FLUOXETINE- fluoxetine tablet, film coated
NorthStar Rx LLC
(floo ox' e teen)
Read the Medication Guide that comes with fluoxetine tablets 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.
What is the most important information I should know about fluoxetine tablets?
Fluoxetine tablets and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
Fluoxetine tablets 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 tablets and 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:
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:
3. Severe allergic reactions:
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 non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
5. 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.
6. Seizures or convulsions
7. Manic episodes:
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:
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:
Do not stop fluoxetine tablets without first talking to your healthcare provider. Stopping fluoxetine tablets too quickly may cause serious symptoms including:
What are fluoxetine tablets?
Fluoxetine tablets are 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 tablets are used to treat:
*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 tablets?
Do not take fluoxetine tablets if you:
People who take fluoxetine tablets close in time to an MAOI may have serious or even lifethreatening side effects. Get medical help right away if you have any of these symptoms:
What should I tell my healthcare provider before taking fluoxetine tablets?Ask if you are not sure.
Before starting fluoxetine tablets, tell your healthcare provider if you:
Are taking certain drugs such as:
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Fluoxetine tablets 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 tablets with your other medicines. Do not start or stop any medicine while taking fluoxetine tablets without talking to your healthcare provider first.
If you take fluoxetine tablets, you should not take any other medicines that contain fluoxetine hydrochloride including:
How should I take fluoxetine tablets?
Take fluoxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of fluoxetine tablets until it is the right dose for you.
Fluoxetine tablets may be taken with or without food.
If you miss a dose of fluoxetine tablets, 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 tablets at the same time.
If you take too much fluoxetine tablets, call your healthcare provider or poison control center right away, or get emergency treatment.
What should I avoid while taking fluoxetine tablets?
Fluoxetine tablets 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 tablets affects you. Do not drink alcohol while using fluoxetine tablets.
What are the possible side effects of fluoxetine tablets?
Fluoxetine tablets may cause serious side effects, including:
See “What is the most important information I should know about fluoxetine tablets?”
Problems with blood sugar control. People who have diabetes and take fluoxetine tablets may have problems with low blood sugar while taking fluoxetine tablets. High blood sugar can happen when fluoxetine tablets are stopped. Your healthcare provider may need to change the dose of your diabetes medicines when you start or stop taking fluoxetine tablets.
Feeling anxious or trouble sleeping
Common possible side effects in people who take fluoxetine tablets include:
Other side effects in children and adolescents 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 fluoxetine tablets. For more information, ask your healthcare provider or pharmacist.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAYREPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.
How should I store fluoxetine tablets?
Store fluoxetine tablets at 20°C to 25°C (68°F to 77°F).
Keep fluoxetine tablets away from light.
Keep fluoxetine tablets bottle closed tightly.
Keep fluoxetine tablets and all medicines out of the reach of children.
General information about fluoxetine tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine tablets for a condition for which it was not prescribed. Do not give fluoxetine tablets to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about fluoxetine tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluoxetine tablets that is written for healthcare professionals.
For more information about fluoxetine tablets call 1-888-375-6847.
What are the ingredients in fluoxetine tablets?
Active ingredients: fluoxetine hydrochloride USP
Inactive ingredients in tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. In addition, the coating for each tablet contains FD&C Blue #1 (10 mg), hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All brand names listed are the registered trademarks of their respective owners.
Medication Guides available at www.northstarrxllc.com/products or call 1-844-375-6847.
NorthStar Rx LLC
Memphis, TN 38141
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 INDIA