Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

DICLOFENAC W/MISOPROSTOL - ORAL TABLET

(dye-KLO-fen-ack WITH my-so-PROSS-tull)

COMMON BRAND NAME(S): Arthrotec

WARNING: This drug must not be used during pregnancy because birth defects and fetal and maternal death have occurred. This drug must not be used in women of childbearing age unless there are no alternatives. When this drug has been used to start labor, or for abortion after the first 3 months of pregnancy, rupture of the uterus could occur. Discuss the risks and benefits with your doctor before using this medication. If a woman must use this medication, four requirements must be met: 1) negative pregnancy test within 2 weeks before starting use of this medication; 2) able to use effective measures to prevent pregnancy (contraception); 3) receive oral and written warnings on the dangers of misoprostol use in women of childbearing age, and the risk of possible birth control failure; 4) must begin use of this drug only on the second or third day of the next normal menstrual period. This medication must not be shared with others.

Uses

Diclofenac relieves pain and swelling. 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.

How To Use

Take this medication by mouth with food or milk or immediately after a meal as directed. Swallow the tablets whole. Do not chew, crush or dissolve the drug. Take this medication with 6 to 8 ounces (180-240ml) of water. Do not lie down for at least 30 minutes after taking this drug. Take this medication exactly as prescribed. Do not increase the dose or take it more often than prescribed. Maximum benefit comes from continued and routine use. Do not use this only when arthritis flares up or for treating other pain, unless directed to do so by your doctor.

Side Effects

Stomach upset, stomach pain, diarrhea or gas may occur the first few days as your body adjusts to the medication. Other side effects reported include headache, dizziness. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you develop: dark urine, vomiting, chest pain, ringing in the ears, unusual bruising or bleeding, increased menstrual bleeding, vision changes, lightheadedness, yellowing of the eyes or skin, mental confusion or depression. If you notice any of the following unlikely but very serious side effects, stop taking this drug and consult your doctor or pharmacist immediately: black stools, persistent stomach/ abdominal pain, vomit that looks like coffee grounds. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history especially: liver disease, kidney disease, blood disorders, ulcers, heart disease, alcohol use, high blood pressure, eye disease, prior Cesarean births or uterus surgery, five or more previous pregnancies, asthma, nasal polyps, any allergies - especially aspirin/NSAID allergy (e.g., ibuprofen, celecoxib). Use caution when performing tasks requiring alertness. Limit alcohol intake as it may intensify the drowsiness effect of this medication. This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information. To minimize dizziness and lightheadedness when rising from a seated or lying position, get up slowly. Infrequently, this medication may increase the skin's sensitivity to sunlight. If this happens to you: avoid prolonged sun exposure, wear protective clothing, use a sunscreen, avoid sunlamps. Caution is advised when this drug is used in the elderly. This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug is excreted into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of any over-the-counter or prescription medication you may take including: aspirin, NSAIDs (e.g., ibuprofen, naproxen), antacids, digoxin, "water pills" (diuretics), "blood thinners" (e.g., warfarin), oral diabetic drugs, high blood pressure medicine, cyclosporine, methotrexate, lithium. Check the ingredients of any nonprescription medicines you may be using since many cough, cold, and pain products contain aspirin or other NSAIDs (e.g., ibuprofen). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, dark stool, diarrhea, fever, ringing in the ears, change in amount of urine, unusually fast or slow heartbeat, slow or shallow breathing, severe headache, seizures, or loss of consciousness.

Notes

Do not share this medication with others.

Missed Dose

If you miss a dose, take it as soon as remembered; do not take it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Storage

Store at room temperature away from heat and light. Do not store in the bathroom.