Diclofenac and Misoprostol (patient information)

IMPORTANT WARNING
For female patients:

Do not take diclofenac and misoprostol if you are pregnant or plan to become pregnant. If you become pregnant while taking diclofenac and misoprostol, stop taking the medication and call your doctor immediately. Diclofenac and misoprostol may cause miscarriage (pregnancy loss), serious bleeding, or premature birth (baby is born too early) if taken during pregnancy.

Women who can become pregnant generally should not take diclofenac and misoprostol. However, you and your doctor may decide that diclofenac and misoprostol combination is needed to treat your condition. In that case you must:

agree to use a reliable method of birth control during your treatment and for at least 1 month or one menstrual cycle after your treatment; have a negative blood test for pregnancy no longer than 2 weeks before you start taking diclofenac and misoprostol; begin taking the medication only on the second or third day of the next normal menstrual period.

For all patients:

People who take nonsteroidal anti-inflammatory medications (NSAIDs) (other than aspirin) such as diclofenac and misoprostol combination may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take diclofenac and misoprostol right before or right after the surgery.

NSAIDs such as diclofenac may cause ulcers, bleeding, or holes in the stomach or intestine. Misoprostol is taken in combination with diclofenac to protect the stomach and intestine, but may not prevent all damage to these parts of the body. Problems with the stomach and intestine may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking diclofenac and misoprostol. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking diclofenac and misoprostol and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to diclofenac and misoprostol. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Do not give this medication to anyone else, especially a woman who is or could become pregnant.

Your doctor or pharmacist will give you the manufacturer's patient information sheet sheet for diclofenac and misoprostol and the general Medication Guide for NSAIDs when you begin your treatment and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the patient information sheet and Medication Guide.

Why this medication is 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 this medication should 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.

Special precautions
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.

Special dietary instructions
Unless your doctor tells you otherwise, continue your normal diet.

What to do if you 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.

Minor side effects
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

Severe side effects
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/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for 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

Other information
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.

Brand names of combination products

 * Arthrotec containing diclofenac and misoprostol®