VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride tablet 
Teva Pharmaceuticals USA Inc

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MEDICATION GUIDE

Venlafaxine (ven la fax een) Hydrochloride Tablets USP

Read the Medication Guide that comes with venlafaxine hydrochloride tablets before you start taking them 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 hydrochloride tablets?

Venlafaxine hydrochloride tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

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:

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

2. Serotonin Syndrome. This condition can be life-threatening and may include:

3. Changes in blood pressure. Venlafaxine hydrochloride tablets may:

4. Enlarged pupils (mydriasis).

5. Anxiety and insomnia.

6. Changes in appetite or weight.

7. Manic/hypomanic episodes:

8. Low salt (sodium) levels in the blood.

Elderly people may be at greater risk for this. Symptoms may include:

9. Seizures or convulsions.

10. Abnormal bleeding: Venlafaxine hydrochloride tablets 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 hydrochloride tablets may cause rare lung problems. Symptoms include:

13. Severe allergic reactions:

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

What are venlafaxine hydrochloride tablets?

Venlafaxine hydrochloride tablets are 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.

Talk to your healthcare provider if you do not think that your condition is getting better with venlafaxine hydrochloride tablets treatment.

Who should not take venlafaxine hydrochloride tablets?

Do not take venlafaxine hydrochloride tablets if you:

People who take venlafaxine hydrochloride tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

What should I tell my healthcare provider before taking venlafaxine hydrochloride tablets? Ask if you are not sure.

Before starting venlafaxine hydrochloride tablets, 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 hydrochloride tablets 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 hydrochloride tablets with your other medicines. Do not start or stop any medicine while taking venlafaxine hydrochloride tablets without talking to your healthcare provider first.

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

How should I take venlafaxine hydrochloride tablets?

  • Take venlafaxine hydrochloride tablets exactly as prescribed. Your healthcare provider may need to change the dose of venlafaxine hydrochloride tablets until it is the right dose for you.
  • Venlafaxine hydrochloride tablets are to be taken with food.
  • If you miss a dose of venlafaxine hydrochloride tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of venlafaxine hydrochloride tablets at the same time.
  • If you take too much venlafaxine hydrochloride tablets, call your healthcare provider or poison control center right away, or get emergency treatment.
  • When switching from another antidepressant to venlafaxine hydrochloride tablets your doctor may want to lower the dose of the initial antidepressant first to avoid side effects

What should I avoid while taking venlafaxine hydrochloride tablets?

Venlafaxine hydrochloride tablets 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 hydrochloride tablets affect you. Do not drink alcohol while using venlafaxine hydrochloride tablets.

What are the possible side effects of venlafaxine hydrochloride tablets? Venlafaxine hydrochloride tablets may cause serious side effects, including:

  • See “What is the most important information I should know about venlafaxine hydrochloride tablets?”
  • Increased cholesterol- have your cholesterol checked regularly
  • Newborns whose mothers take venlafaxine hydrochloride tablets in the third trimester may have problems right after birth including:
  • problems feeding and breathing
  • seizures
  • shaking, jitteriness or constant crying
  • Narrow-angle glaucoma/enlarged pupils. Check eye pressure regularly if you:
  • have a history of increased eye pressure
  • are at risk for certain types of glaucoma

Common possible side effects in people who take venlafaxine hydrochloride tablets include:

  • unusual dreams
  • sexual problems
  • loss of appetite, constipation, diarrhea, nausea or vomiting, or dry mouth
  • feeling tired, fatigued or overly sleepy
  • change in sleep habits, problems sleeping
  • yawning
  • tremor or shaking
  • dizziness, blurred vision
  • sweating
  • feeling anxious, nervous or jittery
  • headache
  • increase in heart rate

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 hydrochloride tablets. 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 hydrochloride tablets?

  • Store venlafaxine hydrochloride tablets at room temperature between 68°F and 77°F (20°C to 25°C).
  • Keep venlafaxine hydrochloride tablets in a dry place.

Keep venlafaxine hydrochloride tablets and all medicines out of the reach of children.

General information about venlafaxine hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use venlafaxine hydrochloride tablets for a condition for which they were not prescribed. Do not give venlafaxine hydrochloride tablets to other people, even if they have the same condition. They may harm them.

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

For more information about venlafaxine hydrochloride tablets call 1-866-832-8537, MEDICAL AFFAIRS.

What are the ingredients in venlafaxine hydrochloride tablets?

Active ingredient: venlafaxine hydrochloride, USP.

Inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, ferric oxide red, lactose monohydrate, magnesium stearate, and sodium starch glycola

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

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Iss. 12/2012

Revised: 01/2013
 
Teva Pharmaceuticals USA Inc