Milnacipran

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.

Milnacipran affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia (a medical condition that causes chronic pain in the muscles and joints). Milnacipran is not used to treat depression but it works similarly to how some antidepressants work.

Milnacipran is used to treat the chronic pain caused by fibromyalgia.

Milnacipran may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include extreme drowsiness, slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• pounding heartbeats or fluttering in your chest;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• little or no urinating;

• seizure (convulsions);

• easy bruising or bleeding (nosebleeds), or signs of stomach bleeding (bloody or tarry stools, coughing up blood);

• manic episodes--racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative;

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

Some side effects may be more likely in older adults.

Common side effects may include:

• nausea, vomiting, constipation;

• dry mouth;

• increased sweating, flushing (warmth, redness, or tingly feeling);

• headache, dizziness;

• sleep problems (insomnia); or

• high blood pressure, pounding heartbeat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• If you have an allergy to milnacipran or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have kidney disease.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking milnacipran within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If the patient is a child. Do not give this medicine to a child.

This is not a list of all drugs or health problems that interact with milnacipran.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hot flashes.
• Sweating a lot.
• Headache.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Dry mouth.
• Dizziness.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Milnacipran HCl

Refer to adult dosing.

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Monitor therapy

Alcohol (Ethyl): May enhance the adverse/toxic effect of Serotonin/Norepinephrine Reuptake Inhibitors. Specifically, risks of psychomotor impairment may be enhanced. Alcohol (Ethyl) may enhance the hepatotoxic effect of Serotonin/Norepinephrine Reuptake Inhibitors. Particularly duloxetine and milnacipran. Management: Patients receiving serotonin/norepinephrine reuptake inhibitors (SNRIs) should be advised to avoid alcohol. Monitor for increased psychomotor impairment and hepatotoxicity in patients who consume alcohol during treatment with SNRIs. Consider therapy modification

Alpha-/Beta-Agonists: Serotonin/Norepinephrine Reuptake Inhibitors may enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Consider therapy modification

Alpha2-Agonists: Serotonin/Norepinephrine Reuptake Inhibitors may diminish the antihypertensive effect of Alpha2-Agonists. Exceptions: Apraclonidine. Monitor therapy

Analgesics (Opioid): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Monitor therapy

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Apixaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely. Monitor therapy

Aspirin: Serotonin/Norepinephrine Reuptake Inhibitors may enhance the antiplatelet effect of Aspirin. Monitor therapy

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Monitor therapy

ClomiPRAMINE: May enhance the adverse/toxic effect of Milnacipran. Specifically, the incidence of euphoria and postural hypotension were higher in patients changing from clomipramine to milnacipran. ClomiPRAMINE may enhance the serotonergic effect of Milnacipran. This could result in serotonin syndrome. Management: Coadminister with caution. Monitor more closely for euphoria, postural hypotension, serotonin toxicity/serotonin syndrome, and other adverse events when switching from clomipramine to milnacipran or if these drugs are to be used in combination. Consider therapy modification

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Monitor therapy

Dabigatran Etexilate: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Dabigatran Etexilate. Agents with Antiplatelet Properties may increase the serum concentration of Dabigatran Etexilate. This mechanism applies specifically to clopidogrel. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Monitor therapy

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Avoid combination

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy

Digoxin: Milnacipran may enhance the adverse/toxic effect of Digoxin. The risk of postural hypotension and tachycardia may be increased, particularly with IV digoxin. Management: Avoid concurrent use of intravenous (IV) digoxin in patients receiving milnacipran. Use caution when using oral digoxin and milnacipran together, monitoring closely for possible postural hypotension and tachycardia. Consider therapy modification

Edoxaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Monitor therapy

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Consider therapy modification

Ibritumomab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Monitor therapy

Iobenguane I 123: Serotonin/Norepinephrine Reuptake Inhibitors may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Ioflupane I 123: Serotonin/Norepinephrine Reuptake Inhibitors may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Linezolid: May enhance the serotonergic effect of Serotonin/Norepinephrine Reuptake Inhibitors. This could result in serotonin syndrome. Avoid combination

MAO Inhibitors: May enhance the serotonergic effect of Serotonin/Norepinephrine Reuptake Inhibitors. This may cause serotonin syndrome. While methylene blue and linezolid are expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Exceptions: Linezolid; Methylene Blue; Tedizolid. Avoid combination

