Milnacipran is not used to treat depression, but it belongs to the same class of medications as many antidepressants. Before you take milnacipran, you should be aware of the risks of taking antidepressants because taking milnacipran may carry similar risks. During clinical studies, this type of antidepressant (‘mood elevator’) caused a small number of children, teenagers, and young adults (up to 24 years of age) to become suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should be treated with an antidepressant or antidepressant-like medication. Children younger than 18 years of age should not normally take milnacipran, but in some cases, a doctor may decide that milnacipran is the best medication to treat a child’s condition.

You should know that your mental health may change in unexpected ways when you take milnacipran even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied, abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking milnacipran, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with milnacipran. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

No matter what your age, before you take an antidepressant, you or your caregiver should talk to your doctor about the risks and benefits of treating your condition with milnacipran or with other treatments. You should also talk about the risks and benefits of not treating your condition. Although taking milnacipran or similar medications may increase the risk that you will become suicidal, you should know that there are other things that also increase this risk. If you have depression or another mental illness, there is a greatly increased risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited), mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Milnacipran is used to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Milnacipran is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amount of serotonin and norepinephrine, natural substances that help stop the movement of pain signals in the brain.

Warnings/Precautions:

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor closely for clinical worsening or unusual changes in all patients. Monitor for serotonin syndrome; discontinue if occurs. Substantial alcohol abuse, chronic liver disease, end stage renal disease: not recommended. Hypertension. Heart disease. Arrhythmias. Monitor BP and HR prior to starting therapy and periodically thereafter; reduce dose or discontinue if elevation is sustained. Seizure disorder. Mania. Severe hepatic dysfunction. Discontinue if jaundice or liver dysfunction occurs. Moderate renal impairment. Volume depleted. Hyponatremia risk (esp. in elderly). History of dysuria. GU obstruction. Risk of bleeding. Controlled narrow-angle glaucoma. Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Pregnancy (Cat.C; see full labeling for effects on fetus). Nursing mothers.

Milnacipran is a serotonin-norepinephrine reuptake inhibitor (SNRI). Exactly how milnacipran works to treat fibromyalgia is not known. It may work by restoring the balance of certain natural substances in the brain (serotonin and norepinephrine).

Do NOT use milnacipran if:

• you are allergic to any ingredient in milnacipran
• you have end-stage kidney disease
• you are taking linezolid or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Milnacipran comes as a tablet to be taken by mouth. It is usually taken two times a day. Milnacipran may be taken with or without food, but taking it with food will decrease the chance that milnacipran will upset your stomach. Take milnacipran at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take milnacipran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will start you on a low dose of milnacipran and gradually increase your dose during the first week of treatment.

Milnacipran may help control the symptoms of fibromyalgia, but will not cure it. Do not stop taking milnacipran without talking to your doctor. If you suddenly stop taking milnacipran, you may experience withdrawal symptoms such as mood changes, irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, confusion, headache, tiredness, difficulty falling asleep or staying asleep, ringing in the ears, abnormal excitement, or seizures. Your doctor will probably decrease your dose gradually.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking milnacipran,

• tell your doctor and pharmacist if you are allergic to milnacipran, any other medications, or any of the ingredients in milnacipran tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take milnacipran. If you stop taking milnacipran, your doctor may tell you that you should wait at least 5 days before you start to take an MAO inhibitor.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, or herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); buspirone; clonidine (Catapres); digoxin (Lanoxicaps, Digitek, Lanoxin); diuretics (‘water pills’); epinephrine (Epipen, Primatene Mist); fentanyl (Abstral, Actiq, Fentora, Onsolis, others); lithium (Eskalith, Lithobid); medications for anxiety, mental illness, pain, or seizures; medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); sedatives; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sleeping pills; tramadol; tranquilizers; selective serotonin/norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta), desvenlafaxine (Pristiq), and venlafaxine (Effexor); and tricyclics antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what nutritional supplements and herbal products you are taking, especially St. John’s wort and tryptophan.
• tell your doctor if you have glaucoma (increased pressure in the eye that may lead to vision loss). Your doctor will probably tell you not to take milnacipran.
• tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had high blood pressure; seizures; an irregular heartbeat; an enlarged or inflamed prostate (a male reproductive gland); difficulty urinating; bleeding problems; or heart, kidney, or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking milnacipran, call your doctor. Milnacipran may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking milnacipran.
• you should know that milnacipran may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• talk to your doctor about the safe use of alcoholic beverages while you are taking milnacipran.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Milnacipran may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• constipation
• stomach pain
• weight loss
• dry mouth
• feeling of extreme facial warmth and/or redness
• headache
• blurred vision
• decreased sexual desire or ability
• pain or swelling of the testicles
• difficulty urinating
• rash
• itching

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• hallucinations (seeing things or hearing voices that do not exist)
• confusion
• difficulty concentrating
• memory problems
• sweating or fever
• diarrhea
• dizziness
• uncontrollable shaking of a part of the body
• severe muscle stiffness
• weakness
• unsteady walking that may cause falling
• seizures
• fainting
• coma (loss of consciousness for a period of time)
• slowed or stopped breathing
• fast or pounding heartbeat
• difficulty breathing
• extreme tiredness
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms
• black and tarry stools
• red blood in stools
• bloody vomit
• vomit that looks like coffee grounds
• unusual bleeding or bruising
• nosebleeds
• tiny red spots directly under the skin

Milnacipran may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• extreme sleepiness
• confusion
• dizziness
• coma (loss of consciousness for a period of time)
• slowed or stopped heartbeat and breathing

Keep all appointments with your doctor. Your doctor will check your blood pressure and pulse regularly during your treatment with milnacipran.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.