VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride capsule, extended release 
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Medication Guide

Venlafaxine Hydrochloride

 (ven" la fax' een hye" droe klor' ide)

Extended-Release Capsules, USP

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

Venlafaxine hydrochloride extended-release capsules 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:

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:

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:

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 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:

13. Severe allergic reactions:

14. Sexual Problems (dysfunction): Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including venlafaxine hydrochloride extended-release capsules, may cause sexual problems. Symptoms in males may include:

Symptoms in females may include:

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with venlafaxine hydrochloride extended-release capsules. There may be treatments your healthcare provider can suggest.

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.

Symptoms may include the following (some of which can be severe and last for a long time):

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:

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

Who should not take venlafaxine hydrochloride extended-release capsules?

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

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:

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:

○   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

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 hydrochloride.

How should I take venlafaxine hydrochloride extended-release capsules?

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 capsule affects 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:

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

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 it was not prescribed. Do not give venlafaxine hydrochloride extended-release capsules to other people, even if they have the same condition. It 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.

Please address medical inquiries to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

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

Active ingredient: Venlafaxine hydrochloride, USP

Inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent.

Medication Guide available at www.zydususa.com/medguides/ or call 1-877-993-8779.

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

Revised: 2/2022
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