DESVENLAFAXINE SUCCINATE- desvenlafaxine succinate tablet, film coated, extended release 
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SPL MEDGUIDE

MEDICATION GUIDE

Desvenlafaxine (des-VEN-la-FAX-een)

Extended-Release Tablets

Read this Medication Guide before you start taking Desvenlafaxine Extended-Release Tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about desvenlafaxine

extended-release tablets?

Desvenlafaxine extended-release tablets can cause serious side effects, including:

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

What is desvenlafaxine extended-release tablets?

Do not take desvenlafaxine extended-release tablets if you:

Do not start taking an MAOI for at least 7 days after you stop treatment with desvenlafaxine extended-release tablets.

Before taking desvenlafaxine extended-release tablets tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Desvenlafaxine extended-release tablets and other medicines may affect each other causing possible serious side effects. Desvenlafaxine extended-release tablets may affect the way other medicines work and other medicines may affect the way desvenlafaxine extended-release tablets works.

Especially tell your healthcare provider if you take:

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take desvenlafaxine extended-release tablets with your other medicines.

Do not start or stop any other medicines during treatment with desvenlafaxine extended-release tablets without talking to your healthcare provider first. Stopping desvenlafaxine extended-release tablets suddenly may cause you to have serious side effects. See, "What are the possible side effects of desvenlafaxine extended-release tablets?"

Know the medicines you take. Keep a list of them to show to your healthcare providers when you get a new medicine.

How should I take desvenlafaxine extended-release tablets?

What should I avoid while taking desvenlafaxine extended-release tablets?

What are the possible side effects of desvenlafaxine extended-release tablets?

Desvenlafaxine extended-release tablets can cause serious side effects, including:

In severe or more sudden cases, signs and symptoms include:

Sexual Problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including Desvenlafaxine

extended-release tablets, may cause sexual problems.

Symptoms in males may include:

o Delayed ejaculation or inability to have an ejaculation

o Decreased sex drive

o Problems getting or keeping an erection

Symptoms in females may include:

o Decreased sex drive

o Delayed orgasm or inability to have an orgasm

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 Desvenlafaxine extended-release tablets. There may be treatments your healthcare

provider can suggest.

The most common side effects of desvenlafaxine extended-release tablets include:

These are not all the possible side effects of desvenlafaxine extended-release tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store desvenlafaxine extended-release tablets?

General Information about the safe and effective use of desvenlafaxine extended-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take desvenlafaxine extended-release tablets for a condition for which it was not prescribed. Do not give desvenlafaxine extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about desvenlafaxine extended-release tablets that is written for healthcare professionals.

For more information, go to www.lupinpharmaceuticals.com or call Lupin Pharmaceuticals, Inc. at 1- 800-399-2561.

What are the ingredients in desvenlafaxine extended-release tablets?

Active ingredient: desvenlafaxine

Inactive ingredients: For the 25 mg tablet, colloidal silicon dioxide, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

For the 50 mg tablet, colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

For the 100 mg tablet, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa - 403 722

INDIA.

Revised: April 2022                                                                                                   ID#: 269600

Revised: 9/2022
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