Medication Guide

Venlafaxine Tablets, USP
(ven'' la fax' een hye'' droe klor' ide)

Read the Medication Guide that comes with venlafaxine tabletsbefore 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 tablets?

Venlafaxine tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

Venlafaxine tablets and other antidepressant medicines may increase suicidal thoughts or actionsin 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 tabletsare 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

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Venlafaxine tablets may be associated with these serious side effects:

2. Serotonin Syndrome

This condition can be life-threatening andmay 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 tabletsmay:

increase your blood pressure. Control high blood pressure before starting treatment and monitor blood pressure regularly

4. Enlarged pupils (mydriasis).

5. Sexual problems (dysfunction).Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including venlafaxine tablets, may cause sexual problems.

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 tablets. There may be treatments your healthcare provider can suggest.

6. Anxiety and insomnia.

7. Changes in appetite or weight.

children and adolescents should have height and weight monitored during treatment

8. 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

9. 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

10. Seizures or convulsions.

11. Abnormal bleeding: Venlafaxine tabletsand 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.

12. Elevated cholesterol.

13. Lung disease and pneumonia: Venlafaxine tabletsmay cause rare lung problems. Symptoms include:

worsening shortness of breath
cough
chest discomfort

14. 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

15. 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.

Do not stop venlafaxine tablets without first talking to your healthcare provider.

Stopping venlafaxine tabletstoo 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 tablets?

Venlafaxine tablets 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.

Talk to your healthcare provider if you do not think that your condition is getting better with venlafaxine tabletstreatment.

Who should not take venlafaxine tablets?

Do not take venlafaxine tabletsif you:

are allergic to venlafaxine hydrochlorideor any of the ingredients in venlafaxine tablets. See the end of this Medication Guide for a complete list of ingredients in venlafaxine tablets.
have uncontrolled narrow-angle 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 tabletsunless directed to do so by your physician.
- Do not start venlafaxine tabletsif you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take venlafaxine tablets 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 tablets? Ask if you are not sure.

Before starting venlafaxine tablets, 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
- meperidine
- methadone
- or other opioids
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 glaucoma
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 tabletswill 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 hydrochloridemay pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking venlafaxine tablets.

Tell your healthcare provider about all the medicines that you take,including prescription and non-prescription medicines, vitamins, and herbal supplements. Venlafaxine tabletsand 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 tabletswith your other medicines. Do not start or stop any medicine while taking venlafaxine tablets without talking to your healthcare provider first.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

If you take venlafaxine tablets,you should not take any other medicines that contain (venlafaxine) including: venlafaxine hydrochloride.

How should I take venlafaxine tablets?

Take venlafaxine tabletsexactly as prescribed. Your healthcare provider may need to change the dose of venlafaxine tabletsuntil it is the right dose for you.
Venlafaxine tabletsare to be taken with food.
If you miss a dose of venlafaxine tablets, 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 tabletsat the same time.
If you take too much venlafaxine hydrochloride, call your healthcare provider or poison control center right away, or get emergency treatment.
When switching from another antidepressant to venlafaxine tabletsyour doctor may want to lower the dose of the initial antidepressant first to avoid side effects.

What should I avoid while takingvenlafaxine tablets?

Venlafaxine tabletscan 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 tabletsaffect you. Do not drink alcohol while using venlafaxine tablets.

What are the possible side effects ofvenlafaxine tablets?

Venlafaxine tabletsmay cause serious side effects, including:

See “What is the most important information I should know aboutvenlafaxine tablets?”
Increased cholesterol- have your cholesterol checked regularly
Newborns whose mothers take venlafaxine tabletsin the third trimester may have problems right after birth including:
- problems feeding and breathing
- seizures
- shaking, jitteriness or constant crying
Narrow-angle glaucoma/enlarged pupils. Check eye pressure regularly if you:
- have a history of increased eye pressure
- are at risk for certain types of glaucoma

Common possible side effects in people who take venlafaxine tabletsinclude :

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 tablets. 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 tablets?

Store venlafaxine tabletsat room temperature between 20° to 25°C (68° to 77°F).
Keep venlafaxine tabletsin a dry place.

Keep venlafaxine tabletsand all medicines out of the reach of children.

General information about venlafaxine tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use venlafaxine tabletsfor a condition for which it was not prescribed. Do not give venlafaxine tabletsto other people, even if they have the same condition. They may harm them.

This Medication Guide summarizes the most important information about venlafaxine tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about venlafaxine tabletsthat is written for healthcare professionals.

For more information about venlafaxine tabletscall 1-833-395-6928.

What are the ingredients in venlafaxine tablets?

Active ingredient: venlafaxine hydrochloride

Inactive ingredients:

Tablets: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, ferric oxide brown, ferric oxide yellow, povidone (Kollidone 30), and magnesium stearate.

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Revised: 2/2024

Document Id: 11830f75-c45c-6bb7-e063-6294a90aa1ca

Set id: 4a82cef5-693e-46e9-90c4-bff753cdce37

Version: 13

Effective Time: 20240216

REMEDYREPACK INC.