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Brand Names: Savella

Generic Name: milnacipran (Pronunciation: mil NA si pran)

• What is milnacipran (Savella)?
• What are the possible side effects of milnacipran (Savella)?
• What is the most important information I should know about milnacipran (Savella)?
• What should I discuss with my healthcare provider before taking milnacipran (Savella)?
• How should I take milnacipran (Savella)?
• What happens if I miss a dose (Savella)?
• What happens if I overdose (Savella)?
• What should I avoid while taking milnacipran (Savella)?
• What other drugs will affect milnacipran (Savella)?
• Where can I get more information?

What is milnacipran (Savella)?

Milnacipran affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia. Milnacipran is not used to treat depression but how it works in the body is similar to how some antidepressants work.

Milnacipran is used to treat a chronic pain disorder called fibromyalgia.

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

What are the possible side effects of milnacipran (Savella)?

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

Call your doctor at once if you have any new or worsening symptoms 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.

Call your doctor at once if you have any of these serious side effects:

• fast or pounding heartbeats;
• painful or difficult urination;
• easy bruising or bleeding, nosebleeds, bloody or tarry stools, coughing up blood;
• confusion, hallucinations, severe weakness, seizure (convulsions);
• high fever, sweating, chills or goose bumps, memory problems, trouble concentrating, loss of coordination, overactive reflexes, vomiting, diarrhea;
• high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats); or
• stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• constipation;
• dry mouth, nausea, stomach pain, heartburn, bloating;
• dizziness, drowsiness, headache, tired feeling;
• stuffy nose, sneezing, or other cold symptoms;
• sleep problems (insomnia);
• swelling in your hands or feet;
• hot flashes, sweating, itching, mild skin rash;
• numbness or tingling;
• blurred vision; or
• decreased sex drive, impotence, or difficulty having an orgasm.

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.

What is the most important information I should know about milnacipran (Savella)?

Do not take milnacipran together with thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take milnacipran. 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 this medication, 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.

Call your doctor at once if you have any new or worsening symptoms 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 milnacipran. Alcohol may increase the risk of damage to your liver.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety can add to sleepiness caused by milnacipran. Tell your doctor if you regularly use any of these other medicines.

Milnacipran can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.