DICLOFENAC SODIUM AND MISOPROSTOL- diclofenac sodium and misoprostol tablet, film coated 
Greenstone LLC


Medication Guide for diclofenac sodium/misoprostol
A combination of diclofenac a Nonsteroidal Anti-inflammatory Drug (NSAID) and misoprostol a GI mucosal protective prostaglandin E1 analog
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: August 2021  
What is the most important information I should know about diclofenac sodium/misoprostol?
Diclofenac sodium/misoprostol contains diclofenac (a nonsteroidal anti-inflammatory drug (NSAID)) and misoprostol, and can cause abortion, premature birth, birth defects, and the uterus to tear (uterine rupture). The risk of uterine rupture increases as your pregnancy advances, if you have given birth to 5 or more children, and if you have had surgery on the uterus, such as a cesarean delivery. Do not take diclofenac sodium/misoprostol if you are pregnant.

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

NSAIDs can cause serious side effects, including:
  • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
    • with increasing doses of NSAIDs
    • with longer use of NSAIDs
Do not take NSAID containing medicines right before or after a heart surgery called a "coronary artery bypass graft (CABG)."
Avoid taking NSAID containing medicines 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
  • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
    • anytime during use
    • without warning symptoms
    • 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", "antiplatelet drugs", "anticoagulants", "SSRIs", or "SNRIs"
  • increasing doses of NSAIDs
  • longer use of NSAIDs
  • smoking
  • drinking alcohol
  • older age
  • poor health
  • advanced liver disease
  • bleeding problems
NSAID containing medicines should only be used:
  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed
What is diclofenac sodium/misoprostol?
Diclofenac sodium/misoprostol contains 2 medicines:
  1. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). See "What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
  2. Misoprostol is a medicine used to protect the lining of the esophagus, stomach and intestines while taking diclofenac.
Diclofenac sodium/misoprostol is a prescription medicine used to treat:
  • symptoms of osteoarthritis or rheumatoid arthritis in people at high risk of developing stomach (gastric) and intestinal (duodenal) ulcers while taking NSAIDs.
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 diclofenac sodium/misoprostol?
Do not take diclofenac sodium/misoprostol:
  • if you are allergic to diclofenac, misoprostol or any other ingredients in diclofenac sodium/misoprostol. See the end of this Medication Guide for a list of ingredients in diclofenac sodium/misoprostol.
  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.
  • if you are pregnant.
  • If you currently have bleeding in your stomach (gastrointestinal bleeding).
Before taking diclofenac sodium/misoprostol, tell your healthcare provider about all of your medical conditions, including if you:
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)?
  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • 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:
  • 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 taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or 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, 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
  • 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.
  • 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.
Active ingredients: diclofenac sodium, misoprostol.
Inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated castor oil, hypromellose, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone (polyvidone) K-30, sodium hydroxide, starch (corn), talc, triethyl citrate.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.
For more information, go to www.greenstonellc.com or call 1-800-438-1985



Revised: 9/2021
Document Id: b0f6c97a-6aeb-43f7-9831-4aebf2136de6
Set id: a7701e8c-4e16-4165-8b83-de2c08d5ded3
Version: 15
Effective Time: 20210910
Greenstone LLC