Prodafem General Information
Prodafem is a type of female hormone (progestin). Prodafem 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. Prodafem has several uses. In women who are not pregnant and not going through menopause, Prodafem 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).
Prodafem is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Prodafem is added to estrogen replacement therapy to reduce the risk of cancer of the uterus.
Prodafem must not be used to test for pregnancy.
How to Use Prodafem
Read the Patient Information Leaflet provided by your pharmacist before you start using Prodafem and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take Prodafem 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 Prodafem 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 Prodafem 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.
Prodafem Possible 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 Prodafem because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using Prodafem 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.
Prodafem 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 Prodafem 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.
Before taking Prodafem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Some Canadian brands of Prodafem 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.
Prodafem should not be used if you have certain medical conditions. Before using Prodafem, 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 Prodafem, 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.
Prodafem 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 Prodafem further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.
Prodafem 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.
Prodafem 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.
Prodafem passes into breast milk. Consult your doctor before breast-feeding.
Prodafem Possible Intercations
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 Prodafem include: aminoglutethimide, drugs affecting liver enzymes that remove Prodafem from your body (such as rifampin, St. John's wort, azole antifungals including itraconazole, certain anti-seizure medicines including carbamazepine/phenobarbital/phenytoin).
Prodafem can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use Prodafem.
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