FLUOXETINE HYDROCHLORIDE- fluoxetine hydrochloride tablet, film coated 
Alvogen Inc.

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MEDICATION GUIDE

FLUOXETINE TABLETS

Read the Medication Guide that comes with fluoxetine 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 want to learn more about.

What is the most important information I should know about fluoxetine?

Fluoxetine and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

Fluoxetine and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
Watch for these changes and call your healthcare provider right away if you notice:
 
- New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
 
- Pay particular attention to such changes when fluoxetine is started or when the dose is changed.

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:

attempts to commit suicide
acting on dangerous impulses
acting aggressive or violent
thoughts about suicide or dying
new or worse depression
new or worse anxiety or panic attacks
feeling agitated, restless, angry, or irritable
trouble sleeping
an increase in activity or talking more than what is normal for you
other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Fluoxetine may be associated with these serious side effects:

2. Serotonin Syndrome. This condition can be life-threatening and may include:

agitation, hallucinations, coma, or other changes in mental status
coordination problems or muscle twitching (overactive reflexes)
racing heartbeat, high or low blood pressure
sweating or fever
nausea, vomiting, or diarrhea
muscle rigidity
dizziness
flushing
tremor
seizures

3. Severe allergic reactions:

trouble breathing
swelling of the face, tongue, eyes, or mouth
rash, itchy welts (hives) or blisters, alone or with fever or joint pain

4. Abnormal bleeding: Fluoxetine and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a nonsteroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Visual problems:

eye pain
changes in vision
swelling or redness in or around the eye

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.

6. Seizures or convulsions

7. Manic episodes:

greatly increased energy
severe trouble sleeping
racing thoughts
reckless behavior
unusually grand ideas
excessive happiness or irritability
talking more or faster than usual

8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

headache
weakness or feeling unsteady
confusion, problems concentrating, or thinking or memory problems

10. Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsades de Pointes). This condition can be life threatening. The symptoms may include:

fast, slow, or irregular heartbeat
shortness of breath
dizziness or fainting

Do not stop fluoxetine without first talking to your healthcare provider. Stopping fluoxetine too quickly may cause serious symptoms including:

anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
headache, sweating, nausea, dizziness
electric shock-like sensations, shaking, confusion

What is fluoxetine?

Fluoxetine is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

Fluoxetine is used to treat:

Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Bulimia Nervosa*
Panic Disorder*
Depressive episodes associated with Bipolar I Disorder, taken with olanzapine (Zyprexa)*
Treatment Resistant Depression (depression that has not gotten better with at least 2 other treatments), taken with olanzapine (Zyprexa)*

*Not approved for use in children.

Talk to your healthcare provider if you do not think that your condition is getting better with fluoxetine treatment.

Who should not take fluoxetine?

Do not take fluoxetine if you:

are allergic to fluoxetine hydrochloride or any of the ingredients in fluoxetine. See the end of this Medication Guide for a complete list of ingredients in fluoxetine.
take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
 
- Do not take an MAOI within 5 weeks of stopping fluoxetine unless directed to do so by your physician.
 
- Do not start fluoxetine if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take fluoxetine 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:

 
- high fever
 
- uncontrolled muscle spasms
 
- stiff muscles
 
- rapid changes in heart rate or blood pressure
 
- confusion
 
- loss of consciousness (pass out)
take Mellaril® (thioridazine). Do not take Mellaril® within 5 weeks of stopping fluoxetine because this can cause serious heart rhythm problems or sudden death.
take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.

What should I tell my healthcare provider before taking fluoxetine? Ask if you are not sure.

