VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride capsule, extended release 
Teva Pharmaceuticals USA Inc

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MEDICATION GUIDE

Venlafaxine (ven la fax een) Hydrochloride Extended-Release Capsules USP

Read the Medication Guide that comes with venlafaxine hydrochloride extended-release capsules 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 extended-release capsules?

Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

Venlafaxine hydrochloride extended-release capsules 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 hydrochloride extended-release capsules are 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 hydrochloride extended-release capsules 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 hydrochloride extended-release capsules 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 hydrochloride extended-release capsules  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 extended-release capsules 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 hydrochloride extended-release capsules without first talking to your healthcare provider. Stopping venlafaxine hydrochloride extended-release capsules too quickly or changing from another antidepressant too quickly may cause serious symptoms including:

anxiety, irritability
feeling tired, restless or problems sleeping
headache, sweating, dizziness
electric shock-like sensations, shaking, confusion, nightmares
vomiting, nausea, diarrhea

What are venlafaxine hydrochloride extended-release capsules?

Venlafaxine hydrochloride extended-release capsules are 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 hydrochloride extended-release capsules are also used to treat:

Panic Disorder (PD)

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

Who should not take venlafaxine hydrochloride extended-release capsules?

Do not take venlafaxine hydrochloride extended-release capsules if you:

are allergic to venlafaxine hydrochloride extended-release capsules or any of the ingredients in venlafaxine hydrochloride extended-release capsules. See the end of this Medication Guide for a complete list of ingredients in venlafaxine hydrochloride extended-release capsules.
have uncontrolled angle-closure glaucoma.
take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
Do not take an MAOI within 7 days of stopping venlafaxine hydrochloride extended-release capsules unless directed to do so by your physician.
Do not start venlafaxine hydrochloride extended-release capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take venlafaxine hydrochloride extended-release capsules 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:

high fever
uncontrolled muscle spasms
stiff muscles
rapid changes in heart rate or blood pressure
confusion
loss of consciousness (pass out)

What should I tell my healthcare provider before taking venlafaxine hydrochloride extended-release capsules? Ask if you are not sure.

Before starting venlafaxine hydrochloride extended-release capsules, tell your healthcare provider if you:

Are taking certain drugs such as:
Medicines used to treat migraine headaches such as:
o
triptans
Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:
o
tricyclic antidepressants
o
lithium
o
SSRIs
o
SNRIs
o
antipsychotic drugs
Medicines used to treat pain such as:
o
tramadol
Medicines used to thin your blood such as:
o
warfarin
Medicines used to treat heartburn such as:
o
Cimetidine
Over-the-counter medicines or supplements such as:
o
Aspirin or other NSAIDs
o
Tryptophan
o
St. John’s Wort
have heart problems
have diabetes
have liver problems
have kidney problems
have thyroid problems
have or had seizures or convulsions
have bipolar disorder or mania
have low sodium levels in your blood
have high blood pressure
have high cholesterol
have or had bleeding problems
are pregnant or plan to become pregnant. It is not known if venlafaxine hydrochloride extended-release capsules will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy
are breastfeeding or plan to breastfeed. Some venlafaxine hydrochloride may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking venlafaxine hydrochloride extended-release capsules.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Venlafaxine hydrochloride extended-release capsules 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 extended-release capsules with your other medicines. Do not start or stop any medicine while taking venlafaxine hydrochloride extended-release capsules  without talking to your healthcare provider first.

If you take venlafaxine hydrochloride extended-release capsules, you should not take any other medicines that contain (venlafaxine) including: venlafaxine HCl.

How should I take venlafaxine hydrochloride extended-release capsules?

Take venlafaxine hydrochloride extended-release capsules exactly as prescribed. Your healthcare provider may need to change the dose of venlafaxine hydrochloride extended-release capsules  until it is the right dose for you.
Venlafaxine hydrochloride extended-release capsules are to be taken with food.
If you miss a dose of venlafaxine hydrochloride extended-release capsules, 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 extended-release capsules at the same time.
If you take too many venlafaxine hydrochloride extended-release capsules, call your healthcare provider or poison control center right away, or get emergency treatment.
When switching from another antidepressant to venlafaxine hydrochloride extended-release capsules 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 extended-release capsules?

Venlafaxine hydrochloride extended-release capsules 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 extended-release capsules affect you. Do not drink alcohol while using venlafaxine hydrochloride extended-release capsules.

What are the possible side effects of venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules may cause serious side effects, including:

See “What is the most important information I should know about venlafaxine hydrochloride extended-release capsules?”
Increased cholesterol- have your cholesterol checked regularly
Newborns whose mothers take venlafaxine hydrochloride extended-release capsules in the third trimester may have problems right after birth including:
problems feeding and breathing
seizures
shaking, jitteriness or constant crying
Angle-closure glaucoma

Common possible side effects in people who take venlafaxine hydrochloride extended-release capsules 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 extended-release capsules. 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 extended-release capsules?

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

Keep venlafaxine hydrochloride extended-release capsules and all medicines out of the reach of children.

General information about venlafaxine hydrochloride extended-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use venlafaxine hydrochloride extended-release capsules for a condition for which they were not prescribed. Do not give venlafaxine hydrochloride extended-release capsules 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 extended-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about venlafaxine hydrochloride extended-release capsules that is written for healthcare professionals.

For more information about venlafaxine hydrochloride extended-release capsules call 1-888-838-2872.

What are the ingredients in venlafaxine hydrochloride extended-release capsules?

Active ingredient: venlafaxine hydrochloride, USP.

Inactive ingredients: black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

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

Rev. C 7/2014

Revised: 08/2014
 
Teva Pharmaceuticals USA Inc