Arthrotec

Disclaimer

Arthrotec Consumer

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.

DICLOFENAC/MISOPROSTOL - ORAL

(dye-KLOE-fen-ack/my-so-PROSS-tull)

COMMON 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 USES: 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.

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