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|Cymbalta Delayed-Release Capsules

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Cymbalta Delayed-Release Capsules

Generic Name: Duloxetine Delayed-Release Capsules (doo-LOX-eh-teen)
Brand Name: Cymbalta

The risk of suicidal thinking and behavior was increased by antidepressants in short-term studies in children and adolescents with certain psychiatric disorders. Anyone considering the use of Cymbalta Delayed-Release Capsules or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be watched closely for worsening of symptoms, suicidal thoughts and behavior, or unusual behavior changes. Families and caregivers should be aware of the need for close observation and communication with the prescriber. Results from several studies in children and adolescents with certain psychiatric disorders revealed a greater risk of side effects related to suicidal thinking and behavior during the first few months of treatment with antidepressants.

Cymbalta Delayed-Release Capsules is used for:

Treating depression and managing pain caused by diabetic peripheral neuropathy (DPNP). It may also be used for other conditions as determined by your doctor.

Cymbalta Delayed-Release Capsules is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). It works by restoring the balance of 2 chemicals in the brain (serotonin and norepinephrine). These chemicals play a role in depression and DPNP.

Do NOT use Cymbalta Delayed-Release Capsules if:

you are allergic to any ingredient in Cymbalta Delayed-Release Capsules
you are taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days
you are taking fluvoxamine, quinolone antibiotics (eg, ciprofloxacin), or thioridazine
you have uncontrolled narrow-angle glaucoma

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cymbalta Delayed-Release Capsules:

Some medical conditions may interact with Cymbalta Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have any mental or mood disorders (eg, bipolar disorder), mania, slowed emptying of the stomach, diabetes, glaucoma, kidney problems, liver problems, high blood pressure, or controlled narrow-angle glaucoma
if you have a history of seizures or alcohol or drug abuse
if you have suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Cymbalta Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Fluvoxamine, quinidine, quinolones (eg, ciprofloxacin), or serotonin reuptake inhibitors (eg, fluoxetine) because the actions and side effects of Cymbalta Delayed-Release Capsules may be increased
Flecainide, MAO inhibitors (eg, phenelzine), phenothiazines (eg, thioridazine), propafenone, or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cymbalta Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cymbalta Delayed-Release Capsules:

Use Cymbalta Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Cymbalta Delayed-Release Capsules may be taken with or without food.
Cymbalta Delayed-Release Capsules comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Cymbalta Delayed-Release Capsules refilled.
Swallow whole. Do not break, crush, or chew before swallowing. Do not sprinkle the contents of the capsule on food or mix with liquids.
Take Cymbalta Delayed-Release Capsules regularly to receive the most benefit from it. Taking Cymbalta Delayed-Release Capsules at the same time each day will help you to remember to take it.
Continue taking Cymbalta Delayed-Release Capsules even if you feel better. Do not miss any doses.
If you miss a dose of Cymbalta Delayed-Release Capsules, 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.

Ask your health care provider any questions you may have about how to use Cymbalta Delayed-Release Capsules.

Important safety information:

Cymbalta Delayed-Release Capsules may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Cymbalta Delayed-Release Capsules. Using Cymbalta Delayed-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
It may take several weeks for Cymbalta Delayed-Release Capsules to work. Do not stop using Cymbalta Delayed-Release Capsules without checking with your doctor.
Do not drink alcohol while you are using Cymbalta Delayed-Release Capsules. Heavy use of alcohol with Cymbalta Delayed-Release Capsules may increase your risk for liver damage.
Antidepressants can increase suicidal thoughts and actions in some children and teenagers. This risk may be higher in individuals with bipolar illness (also called manic-depressive illness), a family history of bipolar illness, or a history of attempting suicide. Pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your doctor right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, other unusual changes in behavior or mood.
LAB TESTS, including blood pressure, may be required to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Caution is advised when using Cymbalta Delayed-Release Capsules in CHILDREN or ADOLESCENTS because they may be more sensitive to the effects of Cymbalta Delayed-Release Capsules. Safety and effectiveness have not been established in CHILDREN and ADOLESCENTS.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Cymbalta Delayed-Release Capsules during pregnancy, especially during the third trimester. It is unknown if Cymbalta Delayed-Release Capsules is excreted in breast milk. Do not breast-feed while taking Cymbalta Delayed-Release Capsules.

Do not suddenly stop taking Cymbalta Delayed-Release Capsules. Some conditions may become worse when the medicine is suddenly stopped. Your dose may need to be slowly lowered to avoid side effects.

Possible side effects of Cymbalta Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; changes in sexual function; constipation; decreased appetite; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; nausea; shaking; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; difficulty urinating; hostility; impulsive behavior or other unusual changes in behavior; infection (chills, fever, sore throat); irritability; mental or mood changes; panic attacks; severe nervousness or anxiety; severe restlessness; suicidal thoughts or behaviors; unusual bruising or bleeding; worsening of depression; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Cymbalta Delayed-Release Capsules:

Store Cymbalta Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cymbalta Delayed-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Cymbalta Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Cymbalta Delayed-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cymbalta Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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