VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride capsule, extended release 
Apotex Corp.

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Medication Guide

VENLAFAXINE XR
(venlafaxine hydrochloride)
(Extended-Release Capsules)

Read the Medication Guide that comes with VENLAFAXINE XR before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

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

VENLAFAXINE XR and other antidepressant medicines may cause serious side effects, including:

1.
Suicidal thoughts or actions:
  • VENLAFAXINE XR and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when VENLAFAXINE XR is started or when the dose is changed.

    Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

    Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

    • attempts to commit suicide
    • acting on dangerous impulses
    • acting aggressive or violent
    • thoughts about suicide or dying
    • new or worse depression
    • new or worse anxiety or panic attacks
    • feeling agitated, restless, angry or irritable
    • trouble sleeping
    • an increase in activity or talking more than what is normal for you
    • other unusual changes in behavior or mood
    • Visual problems
      • eye pain
      • changes in vision
      • swelling or redness in or around the eye

      Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. VENLAFAXINE XR may be associated with these serious side effects:

2.
Serotonin Syndrome
This condition can be life-threatening and may include
:
  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
3.
Changes in blood pressure. VENLAFAXINE XR may:
  • increase your blood pressure. Control high blood pressure before starting treatment and monitor blood pressure regularly
4.
Enlarged pupils (mydriasis).
5.
Anxiety and insomnia.
6.
Changes in appetite or weight.
7.
Manic/hypomanic episodes:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
8.
Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems
9.
Seizures or convulsions.
10.
Abnormal bleeding: VENLAFAXINE XR and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
11.
Elevated cholesterol.
12.
Lung disease and pneumonia: VENLAFAXINE XR may cause rare lung problems. Symptoms include:
  • worsening shortness of breath
  • cough
  • chest discomfort
13.
Severe allergic reactions:
  • trouble breathing
  • swelling of the face, tongue, eyes or mouth
  • rash, itchy welts (hives) or blisters, alone or with fever or joint pain

Do not stop VENLAFAXINE XR without first talking to your healthcare provider. Stopping VENLAFAXINE XR too quickly or changing from another antidepressant too quickly may cause serious symptoms including:

What is VENLAFAXINE XR?

VENLAFAXINE XR is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.

VENLAFAXINE XR is also used to treat:

Talk to your healthcare provider if you do not think that your condition is getting better with VENLAFAXINE XR treatment.

Who should not take VENLAFAXINE XR?

Do not take VENLAFAXINE XR if you:

What should I tell my healthcare provider before taking VENLAFAXINE XR? Ask if you are not sure.

Before starting VENLAFAXINE XR, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. VENLAFAXINE XR and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take VENLAFAXINE XR with your other medicines. Do not start or stop any medicine while taking VENLAFAXINE XR without talking to your healthcare provider first.

If you take VENLAFAXINE XR, you should not take any other medicines that contain (venlafaxine) including: venlafaxine HCl.

How should I take VENLAFAXINE XR?

What should I avoid while taking VENLAFAXINE XR?

VENLAFAXINE XR can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how VENLAFAXINE XR affects you. Do not drink alcohol while using VENLAFAXINE XR.

What are the possible side effects of VENLAFAXINE XR?

VENLAFAXINE XR may cause serious side effects, including:

Common possible side effects in people who take VENLAFAXINE XR include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VENLAFAXINE XR. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store VENLAFAXINE XR?

Keep VENLAFAXINE XR and all medicines out of the reach of children.

General information about VENLAFAXINE XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VENLAFAXINE XR for a condition for which it was not prescribed. Do not give VENLAFAXINE XR to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about VENLAFAXINE XR. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about VENLAFAXINE XR that is written for healthcare professionals.

What are the ingredients in VENLAFAXINE XR?

Active ingredient: (venlafaxine)

Inactive ingredients:

Extended-Release Capsules: cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

Distributed by:
Apotex Corp.
Weston, Florida 33326

LAB-0544-4.0
May 2014

Revised: 06/2014
 
Apotex Corp.