BIJUVA is a brand name for a drug that includes estradiol and progesterone as the active ingredients, with estradiol being solubilized and progesterone micronized in a capsule. This medication is available in capsule form with dosage strengths of 0.5 mg estradiol/100 mg progesterone and 1 mg estradiol/100 mg progesterone. It contains inactive ingredients like ammonium hydroxide, ethanol, and gelatin.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take it with food. Keep taking it unless your care team tells you to stop. 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. Talk to your care team about the use of this medication in children. Special care may be needed.

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 pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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 -Change in vision such as blurry vision, seeing halos around lights, vision loss -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 -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -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 -Swelling of the ankles, hands, or feet -Unusual vaginal discharge, itching, or odor Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Breast pain or tenderness -Confusion -Headache -Nausea -Stomach pain

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?

Do not take this medication with any of the following: -Aromatase inhibitors, such as aminoglutethimide, anastrozole, exemestane, letrozole, testolactone This medication may also interact with the following: -Barbiturates, such as phenobarbital -Bexarotene -Bosentan -Carbamazepine -Certain antibiotics, such as erythromycin and clarithromycin -Certain medications for anxiety or sleep -Certain medications for fungal infections, such as ketoconazole, itraconazole -Certain medications for hepatitis, HIV or AIDS -Cyclosporine -Dantrolene -Ethotoin -Grapefruit juice -Griseofulvin -Isoniazid (INH) -Medications for diabetes -Phenobarbital -Phenytoin -Primidone -Raloxifene -Rifabutin -Rifampin -Rifapentine -Ritonavir -St. John's Wort -Steroid medications, such as prednisone or cortisone -Tamoxifen -Thyroid hormones -Topiramate -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. Tobacco smoking increases the risk of getting a blood clot or having a heart attack or stroke. Avoid smoking. If you are going to need surgery or other procedure, tell your care team that you are using this medication.

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).