You may have heard the phrase "discontinuation symptoms" or "withdrawal." This refers to the symptoms that may occur when a person suddenly stops or quickly lowers his or her daily dose of an antidepressant. Effexor XR is not addictive. An antidepressant is not a controlled substance like a narcotic or a stimulant.

Discontinuation symptoms can include physical symptoms, changes in mood, or sensory disturbances. These symptoms may occur even after skipping only a few doses.

Just as there is a recommended way to start medication, there is a recommended way to stop. Your daily dose of Effexor XR should be lowered gradually by your doctor. This is called "tapering" the dose, and it can take anywhere from a few weeks to a few months, depending on your doctor's instructions and how you respond.

Tapering Your Dose

It is important to take your medication exactly as directed by your doctor. If you are thinking of stopping Effexor XR or reducing your dose, talk with your doctor. He or she can determine how to taper your dose — to help you discontinue therapy as recommended.

• 10 Things to Know
• Dosing and General Information
• Managing Potential Side Effects
• Managing Discontinuation

PATIENT INFORMATION FOR EFFEXOR XR^® (venlafaxine HCl)

Be sure to read the following important information carefully. However, keep in mind that it should not take the place of your health care professional’s instructions. If you do not understand all of this information or want to know more about EFFEXOR XR, ask your health care professional.

What is the most important information that I should know about antidepressant medicines, depression, and other serious mental illnesses?

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults. However, depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. For more information, see the Prescribing Information and the Medication Guide called Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.

What is the most important information that I should know about EFFEXOR XR?

Some people should not take EFFEXOR XR. Discuss this with your health care professional. People taking monoamine oxidase inhibitors (MAOIs) should not take EFFEXOR XR. MAOIs can cause a very serious reaction or even death if taken at the same time as EFFEXOR XR. You must stop taking your MAOI at least 14 days before beginning EFFEXOR XR. Similarly, you should wait 7 days after stopping EFFEXOR XR before starting an MAOI. Be sure to ask your health care professional if a medicine you are taking is an MAOI.

Patients and their families should know that both adults and children taking an antidepressant medicine should be watched closely for signs that their condition is getting worse or that they are becoming suicidal. Pay close attention to any changes (especially sudden changes) in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. All patients should be watched for becoming agitated, irritable, hostile, aggressive, impulsive, restless, or anxious. Such symptoms or any new or sudden changes in mood, thoughts, or feelings should be reported to the patient’s health care professional right away.

A life-threatening condition called serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions can happen with SNRIs and SSRIs alone, including EFFEXOR XR treatment, but particularly with concomitant use of serotonergic drugs (including medicines used to treat migraine headaches known as triptans) or with antipsychotics or other dopamine antagonists, lithium, sibutramine, tramadol, St. John’s wort, MAOIs (including linezolid, an antibiotic), and tryptophan supplements. If you take migraine headache medicines, ask your health care professional if your medicine is a triptan. Before you take EFFEXOR XR and any of these medicines together, talk to your health care professional. If you must take these medicines together, be aware of the possibility of these syndromes. Signs and symptoms of these syndromes may include one or more of the following: restlessness, hallucinations, loss of coordination, fast heartbeat, increased body temperature, muscle stiffness, increase in blood pressure, diarrhea, coma, nausea, vomiting, and confusion. Tell your health care professional about any medications you are taking or plan to take, including herbal preparations and nutritional supplements.

Can children take EFFEXOR XR?

EFFEXOR XR is not approved for use in children under 18. Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in studies in children, teenagers, and young adults ages 18 to 24 with depression and other psychiatric disorders. For more information, see the Prescribing Information and the Medication Guide called Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.

What is EFFEXOR XR used for?

EFFEXOR XR is a prescription medicine used to treat Depression, Generalized Anxiety Disorder (also called GAD), Social Anxiety Disorder (also called SAD), and Panic Disorder (also called PD) in adults.

Depression

Symptoms of depression are different depending on the person. Some people have only a few symptoms, while others may have many symptoms at once. Symptoms of depression include:

Both adults and children with depression can have their depression get worse and/or they can become suicidal. This can happen if they take an antidepressant or not. Patients treated with EFFEXOR XR should be watched closely for signs that their condition is getting worse or that they are becoming suicidal. Such signs should be reported to their health care professional right away.

Generalized Anxiety Disorder (GAD)

GAD is characterized by feelings of excessive anxiety and worry that can’t be controlled and are present for at least 6 months. Other symptoms of GAD may include:

Unreasonable fear of embarrassment

PD is characterized by repeated, unexpected panic attacks, followed by weeks of ongoing concern about having another panic attack. A panic attack involves rapid onset of a specific period of intense fear and discomfort that develops quickly and reaches a peak within 10 minutes. Along with these feelings, other symptoms may include:

Who should not take EFFEXOR XR?

Do not take EFFEXOR XR if you are allergic to EFFEXOR XR (venlafaxine HCl) or any of its ingredients. The inactive ingredients are cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.

