DICLOFENAC SODIUM- diclofenac sodium tablet, film coated, extended release 
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Medication Guide for Non-Steroidal 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 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

with longer use of NSAID medicines 
in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

can happen without warning symptoms 
may cause death

The chance of a person getting an ulcer or bleeding increases with:

taking medicines called “corticosteroids” and “anticoagulants”: 
longer use 
smoking 
drinking alcohol 
older age 
having poor health

NSAID medicines should only be used:

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

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines 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 Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

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

Tell your healthcare provider:

about all of your medical conditions.
about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your
healthcare provider and pharmacist. 
if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Side Effects Image

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

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

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

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

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about
side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Aspirin is an NSAID medicine 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. Aspirin can also cause ulcers in the stomach and intestines.
Some of these NSAID medicines 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.
NSAID medicines that need a prescription
*
Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

 Generic Name

 Tradename

 Celecoxib

 Celebrex

 Diclofenac

 Cataflam, Voltaren, Arthrotec (combined with misoprostol)

 Diflunisal

 Dolobid

 Etodolac

 Lodine, Lodine XL

 Fenoprofen

 Nalfon, Nalfon 200

 Flubiprofen

 Ansaid

 Ibuprofen

 Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone),
Combunox (combined with oxycodone)

 Indomethacin

 Indocin, Indocin SR, Indo-Lemmon, Indomethagan

 Ketoprofen

 Oruvail

 Ketorolac

 Toradol

 Mefenamic Acid

 Ponstel

 Meloxicam

 Mobic

 Nabumetone

 Relafen

 Naproxen

 Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan,
Naprapac (copackaged with lansoprazole)

 Oxaprozin

 Daypro

 Piroxicam

 Feldene

 Sulindac

 Clinoril

 Tolmetin

 Tolectin, Tolectin DS, Tolectin 600

The brands listed maybe the trademarks or register marks of their respective owners and are not trade marks or register marks of Dexcel Ltd.

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

ISS 10/2010

Revised: 1/2021
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