Diclofenac/Misoprostol, Oral

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KEY POINTS

• This medicine is taken by mouth to treat arthritis in people who are at risk of developing stomach or intestinal ulcers due to the use of NSAIDs. Take it exactly as directed.
• Do not take this medicine if you are pregnant because it can seriously harm the baby.
• NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG).
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: nonsteroidal anti-inflammatory (NSAID); prostaglandin analogue

Generic and brand names: diclofenac/misoprostol, oral; Arthrotec

What is this medicine used for?

This medicine is a combination of 2 products:

• A nonsteroidal anti-inflammatory drug (NSAID) taken by mouth to relieve the pain and other symptoms of osteoarthritis (joint disease) and rheumatoid arthritis (connective tissue disease)
• Another medicine used to protect the stomach and intestines from bleeding and ulcers that the NSAID may cause

This medicine is used to treat arthritis in people who are at risk of developing stomach or intestinal ulcers due to the use of NSAIDs.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergy to any medicine
• A blood clotting disorder or anemia
• A stroke or transient ischemic attack (TIA)
• Asthma
• Heart disease, heart failure, or a heart attack
• High blood pressure
• Inflammatory bowel disease
• Liver or kidney disease
• Nasal polyps
• Peripheral vascular disease
• Porphyria (nerve pain or sensitivity to sunlight)
• Ulcers

Tell your healthcare provider if you drink alcohol or smoke regularly.

Females of childbearing age: Do not take this medicine if you are pregnant because it can seriously harm the baby. Do not start this medicine unless you have a negative pregnancy test within 2 weeks of taking this medicine. Then start taking the medicine on the second or third day of your next menstrual period. Talk to your healthcare provider if you need birth control while you are taking this medicine. If you become pregnant while taking this medicine, stop taking this medicine and call your healthcare provider immediately. Do not breast-feed while taking this medicine without your healthcare provider’s approval. Do not give this medicine to other women. Your healthcare provider may require you to sign a form indicating that you understand these warnings.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

It is best to take this medicine with food. Taking it with meals may lessen the chance the drug will upset your stomach. Swallow the tablets whole with water. Do not break, crush, chew, or dissolve the tablets in water.

Take this medicine 2 hours before or 2 hours after you take an antacid.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: stomach pain, vomiting blood, bloody bowel movements, weakness, tiredness, nausea, vomiting, diarrhea, confusion, drowsiness, seizures, slow or irregular heartbeat, shakiness, trouble breathing, decreased urination.

What should I watch out for?

Warning: This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This may happen without warning symptoms. You may be at higher risk if you smoke, are over the age of 65 or in poor health, drink alcohol, or take this medicine for a long time. If you have stomach pain, or bloody or black tarry bowel movements, stop taking this medicine and contact your healthcare provider right away.

NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This chance increases if you:

• Use NSAIDs for a long time
• Have heart disease

Talk with your healthcare provider about this.

This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG). Talk with your healthcare provider about this.

This medicine has been linked with increased risk for high blood pressure.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

You may have swelling of the ankles, feet, or hands while taking this medicine. If this becomes bothersome, contact your healthcare provider.

Contact your healthcare provider if your pain does not improve in a few days, if it gets worse, or if you have other side effects that you think are caused by this medicine.

Do not drink alcohol unless your healthcare provider approves. Alcohol may increase dizziness or increase the risk of side effects to this medicine.

Although rare, this medicine may increase the skin's sensitivity to sunlight. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); blisters or peeling skin; sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; crushing chest pain or chest heaviness; sudden shortness of breath.

Serious (Report these to your healthcare provider right away.): Bloody, black, or tarry bowel movement; vomiting or coughing up blood or material that looks like coffee grounds; unusual bruising or bleeding; unusual vaginal bleeding; severe stomach pain; yellowing of your eyes or skin; dark urine; light-colored bowel movements; unexplained fever or chills; headache; unexplained muscle aches and tiredness; swelling in your hands, feet, or ankles; severe nausea or diarrhea; decreased urination.

Other: Gas, mild nausea or diarrhea, dizziness, constipation, cramps or stomach pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antacids that contain magnesium, such as Gaviscon, Maalox, Mylanta, and Phillips' Chewable Tablets
• Antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), and moxifloxacin (Avelox)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as capecitabine (Xeloda), dasatinib (Sprycel), floxuridine, fluorouracil (Adrucil, Carac, Efudex, Fluoroplex), ibritumomab (Zevalin), ibrutinib (Imbruvica), obinutuzumab (Gazyva), pemetrexed (Alimta), and pralatrexate (Folotyn)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), and gemfibrozil (Lopid)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia), and tolbutamide
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Haloperidol (Haldol)
• HIV medicines such as delavirdine (Rescriptor), tenofovir (Viread), and tipranavir (Aptivus)
• Hydralazine
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natural remedies such as alfalfa, anise, bilberry, bladderwrack, bromelain, cat's claw, celery, chamomile, cranberry, dong quai, evening primrose, fenugreek, feverfew, fish oil, garlic, ginkgo biloba, ginseng, glucosamine, green tea, horse chestnut, licorice, red clover, red yeast rice, and SAMe
• Osteoporosis medicines such as alendronate (Fosamax), ibandronate (Boniva), and risedronate (Actonel, Atelvia)
• Other medicines that contain nonsteroidal anti-inflammatory medicines (NSAIDs) such as other pain or fever medicines, or allergy, cold, or cough medicines
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Probenecid
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rifampin (Rifadin)
• Tizanidine (Zanaflex)
• Voriconazole (Vfend)

Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.