Savella is an oral medication containing the active ingredient milnacipran hydrochloride, which is a selective norepinephrine and serotonin reuptake inhibitor. It is available in film-coated tablet form with dosage strengths of 12.5 mg, 25 mg, 50 mg, and 100 mg. The tablets include inactive ingredients such as dibasic calcium phosphate, povidone, and magnesium stearate. Savella is intended to affect neurotransmitter levels by blocking the reuptake of norepinephrine and serotonin, with a stronger effect on norepinephrine.

How should I use this medication?

Take this medication by mouth with a glass of water. You can take it with or without food. If it upsets your stomach, take it with food. Follow the directions on the prescription label. Do not take your medication more often than directed. Do not stop taking this medication suddenly except upon the advice of your care team. Stopping this medication too quickly may cause serious side effects or your condition may worsen. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip that dose and take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding -Heart palpitations—rapid, pounding, or irregular heartbeat -Increase in blood pressure -Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion -Seizures -Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss -Thoughts of suicide or self-harm, worsening mood, or feelings of depression -Trouble passing urine Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Change in sex drive or performance -Constipation -Dizziness -Dry mouth -Excessive sweating -Nausea -Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Bleeding disorder -Frequently drink alcohol -Glaucoma -Heart disease -High blood pressure -Irregular heartbeat -Kidney disease -Liver disease -Mania or bipolar disorder -Prostate disease -Seizures -Suicidal thoughts, plans, or attempt by you or a family member -Taken an MAOIs, such as Marplan, Nardil, and Parnate in the last 14 days -An unusual or allergic reaction to milnacipran, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Desvenlafaxine -Duloxetine -Levomilnacipran -Linezolid -MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate -Methylene blue -Venlafaxine This medication may also interact with the following: -Amphetamines -Aspirin and aspirin-like medications -Clonidine -Digoxin -Epinephrine -Furazolidone -Lithium -Medications for blood pressure -Medications for migraines, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan -Medications that treat or prevent blood clots, such as warfarin, enoxaparin, dalteparin -NSAIDS, medications for pain and inflammation, such as ibuprofen or naproxen -Other medications for mental health conditions -Procarbazine -Rasagiline -St. John's wort -Tramadol -Tryptophan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not get better or if they get worse. Visit your care team for regular checks on your progress. Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your care team. This medication can cause an increase in blood pressure. Check with your care team for instructions on monitoring your blood pressure while taking this medication. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. Your mouth may get dry. Chewing sugarless gum, sucking hard candy and drinking plenty of water will help. Contact your care team if the problem does not go away or is severe.

What are the most serious risks of this medication?

This medication may increase thoughts of suicide. This may be more common in children, teenagers, and young adults. The risk may increase after first starting the medication and after dose changes. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide.