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:

• Generalized Anxiety Disorder (GAD)

• Social Anxiety Disorder (SAD)

• 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:

• Amphetamines

• Medicines used to treat migraine headaches such as:

triptans

• Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:

tricyclic antidepressants

lithium

SSRIs

SNRIs

antipsychotic drugs

• Medicines used to treat pain such as:

tramadol

• Medicines used to thin your blood such as:

warfarin

• Medicines used to treat heartburn such as:

Cimetidine

• Over-the-counter medicines or supplements such as:

Aspirin or other NSAIDs

Tryptophan

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 breast-feeding or plan to breast-feed.

• 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

1-855-361-3993.

What are the ingredients in venlafaxine hydrochloride extended-release capsules

USP?

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 AvKARE.

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

antidepressants.

Manufactured for:

AvKARE

Pulaski, TN 38478

Mfg. Rev. 08/17

AV Rev. 06/21 (P)