This medicine is a serotonin and norepinephrine reuptake inhibitor (SNRI) used for treating fibromyalgia.
Follow the directions for taking this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. STORE THIS MEDICINE at 77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. TAKE THIS MEDICINE ON A REGULAR SCHEDULE to get the most benefit from it. Taking this medicine at the same time each day will help you remember to take it. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. DO NOT SUDDENLY STOP TAKING THIS MEDICINE without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, nausea, nightmare, ringing in the ears, seizures, trouble sleeping, unusual tiredness, or vomiting. You will be closely monitored when you start this medicine and whenever a change in dose is made. IF YOU MISS A DOSE of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
WARNING: This medicine is similar to certain antidepressant medicines. Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using this medicine outweigh the risks. Families and caregivers must closely watch patients who take this medicine. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor. THIS MEDICINE IS NOT APPROVED FOR USE in children or to treat depression. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days. DO NOT TAKE THIS MEDICINE IF you are taking tryptophan, a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine), or another SNRI (eg, duloxetine). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking a 5-HT1 receptor agonist (eg, sumatriptan), lithium, rasagiline, St. John's wort, tramadol, a diuretic (eg, furosemide, hydrochlorothiazide), an anticoagulant (eg, warfarin), aspirin, a non-steroidal anti-inflammatory drug (NSAIDS) (eg, ibuprofen), digoxin, epinephrine, norepinephrine, or clonidine. IF YOU ARE BEING SWITCHED TO THIS MEDICINE AFTER TAKING another medicine called clomipramine, you may have an increased risk for certain side effects (eg, dizziness or lightheadedness upon standing, exaggerated sense of well-being). Contact your doctor if any of these symptoms occur. IF YOUR DOCTOR TELLS YOU TO STOP taking this medicine, you will need to wait for at least 5 days before beginning to take certain other medicines (eg, MAOIs). Ask your doctor when you should start to take your new medicines after you have stopped taking this medicine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of seizures, heart problems (eg, heart failure, irregular heartbeat), recent heart attack, high blood pressure, bleeding problems, kidney problems, liver problems, urinary blockage or trouble urinating, enlarged prostate, increased eye pressure (eg, glaucoma); allergies (including tartrazine); pregnancy; or breast-feeding. Tell your doctor if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse. Tell your doctor if you are dehydrated, have low blood sodium levels, or drink alcohol. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have uncontrolled narrow-angle glaucoma or end-stage kidney disease. This medicine should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include constipation; decreased sexual desire or ability; dizziness; dry mouth; headache; hot flush; increased sweating; loss of appetite; nausea; trouble sleeping; or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bizarre behavior; bloody or black tarry stools; confusion; dark urine; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; memory problems; muscle pain or weakness; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, restlessness, or inability to sit still; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, or diarrhea; severe or persistent trouble sleeping; stomach pain; suicidal thoughts or attempts; tremor; trouble urinating; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms may include chest pain; confusion; coma; dark urine; severe or persistent dizziness, drowsiness, or headache; trouble breathing; yellowing of the skin or eyes.
SEVERAL WEEKS MAY PASS before your symptoms improve. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of reach of children and pets.