Diclofenac/Misoprostol, Oral

What are other names for this medicine?

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

Generic and brand names: diclofenac and 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 people who are at risk of developing stomach or intestinal ulcers due to the use of NSAIDs.

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

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

• an allergy to any medicine
• a blood clotting disorder
• asthma
• diabetes
• heart disease
• high blood pressure
• inflammatory bowel disease
• liver or kidney 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. 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?

Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Swallow the tablets whole with water. Do not crush, chew, or dissolve the tablets in water.

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

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 should I watch out for?

This medicine may damage your heart. Talk with your healthcare provider about this. If you notice an uneven or fast heart beat, chest pain, trouble breathing, sudden weight gain, swollen feet or ankles, call your healthcare provider.

Diarrhea, abdominal pain, upset stomach, and nausea may occur during the first few weeks of taking this medicine. These may stop with continued use. Black tarry stools or severe abdominal pain may be symptoms of a bleeding ulcer. If you develop severe diarrhea, cramping, or nausea, contact your healthcare provider right away.

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

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.

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, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Diabetics: 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).

Serious (report these to your healthcare provider right away): Bloody, black, or tarry stool; vomiting or coughing up blood or material that looks like coffee grounds; unusual bleeding or bruising; unusual vaginal bleeding; yellowing of your eyes or skin; unexplained fever; headache; unexplained muscle aches and tiredness; swelling in your hands, feet, or ankles; severe nausea or diarrhea; trouble urinating; pain while urinating.

Other: Intestinal gas, mild nausea and diarrhea that stop with continued use, weight gain, 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:

• antacids containing magnesium such as Mag-OX, Milk of Magnesia, and Maalox (Take them 2 hours apart from doses of this medicine.)
• antiplatelet medicines such as clopidogrel (Plavix), dipyridamole (Persantine), and ticlopidine (Ticlid)
• aspirin and other salicylates
• ACE inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• angiotensin receptor II blockers such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• beta blockers such as atenolol (Tenormin), acebutolol (Sectral), pindolol, metoprolol (Lopressor, Toprol XL), sotalol (Betapace), nadolol (Corgard), propranolol (Inderal), labetalol (Normodyne, Trandate), and carvedilol (Coreg)
• blood thinners such as warfarin (Coumadin), dalteparin (Fragmin, enoxaparin (Lovenox), danaparoid (Orgaran), and heparin
• calcium channel blockers such as nifedipine (Adalat, Procardia), isradipine (DynaCirc), felodipine (Plendil), verapamil (Calan, Isoptin), diltiazem (Cardizem), and nicardipine (Cardene)
• corticosteroids such as cortisone (Cortone), betamethasone (Celestone), dexamethasone, fludrocortisone (Florinef), hydrocortisone (Cortef, Hydrocortone, A-HydroCort), methylprednisolone (Medrol), prednisone (Meticorten, Orasone), prednisolone (Delta-Cortef), and triamcinolone (Aristocort, Kenacort)
• diabetes medicines such as insulin, glipizide (Glucotrol), glyburide (DiaBeta, Glynase, Micronase), and glimepiride (Amaryl) (You may need to change your dosage.)
• digoxin (Lanoxin)
• diuretics such as furosemide (Lasix), hydrochlorothiazide (HCTZ, Oretic), amiloride (Midamor), spironolactone (Aldactone), and triamterene (Dyrenium, Dyazide, Maxzide)
• herbal remedies such as garlic, ginkgo biloba, and ginseng
• immunosuppressants such as azathioprine (Imuran), cyclosporine (Sandimmune, Neoral), mycophenolate mofetil (CellCept), sirolimus (Rapamune), and tacrolimus (Prograf, Protopic)
• lithium (Lithobid, Eskalith)
• medicines to lower cholesterol such as colestipol (Colestid) and cholestyramine (Questran)
• methotrexate (Rheumatrex)
• pain medicines such as ibuprofen (Motrin, Motrin IB, Advil, Nuprin), naproxen (Naprosyn, Anaprox, Aleve, Naprelan), ketoprofen (Orudis, Orudis KT, Oruvail), nabumetone (Relafen), indomethacin (Indocin), ketorolac (Toradol), mefenamic acid (Ponstel), sulindac (Clinoril), piroxicam (Feldene), diclofenac (Voltaren, Cataflam), oxaprozin (Daypro), and celecoxib (Celebrex)

Do not drink alcohol while taking this medicine.

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. 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.

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.