MEDICATION GUIDE FLUOXETINE CAPSULES
Read the Medication Guide that comes with fluoxetine capsules
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
doctor about your medical condition or treatment. Talk with your doctor or
pharmacist if there is something you do not understand or you want to learn more
about fluoxetine.
What is the most important information I should know about
fluoxetine?
Antidepressant medicines, depression and other serious
mental illnesses and suicidal thoughts or actions:
Talk to your or your family member’s, healthcare provider
about
- all risks and benefits of treatment with antidepressant medicines
- all treatment choices for depression or other serious mental
illness
-
Antidepressant medicines may increase suicidal thoughts or
actions in some children, teenagers and young adults within the first few months
of treatment.
-
Depression and other serious mental illnesses are the most
important causes of suicidal thoughts and actions. Some people may have a
particularly high risk of having suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness (also
called manic-depressive illness) or suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts
and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood,
behaviors, thoughts or feelings. This is very important when an antidepressant
medicine is started or when the dose is changed.
- Call the healthcare provider right away to report new or sudden changes in
mood, behavior, thoughts or feelings.
- Keep all follow-up visits with the healthcare provider as scheduled. Call
the healthcare provider between visits as needed, especially if you have
concerns about symptoms.
Call a healthcare provider right away if you or your family
member has any of the following symptoms, especially if they are new, worse or
worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling very agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- or other unusual changes in behavior or mood
What else do I need to know about antidepressant
medicines?
-
Never stop an antidepressant medicine without first talking
to a healthcare provider. Stopping an antidepressant medicine suddenly
can cause other symptoms.
-
Antidepressants are medicines used to treat depression and
other illnesses. It is important to discuss all the risks of treating
depression and also the risks of not treating it. Patients and their families or
other caregivers should discuss all treatment choices with the healthcare
provider, not just the use of antidepressants.
-
Antidepressant medicines have other side effects.
Talk to the healthcare provider about the side effects of the medicine
prescribed for you or your family member.
-
Antidepressant medicines can interact with other
medicines. Know all of the medicines that you or your family member
takes. Keep a list of all medicines to show the healthcare provider. Do not
start new medicines without first checking with your healthcare provider.
-
Not all antidepressant medicines prescribed for children
are FDA approved for use in children. Talk to your child’s healthcare
provider for more information.
What is fluoxetine?
Fluoxetine is a prescription medicine used:
- for short and long-term treatment of depression in adults and children over
the age of 8.
- for short and long-term treatment of obsessive compulsive disorder (OCD) in
adults and children over the age of 7.
- for short and long-term treatment of bulimia nervosa in adults.
- for short-term treatment of panic disorder, with or without agoraphobia, in
adults.
- with the medicine olanzapine (Zyprexa®†), for the
short-term treatment of episodes of depression that happen with bipolar I
disorder.
It is not known if fluoxetine and olanzapine (Zyprexa®†) taken together is safe and works in children under 18 years
of age.
The symptoms of depression (major depressive disorder and bipolar I disorder)
include decreased mood, decreased interest, increased guilty feelings, decreased
energy, decreased concentration, changes in appetite and suicidal thoughts or
behavior. With treatment, some of your symptoms of depression may improve.
OCD is an anxiety disorder and is characterized by recurrent, unwanted
thoughts (obsessions) and/or repetitive behaviors (compulsions). With treatment,
some of your symptoms of OCD may improve.
Panic disorder is an anxiety disorder that includes panic attacks, which are
sudden feelings of terror for no reason. You may also have physical symptoms,
such as; fast heartbeat, chest pain, breathing difficulty, dizziness. With
treatment, some of your symptoms of panic disorder may improve.
Bulimia nervosa, involves periods of overeating followed by purging (e.g.
vomiting, excessive laxative use). With treatment, some of your symptoms of
bulimia nervosa may improve.
If you do not think you are getting better, call your doctor.
Who should not take fluoxetine?
What should I tell my doctor before taking fluoxetine?
Fluoxetine may not be right for you. Before starting fluoxetine, tell your
doctor about all your medical conditions, including if you have or had any of
the following:
- seizures (convulsions)
- bipolar disorder (mania)
- are pregnant or plan to become pregnant. It is not known if fluoxetine will
harm your unborn baby.
- are breast-feeding or plan to breast-feed. Fluoxetine can pass into your
breast milk and may harm your baby. You should not breast-feed while taking
fluoxetine. Talk to your doctor about the best way to feed your baby if you take
fluoxetine.
