GENERIC NAME: DICLOFENAC/MISOPROSTOL - ORAL (dye-KLOE-fen-ack/my-so-PROSS-tull)
BRAND NAME(S): Arthrotec
WARNING: This medication is a combination of 2 drugs, diclofenac and misoprostol. Do not take this medication if you are pregnant or think that you may be pregnant. Misoprostol may cause loss of pregnancy, premature birth, or birth defects. In rare cases, serious complications (e.g., uterine rupture) have occurred when misoprostol was used to start labor or used in combination with another drug to end pregnancy after the eighth week. These complications have resulted in harm to the unborn baby and mother.
Avoid pregnancy while taking this medication and for at least one month or one complete menstrual cycle after you have stopped treatment. If you become pregnant while taking this medication, contact your doctor immediately.
If you are of a woman of childbearing age, do not use this medication unless you require a nonsteroidal anti-inflammatory drug (NSAID) such as diclofenac and you are at high risk of having an ulcer or ulcer complications from NSAID treatment.
Female patients must meet the following four requirements in order to use this drug: 1) test negative for pregnancy within 2 weeks before starting treatment; 2) use effective birth control to prevent pregnancy; 3) receive oral and written warnings on the dangers of using misoprostol while of childbearing age and the risks of possible birth control failure; 4) start taking this medication only on the second or third day of the next normal menstrual period.
This medication must not be shared with others.
Diclofenac may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This side effect can occur without warning at any time during treatment with diclofenac. The elderly are at increased risk for serious stomach/intestinal bleeding.
Drugs related to diclofenac have rarely caused blood clots to form, resulting in serious (possibly fatal) heart attacks and strokes. This medication might also rarely cause similar problems. The risk of these serious side effects may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use of this medication. This drug should not be taken right before or after heart bypass surgery (CABG).
Stop taking this medication and seek immediate medical attention if you notice any of the following rare but very serious side effects: black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, shortness of breath, weakness on one side of the body, sudden vision changes, slurred speech.
USES: Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. Diclofenac is known as a nonsteroidal anti-inflammatory drug (NSAID). Misoprostol protects the stomach from diclofenac's irritating effects. This combination medication is used to treat arthritis in people at high risk of developing stomach ulcers and serious complications such as bleeding.If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used to treat gout attacks.
HOW TO USE: Read the Patient Information Leaflet and the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug.Swallow this medication whole. Do not crush, chew, or dissolve the tablets. Doing so may increase side effects.Take this medication with food to prevent stomach upset and to reduce the chances of diarrhea. Avoid taking antacids that contain magnesium while using this medication because they may worsen diarrhea. If you need an antacid, consult your doctor or pharmacist to help you choose a product.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To minimize side effect risks (e.g., stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often than prescribed. For ongoing conditions such as arthritis, continue taking it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.Take this medication regularly in order to get the most benefit from it. Remember to take it at the same times each day. It may take up to 2 weeks of regular use before the full benefits of this medication take effect.Inform your doctor if your condition worsens.
SIDE EFFECTS: See also Warning section.Diarrhea and upset stomach may occur within a few weeks after you start taking this medication, and usually last for about 1 week. See How to Use for ways to reduce diarrhea.Nausea, heartburn, gas, stomach pain, constipation, headache, drowsiness, and dizziness may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rarely, diarrhea can become so severe and persistent that it may lead to a large loss of your body's water and minerals (dehydration). Be sure to drink plenty of fluids and get enough minerals/electrolytes to prevent dehydration. Tell your doctor immediately if you develop any of the following signs: severe/persistent diarrhea, stomach cramps, severe dizziness, decreased amount of urine, muscle weakness.Tell your doctor immediately if any of these unlikely but serious side effects occur: difficult/painful swallowing, swelling of the hands/feet, sudden/unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), mental/mood changes (e.g., depression), fast/pounding heartbeat, persistent/severe headache, fainting, unusual/heavy vaginal bleeding, menstrual problems/irregular periods, unusual tiredness.Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck, seizures.This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, stop taking diclofenac/misoprostol and tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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PRECAUTIONS: Before taking diclofenac/misoprostol, tell your doctor or pharmacist if you are allergic to either of these drugs; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG), certain liver problem (hepatic porphyria).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, inflammatory bowel disease), heart disease (e.g., history of heart attack), high blood pressure, stroke, swelling (edema, fluid retention), blood disorders (e.g., anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps).Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.Before having surgery, tell your doctor or dentist that you are using this medication.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.Diclofenac may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding, kidney problems, and worsening heart problems.This medication must not be used during pregnancy. It can harm the unborn baby and mother. Use reliable forms of birth control to prevent pregnancy while taking this medication. If you become pregnant or think you may be pregnant, inform your doctor immediately. See Warning section.This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also the How to Use section.Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.This drug should not be used with the following medication because very serious interactions may occur: cidofovir.If you are currently using the medication listed above, tell your doctor or pharmacist before starting diclofenac/misoprostol.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aliskiren, ACE Inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), corticosteroids (e.g., prednisone), cyclosporine, desmopressin, digoxin, lithium, methotrexate, pemetrexed, probenecid.This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, vomit that looks like coffee grounds, persistent diarrhea, extreme drowsiness, slow/shallow breathing, slow/irregular heartbeat, seizures.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as complete blood count, liver and kidney function tests) should be performed periodically to check for side effects. Consult your doctor for more details. Keep all doctor appointments and lab visits so your therapy can be monitored closely.Non-drug treatment for arthritis that is approved by your doctor (e.g., weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store the U.S. product at room temperature at or below 77 degrees F (25 degrees C) away from light and moisture.Store the Canadian product at room temperature at 59-77 degrees F (15-25 degrees C) away from light and moisture.Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.