Drug Name: ARTHROTEC 50 ARTHROTEC 50 DESCRIPTION: DICLOFENAC W/MISOPROSTOL - ORAL TABLET (dye-KLO-fen-ack WITH my-so-PROSS-tull) COMMON ARTHROTEC 50 BRAND NAME(S): Arthrotec ARTHROTEC 50 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. To minimize dizziness and lightheadedness when rising from a seated or lying position, get up slowly. Notify your doctor if you develop: dark or bloody stools; dark urine, nausea, vomiting, chest pain, ringing in the ears, breathing trouble; unusual bruising or bleeding; swelling of the feet or ankles; increased menstrual bleeding, vision changes, lightheadedness; yellowing of the eyes or skin; mental confusion or depression; itching, skin rash. Infrequently, ARTHROTEC 50 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. 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, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist. HOW TO USE ARTHROTEC 50: ARTHROTEC 50: Take ARTHROTEC 50 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 ARTHROTEC 50 with 6 to 8 ounces (180-240ml) of water. Do not lie down for at least 30 minutes after taking ARTHROTEC 50. Take ARTHROTEC 50 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. ARTHROTEC 50 WARNING: ARTHROTEC 50 must not be used during pregnancy because birth defects, fetal, and maternal death have occurred. ARTHROTEC 50 must not be used in women of childbearing age unless there are no alternatives. When ARTHROTEC 50 has been used to start labor, uterine rupture has occurred. Discuss the risks and benefits with your doctor before using ARTHROTEC 50 for this purpose. If a woman must use ARTHROTEC 50, four requirements must be met: 1) negative pregnancy test within 2 weeks before starting use of ARTHROTEC 50; 2) be able use effective measures to prevent pregnancy (contraception); 3) receive oral and written warnings on the dangers of misoprostol use in women of childbearing age; 4) must begin use of ARTHROTEC 50 only on the second or third day of next normal menstrual period. ARTHROTEC 50 must not be shared with others. ARTHROTEC 50 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. ARTHROTEC 50 PRECAUTIONS: Tell your doctor your medical history especially: liver disease, kidney disease, blood disorders, ulcers, heart disease, alcohol use, high blood pressure, eye disease, any allergies (especially drug allergies). 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. Caution is advised when ARTHROTEC 50 is used in the elderly. ARTHROTEC 50 should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. ARTHROTEC 50 is excreted into breast milk. Consult your doctor before breast-feeding. ARTHROTEC 50 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. ARTHROTEC 50 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. ARTHROTEC 50 NOTES: Do not share ARTHROTEC 50 with others. MISSED ARTHROTEC 50 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. ARTHROTEC 50 STORAGE: Store at room temperature away from heat and light. Do not store in the bathroom. |