Savella 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).

Savella is not used to treat depression but it works similarly to how some antidepressants work.

Savella is used to treat the chronic pain caused by fibromyalgia (a medical condition that causes chronic pain in the muscles and joints).

Do not use Savella if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. After you stop taking milnacipran, you must wait at least 5 days before you start taking an MAOI.

You may have thoughts about suicide when you first start taking Savella, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

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

Avoid drinking alcohol while taking Savella. It may increase your risk of liver damage.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Savella. Milnacipran may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Savella is not approved for use by anyone younger than 18 years old.

Do not stop using Savella without first asking your doctor.

Take Savella exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Tell your doctor if you feel an increased urge to take more of this medicine.

You may take medicine with or without food, but food may help you tolerate the medicine better.

Your blood pressure and heart rate will need to be checked often.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using Savella suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Fibromyalgia:

Maintenance dose: 50 mg orally 2 times a day
Maximum dose: 100 mg orally 2 times a day (200 mg orally per day)

Comments:
-Dosing may be titrated according to the following schedule:
-Initial dose on day 1: 12.5 mg orally once
-Days 2 and 3: 12.5 mg orally 2 times a day
-Days 4 through 7: 25 mg orally 2 times a day
-After day 7: 50 mg orally 2 times a day

Use: Management of fibromyalgia

You should not use Savella if you are allergic to milnacipran.

Savella should not be given to a child younger than 18 years old.

To make sure Savella is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• heart disease, high blood pressure;

• seizures or epilepsy;

• bipolar disorder (manic depression);

• bleeding problems;

• low levels of sodium in your blood;

• sexual problems;

• if you drink alcohol; or

• if you take a blood thinner such as warfarin (Coumadin, Jantoven).

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with milnacipran and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking Savella. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking this medicine during pregnancy may cause serious lung problems or other complications in the baby. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of milnacipran on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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).

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid drinking alcohol.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Savella may cause you to bruise or bleed easily.

Get emergency medical help if you have signs of an allergic reaction to Savella: 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:

• little or no urination;

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

• a seizure;

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

• liver problems - stomach pain (upper right side), itching, dark urine, jaundice (yellowing of the skin or eyes);

• low sodium level - headache, confusion, severe weakness, vomiting, problems with thinking or memory, feeling unsteady; or

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

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Some side effects may be more likely in older adults.

Common Savella side effects may include:

• nausea, vomiting, constipation;

• dry mouth;

• increased blood pressure;

• fast or pounding heartbeats;

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

• headache, dizziness; or

• trouble sleeping.

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.

Using Savella with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with milnacipran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.