| Levomilnacipran (lee” voe mil na’ si pran) Extended-Release Capsules |
|
What is the most important information I should know about levomilnacipran extended-release capsules?
Levomilnacipran extended-release capsules may cause serious side effects, including:
-
Increased risk of suicidal thoughts and actions. Levomilnacipran extended-release capsules and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years and younger, especially within the first few months of treatment or when the dose is changed. Levomilnacipran extended-release capsules are not for use in children.
-
Depression or other mental illnesses are the most important causes of suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions?
- Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
- Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call your healthcare provider or get emergency medical help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
|
- attempts to commit suicide
|
- acting on dangerous impulses
|
- acting aggressive, being angry or violent
|
- thoughts about suicide or dying
|
|
|
|
|
|
- feeling very agitated or restless
|
- new or worse irritability
|
|
- an extreme increase in activity or talking (mania)
|
- other unusual changes in behavior or mood
|
|
What are levomilnacipran extended-release capsules?
Levomilnacipran extended-release capsules are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults.
It is not known if levomilnacipran extended-release capsules are safe and effective for use in children.
It is not known if levomilnacipran extended-release capsules are safe and effective for the management of fibromyalgia. Levomilnacipran extended-release capsules are not for use for the management of fibromyalgia. |
|
Do not take levomilnacipran extended-release capsules if you:
- are allergic to levomilnacipran, milnacipran HCl, or any of the ingredients in levomilnacipran extended-release capsules. See the end of this Medication Guide for a complete list of ingredients in levomilnacipran extended-release capsules.
- are taking or have taken within the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue.
Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.
Do not start taking an MAOI for at least 7 days after you stop treatment with levomilnacipran extended-release capsules.
|
|
Before taking levomilnacipran extended-release capsules, tell your healthcare provider about all your medical conditions, including if you:
- have or have a family history of suicide, depression, bipolar disorder, mania, or hypomania
- have high blood pressure
- have or had heart problems, including fast heartbeat, or stroke
- have or had bleeding problems
- have glaucoma (high pressure in the eye)
- have or had problems urinating (hesitation) or emptying your bladder (retention)
- have or had seizures (convulsions)
- have low sodium levels in your blood
- have or had kidney problems
- drink alcohol
- are pregnant or plan to become pregnant. Levomilnacipran extended-release capsules may harm your unborn baby. Taking levomilnacipran extended-release capsules during your third trimester of pregnancy may cause you to have an increased risk of bleeding after your delivery and may also cause your baby to be at increased risk for withdrawal symptoms, or breathing, temperature control, feeding or other problems at birth. Talk to your healthcare provider about the risks to you and your baby if you take levomilnacipran extended-release capsules during pregnancy.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with levomilnacipran extended-release capsules.
- There is a pregnancy registry for women who are exposed to levomilnacipran extended-release capsules during pregnancy. The purpose of the registry is to collect information about the health of women exposed to levomilnacipran extended-release capsules and their baby. If you become pregnant during treatment with levomilnacipran extended-release capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. It is not known if levomilnacipran passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with levomilnacipran extended-release capsules.
- If you breastfeed during treatment with levomilnacipran extended-release capsules, call your healthcare provider if your baby develops sleepiness or fussiness, or is not feeding or gaining weight well.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Levomilnacipran extended-release capsules and other medicines may affect each other causing possible serious side effects.
Levomilnacipran extended-release capsules may affect the way other medicines work and other medicines may affect the way levomilnacipran extended-release capsules works.
Especially tell your healthcare provider if you take:
- MAOIs
- medicines used to treat migraine headache known as triptans
- tricyclic antidepressants
- lithium
- tramadol, fentanyl, meperidine, methadone, or other opioids
- tryptophan
- buspirone
- amphetamines
- St. John’s Wort
- medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) and warfarin
- diuretics
- medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take levomilnacipran extended-release capsules with your other medicines.
Do not start or stop any other medicines during treatment with levomilnacipran extended-release capsules without talking to your healthcare provider first. Stopping levomilnacipran extended-release capsules suddenly may cause you to have serious side effects. See, “What are the possible side effects of levomilnacipran extended-release capsules?”
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
|
|
How should I take levomilnacipran extended-release capsules?
- Take levomilnacipran extended-release capsules exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking levomilnacipran extended-release capsules without first talking to your healthcare provider.
- Your healthcare provider may need to change the dose of levomilnacipran extended-release capsules until it is the right dose for you.
- Take levomilnacipran extended-release capsules one time each day at about the same time each day.
- Take levomilnacipran extended-release capsules with or without food.
