Prempro contains medroxyprogesterone acetate, a derivative of progesterone, and conjugated estrogens from natural sources. It is available as tablets in different dosage strengths: 0.3 mg/1.5 mg, 0.45 mg/1.5 mg, 0.625 mg/2.5 mg, and 0.625 mg/5 mg, for oral administration. Key inactive ingredients include calcium phosphate tribasic, microcrystalline cellulose, and lactose monohydrate.

How should I use this medication?

Take this medication by mouth with a drink of water. You may take this medication with food. Follow the directions on the prescription label. You will take one tablet daily at roughly the same time each day. Do not take your medication more often than directed. Talk to your care team about the use of this medication in children. Special care may be needed. A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pet. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain -Breast tissue changes, new lumps, redness, pain, or discharge from the nipple -Gallbladder problems—severe stomach pain, nausea, vomiting, fever -Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded -Heavy vaginal bleeding -Increase in blood pressure -New or worsening migraines or headaches -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss -Unusual vaginal discharge, itching, or odor -Worsening mood, feelings of depression Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Acne -Breast pain or tenderness -Dark patches of skin on the face or other sun-exposed areas -Irregular menstrual cycles or spotting -Nausea -Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Blood vessel disease or blood clots -Breast, cervical, endometrial, or uterine cancer -Depression -Diabetes -Endometriosis -Fibroids -Gallbladder disease -Heart disease or recent heart attack -High blood cholesterol -High blood pressure -High level of calcium in the blood -Hysterectomy -Kidney disease -Liver disease -Migraine headaches -Porphyria -Protein C deficiency -Protein S deficiency -Stroke -Systemic lupus erythematosus (SLE) -Tobacco use -Vaginal bleeding -An unusual or allergic reaction to estrogens, progestins, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Barbiturates, such as phenobarbital -Benzodiazepines -Bosentan -Bromocriptine -Carbamazepine -Cimetidine -Cyclosporine -Dantrolene -Grapefruit juice -Griseofulvin -Hydrocortisone, cortisone, or prednisolone -Isoniazid (INH) -Medications for diabetes -Methotrexate -Mineral oil -Phenytoin -Raloxifene -Rifabutin, rifampin, or rifapentine -Tamoxifen -Thyroid hormones -Topiramate -Tricyclic antidepressants -Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam. You should also discuss the need for regular mammograms with your care team, and follow their guidelines. This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid. If you have any reason to think you are pregnant, stop taking this medication at once and contact your care team. Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. This risk is higher if you are over the age of 35. If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your care team. If you are going to have elective surgery, you may need to stop taking this medication beforehand. Consult your care team for advice prior to scheduling the surgery.

What are the most serious risks of this medication?

Do not use this medicine to prevent heart disease. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, or blood clots. Estrogens with progestins may increase your chances of getting breast cancer. Talk to your healthcare provider before taking this medicine if you have ever had cancer. Call your healthcare provider right away if you get new breast lumps. Estrogens with or without progestins may increase your chance of getting dementia based on a study of women 65 years of age or older. If you have a uterus, using estrogens alone (without progestins) may increase your chance of uterine cancer (cancer of the womb).