Why is this medication prescribed?
The combination of diclofenac and misoprostol is used to relieve the pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints) in patients who have a high risk of developing stomach ulcers. Diclofenac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain and inflammation. Misoprostol is in a class of medications called prostaglandins. It prevents ulcers caused by diclofenac by protecting the stomach lining and decreasing stomach acid production.
How should this medicine be used?
The combination of diclofenac and misoprostol comes as a tablet to take by mouth. It is usually taken with food two to four times a day. To help you remember to take diclofenac and misoprostol, take it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take diclofenac and misoprostol combination exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking diclofenac and misoprostol,
tell your doctor and pharmacist if you are allergic to diclofenac (Cataflam, Voltaren XR), misoprostol (Cytotec), aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); prostaglandins such as alprostadil (Caverject, Muse), carboprost (Hemabate), dinoprostone (Cervidil, Prepidil, Prostin E2) and mifepristone (Mifeprex); any other medications, or any of the inactive ingredients in diclofenac and misoprostol tablets. Ask your pharmacist for a list of the inactive ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); antacids containing magnesium (Mylanta, Maalox, others); cyclosporine (Neoral, Sandimmune); digoxin (Lanoxin); diuretics ('water pills'); insulin and oral medications for diabetes; methotrexate (Rheumatrex); lithium (Eskalith, Lithobid); and phenobarbital (Luminal, Solfoton). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or inflammatory bowel disease (swelling of the lining of the intestine that may cause painful or bloody diarrhea and cramping); asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys); hepatic porphyria (an abnormal increase in the amount of certain natural substances made by the liver); liver or kidney disease; or swelling of the hands, feet, ankles, or lower legs.
tell your doctor if you are breast-feeding. You should not breast-feed while you are taking this medication.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking diclofenac and misoprostol.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Diclofenac and misoprostol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
diarrhea
gas or bloating
Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more diclofenac and misoprostol until you speak to your doctor.
unexplained weight gain
excessive tiredness
lack of energy
itching
upset stomach
loss of appetite
pain in the upper right part of the stomach
yellowing of the skin or eyes
flu-like symptoms
pale skin
fast heartbeat
headache
stiff neck
sore throat
muscle pain
confusion
sensitivity to light
fever
blisters
rash
hives
swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
hoarseness
unusual vaginal bleeding
cloudy, discolored, or bloody urine
back pain
difficult or painful urination
Diclofenac and misoprostol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
stomach pain
vomiting
diarrhea
confusion
drowsiness
low muscle tone
shaking of a part of the body that you cannot control
seizures
shortness of breath
fever
fast, pounding, or slow heartbeat
dizziness
fainting
What other information should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking diclofenac and misoprostol.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
