day of the month or just for the 2
weeks before your period through the first full day of your period. To help
you remember, mark your calendar.
If you are using the liquid form of this medication, measure the dose
carefully using a special measuring device/spoon. Do not use a household
spoon because you may not get the correct dose.
The dosage is based on your medical condition and response to treatment. To
reduce your risk of side effects, your doctor may start you at a low dose
and gradually increase your dose. Follow your doctor's instructions
carefully. Do not take more or less medication or take it more frequently
than prescribed. Your condition will not improve any faster, and your risk
of side effects will increase. Use this medication regularly in order to get
the most benefit from it. To help you remember, use it at the same time(s)
each day.
SIDE EFFECTS: Nausea, drowsiness, dizziness, anxiety, trouble
sleeping, loss of appetite, weakness, tiredness, sweating, or yawning may
occur. If any of these effects persist or worsen, tell your doctor promptly.
serious side effects occur: unusual or severe mental/mood changes ( such as
agitation, unusual high energy/excitement, thoughts of suicide),
uncontrolled movements (for example, movements of the lips/tongue),
shakiness (tremor), restlessness, inability to keep still, decreased
interest in sex, changes in sexual ability, blurred vision,
numbness/tingling. This medication may rarely cause a very serious condition
called serotonin syndrome. The risk increases when this medication is used
with certain other drugs such as "triptans" used to treat migraine headaches
(including sumatriptan, eletriptan), certain antidepressants including other
SSRIs (such as citalopram, paroxetine) and SNRIs (such as duloxetine,
venlafaxine), lithium, tramadol, tryptophan, or a certain drug to treat
obesity (sibutramine). See also Drug Interactions section. Before taking
this drug, tell your doctor if you take any of these medications. Serotonin
syndrome may be more likely when you start or increase the dose of any of
these medications. Seek immediate medical attention if you develop some of
the following symptoms: hallucinations, unusual restlessness, loss of
coordination, fast heartbeat, severe dizziness, unexplained fever, severe
nausea/vomiting/diarrhea, twitchy muscles. A very serious allergic reaction
to this drug is rare. However, seek immediate medical attention if you
notice any symptoms of a serious allergic reaction, including: rash,
itching/swelling (especially of the face/tongue/throat), severe dizziness,
trouble breathing.
PRECAUTIONS: Before using this medication, tell your doctor or
pharmacist your medical history, especially of: personal or family history
of bipolar/manic-depressive disorder, personal or family history of suicide
attempts, liver problems, diabetes, low sodium in the blood, severe loss of
body water (dehydration), seizures, stomach/intestinal ulcers.
This drug may make you dizzy or drowsy. Use caution while driving, using
machinery, or doing any other activity that requires alertness. Avoid
alcoholic beverages.
If you have diabetes, fluoxetine may affect your blood sugar levels. Monitor
your blood sugar regularly and share the results with your doctor. Your
doctor may need to adjust your medication, diet, and exercise when you start
or stop fluoxetine. Liquid forms of this product may contain sugar and/or
alcohol. Caution is advised if you have diabetes, alcohol dependence, or
liver disease. Ask your doctor or pharmacist about using this product
safely.
Caution is advised when using this product in the elderly because they may
be more sensitive to its effects. The elderly are more likely to lose too
much salt (hyponatremia), especially if they are also taking "water pills"
(diuretics) with this medication.
During pregnancy, this medication should be used only when clearly needed.
It may harm an unborn baby. Also, babies born to mothers who have used this
drug during the last 3 months of pregnancy may infrequently develop
withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle
stiffness, or constant crying. If you notice any of these symptoms in your
newborn, tell the doctor promptly.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If
it is near the time of the next dose, skip the missed dose and resume your
usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30
degrees C) away from light and moisture. Do not store in the bathroom. Keep
all medicines away from children and pets.
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