When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to duloxetine.

How to Use This Medicine:
Capsule, Delayed Release Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Delayed-release capsule: Swallow the capsule whole. Do not crush, chew, break, or open it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

• Do not take duloxetine if you have used an MAO inhibitor (MAOI) within the past 14 days. Do not start taking an MAO inhibitor within 5 days of stopping duloxetine.
• Some medicines can affect how duloxetine works. Tell your doctor if you are using any of the following:
  
  • Buspirone, fentanyl, lithium, St John's wort, tramadol, tryptophan, or warfarin
  • Diuretic (water pill)
  • Medicine for heart rhythm problems (including flecainide, propafenone, quinidine)
  • Triptan medicine to treat migraine headaches
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Other medicine to treat depression or mood disorders (including desipramine, fluoxetine, paroxetine)
  • Phenothiazine medicine (including chlorpromazine, perphenazine, prochlorperazine, promethazine, thioridazine)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, digestion problems, glaucoma, heart disease, high or low blood pressure, or problems with urination. Tell your doctor if you have a history of seizures, or drug or alcohol addiction.
• 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 cause the following problems:
  
  • Serious liver problems
  • A serious drug reaction called serotonin syndrome (more likely when used with certain other medicines)
  • Increased risk of bleeding problems
  • Serious skin reactions
  • Low sodium levels in the blood
• This medicine can cause changes in your blood pressure. This may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand up slowly to avoid falls.
• 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.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
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
• Blistering, peeling, red skin rash
• Confusion, weakness, muscle twitching
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Decrease in how much or how often you urinate
• Eye pain, vision changes, seeing halos around lights
• Feeling more energetic than usual
• Lightheadedness, dizziness, or fainting
• Restlessness, fever, fast heartbeat, sweating, muscle spasms, diarrhea, seeing or hearing things that are not there
• Unusual moods or behaviors, worsening depression, thoughts about hurting yourself, trouble sleeping
• Unusual bleeding or bruising

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

• Decrease in appetite or weight
• Dry mouth, constipation, mild nausea
• Unusual drowsiness or tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088