DICLOFENAC/MISOPROSTOL - ORAL

PHONETIC PRONUNCIATION: (dye-KLOE-fen-ak/MYE-soe-PROS-tol)

COMMON BRAND NAME(S): Arthrotec

GENERIC NAME(S): diclofenac sodium/misoprostol

Uses

USES: Diclofenac is used to reduce pain, swelling, and joint stiffness from arthritis. 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 getting stomach/intestinal ulcers and complications from the ulcers (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.

How to use DICLOFENAC/MISOPROSTOL - ORAL

HOW TO USE: Read 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, ask your doctor or pharmacist. Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. Swallow the tablets whole. Do not crush, chew, or dissolve the tablets. Doing so can increase the risk of side effects. Do not take tablets that are broken. 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 reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. For ongoing conditions such as arthritis, keep taking this medication as directed. Discuss the risks and benefits with your doctor or pharmacist. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take up to 2 weeks of taking this drug regularly before you get the full benefit. Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

SIDE EFFECTS: See also Warning section. Diarrhea and stomach/abdominal pain may occur within a few weeks after you start taking this medication, and usually last for about one week. Nausea, heartburn, gas, upset stomach, drowsiness, and dizziness may also occur. If any of these effects last or get worse, tell 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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Diarrhea that is severe or doesn't stop may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness. Tell your doctor right away if you have any serious side effects, including: difficult/painful swallowing, hearing changes (such as ringing in the ears), mental/mood changes (such as depression), easy bruising/bleeding, unusual/heavy vaginal bleeding, menstrual problems/irregular periods, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Get medical help right away if you have any very serious side effects, including: signs of kidney problems (such as change in the amount of urine), unexplained stiff neck, seizures. This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Warning section. Before taking this medication, tell your doctor or pharmacist if you are allergic to diclofenac or misoprostol; or to aspirin or other NSAIDs (such as 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, stomach/intestinal/esophagus problems (such as bleeding, heartburn, ulcers), heart disease (such as previous heart attack), high blood pressure, stroke, swelling (edema, fluid retention), blood disorders (such as anemia), bleeding/clotting problems, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), 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 a change in the amount of urine. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana. Diclofenac may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney problems. This medication must not be used during pregnancy. It may harm the mother and unborn baby. Use reliable forms of birth control to prevent pregnancy while taking this medication and for at least one month or one completed menstrual cycle after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor right away. This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, corticosteroids (such as dexamethasone, prednisone), lithium, methotrexate, "water pills" (diuretics such as furosemide). 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 keep taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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: diarrhea that doesn't stop, severe stomach pain, severe drowsiness, slow/shallow breathing, seizures.

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Warning

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 problems (such as 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 problems have caused harm to the mother and unborn baby. 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 right away. If you are of a woman of childbearing age, do not use this medication unless you need 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. Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk 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). Do not take this drug right before or after heart bypass surgery (CABG). Also, diclofenac may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect. Stop taking this medication and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes. Talk to your doctor or pharmacist about the benefits and risks of taking this drug.

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.