FLUVOXAMINE MALEATE- fluvoxamine maleate capsule, extended release
Bionpharma Inc.
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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 aboutfluvoxamine maleate extended-release capsules?
Fluvoxamine maleate extended-release capsules are 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 capsulesmay 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 maleate extended-release capsules, may cause sexual problems.
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 takingfluvoxamine maleate extended-release capsules without first talking to your healthcare provider.Stopping fluvoxamine maleate extended-release capsules may cause serious symptoms, including:
What arefluvoxamine maleate extended-release capsules?
Fluvoxamine maleate extended-release capsules are 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 capsules treatment.
Who should not takefluvoxamine maleate extended-release capsules?
Do not take fluvoxamine maleate extended-release capsules if you:
What should I tell my healthcare provider before takingfluvoxamine 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 takefluvoxamine maleate extended-release capsules?
What should I avoid while takingfluvoxamine 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 offluvoxamine maleate extended-release capsules?
Fluvoxamine maleate extended-release capsules 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 storefluvoxamine maleate extended-release capsules?
Keepfluvoxamine maleate extended-release capsules and all medicines out of the reach of children.
General information aboutfluvoxamine 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 it was 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 1-888-235-BION or 1-888-235-2466.
What are the ingredients influvoxamine maleate extended-release capsules?
Active ingredient:fluvoxamine maleate, USP
Inactive ingredients: D&C Red 28, ethylcellulose, FD&C Blue 1, gelatin, hydroxypropyl cellulose, hypromellose, povidone, sugar spheres, triethyl citrate, and titanium dioxide. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.
Distributed by:
Bionpharma Inc.
Princeton, NJ 08540
MADE IN INDIA
Revised: October 2023
FDA-06
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Brands listed are the trademarks of their respective owners.
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