Fluvoxamine Maleate (Page 11 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fluvoxamine Maleate Tablets USP are available in the following strengths, colors, imprints, and presentations:

Tablets 25 mg: unscored, white, elliptical, film-coated (debossed “1222” on one side)
Bottles of 100 ……………………………………………………NDC 62559-158-01

Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “1225” on one side and scored on the other)
Bottles of 100 ……………………………………………………NDC 62559-159-01

Tablets 100 mg: scored, beige, elliptical, film-coated (debossed “1221” on one side and scored on the other)
Bottles of 100 ……………………………………………………NDC 62559-160-01

Keep out of reach of children.

Fluvoxamine Maleate Tablets should be protected from high humidity and stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in tight containers.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Fluvoxamine Maleate Tablets and should counsel them in the appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for Fluvoxamine Maleate Tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Fluvoxamine Maleate Tablets.

Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate the need for very close monitoring and possibly changes in the medication [see Boxed Warning, Warnings and Precautions (5.1)].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome particularly with the concomitant use of fluvoxamine with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) [see Warnings and Precautions (5.2)].

Angle Closure Glaucoma

Patients should be advised that taking Fluvoxamine Maleate Tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.3)].

Interference with Cognitive or Motor Performance

Since any psychoactive drug may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain that Fluvoxamine Maleate Tablets therapy does not adversely affect their ability to engage in such activities.

Pregnancy

Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Fluvoxamine Maleate Tablets.
Advise patients that Fluvoxamine Maleate Tablets use late in pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).
Advise women that there is a risk of relapse with discontinuation of antidepressants.
Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Fluvoxamine Maleate Tablets during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise breastfeeding women using Fluvoxamine Maleate Tablets to monitor infants for diarrhea, vomiting, decreased sleep, and agitation and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].

Concomitant Medication

Patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for clinically important interactions with Fluvoxamine Maleate Tablets.

Patients should be cautioned about the concomitant use of fluvoxamine and NSAIDs, aspirin, or other drugs that affect coagulation since the combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions (5.8)].

Because of the potential for the increased risk of serious adverse reactions including severe lowering of blood pressure and sedation when fluvoxamine and tizanidine are used together, fluvoxamine should not be used with tizanidine [see Warnings and Precautions (5.5)].

Because of the potential for the increased risk of serious adverse reactions when fluvoxamine and alosetron are used together, fluvoxamine should not be used with LotronexTM (alosetron) [see Warnings and Precautions (5.7)].

Sexual Dysfunction

Advise patients that use of Fluvoxamine Maleate Tablets may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.16)].

Alcohol

As with other psychotropic medications, patients should be advised to avoid alcohol while taking Fluvoxamine Maleate Tablets.

Allergic Reactions

Patients should be advised to notify their physicians if they develop a rash, hives, or a related allergic phenomenon during therapy with Fluvoxamine Maleate Tablets.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of ANI Pharmaceuticals, Inc.

Manufactured by:
ANI Pharmaceuticals Canada, Inc.
Oakville, ON L6H 1M5
Canada

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
Logo

MEDICATION GUIDE

Fluvoxamine (Flu VOX ah meen) Maleate Tablets

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

What is the most important information I should know about Fluvoxamine Maleate Tablets?

Fluvoxamine is the same kind of medicine as those used to treat depression and may cause serious side effects, including:

1. Suicidal thoughts or actions:

Fluvoxamine Maleate Tablets and 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 Fluvoxamine Maleate Tablets 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

Tell your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Fluvoxamine Maleate Tablets 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

3. 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.

4. 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

5. Abnormal bleeding: Fluvoxamine Maleate Tablets and antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin® , Jantoven®), or a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen, naproxen, or aspirin).

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. Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including Fluvoxamine Maleate Tablets, may cause sexual problems.

Symptoms in males may include:
Delayed ejaculation or inability to have an ejaculation
Decreased sex drive
Problems getting or keeping an erection
Symptoms in females may include:
Decreased sex drive
Delayed orgasm or inability to have an orgasm

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 Tablets. There may be treatments your healthcare provider can suggest.

Do not stop Fluvoxamine Maleate Tablets without first talking to your healthcare provider.

Stopping Fluvoxamine Maleate Tablets 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 are Fluvoxamine Maleate Tablets?

Fluvoxamine Maleate Tablets are a prescription medicine used to treat obsessive compulsive disorder (OCD). 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 Tablets treatment.

Who should not take Fluvoxamine Maleate Tablets?

Do not take Fluvoxamine Maleate Tablets if you:

are allergic to fluvoxamine maleate or any of the ingredients in Fluvoxamine Maleate Tablets. See the end of this Medication Guide for a complete list of ingredients in Fluvoxamine Maleate Tablets.
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 2 weeks of stopping Fluvoxamine Maleate Tablets unless directed to do so by your physician.
Do not start Fluvoxamine Maleate Tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
People who take Fluvoxamine Maleate Tablets 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 2 weeks of stopping Fluvoxamine Maleate Tablets because this can cause serious heart rhythm problems or sudden death.
take Orap® (pimozide) because taking this drug with Fluvoxamine Maleate Tablets can cause serious heart rhythm problems or sudden death.
take Zanaflex® (tizanidine). Fluvoxamine Maleate Tablets could increase the amount of Zanaflex in your body, which could increase its actions and side effects. This could include drowsiness and a drop in blood pressure and affecting how well you do things that require alertness.
Take Lotronex® (alosetron). Fluvoxamine Maleate Tablets may increase the amount of Lotronex in your body, which could increase its actions and side effects.

