Diclofenac; Misoprostol Delayed-Release Tablets

What is this medication?

DICLOFENAC; MISOPROSTOL (dye KLOE fen ak; mye soe PROST ole) treats arthritis in people at risk of stomach ulcers from taking NSAID medications. Diclofenac works by decreasing pain and inflammation. Misoprostol works by reducing the amount of acid in the stomach and protecting the stomach lining from irritation. This medication is a combination of an NSAID and a prostaglandin.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Arthrotec

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Asthma
• Bleeding problems
• Dehydration
• Frequently drink alcohol
• Have had a heart attack, stroke, or mini-stroke
• Heart bypass surgery, or CABG, within the past 2 weeks
• Heart or blood vessel conditions
• Heart failure
• High blood pressure
• Kidney disease
• Liver disease
• Stomach bleeding
• Stomach ulcers, other stomach or intestine problems
• Tobacco use
• An unusual or allergic reaction to diclofenac, misoprostol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

People 65 years and older may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cidofovir
• Ketorolac

This medication may also interact with the following:

• Alcohol
• Aspirin and aspirin-like medications
• Blood thinners
• Cyclosporine
• Digoxin
• Diuretics
• Lithium
• Medications for blood pressure
• Methotrexate
• Other NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Some medications for depression
• Steroid medications, such as prednisone or cortisone
• Supplements, such as garlic, ginger, ginkgo, methylsulfonylmethane (MSM)

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not take aspirin or other NSAIDs, such as ibuprofen or naproxen, while you are taking this medication. Side effects, such as upset stomach, nausea, and ulcers, may be more likely to occur. Many over-the-counter medications contain aspirin, ibuprofen, or naproxen. It is important to read labels carefully. Talk to your care team about all the medications you take. They can tell you what is safe to take together.

This medication can cause serious bleeding, ulcers, or tears in the stomach. These problems can occur at any time and with no warning signs. They are more common with long-term use. Talk to your care team right away if you have stomach pain, bloody or black, tar-like stools, or vomit blood that is red or looks like coffee grounds.

This medication increases the risk of blood clots, heart attack, and stroke. These events can occur at any time. They are more common with long-term use and in those who have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your care team. They can help you find an option that works for you.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Do not take this medication if you may be pregnant. This medication may end your pregnancy. Also, serious birth defects can occur if you take this medication during pregnancy. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication. Your care team can help you find the option that works for you.

This medication may cause infertility. It is usually temporary. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Increase in blood pressure
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Round red or dark patches on the skin that may itch, burn, and blister
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Headache
• Loss of appetite
• Nausea
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep container tightly closed.

Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.