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|Effexor XR Extended-Release Capsules

Effexor XR Extended-Release Capsules

Effexor XR Extended-Release Capsules is used for:

Treating depression, generalized or social anxiety disorder, or panic disorder. It may also be used for other conditions as determined by your doctor.

Effexor XR Extended-Release Capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI). It works by restoring the balance of certain natural substances in the brain (serotonin and norepinephrine), which helps to improve certain mood problems.

Do NOT use Effexor XR Extended-Release Capsules if:

• you are allergic to any ingredient in Effexor XR Extended-Release Capsules
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John"s wort within the last 14 days
• you are taking a fenfluramine derivative (eg, dexfenfluramine), nefazodone, sibutramine, or tryptophan

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

Before using Effexor XR Extended-Release Capsules:

Some medical conditions may interact with Effexor XR Extended-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 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
• if you have a history of seizures, heart problems, (eg, heart failure, irregular heartbeat), abnormal electrocardiogram, recent heart attack, high blood pressure, overactive thyroid, liver problems, kidney problems, stomach or bowel bleeding, increased eye pressure (eg, glaucoma), nervous system problems, or metabolism problems
• if you are dehydrated, have low blood sodium levels, or drink alcohol
• if you will be having electroconvulsive therapy (ECT)

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

• Certain diet medicines (eg, phentermine, fenfluramine), linezolid, lithium, MAOIs (eg, phenelzine), metoclopramine, nefazodone, selegiline, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) serotonin and norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), serotonin 5-HT₁ receptor agonists (eg, sumatriptan), sibutramine,St. John"s wort, tramadol, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
• Cimetidine or ketoconazole because they may increase the risk of Effexor XR Extended-Release Capsules"s side effects
• Cyproheptadine because it may decrease Effexor XR Extended-Release Capsules"s effectiveness
• Aripiprazole, haloperidol, phenothiazines (eg, chlorpromazine, thioridazine), or risperidone because the risk of their side effects may be increased by Effexor XR Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Effexor XR Extended-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 Effexor XR Extended-Release Capsules:

Use Effexor XR Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Effexor XR Extended-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Effexor XR Extended-Release Capsules refilled.
• Take Effexor XR Extended-Release Capsules by mouth with food.
• Take Effexor XR Extended-Release Capsules with a full glass of water (8 oz/240 mL).
• Swallow Effexor XR Extended-Release Capsules whole. Do not break, crush, chew, or place in water before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing.
• Effexor XR Extended-Release Capsules works best if it is taken at the same time each day.
• Continue to take Effexor XR Extended-Release Capsules even if you feel well. Do not miss any doses.
• Do not suddenly stop taking Effexor XR Extended-Release Capsules without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, drowsiness, confusion, headache, increased sweating, nausea, ringing in the ears, seizures, tremor, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Effexor XR Extended-Release Capsules and whenever a change in dose is made.
• If you miss a dose of Effexor XR Extended-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 Effexor XR Extended-Release Capsules.

Important safety information:

• Effexor XR Extended-Release Capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Take Effexor XR Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using Effexor XR Extended-Release Capsules.
• Do not use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Effexor XR Extended-Release Capsules without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• 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.
• Children and teenagers who take Effexor XR Extended-Release Capsules may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if a family member has had it. Watch patients who take Effexor XR Extended-Release Capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Serotonin syndrome is a possibly fatal syndrome that can be caused by Effexor XR Extended-Release Capsules. Your risk may be greater if you take Effexor XR Extended-Release Capsules with certain other medicines (eg, "triptans," MAOIs, SSRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
• If your doctor tells you to stop taking Effexor XR Extended-Release Capsules, you will need to wait for a period of time before beginning to take certain other medicines (eg, MAOIs, nefazodone, thioridazine). Ask your doctor when you should start to take your new medicines after you have stopped taking Effexor XR Extended-Release Capsules.
• Effexor XR Extended-Release Capsules may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
• Lab tests, including blood pressure and blood cholesterol levels, may be performed while you use Effexor XR Extended-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Effexor XR Extended-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
• Caution is advised when using Effexor XR Extended-Release Capsules in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
• Effexor XR Extended-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• Effexor XR Extended-Release Capsules may cause weight changes and growth changes. CHILDREN and teenagers may need regular weight and growth checks while they take Effexor XR Extended-Release Capsules.
• PREGNANCY and BREAST-FEEDING: Effexor XR Extended-Release Capsules may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Effexor XR Extended-Release Capsules while you are pregnant. Effexor XR Extended-Release Capsules is found in breast milk. Do not breast-feed while taking Effexor XR Extended-Release Capsules.

Possible side effects of Effexor XR Extended-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:

Abnormal dreams; blurred vision; changes in taste; constipation; decreased sexual desire or ability; dizziness; drowsiness; dry mouth; flushing; headache; increased sweating; loss of appetite; nausea; nervousness; stomach upset; trouble sleeping; vomiting; weakness; weight loss; yawning.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; chest pain or discomfort; confusion; decreased urination; fast or irregular heartbeat; fever, chills, or sore throat; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, restlessness, or inability to sit still; persistent or severe ringing in the ears; seizures; severe or persistent anxiety, nervousness, or trouble sleeping; severe or persistent cough; severe or persistent headache, dizziness, or stomach pain; shortness of breath; significant weight loss; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; vision problems; worsening of depression.

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. Symptoms may include coma; dilated pupils; fainting; fast, slow, or irregular heartbeat; muscle pain or weakness; new or worsening mental or mood problems; seizures; severe or persistent dizziness, drowsiness, or vomiting; trouble breathing; yellowing of the eyes or skin.

Store Effexor XR Extended-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Effexor XR Extended-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Effexor XR Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Effexor XR Extended-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 summary only. It does not contain all information about Effexor XR Extended-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.