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Misoprostol

Warning

Do not take this medication if you think that you may be pregnant. It may cause a pregnancy to end, premature birth, or birth defects. In rare cases, serious complications (such as uterine rupture) have occurred when misoprostol was used to start labor or end a pregnancy. These complications have resulted in harm to the unborn baby and mother. The risk for uterine rupture increases as your pregnancy advances and if you had prior uterine surgery (including Cesarean delivery) or if you had five or more previous pregnancies.

Avoid pregnancy while taking misoprostol and for at least one month or one completed menstrual cycle after you have stopped treatment. If you become pregnant while taking misoprostol, contact your doctor right away.

If you are pregnant, do not take this medication to reduce the risk of stomach ulcers due to aspirin or other related drugs (non-steroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Also, if you are of childbearing age, do not use this drug to reduce the risk of ulcers from NSAIDs unless you are at high risk of having an ulcer or ulcer complications.

Female patients must meet the following four requirements in order to use this drug: 1) test negative for pregnancy within two 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 misoprostol only on the second or third day of the next normal menstrual period.

This medication must not be shared with others.

Precautions

Before taking misoprostol, tell your doctor or pharmacist if you are allergic to it; 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: stomach/intestinal disease (such as inflammatory bowel disease).

Daily use of alcohol and tobacco may increase your risk for stomach bleeding. Limit alcohol beverages and stop smoking. Consult your doctor or pharmacist for more information.

If you are taking this medication in combination with mifepristone to end a pregnancy, rarely the pregnancy may not end. It is very important for you to be closely monitored by your doctor and to keep your scheduled appointments to follow your progress. Be sure to have clear instructions from your doctor about who to call and what to do in case of an emergency. Expect vaginal bleeding after you take the combined medicine, however tell your doctor right away if you develop any unlikely symptoms such as severe/prolonged vaginal bleeding, signs of infection (including fever, chills), or fainting.

This drug must not be used during pregnancy to prevent stomach ulcers because of possible harm to an unborn baby (see also Warnings). If you are of childbearing age, use effective birth control methods while taking misoprostol and for at least one month or one completed menstrual cycle after you stop taking it. If you become pregnant or think you may be pregnant, inform your doctor right away.

This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Side Effects

Nausea or stomach cramps may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

Diarrhea is common with misoprostol and usually occurs about two weeks after you start taking it, and lasts for about a week. Be sure to keep up your intake of fluids and minerals/electrolytes to prevent dehydration. Diarrhea that doesn't stop may sometimes lead to a large loss of your body's water and minerals. Tell your doctor right away if you develop any of these serious signs of dehydration and mineral imbalance: dizziness, decreased urination, mental/mood changes, muscle weakness, slow/irregular heartbeat.

Tell your doctor right away if you have any serious side effects, including: menstrual problems or irregularities, unusual/heavy vaginal bleeding.

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.

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