Duloxetine Delayed-Release Capsules

What is this medication?

DULOXETINE (doo LOX e teen) treats depression, anxiety, fibromyalgia, and certain types of chronic pain such as nerve, bone, or joint pain. It increases the amount of serotonin and norepinephrine in the brain, hormones that help regulate mood and pain. It belongs to a group of medications called SNRIs.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Cymbalta, Drizalma, Irenka

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bipolar disorder
• Glaucoma
• High blood pressure
• Kidney disease
• Liver disease
• Seizures
• Suicidal thoughts, plans or attempt; a previous suicide attempt by you or a family member
• Take medications that treat or prevent blood clots
• Taken medications called MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate within 14 days
• Trouble passing urine
• An unusual reaction to duloxetine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Do not crush, cut or chew some capsules of this medication. Some capsules may be opened and sprinkled on applesauce. Check with your care team or pharmacist if you are not sure. You can take this medication with or without food. Take your medication at regular intervals. Do not take your medication more often than directed. Do not stop taking this medication suddenly except upon the advice of your care team. Stopping this medication too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team regarding the use of this medication in children. While this medication may be prescribed for children as young as 7 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Desvenlafaxine
• Levomilnacipran
• Linezolid
• MAOIs like Carbex, Eldepryl, Emsam, Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)
• Milnacipran
• Safinamide
• Thioridazine
• Venlafaxine
• Viloxazine

This medication may also interact with the following:

• Alcohol
• Amphetamines
• Aspirin and aspirin-like medications
• Certain antibiotics like ciprofloxacin and enoxacin
• Certain medications for blood pressure, heart disease, irregular heart beat
• Certain medications for depression, anxiety, or psychotic disturbances
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• Cimetidine
• Fentanyl
• Lithium
• NSAIDS, medications for pain and inflammation, like ibuprofen or naproxen
• Phentermine
• Procarbazine
• Rasagiline
• Sibutramine
• St. John's wort
• Theophylline
• Tramadol
• Tryptophan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not get better or if they get worse. Visit your care team for regular checks on your progress. Because it may take several weeks to see the full effects of this medication, it is important to continue your treatment as prescribed by your care team.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

Manic episodes may happen in patients with bipolar disorder who take this medication. Watch for changes in feelings or behaviors such as feeling anxious, nervous, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or trouble sleeping. These symptoms can happen at any time, but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you notice any of these symptoms.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

This medication can cause an increase in blood pressure. This medication can also cause a sudden drop in your blood pressure, which may make you feel faint and increase the chance of a fall. These effects are most common when you first start the medication or when the dose is increased, or during use of other medications that can cause a sudden drop in blood pressure. Check with your care team for instructions on monitoring your blood pressure while taking this medication.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water, may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, red or dark brown urine, vomiting blood or brown material that looks like coffee grounds, small, red or purple spots on skin, unusual bleeding or bruising
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Serotonin syndrome—irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizures, chills, vomiting, diarrhea
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression
• Trouble passing urine

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Constipation
• Diarrhea
• Dizziness
• Dry mouth
• Excessive sweating
• Loss of appetite
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 to 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.