Fluoxetine Oral - FLUOXETINE ENTERIC - COATED

Warnings
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 children/teenagers) 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 children/teenagers), even if treatment is not for a mental/mood condition.
Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

Uses
This long-acting form of fluoxetine is used to treat depression in people who have been successfully treated with the form of fluoxetine that is taken daily. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, anxiety disorders (panic attacks), and obsessive-compulsive disorder.
SSRIs work by helping to restore the balance of certain natural substances in the brain (neurotransmitters such as serotonin). Fluoxetine may decrease anxiety, improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living.

How to use Fluoxetine Oral
Read the Medication Guide provided by your pharmacist before you start using fluoxetine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth, usually once a week with or without food or as directed by your doctor. Swallow the capsule whole. Do not crush or chew the contents of the capsule. Start taking this medication 7 days after your last dose of the form of fluoxetine that is taken daily.
The dosage is based on your medical condition and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, take it on the same day of the week. Mark a calendar to help you remember when you should take your next dose.
It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without first consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.
Tell your doctor if your condition does not improve or if it worsens.

Precautions

Before taking fluoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
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.
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.
This medication is not recommended for use during pregnancy. 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.
Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.
This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Additional Information

Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: irregular heartbeat, fainting, severe dizziness, seizures.

NOTES:
Psychiatric/medical checkups must be done periodically to monitor your progress and check for side effects. Consult your doctor for more details.
Do not share this medication with others.

MISSED DOSE:
If you miss a dose, contact your doctor or pharmacist to establish a new 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.
Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Side Effects
See also Warning section.
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.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual or severe mental/mood changes (e.g., agitation, unusual high energy/excitement, thoughts of suicide), uncontrolled movements (e.g., of the lips/tongue), shakiness (tremor), restlessness, inability to keep still, decreased interest in sex, changes in sexual ability, blurred vision, numbness/tingling.
Tell your doctor immediately if any of these rare but very serious side effects occur: bloody/black/tarry stools, vomit that looks like coffee grounds, easy bruising/bleeding, fainting, fast/irregular heartbeat, muscle weakness/spasm, seizures, change in amount of urine.
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 (e.g., sumatriptan, eletriptan), certain antidepressants including other SSRIs (e.g., citalopram, paroxetine) and SNRIs (e.g., 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.
For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.
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, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Interactions
Before taking fluoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
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.
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.
This medication is not recommended for use during pregnancy. 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.
Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.
This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.