"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
Provera Consumer (continued)
Remember that your doctor has prescribed this medication because he or she 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.
Tell your doctor immediately if any of these serious side effects occur: unusual vaginal bleeding (e.g., spotting, breakthrough bleeding), mental/mood changes (e.g., depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, unusual tiredness.
This medication may rarely cause very serious (possibly fatal) problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs or legs, blindness). Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Provera (medroxyprogesterone acetate tablets) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Some Canadian brands of this product may contain inactive ingredients (such as soybean), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, history of bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), recent stroke or heart attack (within 1 year).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), kidney disease, obesity, heart disease (e.g., past heart attacks, coronary artery disease, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details.
Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.
This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen, and wear protective clothing when outdoors.
This medication must not be used during pregnancy because it may harm an unborn baby, especially during the first 4 months of pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.
This drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Provera Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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