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DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE- diclofenac sodium and misoprostol tablet, delayed release


  1. Patient Information
  2. This Chance Increases:
  3. Nsaid Medicines Can Cause Ulcers And Bleeding In The Stomach And Intestines At Any Time During Treatment. Ulcers And Bleeding:
  4. The Chance Of A Person Getting An Ulcer Or Bleeding Increases With:
  5. Nsaid Medicines Should Only Be Used:
  6. Nsaid Medicines Are Used To Treat Pain And Redness, Swelling, And Heat (inflammation) From Medical Conditions Such As:
  7. Who Should Not Take A Non-steroidal Anti-inflammatory Drug (nsaid)? Do Not Take An Nsaid Medicine:
  8. Tell Your Healthcare Provider:
  9. Serious Side Effects Include:
  10. Other Side Effects Include:
  11. Get Emergency Help Right Away If You Have Any Of The Following Symptoms:
  12. Stop Your Nsaid Medicine And Call Your Healthcare Provider Right Away If You Have Any Of The Following Symptoms:

Patient Information 

Read this leaflet before taking diclofenac sodium and misoprostol delayed-release tablets (diclofenac sodium 50 or 75 mg/misoprostol 200 mcg) and each time your prescription is renewed, because the leaflet may be changed.

Diclofenac sodium and misoprostol delayed-release tablets are being prescribed by your doctor for treatment of your arthritis symptoms while at the same time providing protection from the development of stomach and intestinal ulcers due to the arthritis medication. Diclofenac sodium and misoprostol delayed-release tablets contain diclofenac, an arthritis medication. Diclofenac sodium and misoprostol delayed-release tablets also contain misoprostol to decrease the chance of getting stomach and intestinal ulcers that sometimes develop with NSAID medications. Serious side effects are still possible, however, and you should report to your doctor any signs or symptoms of gastrointestinal ulceration or bleeding, skin rash, weight gain or swelling. If signs of liver toxicity occur (nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, and flu-like symptoms), you should stop therapy and

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

______________________________________________________________________________________________________________________________________

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.

Serious Side Effects Include: 


  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma

Other Side Effects Include: 


  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

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
  • skin rash or blisters with fever
  • unusual weight gain
  • 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.
  • 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 NameTradename
CelecoxibCelebrex
DiclofenacCataflam, Voltaren, Arthrotec(combined with misoprostol)
DiflunisalDolobid
EtodolacLodine, Lodine XL
FenoprofenNalfon, Nalfon 200
FlurbiprofenAnsaid
IbuprofenMotrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
IndomethacinIndocin, Indocin SR, Indo-Lemmon, Indomethagan
KetoprofenOruvail
KetorolacToradol
Mefenamic AcidPonstel
MeloxicamMobic
NabumetoneRelafen
NaproxenNaprosyn, Anaprox, Anaprox DS, EC- Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
OxaprozinDaypro
PiroxicamFeldene
SulindacClinoril
TolmetinTolectin, Tolectin DS, Tolectin 600

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



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