Milnacipran

IMPORTANT WARNING:

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/ucm085729.htm.

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.

WHY is this medicine prescribed?

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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Milnacipran comes as a tablet to be taken by mouth. The first dose of milnacipran is usually taken once on day 1 of therapy. After that, 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. Your doctor will probably decrease your dose gradually. 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. Tell your doctor if you experience any of these symptoms when your dose of milnacipran is decreased.

What SPECIAL PRECAUTIONS should I follow?

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: amphetamines such as amphetamine (in Adderall, in Mydayis), dextroamphetamine (Dexedrine, in Adderall), and methamphetamine (Desoxyn); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); buspirone; clonidine (Catapres); digoxin (Lanoxin); diuretics ('water pills'); epinephrine (Epipen, Primatene Mist); fentanyl (Actiq, Duragesic, Fentora, Subsys); lithium (Lithobid); medications for anxiety, mental illness, pain, or seizures; medications for migraine headaches such as almotriptan, 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, in Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sleeping pills; tramadol (Conzip, Qdola, Ultram, in Ultracet); tranquilizers; selective serotonin/norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta), desvenlafaxine (Pristiq), and venlafaxine (Effexor); and tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine. 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 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; low sodium levels in the blood; 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.

• you should know that milnacipran may make you drowsy and may affect your judgment, thinking, and movements. 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.

• you should know that milnacipran may cause high blood pressure. Your blood pressure and pulse (heart rate) should be checked before starting treatment and regularly while you are receiving milnacipran.

• you should know that milnacipran may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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
• extreme tiredness
• lack of energy
• loss of appetite
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
• 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 or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, nausea, vomiting, or diarrhea
• 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)
• fast or irregular heartbeat
• difficulty breathing
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• dark colored urine
• 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).

What should I know about STORAGE and DISPOSAL of this medication?

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 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

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

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.