drug-information.ru

|Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules

Duloxetine 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.

Duloxetine 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 Duloxetine Delayed-Release Capsules if:

• you are allergic to any ingredient in Duloxetine 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 Duloxetine Delayed-Release Capsules:

Some medical conditions may interact with Duloxetine 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 Duloxetine 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 Duloxetine 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 Duloxetine 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 Duloxetine Delayed-Release Capsules:

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

• Duloxetine Delayed-Release Capsules may be taken with or without food.
• Duloxetine Delayed-Release Capsules comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Duloxetine 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 Duloxetine Delayed-Release Capsules regularly to receive the most benefit from it. Taking Duloxetine Delayed-Release Capsules at the same time each day will help you to remember to take it.
• Continue taking Duloxetine Delayed-Release Capsules even if you feel better. Do not miss any doses.
• If you miss a dose of Duloxetine 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 Duloxetine Delayed-Release Capsules.

Important safety information:

• Duloxetine 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 Duloxetine Delayed-Release Capsules. Using Duloxetine 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 Duloxetine Delayed-Release Capsules to work. Do not stop using Duloxetine Delayed-Release Capsules without checking with your doctor.
• Do not drink alcohol while you are using Duloxetine Delayed-Release Capsules. Heavy use of alcohol with Duloxetine 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 Duloxetine Delayed-Release Capsules in CHILDREN or ADOLESCENTS because they may be more sensitive to the effects of Duloxetine 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 Duloxetine Delayed-Release Capsules during pregnancy, especially during the third trimester. It is unknown if Duloxetine Delayed-Release Capsules is excreted in breast milk. Do not breast-feed while taking Duloxetine Delayed-Release Capsules.

Do not suddenly stop taking Duloxetine 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 Duloxetine 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.

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.

Store Duloxetine 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 Duloxetine Delayed-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Duloxetine Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Duloxetine 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 Duloxetine 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.