PROMETRIUM contains micronized progesterone in capsule form for oral administration. Progesterone is a hormone that is chemically identical to that produced by the human ovary. The capsules are available in 100 mg and 200 mg dosage strengths. Key inactive ingredients include gelatin, glycerin, lecithin, peanut oil, and titanium dioxide.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. 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. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed. 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 -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 -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): -Bloating -Breast pain or tenderness -Dizziness -Drowsiness -Headache -Irregular menstrual cycles or spotting -Mood swings -Nausea -Swelling of the ankles, hands, or feet

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: -Autoimmune disease, such as systemic lupus erythematosus (SLE) -Blood vessel disease, blood clotting disorder, or suffered a stroke -Breast, cervical, or vaginal cancer -Dementia -Diabetes -Heart disease, high blood pressure or recent heart attack -High blood lipids or cholesterol -Hysterectomy -Kidney disease -Liver disease -Recent miscarriage -Tobacco use -Vaginal bleeding -An unusual or allergic reaction to progesterone, peanuts, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Bosentan This medication may also interact with the following: -Barbiturate medications for sleep or seizures -Bexarotene -Carbamazepine -Ethotoin -Ketoconazole -Phenytoin -Rifampin

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. This medication can cause tooth and gum problems. Tenderness, swelling, or minor bleeding of the gums may occur. Brushing and flossing your teeth regularly may reduce the risk of side effects. Visit your dentist on a regular basis. Tell your dentist about any medications you are taking. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

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.