ETODOLAC- etodolac tablet, film coated 
Proficient Rx LP

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Medication Guide

for

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

Increased risk of heart attack or stroke that can lead to death.  Increased risk of heart attack or stroke that can lead to death.
with increasing doses of NSAIDs
with longer use of NSAIDs

Do not take NSAIDs right before or after heart surgery called a “coronary artery bypass graft (CABG)”. Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

1.
Increased risk of bleeding, ulcers and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
1.
 at anytime during use
2.
without warning symptoms
3.
that may cause death

The risk of getting an ulcer or bleeding increases with:

past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
increasing doses of NSAIDs
longer use of NSAIDs
smoking
drinking alcohol
older age
poor health
advanced liver disease
bleeding problems

NSAIDs medicines should only be used:

exactly as prescribed
at the lowest dose possible for your treatment
for the shortest time needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not take a NSAIDs?

Do not take an NSAIDs:

if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs
for pain right before or after heart bypass surgery

Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:

1.
have liver or kidney problems
2.
have high blood pressure
3.
have asthma
4.
are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
5.
are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

1.
new or worse high blood pressure
2.
heart failure
3.
liver problems including liver failure
4.
kidney problems including kidney failure
5.
low red blood cells (anemia)
6.
life-threatening skin reactions
7.
life-threatening allergic reactions
8.
Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness

Get emergency help right away if you get any of the following symptoms:

1.
shortness of breath or trouble breathing
2.
chest pain
3.
weakness in one part or side of your body
1.
slurred speech
2.
swelling of the face or throat

Stop taking NSAID and call your healthcare provider right away if you get any of the following symptoms:

1.
nausea
2.
more tired or weaker than usual
3.
diarrhea
4.
itching
5.
your skin or eyes look yellow
6.
indigestion or stomach pain
7.
flu-like symptoms
8.
vomit blood
1.
there is blood in your bowel movement or it is black and sticky like tar
2.
unusual weight gain
3.
skin rash or blisters with fever
4.
swelling of the arms, legs, hands and feet

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. 

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

Other information about NSAIDs:

1.
Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
2.
Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

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

Manufactured by

Apotex Inc.

Toronto, Ontario

Canada M9L 1T9

Manufactured for

Apotex Corp.

Weston, Florida

33326

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA

91320

Revised: July 2015

Revised: 7/2020
Proficient Rx LP