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

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SPL MEDGUIDE

MEDICATION GUIDE

Venlafaxine hydrochloride extended-release capsules, USP

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

What is the most important information I should know about Venlafaxine hydrochloride extended-release capsules?

Venlafaxine hydrochloride extended-release capsules may cause serious side effects, including:

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

    ○  Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

    ○  This is very important when an antidepressant medicine is started or when the dose is changed.

    ○  Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

    ○  Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency help right away if you or a family member have any of the following symptoms, especially if they are new, worse, or worry you:

   ●  attempts to commit suicide
   ●  acting aggressive, being angry, or violent
   ●  new or worse depression
   ●  panic attacks
   ●  new or worse irritability
   ●  an extreme increase in activity or talking (mania)
   ●  thoughts about suicide or dying
   ●  acting on dangerous impulses
   ●  new or worse anxiety
   ●  feeling very agitated, or restless
   ●  trouble sleeping
   ●  other unusual changes in behavior or mood

What is Venlafaxine hydrochloride extended-release capsules?

Venlafaxine hydrochloride extended-release capsules is a prescription medicine used to treat adults with:

It is not known if Venlafaxine hydrochloride extended-release capsules is safe and effective for use in children.

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

See the end of this Medication Guide for a complete list of ingredients in Venlafaxine hydrochloride extended-release capsules.

take a Monoamine Oxidase Inhibitor (MAOIhave stopped taking an MAOI in the last 14 days

Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including MAOIs such as linezolid or intravenous methylene blue.

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

Before taking Venlafaxine hydrochloride extended-release capsules 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.

Venlafaxine hydrochloride extended-release capsules and other medicines may affect each other causing possible serious side effects. Venlafaxine hydrochloride extended-release capsules may affect the way other medicines work and other medicines may affect the way Venlafaxine hydrochloride extended-release capsules 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 Venlafaxine hydrochloride extended-release capsules with your other medicines.

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

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

How should I take Venlafaxine hydrochloride extended-release capsules?

What should I avoid while taking 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:

    ○  Agitation
    ○  Confusion
    ○  fast heartbeat
    ○  dizziness
    ○  flushing
    ○  tremors, stiff muscles, or muscle twitching
    ○  seizures
    ○  seeing or hearing things that are not real (hallucinations)
    ○  coma
    ○  changes in blood pressure
    ○  sweating
    ○  high body temperature (hyperthermia)
    ○  loss of coordination
    ○  nausea, vomiting, diarrhea
    ○  greatly increased energy
    ○  racing thoughts
    ○  unusually grand ideas
    ○  talking more or faster than usual
    ○  severe trouble sleeping
    ○  reckless behavior
    ○  excessive happiness or irritability

Your healthcare provider may want to decrease your dose slowly. Symptoms may include:

  ○  dizziness
  ○  irritability and agitation
  ○  anxiety
  ○  sweating
  ○  seizures
  ○  ringing in your ears (tinnitus)
  ○  nausea
  ○  problems sleeping
  ○  tiredness
  ○  confusion
  ○  electric shock sensation (paresthesia)
  ○  headache
  ○  diarrhea
  ○  abnormal dreams
  ○  changes in your mood
  ○  hypomania

Seizures (convulsions).

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

    ○  hallucinations (seeing or hearing things that are not real)

    ○  fainting

    ○  seizures

    ○  coma

    ○  respiratory arrest

Symptoms in males may include:

     ○  delayed ejaculation or inability to have an ejaculation

     ○  decreased sex drive

     ○  problems getting or keeping an erection

Symptoms in females may include:

     ○  decreased sex drive

     ○  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 Venlafaxine hydrochloride extended-release capsules. There may be treatments your healthcare provider can suggest.

Your healthcare provider may tell you to stop taking Venlafaxine hydrochloride extended-release capsules if you develop serious side effects during treatment with Venlafaxine hydrochloride extended-release capsules.

The most common side effects of Venlafaxine hydrochloride extended-release capsules include:

  ○  nausea
  ○  dry mouth
  ○  male and female sexual problems
  ○  loss of appetite (anorexia)
  ○  sleepiness
  ○  sweating
  ○  constipation

These are not all the possible side effects of Venlafaxine hydrochloride extended-release capsules.

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 Venlafaxine hydrochloride extended-release capsules?

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

General Information about the safe and effective use of 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 symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Venlafaxine hydrochloride extended-release capsules that is written for healthcare professionals.

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

Active ingredient: venlafaxine

Inactive ingredients: 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 black oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide.

Please address medical inquiries to, Inventia Healthcare Limited at 1-855-642-2594.

This Medication was approved by the U.S. Food and Drug Administration.

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: 11/2022

Revised: 12/2022
Florida Pharmaceutical Products, LLC