FLUVOXAMINE MALEATE- fluvoxamine maleate capsule, extended release
Actavis Pharma, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Fluvoxamine Maleate (floo vox' a meen mal' ee ate)
Extended-Release Capsules
Read the Medication Guide that comes with fluvoxamine maleate extended-release 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 healthcare provider about your medical condition or treatment. Talk to 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 fluvoxamine maleate extended-release capsules?
Fluvoxamine maleate extended-release is the same kind of medicine as those used to treat depression. These medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
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 in 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 in an emergency. Fluvoxamine maleate extended-release capsules may be associated with these serious side effects:
2. Serotonin Syndrome. This condition can be life-threatening and may include:
3. 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.
4. Severe allergic reactions:
5. Abnormal bleeding: Fluvoxamine maleate extended-release capsules 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.
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. Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including fluvoxamine, may cause sexual problems.
Symptoms in males may include:
Symptoms in females may include:
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with fluvoxamine maleate extended-release capsules. There may be treatments your healthcare provider can suggest.
Do not stop taking fluvoxamine maleate extended-release capsules without first talking to your healthcare provider. Stopping fluvoxamine maleate extended-release capsules may cause serious symptoms, including:
What are fluvoxamine maleate extended-release capsules?
Fluvoxamine maleate extended-release capsules are a prescription medicine used to treat obsessive compulsive disorder (OCD). It is the same kind of drug that is used to treat depression. It is important to talk with your healthcare provider about the risks of treating OCD and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
Talk to your healthcare provider if you do not think that your condition is getting better with fluvoxamine maleate extended-release treatment.
Who should not take fluvoxamine maleate extended-release capsules?
Do not take fluvoxamine maleate extended-release capsules if you:
People who take fluvoxamine maleate extended-release capsules 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:
What should I tell my healthcare provider before taking fluvoxamine maleate extended-release capsules? Ask if you are not sure.
Before starting fluvoxamine maleate extended-release capsules, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Fluvoxamine maleate extended-release capsules 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 fluvoxamine maleate extended-release capsules with your other medicines. Do not start or stop any medicine while taking fluvoxamine maleate extended-release capsules without talking to your healthcare provider first.
If you take fluvoxamine maleate extended-release capsules, you should not take any other medicines that contain fluvoxamine maleate including: Fluvoxamine Maleate Immediate-Release Tablets.
How should I take fluvoxamine maleate extended-release capsules?
What should I avoid while taking fluvoxamine maleate extended-release capsules?
Fluvoxamine maleate extended-release capsules 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 fluvoxamine maleate extended-release capsules affect you. Do not drink alcohol while using fluvoxamine maleate extended-release capsules.
What are the possible side effects of fluvoxamine maleate extended-release capsules?
Fluvoxamine maleate extended-release may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about fluvoxamine maleate extended-release capsules?”
Common possible side effects in people who take fluvoxamine include:
Other side effects in children and adolescents taking fluvoxamine 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 fluvoxamine maleate extended-release capsules. For more information, ask your healthcare provider 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 fluvoxamine maleate extended-release capsules?
Keep fluvoxamine maleate extended-release capsules and all medicines out of the reach of children.
General information about fluvoxamine maleate extended-release capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluvoxamine maleate extended-release capsules for a condition for which they were not prescribed. Do not give fluvoxamine maleate extended-release capsules to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about fluvoxamine maleate extended-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluvoxamine maleate extended-release capsules that is written for healthcare professionals.
For more information about fluvoxamine maleate extended-release capsules, call Teva at 1-888-838-2872.
What are the ingredients in fluvoxamine maleate extended-release capsules?
Active ingredient: fluvoxamine maleate
Inactive ingredients: ammonio methacrylate copolymer, type A, ammonio methacrylate copolymer, type B, black iron oxide, FD&C Blue #1, gelatin, hydroxypropyl cellulose, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, yellow iron oxide. The capsules are imprinted with black Tek-Print ink SW-9008 and SW-9009 which contain black iron oxide, potassium hydroxide, propylene glycol and shellac.
Brands listed are the trademarks of their respective owners.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054
Rev. E 10/2023