Estrogen and Progestin (Hormone Replacement Therapy)

Hormone replacement therapy may increase the risk of heart attack, stroke, breast cancer, and blood clots in the lungs and legs. Tell your doctor if you smoke and if you have or have ever had breast lumps or cancer; a heart attack; a stroke; blood clots; high blood pressure; high blood levels of cholesterol or fats; or diabetes. If you are having surgery or will be on bedrest, talk to your doctor about stopping estrogen and progestin at least 4 to 6 weeks before the surgery or bedrest.

If you experience any of the following side effects, call your doctor immediately: sudden, severe headache; sudden, severe vomiting; sudden partial or complete loss of vision; speech problems; dizziness or faintness; weakness or numbness of an arm or a leg; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; or calf pain.

Talk to your doctor about the risks and benefits of taking estrogen and progestin.

Combinations of estrogen and progestin are used to treat certain symptoms of menopause. Estrogen and progestin are two female sex hormones. Hormone replacement therapy works by replacing estrogen hormone that is no longer being made by the body. Estrogen reduces feelings of warmth in the upper body and periods of sweating and heat (hot flashes), vaginal symptoms (itching, burning, and dryness) and difficulty with urination, but it does not relieve other symptoms of menopause such as nervousness or depression. Estrogen also prevents thinning of the bones (osteoporosis) in menopausal women. Progestin is added to estrogen in hormone replacement therapy to reduce the risk of uterine cancer in women who still have their uterus.

Hormone replacement therapy comes as a tablet to take by mouth. It is usually taken once a day. To help you remember to take hormone replacement therapy, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take this medication exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not stop taking this medication without talking to your doctor.

Activella, FemHrt, and Prempro come as tablets containing estrogen and progestin. Take one tablet every day.

Ortho-Prefest comes in a blister card containing 30 tablets. Take one pink tablet (containing only estrogen) once daily for 3 days, then take one white tablet (containing estrogen and progestin) once daily for 3 days. Repeat this process until you finish all the tablets on the card. Begin a new blister card the day after you finish the last one.

Premphase comes in a dispenser containing 28 tablets. Take one maroon tablet (containing only estrogen) once daily on days 1 to 14, and take one light-blue tablet (containing estrogen and progestin) once daily on days 15 to 28. Begin a new dispenser the day after you finish the last one.

Before taking hormone replacement therapy, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking hormone replacement therapy,

• tell your doctor and pharmacist if you are allergic to estrogen, progestin, or any other medications.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking hormone replacement therapy. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have had a hysterectomy and if you have or have ever had asthma; toxemia (high blood pressure during pregnancy); depression; epilepsy (seizures); migraine headaches; liver, heart, gallbladder, or kidney disease; jaundice (yellowing of the skin or eyes); vaginal bleeding between menstrual periods; and excessive weight gain and fluid retention (bloating) during the menstrual cycle.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor immediately. Estrogen and progestin may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist you are taking hormone replacement therapy.
• tell your doctor if you smoke cigarettes. Smoking while taking this medication may increase your risk of serious side effects such as blood clots and stroke. Smoking also may decrease the effectiveness of this medication.
• tell your doctor and pharmacist if you wear contact lenses. If you notice changes in vision or ability to wear your lenses while taking hormone replacement therapy, see an eye doctor.

Ask your doctor about taking calcium supplements if you are taking this medication for prevention of osteoporosis. Follow all dietary and exercise recommendations, as both can help prevent bone disease.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Hormone replacement therapy may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• upset stomach
• vomiting
• stomach cramps or bloating
• diarrhea
• appetite and weight changes
• changes in sex drive or ability
• nervousness
• brown or black skin patches
• acne
• swelling of hands, feet, or lower legs (fluid retention)
• bleeding or spotting between menstrual periods
• changes in menstrual flow
• breast tenderness, enlargement, or discharge
• difficulty wearing contact lenses

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• double vision
• severe abdominal pain
• yellowing of the skin or eyes
• severe mental depression
• unusual bleeding
• loss of appetite
• rash
• extreme tiredness, weakness, or lack of energy
• fever
• dark-colored urine
• light-colored stool

Hormone replacement therapy may increase the risk of developing endometrial cancer and gallbladder disease. Talk to your doctor about the risks of taking this medication.

Hormone replacement therapy may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• upset stomach
• vomiting

Keep all appointments with your doctor and the laboratory. You should have a complete physical exam, including blood pressure measurements, breast and pelvic exams, and a Pap test at least yearly. Follow your doctor's directions for examining your breasts; report any lumps immediately.

If you are taking hormone replacement therapy to treat symptoms of menopause, your doctor will check every 3 to 6 months to see if you still need this medication. If you are taking this medication to prevent thinning of the bones (osteoporosis), you will take it for a longer period of time.

Before you have any laboratory tests, tell the laboratory personnel that you take hormone replacement therapy, because this medication may interfere with some laboratory tests.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Bijuva^® (as a combination product containing Estradiol, Progesterone)

• Activella^® (containing Estradiol, Norethindrone)
• Angeliq^® (containing Drospirenone, Estradiol)
• FemHRT^® (containing Ethinyl Estradiol, Norethindrone)
• Jinteli^® (containing Ethinyl Estradiol, Norethindrone)
• Mimvey^® (containing Estradiol, Norethindrone)
• Prefest^® (containing Estradiol, Norgestimate)
• Premphase^® (containing Conjugated Estrogens, Medroxyprogesterone)
• Prempro^® (containing Conjugated Estrogens, Medroxyprogesterone)

• HRT