This medicine is a progestin used to treat certain menstrual problems (eg, abnormal bleeding, lack of menstrual period). Progestins lower the risk of estrogen-related cancer of the uterus. This medicine may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. An additional patient information leaflet is available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. THIS MEDICINE MAY BE TAKEN on an empty stomach or with food. TAKE THIS MEDICINE at the same time every day, not more than 24 hours apart. STORE THIS MEDICINE between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
WARNING: This medicine combined with estrogen should not be used to prevent heart disease, heart attacks, strokes, or dementia. Progestin hormones combined with estrogen may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), and breast cancer in some women. Talk with your doctor if you have questions about the benefits and risks of using this medicine. THIS MEDICINE SHOULD BE USED FOR THE SHORTEST POSSIBLE TIME at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use this medicine. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking aprepitant or rifamycins (eg, rifampin). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including a history of asthma, the blood disease porphyria, mental or mood problems (eg, depression), diabetes, eye or vision problems, fluid retention or swelling (edema), gallbladder or pancreas problems, heart problems, high blood pressure, stroke or bleeding in the brain, high cholesterol or triglyceride levels, kidney problems, high or low blood calcium levels, lupus, migraines, seizures (eg, epilepsy), thyroid problems, abnormal mammogram or breast lumps, endometriosis, ovarian cancer, yellowing of the eyes or skin during pregnancy or with past estrogen use, allergies, pregnancy, or breast-feeding. Tell your doctor if a family member has a history of breast cancer or blood clots (eg, in the legs or lungs).Tell your doctor if you smoke, use tobacco products, are very overweight, have had a miscarriage, or have had your uterus removed (hysterectomy). Tell your doctor if you will be having surgery or will be confined to a bed or chair for a period of time. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are pregnant, suspect you may be pregnant, or if this medicine is being used to test for pregnancy. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have undiagnosed abnormal vaginal bleeding; blood clots (eg, in the lungs or legs); known or suspected breast cancer or other estrogen- or progesterone-dependent cancer; liver disease; or a history of breast cancer, blood clots, or liver problems. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have had a heart attack or stroke within the past 12 months. Use of this medicine in children is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include acne; breast pain or tenderness; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; dizziness; drowsiness; headache; mild fluid retention; mild hair loss; mild nausea or vomiting; nervousness; sleeplessness; stomach cramps or bloating; or weight gain or loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal vaginal bleeding; breast lumps, pain, or discharge; bulging eyes; calf or leg pain, swelling, redness, or tenderness; coughing up blood; fainting; fever; mental or mood changes (eg, depression); migraines; new or worsening memory problems; severe or persistent stomach pain or tenderness; shortness of breath; sudden loss of coordination; sudden, severe, or persistent headache or dizziness; swelling; symptoms of a heart attack (eg, chest, jaw, or arm pain; fainting; sudden, severe nausea or vomiting; unusual sweating; weakness); symptoms of a stroke (eg, confusion; slurred speech; one-sided weakness); vaginal discharge, itching, or odor; vision loss or other vision changes; or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.