EFFEXOR XR can make some conditions worse. Tell your health care professional about all your medical problems. Be sure to tell your health care professional if you have or had:

• suicidal thoughts.
• high blood pressure. EFFEXOR XR can increase your blood pressure.
• heart disease. EFFEXOR XR can increase your heart rate (pulse).
• liver or kidney problems. Your dose of EFFEXOR XR may need to be different.
• symptoms of mania or hypomania, such as persistently elevated or irritable mood, a decreased need for sleep, racing thoughts, hyperactivity, and rapid, excessive speech.
• glaucoma. EFFEXOR XR may increase your eye pressure.
• seizures.
• thyroid problems.

Tell your health care professional about all medicines that you are taking or plan to take, including prescription and non-prescription medicines and supplements (including natural and herbal supplements). Taking EFFEXOR XR with aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or other drugs that affect coagulation may increase the risk of bleeding events. Your health care professional will decide if you can take EFFEXOR XR with other medicines.

EFFEXOR XR is not recommended for weight loss alone or in combination with phentermine or other products.

How does EFFEXOR XR work?

EFFEXOR XR is thought to work by affecting two naturally occurring brain chemicals, serotonin and norepinephrine. This helps relieve your symptoms. It may take several weeks for your symptoms to get better with EFFEXOR XR.

How should I take EFFEXOR XR?

• EFFEXOR XR can be prescribed in different dosage strengths (37.5 mg, 75 mg, and 150 mg). The usual starting dose is 75 mg for depression, GAD, and SAD and 37.5 mg for PD, but only your health care professional can tell you which dose is right for you and whether it will need to be adjusted over time.
• EFFEXOR XR should be taken as a single dose with food at about the same time every day, either in the morning or evening.
• The capsule should be swallowed whole; it should not be divided, crushed, chewed, or placed in water.
• The capsule can also be carefully opened and its contents sprinkled onto a spoonful of applesauce. This should be swallowed immediately and followed by drinking a glass of water. Do not chew this mixture before swallowing.
• If you miss a dose of EFFEXOR XR, it can be taken later that day. Don't try to "make up" for the missed dose by taking two doses the next day.

In case of an overdose, call your health care professional or poison control center or go to the emergency room right away.

What should I avoid while taking EFFEXOR XR?

Please tell your health care professional if you are pregnant, intend to become pregnant, or are breast-feeding. Some newborns whose mothers took EFFEXOR XR late in the third trimester have had problems. Because of those problems, the newborns needed long hospital stays, help with breathing, and tube feeding. Until you see how EFFEXOR XR affects you, be careful doing such activities as driving a car or operating machinery. Avoid drinking alcohol while taking EFFEXOR XR. EFFEXOR XR may cause other side effects besides those listed below.

What are the possible side effects of EFFEXOR XR?

EFFEXOR XR may cause side effects in some people. In clinical studies, some people had to stop taking EFFEXOR XR because of side effects.

In clinical studies, the most common side effects included:

EFFEXOR XR may cause an increase in your cholesterol. Your health care professional may want to do blood tests to check your serum cholesterol periodically.

Tell your health care professional right away if you have:

• increases in blood pressure or heart rate.
• extreme confusion, unsteadiness, or seizures, which may indicate very low levels of sodium in the blood.
• abnormal bleeding or bruising.
• sudden, unexpected eye pain, eye redness, or changes in vision, which may indicate increased eye pressure.
• symptoms of mania or hypomania, such as persistently elevated or irritable mood, a decreased need for sleep, racing thoughts, hyperactivity, and rapid, excessive speech.
• signs and symptoms of serotonin syndrome or Neuroleptic Malignant Syndrome-like reactions, which may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heartbeat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting, muscle stiffness, and confusion.

EFFEXOR XR may cause an increase in your blood pressure. Your health care professional may want your blood pressure to be checked more often.

EFFEXOR XR may increase your eye pressure. You may need more frequent eye exams to detect an increase in eye pressure.

For more information on these and other side effects associated with EFFEXOR XR, talk to your health care professional or visit our website at www.EFFEXORXR.com.

What happens when I stop using EFFEXOR XR?

Symptoms are known to occur when people stop using EFFEXOR XR, especially when they suddenly stop therapy.

When people suddenly stop using EFFEXOR XR, they can get symptoms from stopping the medicine too fast. Some of these symptoms include:

Do not stop taking EFFEXOR XR without talking with your health care professional first. Your health care professional may want to slowly decrease your dose of EFFEXOR XR to help avoid these kinds of symptoms.

General advice about EFFEXOR XR

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use EFFEXOR XR for a condition that has not been prescribed by your health care professional. Do not give EFFEXOR XR to other people, even if they have the same symptoms you have. It may harm them.

This is a summary of the most important information about EFFEXOR XR. If you would like more information, talk with your (or your family member’s) health care professional about all the risks and benefits of antidepressant medicines and all treatment choices for depression or other serious mental illnesses. You can ask your health care professional for information about EFFEXOR XR that is written for health professionals.

What are the ingredients in EFFEXOR XR?

EFFEXOR XR contains venlafaxine hydrochloride, an antidepressant. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.

How do I store EFFEXOR XR?

Store EFFEXOR XR at room temperature (68° to 77°F or 20° to 25°C). Keep EFFEXOR XR away from children.

For more information on EFFEXOR XR

This page is only a summary. For more complete information, talk to your health care professional. You can also go to www.EFFEXORXR.com.

This brief summary is based on EFFEXOR XR Prescribing Information W10404C040, revised July 2009.