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Methylene Blue: Serotonin/Norepinephrine Reuptake Inhibitors may enhance the serotonergic effect of Methylene Blue. This could result in serotonin syndrome. Avoid combination

Methylene Blue: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Monitor therapy

Metoclopramide: May enhance the adverse/toxic effect of Serotonin/Norepinephrine Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving metoclopramide with serotonin/norepinephrine reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

NSAID (Nonselective): Serotonin/Norepinephrine Reuptake Inhibitors may enhance the antiplatelet effect of NSAID (Nonselective). Monitor therapy

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. Monitor therapy

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Rivaroxaban: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Rivaroxaban. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Monitor therapy

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Monitor therapy

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid. Monitor therapy

Tedizolid: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Tositumomab and Iodine I 131 Tositumomab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Tositumomab and Iodine I 131 Tositumomab. Specifically, the risk of bleeding-related adverse events may be increased. Monitor therapy

TraMADol: Serotonin Modulators may enhance the adverse/toxic effect of TraMADol. The risk of seizures may be increased. TraMADol may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Avoid combination

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Milnacipran may enhance the adverse/toxic effect of Vitamin K Antagonists. Specifically, the risk for bleeding may be increased. Monitor therapy

Blood pressure and heart rate should be regularly monitored; renal function should be monitored for dosing purposes; mental status for suicidal ideation (especially at the beginning of therapy or when doses are increased or decreased); intraocular pressure should be monitored in those with baseline elevations or a history of glaucoma

-Mild renal impairment (CrCl 50 to 80 mL/min): No adjustment recommended
-Moderate renal impairment (CrCl 30 to 49 mL/min): Use with caution
-Severe renal impairment (CrCl 5 to 29 mL/min): 25 mg orally twice a day (maintenance dose). Based on individual patient response, the dose may be increased to 50 mg twice a day
-End-stage renal disease: Not recommended

-Mild to moderate hepatic impairment: No adjustment recommended
-Severe hepatic impairment: Use with caution

FDA-Approved Medication Guide

Milnacipran Hydrochloride (mil naʹ si pran hyeʺ droe klorʹ ide) Tablets

Milnacipran HCl tablets are not used to treat depression, but it acts like medicines that are used to treat depression (antidepressants) and other psychiatric disorders.

Read the Medication Guide that comes with Milnacipran HCl 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 Milnacipran HCl tablets?

Milnacipran HCl tablets and antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

• Milnacipran HCl tablets and antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and 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, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when Milnacipran HCl tablets are 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 or go to the nearest hospital emergency room if you 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
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry or irritable
• trouble sleeping (insomnia)
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood

Call your healthcare provider right away or go to the nearest hospital emergency room if you have any symptoms of the serious side effects listed below:

2. Serotonin Syndrome. This condition can be life-threatening, symptoms may include:

• agitation, hallucinations, coma or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• sweating or fever
• diarrhea
• muscle rigidity
• dizziness
• tremor

  Symptoms such as racing heartbeat, high or low blood pressure, nausea, vomiting, and flushing are common with Milnacipran HCl tablets. Call your healthcare provider right away if you get these symptoms and they are severe or if they happen with any of the symptoms of serotonin syndrome listed above.

3. Increase in blood pressure or heart rate: Milnacipran HCl tablets may increase your blood pressure or heart rate. Your blood pressure and heart rate should be checked before you start and during treatment with Milnacipran HCl tablets. Before taking Milnacipran HCl tablets, tell your healthcare provider if you have high blood pressure or problems with your heart or blood vessels (cardiovascular disease).

4. Seizures or convulsions.

5. Liver problems. Symptoms of liver problems may include:

• itching
• right upper abdominal pain
• dark urine
• yellowing of your skin or eyes
• enlarged liver
• increased liver enzymes

6. 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

7. Abnormal bleeding: Milnacipran HCl tablets and other similar medicines (antidepressants) may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a nonsteroidal anti-inflammatory drug (NSAID), or aspirin.

8. 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

9. Problems with urination

• decreased urine flow
• unable to pass any urine

Men may be more likely to have these symptoms, and may develop pain in their testicles or have problems with ejaculation.

10. Visual problems

• eye pain
• changes in vision
• swelling or redness in or around 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.

Do not stop Milnacipran HCl tablets without first talking to your healthcare provider.

Stopping Milnacipran HCl tablets too quickly may cause symptoms, some serious, including:

• anxiety, irritability, or confusion
• feeling tired or problems sleeping
• headache, dizziness, seizures
• electric shock-like sensations, ringing in ears

What are Milnacipran HCl tablets?