Before starting fluoxetine, tell your healthcare provider if you:

are taking certain drugs or treatments such as:
 
- Triptans used to treat migraine headache
 
- Medicines used to treat mood, anxiety, psychotic, or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, MAOIs, or antipsychotics
 
- Tramadol and fentanyl
 
- Amphetamines
 
- Over-the-counter supplements such as tryptophan or St. John’s Wort
 
- Electroconvulsive therapy (ECT)
have liver problems
have kidney problems
have heart problems
have or had seizures or convulsions
have bipolar disorder or mania
have low sodium levels in your blood
have a history of a stroke
have high blood pressure
have or had bleeding problems
are pregnant or plan to become pregnant. It is not known if fluoxetine will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
are breast-feeding or plan to breast-feed. Some fluoxetine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking fluoxetine.

Tell your healthcare provider about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Fluoxetine 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 fluoxetine with your other medicines. Do not start or stop any medicine while taking fluoxetine without talking to your healthcare provider first.

If you take fluoxetine, you should not take any other medicines that contain fluoxetine hydrochloride including:

Symbyax® (olanzapine and fluoxetine hydrochloride)
Sarafem® (fluoxetine)
Prozac®
Prozac® Weekly

How should I take fluoxetine?

Take fluoxetine exactly as prescribed. Your healthcare provider may need to change the dose of fluoxetine until it is the right dose for you. Each tablet can be broken in half (along the functional score).
Fluoxetine may be taken with or without food.
If you miss a dose of fluoxetine, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluoxetine at the same time.
If you take too much fluoxetine, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking fluoxetine?

Fluoxetine 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 fluoxetine affects you. Do not drink alcohol while using fluoxetine.

What are the possible side effects of fluoxetine?

Fluoxetine may cause serious side effects, including:

See “What is the most important information I should know about fluoxetine?”
Problems with blood sugar control. People who have diabetes and take fluoxetine may have problems with low blood sugar while taking fluoxetine. High blood sugar can happen when fluoxetine is stopped. Your healthcare provider may need to change the dose of your diabetes medicines when you start or stop taking fluoxetine.
Feeling anxious or trouble sleeping

Common possible side effects in people who take fluoxetine include:

unusual dreams
sexual problems
loss of appetite, diarrhea, indigestion, nausea or vomiting, weakness, or dry mouth
flu symptoms
feeling tired or fatigued
change in sleep habits
yawning
sinus infection or sore throat
tremor or shaking
sweating
feeling anxious or nervous
hot flashes
rash

Other side effects in children and adolescents include:

increased thirst
abnormal increase in muscle movement or agitation
nose bleed
urinating more often
heavy menstrual periods
possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with fluoxetine.

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 fluoxetine. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store fluoxetine?

Store fluoxetine at room temperature between 68°F and 77°F (20°C to 25°C).
Keep fluoxetine away from light.
Keep fluoxetine bottle closed tightly.

Keep fluoxetine and all medicines out of the reach of children.

General information about fluoxetine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine for a condition for which it was not prescribed. Do not give fluoxetine to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about fluoxetine. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluoxetine that is written for healthcare professionals.

For more information about fluoxetine call 1-866-770-3024.

What are the ingredients in fluoxetine tablets, 60 mg?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: mannitol, microcrystalline cellulose, maize starch, povidone, hypromellose, magnesium stearate, titanium dioxide, sucrose, glycerol, and polysorbate.

This Medication Guide has been approved by the US Food and Drug Administration.

Symbyax and Prozac are registered trademarks of Eli Lilly and Company.
Prozac Weekly is a registered trademark of Eli Lilly and Company.
Sarafem is a registered trademark of Warner Chilcott.
Mellaril is a registered trademark of Novartis AG Corporation.
Orap is a registered trademark of Teva Pharmaceuticals USA.
Coumadin is a registered trademark of Bristol Myers Squibb.
Jantoven is a registered trademark of Upsher-Smith Laboratories Inc.

Manufactured by:
Orion Pharmaceuticals
FN-02200
Espoo, Finland

Distributed by:
Alvogen, Inc.
Pine Brook, NJ 07058 USA

Revised October 2017
PL600-01 R

Revised: 11/2018
Alvogen Inc.