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Drug Information For:

MISOPROSTOL 100MCG TABLETS

Ingredient Name:

MISOPROSTOL (mye-soe-PROST-ole)

Drug Manufacturer:

IVAX

Common Uses:

This medicine is a prostaglandin used to reduce the risk of stomach ulcers in certain patients who take nonsteroidal anti-inflammatory drugs (NSAIDs). It may also be used to treat other conditions as determined by your doctor.

Before Using This Medicine:

WARNING: Do not take this medicine to reduce the risk of stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs) if you are pregnant. This medicine may cause abortion, premature birth, or birth defects if taken during pregnancy. Life-threatening problems such as uterine rupture (tear) have occurred in pregnant women who have taken this medicine to cause abortion after the eighth week of pregnancy or to induce labor. Do not share this medicine with others. Women of childbearing potential should not take this medicine to reduce the risk of stomach ulcers caused by NSAIDs unless there is a high risk of developing stomach ulcers or complications from stomach ulcers due to the use of NSAIDs. If it is necessary for women of childbearing potential to take this medicine, they must: have a negative pregnancy test within 2 weeks before starting therapy; comply with effective birth control measures; receive written and oral warnings about the risks of taking this medicine, the risks of possible failure of birth-control methods, and the dangers to other women of childbearing potential who may take this medicine by mistake; and agree to begin taking this medicine only on the second or third day of the next normal menstrual period. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of heart disease, inflammatory bowel disease (IBS), dehydration or other problems that may be worsened if you become dehydrated, allergies, pregnancy or if you are able to become pregnant, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

How to Use This Medicine:

Follow the directions for using this medicine provided by your doctor. THIS MEDICINE COMES with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE with food or milk, unless your doctor tells you otherwise. DO NOT TAKE AN ANTACID that has magnesium in it within 1 hour before or 2 hours after you take this medicine. The last dose of the day should be taken at bedtime. TAKING THIS MEDICINE after meals and at bedtime may decrease the risk of diarrhea. STORE THIS MEDICINE at room temperature in a tightly-closed container, away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Cautions:

DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product or to similar medicines (prostaglandins). THIS MEDICINE MAY CAUSE diarrhea, nausea, or stomach pain or cramps. If this occurs, it usually develops within the first few weeks after starting this medicine. If these effects develop and last longer than 1 week, contact your health care provider. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. FOR WOMEN: If you may become pregnant, you must use an effective form of birth control while you take this medicine. If you have questions about effective birth control, talk with your doctor. DO NOT USE THIS MEDICINE if you are pregnant. It has been shown to cause harm to the fetus. AVOID BECOMING PREGNANT while you are taking it. Avoid becoming pregnant for at least 1 month or through 1 menstrual cycle after you stop taking it. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. THIS MEDICINE IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible Side Effects:

SIDE EFFECTS that may occur while taking this medicine include diarrhea or stomach pain. If they continue and are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience black, tarry stools; blood in the urine; changes in hearing or deafness; changes in menstrual period; chest pain; fainting; fever; headache; dizziness; blurred vision; irregular heartbeat; mood or mental changes (eg, anxiety, confusion, depression); persistent or severe diarrhea, nausea, or stomach pain or cramping; unusual bleeding or bruising; unusual tiredness or weakness; vomit that looks like coffee grounds; or wheezing or shortness of breath. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Overdose:

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe dizziness or drowsiness, tremors, seizures, difficulty breathing, stomach pain, severe diarrhea, fever, and slow or irregular heartbeat.

Additional Information:

DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

Copyright 2014 Wolters Kluwer Health, Inc.

Disclaimer

- This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. By searching these web site pages, you agree to our terms and conditions of use.