Milnacipran HCl tablets are a prescription medicine used to manage fibromyalgia. It is important to talk with your healthcare provider about the risks of treating fibromyalgia and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

It is not known if Milnacipran HCl tablets are safe and effective in children.

Who should not take Milnacipran HCl tablets?

Do not take Milnacipran HCl tablets if you:

• 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 5 days of stopping Milnacipran HCl tablets unless your healthcare provider tells you to.
  • Do not start Milnacipran HCl tablets if you stopped taking an MAOI in the last 14 days unless your healthcare provider tells you to.
  • People who take Milnacipran HCl 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)

What should I tell my healthcare provider before taking Milnacipran HCl tablets?

Before starting Milnacipran HCl tablets, tell your healthcare provider if you:

• have heart problems or high blood pressure
• have liver problems
• have kidney problems
• have or had seizures or convulsions
• have bipolar disorder or mania
• have low sodium levels in your blood
• have or had bleeding problems
• drink alcohol. Talk to your healthcare provider about how often and how much alcohol you drink.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Milnacipran HCl tablets will harm your unborn baby.

• are breastfeeding or plan to breastfeed. Milnacipran HCl can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby while taking Milnacipran HCl tablets.

  Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Milnacipran HCl tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.

  Your healthcare provider or pharmacist can tell you if it is safe to take Milnacipran HCl tablets with your other medicines. Do not start or stop any medicine while taking Milnacipran HCl tablets without talking to your healthcare provider first.

  How should I take Milnacipran HCl tablets?

• Take Milnacipran HCl tablets exactly as your healthcare provider tells you.
• Your healthcare provider will slowly increase your dose to find the dose that is right for you.
  • On the first day of treatment, you will take 1 dose of Milnacipran HCl tablets as prescribed.
  • After your first dose, your healthcare provider will tell you how much Milnacipran HCl tablets to take and when to take it, usually 2 times each day.
• You may take Milnacipran HCl tablets with or without food. Taking Milnacipran HCl tablets with food may help you tolerate it better.
• If you miss a dose, skip the missed dose and take the next dose at your regular time.
• Tell your healthcare provider if you feel that your condition is not improving during treatment with Milnacipran HCl tablets.
• If you take too much Milnacipran HCl tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Milnacipran HCl tablets?

• Do not drive or operate machinery until you know how Milnacipran HCl tablets affect you. Milnacipran HCl tablets may make you less alert and affect your reaction time.

  What are the possible side effects of Milnacipran HCl tablets?

  Milnacipran HCl tablets may cause side effects, some serious, including:

• See “What is the most important information I should know about Milnacipran HCl tablets?”

The most common side effects of Milnacipran HCl tablets include:

• nausea
• headache
• constipation
• dizziness
• trouble sleeping
• hot flush
• increased sweating
• vomiting
• irregular heartbeat (palpitations)
• heart rate increased
• dry mouth
• high blood pressure (hypertension)

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 Milnacipran HCl tablets. 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 store Milnacipran HCl tablets?

• Store at room temperature between 68° to 77°F (20° to 25°C).

Keep Milnacipran HCl tablets and all medicines out of the reach of children.

General information about the safe and effective use of Milnacipran HCl tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Milnacipran HCl tablets for a condition for which it was not prescribed. Do not give Milnacipran HCl tablets to other people, even if they have the same condition. It may harm them.

You may ask your healthcare provider or pharmacist for information about Milnacipran HCl tablets that is written for health professionals.

For more information call 1-877-835-5472 or go to www.amneal.com.

What are the ingredients in Milnacipran HCl tablets?

Active ingredient: Milnacipran hydrochloride

Inactive ingredients: carboxymethylcellulose calcium, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, silicon dioxide and talc.

The film coat contains the inactive ingredients:

12.5 mg tablets: Erythrosine dye, FD&C Blue #1 Aluminum Lake, hypromellose, polyethylene glycol and titanium dioxide

25 mg tablets: Hypromellose, polyethylene glycol, talc and titanium dioxide

50 mg tablets: Hypromellose, polyethylene glycol, talc and titanium dioxide

100 mg tablets: FD&C Red #40 Aluminum Lake, hypromellose, polyethylene glycol, talc and titanium dioxide

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

*All trademarks are the property of their respective owners.

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad 382220, INDIA

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 05-2018-01