Medroxyprogesterone 2.5mg Tablets (Greenstone)

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.

MEDROXYPROGESTERONE - ORAL

(med-ROX-ee-proe-JES-ter-one)

COMMON BRAND NAME(S): Provera

WARNING: Medroxyprogesterone is sometimes used with another medication (a type of estrogen) as combination hormone replacement therapy (HRT) in women after menopause. Combination HRT can rarely cause very serious side effects such as heart disease (for example, heart attacks), stroke, serious blood clots (possibly in the lungs and legs), dementia, and breast cancer. Some of these risks appear to depend on the length of treatment and other factors. Therefore, combination HRT should be used for the shortest possible length of time at the lowest effective dose so you can obtain the benefits and minimize the chance of serious side effects from long-term treatment. Combination HRT should not be used to prevent heart disease or dementia. Discuss the risks and benefits of treatment and your personal health history with your doctor. If you take combination HRT, check with your doctor regularly (for example, every 3-6 months) to see if you still need to take it. If you use this medication for an extended period, you should have a complete physical exam at regular intervals (for example, once a year) or as directed by your doctor. See Notes section.

USES: Medroxyprogesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. This medication has several uses. In women who are not pregnant and not going through menopause, this medication is used to treat abnormal bleeding from the uterus and to restore normal menstrual periods in women who have stopped having them for several months (amenorrhea). Medroxyprogesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Medroxyprogesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. This medication must not be used to test for pregnancy.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor. Follow the dosing schedule carefully. Ask your doctor if you have any questions. The dosage is based on your medical condition and response to therapy. For use in combination hormone replacement therapy with estrogens, take this medication usually once daily for the prescribed number of days each month as directed. For the treatment of stopped menstrual periods (amenorrhea) and abnormal bleeding from the uterus, take this drug usually once daily for 5-10 days during the second half of the planned menstrual cycle or as directed by your doctor. Withdrawal bleeding usually occurs within 3-7 days after you stop taking the medication. Inform your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, drowsiness, or weight gain/loss may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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 right away 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 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.

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. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (such as on 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 face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use 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 right away. This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: aminoglutethimide, drugs affecting liver enzymes that remove medroxyprogesterone from your body (such as rifampin, St. John\'s wort, azole antifungals including itraconazole, certain anti-seizure medicines including carbamazepine/phenobarbital/phenytoin). This medication can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this medication.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting.

NOTES: Do not share this medication with others. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals (such as once a year) or as directed by your doctor. Follow your doctor\'s instructions on how to examine your own breasts and report any lumps right away. You should also be regularly screened for cervical cancer (for example, by having a Pap test) and have periodic mammograms as determined by your doctor. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2019. Copyright(c) 2019 First Databank, Inc.