What should I tell my healthcare provider before taking Fluvoxamine Maleate Tablets? Ask if you are not sure.
Before starting Fluvoxamine Maleate Tablets, tell your healthcare provider if you:

Are taking certain drugs such as:
Monoamine oxidase inhibitors (MAOIs) such as Emsam® (selegiline), Nardil® (phenelzine), or Parnate® (tranylcypromine)
Mellaril ® (thioridazine): used to treat mental or mood problems
Zanaflex® (tizanidine): used to treat spasticity (a condition in which muscles keep tightening and cramping)
Orap® (pimozide): used to treat Tourette Syndrome (a brain condition causing tics)
Lotronex® (alosetron): used to treat a condition with diarrhea, continuing stomach pain, cramps, and bloating
Triptans: used to treat migraine headache
Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, or antipsychotics
Tramadol: used to reduce pain
Benzodiazepines: used to reduce anxiety, stress, emotional upset, or seizures; helps you sleep; helps with alcohol withdrawal; reduces restlessness; and relaxes muscles
Methadone: used to relieve pain or to help with addiction
Clozapine: used to treat mental disorders
Mexiletine: used to treat abnormalities in heart rhythm
Theophylline: used to treat swollen air passages in your lungs, to relax the muscles in your chest to ease shortness of breath, often to treat asthma
Warfarin and other drugs that affect how your blood clots
Diuretics to treat high blood pressure, congestive heart failure, or swelling
Over-the-counter supplements such as tryptophan or St. John’s Wort
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. Talk to your healthcare provider about the risk to your unborn baby if you take Fluvoxamine Maleate Tablets.
Talk to your healthcare provider about the benefits and risks of treating OCD during pregnancy.
If you become pregnant during treatment with Fluvoxamine Maleate Tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185.
are breast-feeding or plan to breast-feed. Fluvoxamine Maleate Tablets pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Fluvoxamine Maleate Tablets.

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

If you take Fluvoxamine Maleate Tablets, you should not take any other medicines that contain fluvoxamine including: LUVOX CR®

How should I take Fluvoxamine Maleate Tablets?

Take Fluvoxamine Maleate Tablets exactly as prescribed. Your healthcare provider may need to change the dose of Fluvoxamine Maleate Tablets until it is the right dose for you.
Fluvoxamine Maleate Tablets may be taken with or without food.
If you miss a dose of Fluvoxamine Maleate 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 Fluvoxamine Maleate Tablets at the same time.
If you take too much Fluvoxamine Maleate Tablets, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking Fluvoxamine Maleate Tablets?

Fluvoxamine Maleate 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 Fluvoxamine Maleate Tablets affects you. Do not drink alcohol while using Fluvoxamine Maleate Tablets.

What are the possible side effects of Fluvoxamine Maleate Tablets?

Fluvoxamine Maleate Tablets may cause serious side effects, including:

See “What is the most important information I should know about Fluvoxamine Maleate Tablets?”
Feeling anxious or trouble sleeping

Common possible side effects in people who take Fluvoxamine Maleate Tablets include:

nausea
sleepiness
weakness
indigestion
sweating
loss of appetite
shaking
vomiting
delayed ejaculation
inability to have an orgasm
decreased sex drive
dry mouth
stuffy nose
unusual taste
frequent urination

Other side effects in children and adolescents include:

agitation or abnormal increase in activity
feeling depressed or sad
excessive gas
heavy menstrual periods
rash
possible slowed growth rate and weight change

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

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS at 1-800-308-6755 or FDA at 1-800-FDA-1088.

How should I store Fluvoxamine Maleate Tablets?

Store Fluvoxamine Maleate Tablets at room temperature between 59°F to 86°F (15°C to 30°C).

Keep Fluvoxamine Maleate Tablets away from high humidity.
Keep Fluvoxamine Maleate Tablets bottle closed tightly.

Keep Fluvoxamine Maleate Tablets and all medicines out of the reach of children.

General information about Fluvoxamine Maleate Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Fluvoxamine Maleate Tablets for a condition for which it was not prescribed. Do not give Fluvoxamine Maleate Tablets 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 Tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Fluvoxamine Maleate Tablets that is written for healthcare professionals.

For more information about Fluvoxamine Maleate Tablets call toll free at 1-800-308-6755 or go to www.anipharmaceuticals.com.

What are the ingredients in Fluvoxamine Maleate Tablets?

Active ingredient: Fluvoxamine maleate

Inactive ingredients:

The 25 mg tablets: mannitol, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (potato), silicon dioxide, sodium stearyl fumarate, starch (corn), talc, and titanium dioxide.

The 50 mg and 100 mg tablets: In addition to the above inactive ingredients, contain synthetic iron oxides.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of ANI Pharmaceuticals, Inc.

Manufactured by:
ANI Pharmaceuticals Canada, Inc.
Oakville, ON L6H 1M5
Canada

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623

N9212A Rev 07/21

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

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