VENLAFAXINE HYDROCHLORIDE- venlafaxine hydrochloride capsule, extended release 
Florida Pharmaceutical Products, LLC

----------

                                                                                                                   Medication Guide

                                                                                     Venlafaxine Hydrochloride Extended-release Capsules, USP
                                                                                                        (ven'' la fax' eenhye'' droeklor' ide)

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:

•       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:

3. Changes in blood pressure. Venlafaxine hydrochloride extended-release capsules 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 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:

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:

What is venlafaxine hydrochloride extended-release capsules?

Venlafaxine hydrochloride extended-release capsules is 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 is 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:

•   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?

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  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, Florida Pharmaceutical Products, LLC at 1-800-315-0985.

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

Active ingredient: (venlafaxine)

Inactive ingredients:

Extended-Release Capsules: ethylcellulose,hypromellose and sugar spheres. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The 37.5 mg capsules also contain iron oxide black. The 75 mg capsules also contain FD&C red No.3 and FD&C yellow No. 6. The 150 mg capsules also contain iron oxide red and iron oxide yellow.

The 37.5 mg, 75 mg and 150 mg capsules are imprinted with black and grey ink which contains iron oxide black, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide.

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

Manufactured for:

Inventia Healthcare Limited

F1-F1/1-F75/1, Additional Ambernath M.I.D.C.,

Ambernath (East)-421506,

Dist. Thane, Maharashtra, India

Manufactured for:

Florida Pharmaceutical Products, LLC

6111 Broken Sound Pkwy NW

Suite 160 Boca Raton, FL 33487

Toll Free Number: 1-800-315-0985

Revised: 04/2020

ATE0704G/01

Revised: 4/2020
Florida Pharmaceutical Products, LLC