Milnacipran (By mouth)

Savella, Savella Titration Pack

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, skip the missed dose and take your next dose at your regularly scheduled time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor (MAOI) within the past 14 days. Do not take an MAOI for at least 5 days after stopping this medicine.
• Some medicines can affect how milnacipran works. Tell your doctor if you are using any of the following:
  • Buspirone, clomipramine, clonidine, digoxin, fentanyl, lithium, St John's wort, tramadol, or tryptophan supplement
  • Amphetamines
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Tricyclic antidepressant or other medicine to treat depression
  • Triptan medicine to treat migraine headaches
  .
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, heart rhythm problems, high blood pressure, glaucoma, an enlarged prostate, or a history of painful or difficult urination. Also tell your doctor if you have a history of seizures, or if you drink alcohol.
• This medicine may cause the following problems:
  • Serotonin syndrome (more likely when used with certain other medicines)
  • High blood pressure
  • Liver problems
  • Hyponatremia (low sodium levels)
  • Higher risk of bleeding problems (especially if used with a blood thinner or NSAID medicine)
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may make you drowsy or less alert. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Your blood pressure and heart rate will also be monitored while you use this medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, sweating, muscle spasms, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Confusion, weakness, and muscle twitching
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Eye pain, vision changes, seeing halos around lights
• Fast, pounding, or uneven heartbeat or pulse
• Increased energy, racing thoughts, reckless behavior, talking more than usual, trouble sleeping
• Seizures or tremors
• Unusual behavior or thoughts about hurting yourself or others
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Mild headache or dizziness

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088