• 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

• older age

• longer use of NSAIDs

• poor health

• smoking

• advanced liver disease

• drinking alcohol

• bleeding problems

1. NSAID containing medicines should only be used:
   

1. What is diclofenac sodium and misoprostol delayed-release tablets?

It is not known if diclofenac sodium and misoprostol delayed-release tablets are safe and effective for use in children.

1. What are NSAIDs?

Who should not take diclofenac sodium and misoprostol delayed-release tablets? 

Do not take diclofenac sodium and misoprostol delayed-release tablets:

• If you are pregnant.
• Right before or after heart bypass surgery.
• If you currently have bleeding in your stomach (gastrointestinal bleeding).
• If you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
• If you are allergic to diclofenac sodium and misoprostol, other prostaglandins or any other ingredients in diclofenac sodium and misoprostol delayed-release tablets. See the end of this Medication Guide for a list of ingredients in diclofenac sodium and misoprostol delayed-release tablets.

Before taking diclofenac sodium and misoprostol delayed-release tablets, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems.
• have high blood pressure.
• have heart problems, including a history of heart failure or heart attack.
• have asthma.
• are pregnant or plan to become pregnant. See “Who should not take diclofenac sodium and misoprostol delayed-release tablets?”
• are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and 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
• asthma attacks in people who have asthma
• 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

• slurred speech

• chest pain

• swelling of the face or throat

• weakness in one part or side of your body

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

• nausea

• vomit blood

• more tired or weaker than usual

• there is blood in your bowel

• diarrhea

• movement or it is black and sticky like tar

• itching

• unusual weight gain

• your skin or eyes look yellow

• skin rash or blisters with fever

• indigestion or stomach pain

• swelling of the arms, legs, hands and feet

• flu-like symptoms

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.

• 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.

What are the ingredients in diclofenac sodium and misoprostol delayed-release tablets?