Tell your doctor about all the medicines that you
take, including prescription and non-prescription medicines, vitamins and
herbal supplements. Fluoxetine and some medicines may interact with each other
and may not work as well, or cause possible serious side effects. Your doctor
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
doctor first.
If you take fluoxetine, you should not take any other
medicines that contain fluoxetine hydrochloride:
- Symbyax®†
- Sarafem®†
- Prozac Weekly®†
You could take too much medicine (overdose).
How should I take fluoxetine?
- Take fluoxetine exactly as prescribed. Your doctor may need to change
(adjust) the dose of fluoxetine until it is right for you.
- 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.
-
To prevent serious side effects, do not stop taking
fluoxetine suddenly. If you need to stop taking fluoxetine, your doctor can tell
you how to safely stop taking it.
-
If you take too much fluoxetine, call your doctor or poison
control center right away, or get emergency treatment.
- Fluoxetine can be taken with or without food.
- Fluoxetine is usually taken once a day, depending on how your doctor
prescribes your medicine.
- If you do not think you are getting better or have any concerns about your
condition while taking fluoxetine, call your doctor.
What should I avoid while taking fluoxetine?
- Fluoxetine can cause sleepiness and 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.
What are the possible side effects of fluoxetine?
Fluoxetine may be associated with the following serious
risks:
-
Serotonin Syndrome: This is a condition that can be
life threatening. Call your doctor right away if you become severely ill and
have some or all of these symptoms:
- agitation
- hallucinations
- problems with coordination
- racing heart beat
- over-active reflexes
- fever
- nausea, vomiting and diarrhea
-
Severe allergic reactions: Tell your doctor right
away if you get red itchy welts (hives) or, a rash alone or with fever and joint
pain, while taking fluoxetine. Call your doctor right away if you become
severely ill and have some or all of these symptoms:
- swelling of your face, eyes or mouth
- trouble breathing
-
Abnormal bleeding: Tell your doctor if you notice
any increased or unusual bruising or bleeding while taking fluoxetine,
especially if you take one of these medicines:
- the blood thinner warfarin (Coumadin®†, Jantoven®†)
- a non-steroidal anti-inflammatory drug (NSAID)
- aspirin
-
Mania: You may have a high mood, become extremely
irritable, have too much energy, feel pressure to keep talking or have a
decreased need for sleep.
-
Seizures
-
Loss of appetite
-
Low salt (sodium) levels in the blood
(hyponatremia): Call your doctor right away if you become severely ill
and have some or all of these symptoms:
- headache
- feel weak
- confusion
- problems concentrating
- memory problems
- feel unsteady
Common possible side effects of fluoxetine include:
abnormal dreams, orgasm problems, decreased appetite, anxiety, weakness,
diarrhea, dry mouth, indigestion, flu, difficulty maintaining an erection for
sexual activity, trouble sleeping, decreased sex drive, feeling sick to your
stomach, nervousness, sore throat, rash, watery nasal discharge, sleepiness,
sweating, tremor (shakes), hot flashes and yawn.
Tell your doctor about any side effect that bothers you or that does not go
away.
These are not all the possible side effects with fluoxetine. For more
information, ask your doctor 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 fluoxetine capsules?
- Store fluoxetine capsules at 20° to 25°C (68° to 77°F). [See USP Controlled
Room Temperature.]
- 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 capsules. If you would like more information, talk with your doctor.
You can ask your doctor or pharmacist for information about fluoxetine that was
written for healthcare professionals. For more information about fluoxetine call
Mylan Pharmaceuticals Inc. at 1-877-446-3769 (1-877-4-INFO-RX).
What are the ingredients in fluoxetine capsules?
Active ingredients: fluoxetine hydrochloride, USP
Inactive ingredients: colloidal silicon dioxide,
magnesium stearate, pregelatinized starch and sodium lauryl sulfate. In
addition, each of the empty gelatin capsules contains gelatin, sodium lauryl
sulfate and titanium dioxide and the following colorant agents: 10 mg – FD&C
Red No. 40; the 20 mg – FD&C Blue No. 1 and FD&C Red No. 40; and the 40
mg – FD&C Blue No. 1 and FD&C Red No. 3. The imprinting ink contains the
following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue
No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40
Aluminum Lake, propylene glycol and shellac glaze.
† The brand names mentioned in this Medication Guide
are registered trademarks of their respective manufacturers.
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505
JULY 2009
MG:FLUX:R1
Physicians Total Care, Inc.