- Swallow levomilnacipran extended-release capsules whole. Do not open, chew, or crush the levomilnacipran extended-release capsules.
- If you miss a dose of levomilnacipran extended-release capsules, 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 2 doses of levomilnacipran extended-release capsules at the same time.
- If you take too much levomilnacipran extended-release capsules, call your healthcare provider or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
|
|
What should I avoid while taking levomilnacipran extended-release capsules?
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how levomilnacipran extended-release capsules affects you. Levomilnacipran extended-release capsules can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.
- Avoid drinking alcohol during treatment with levomilnacipran extended-release capsules.
|
|
What are the possible side effects of levomilnacipran extended-release capsules?
Levomilnacipran extended-release capsules may cause serious side effects, including:
- See “What is the most important information I should know about levomilnacipran extended-release capsules?”
-
Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when levomilnacipran extended-release capsules is taken with certain other medicines. See “Do not take levomilnacipran extended-release capsules if you.” Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
|
|
|
- seeing or hearing things that are not real (hallucinations)
|
|
|
|
|
|
|
|
|
|
|
|
- high body temperature (hyperthermia)
|
- tremors, stiff muscles, or muscle twitching
|
|
|
|
- nausea, vomiting, diarrhea
|
-
High blood pressure (hypertension). Your healthcare provider should check your blood pressure before you start and during treatment with levomilnacipran extended-release capsules. If you have high blood pressure, it should be controlled before you start treatment with levomilnacipran extended-release capsules.
-
Increased heart rate. Your healthcare provider should check your heart rate before you start and during treatment with levomilnacipran extended-release capsules. If you have heart problems or problems with an abnormal heartbeat, your problems should be treated before you start treatment with levomilnacipran extended-release capsules.
-
Increased risk of bleeding. Taking levomilnacipran extended-release capsules with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
-
Eye problems (angle-closure glaucoma). Levomilnacipran extended-release capsules, may cause a type of eye problem called angle-closure glaucoma in people with certain eye problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have changes in your vision, eye pain, or swelling or redness in or around the eye.
-
Problems with urination. Levomilnacipran extended-release capsules may cause you to have problems with urination including decreased urine flow and being unable to pass any urine. Tell your healthcare provider if you develop any problems with urine flow during treatment with levomilnacipran extended-release capsules.
-
Manic episodes. Manic episodes may happen in people with bipolar disorder who take levomilnacipran extended-release capsules. Symptoms may include:
|
|
|
|
|
|
|
|
|
- excessive happiness or irritability
|
- talking more or faster than usual
| |
-
Discontinuation syndrome. Suddenly stopping levomilnacipran extended-release capsules may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
|
|
|
|
- irritability and agitation
|
|
|
|
|
- electric shock sensation (paresthesia)
|
|
|
|
- ringing in your ears (tinnitus)
|
|
|
|
|
|
|
|
|
|
|
|
- weakness and unsteadiness on your feet which can lead to falls
| |
|
In more severe or more sudden cases, signs and symptoms include:
|
- hallucinations (seeing or hearing things that are not real)
|
|
|
|
|
- stopping breathing (respiratory arrest)
| |
-
Sexual problems (dysfunction). Taking levomilnacipran extended-release capsules, 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 levomilnacipran extended-release capsules. There may be treatments your healthcare provider can suggest.
The most common side effects of levomilnacipran extended-release capsules, include:
|
|
|
- problems getting or keeping an erection
|
|
|
- delayed ejaculation or inability to have an ejaculation
|
|
|
|
|
|
- fast or irregular heartbeat (palpitations)
|
|
These are not all the possible side effects of levomilnacipran extended-release capsules.
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 levomilnacipran extended-release capsules?
- Store levomilnacipran extended-release capsules at room temperature between 68° to 77°F (20° to 25°C).
-
Keep levomilnacipran extended-release capsules and all medicines out of the reach of children.
|
|
General information about the safe and effective use of levomilnacipran extended-release capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levomilnacipran extended-release capsules for a condition for which it was not prescribed. Do not give levomilnacipran extended-release capsules to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about levomilnacipran extended-release capsules that is written for healthcare professionals.
|
|
What are the ingredients in levomilnacipran extended-release capsules?
Active ingredient: levomilnacipran hydrochloride
Inactive ingredients: ethylcellulose, hypromellose, povidone, red iron oxide (80 mg and 120 mg), sugar sphere [sucrose, starch (Biological source: maize) and purified water], talc, triethyl citrate, titanium dioxide and yellow iron oxide (20 mg and 40 mg).
Each capsule is imprinted with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.
For more information, go to www.amneal.com or call 1-877-835-5472.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382220, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 11-2023-04
|