Milnacipran

What it is used for

SAVELLA is indicated for the management of fibromyalgia. SAVELLA is not approved for use in pediatric patients. SAVELLA ® is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia. SAVELLA is not approved for use in pediatric patients.

The most important thing to know

SAVELLA and antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: SAVELLA 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 SAVELLA is 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 feeling agitated, restless, angry or irritable acting on dangerous impulses trouble sleeping (insomnia) acting aggressive, being angry, or violent an increase in activity or talking more than what is normal for you thoughts about suicide or dying other unusual changes in behavior or mood new or worse depression new or worse anxiety or panic attacks 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 SAVELLA.

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: SAVELLA may increase your blood pressure or heart rate. Check your blood pressure and heart rate before you start and during treatment with SAVELLA.

Before taking SAVELLA, 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: SAVELLA 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. V isual 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. 11. Sexual problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including SAVELLA, may cause sexual problems.

Symptoms in males may include Delayed ejaculation or inability to have an ejaculation Decreased sex drive Pr

How to take it

Take SAVELLA 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 SAVELLA as prescribed. After your first dose, your healthcare provider will tell you how much SAVELLA to take and when to take it, usually 2 times each day.

You may take SAVELLA with or without food. Taking SAVELLA 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 SAVELLA. If you take too much SAVELLA, call your healthcare provider or go to the nearest hospital emergency room right away.

Side effects, and when to stop

SAVELLA may cause side effects, some serious, including: The most common side effects of SAVELLA include: nausea vomiting headache irregular heartbeat (palpitations) constipation heart rate increased dizziness dry mouth trouble sleeping high blood pressure (hypertension) hot flush increased sweating 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 SAVELLA. 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.

Who should not take it

Do not take SAVELLA 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 SAVELLA unless your healthcare provider tells you to. Do not start SAVELLA if you stopped taking an MAOI in the last 14 days unless your healthcare provider tells you to.

People who take SAVELLA 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 to say before you start

Before starting SAVELLA, 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 SAVELLA will harm your unborn baby. are breastfeeding or plan to breastfeed. SAVELLA 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 SAVELLA.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. SAVELLA and some medicines may interact with each other, may not work as well, or may cause serious side effects. Especially tell your healthcare provider if you take: triptans used to treat migraine headache medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs or MAOIs tramadol, fentanyl, meperidine, methadone, or other opioids amphetamines the blood thinner warfarin (Coumadin, Jantoven) non-steroidal anti-inflammatory drug (NSAID) (like ibuprofen, naproxen or aspirin) over-the-counter supplements such as tryptophan or St.

John’s Wort Ask your healthcare provider for a list of these medicines if you are not sure. Your healthcare provider or pharmacist can tell you if it is safe to take SAVELLA with your other medicines. Do not start or stop any medicine while taking SAVELLA without talking to your healthcare provider first.

What to avoid

Do not drive or operate machinery until you know how SAVELLA affects you. SAVELLA may make you less alert and affect your reaction time.

Storing it

Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep SAVELLA and all medicines out of the reach of children.