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Generic Name: Norethindrone/Ethinyl Estradiol (HRT) (nor-eth-IN-drone/ETH-in-il ess-tra-DYE-ole)
Brand Name: Femhrt
Do not use Femhrt to prevent heart disease, heart attacks, strokes, or dementia. Femhrt may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots in the lung or leg, or breast cancer. Talk with your doctor regularly about whether you still need treatment with Femhrt .
Femhrt is used for:
Treating hot flashes, night sweats, and other symptoms associated with menopause. It is also used to prevent thinning bones
(osteoporosis) in women past menopause.
Femhrt is an estrogen and progestin combination. It helps maintain 2 female sex hormone levels that fall as a woman reaches menopause.
Do NOT use Femhrt if:
- you are allergic to any ingredient in Femhrt
- you have a history of heart attack, stroke, aneurysm, or heart disease
- you have or have had certain cancers, including cancer of the breast, uterus, cervix, or vagina, or an estrogen-dependent tumor
- you have unexplained vaginal bleeding
- you have or have a history of blood clots in the legs, lungs, heart, or other parts of the body
- you are or suspect you are pregnant
Contact your doctor or health care provider right away if any of these apply to you.
Before using Femhrt :
Some medical conditions may interact with Femhrt . Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
- if you are planning to
become pregnant or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines or other substances
- if you have breast nodules, disease of the breast, an abnormal breast x-ray or mammogram, a strong family history of breast cancer or hypercalcemia
(high level of calcium in the blood)
- if you have or have a history of endometriosis, endometrial cancer, or inflammation of the pancreas
- if you have diabetes, lupus, or gallbladder, heart, liver, or kidney problems
- if you have high blood pressure, vision problems, or yellowing of the skin or eyes
- if you are obese or scheduled to have surgery
- if you use tobacco, have migraines, other headaches, or epilepsy
- if you have high protein, cholesterol, triglycerides, or calcium levels in your blood
Some MEDICINES MAY INTERACT with Femhrt . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Acitretin, aprepitant, azole antifungals (eg, ketoconazole), barbiturates
(eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), rifampin, St. John"s wort, tetracyclines
(eg, doxycycline), topiramate, or troglitazone because they may decrease Femhrt "s effectiveness. If you are taking Femhrt for birth control, an alternative form of birth control (eg, condoms)
will be needed while on these medicines, and until your next period after stopping these medicines.
- Oral anticoagulants (eg, warfarin), beta-blockers (eg, metoprolol), corticosteroids (eg, hydrocortisone),
cyclosporine, theophyllines, or troleandomycin because the risk of their side effects may be increased by Femhrt
- Oral anticoagulants (eg, warfarin) or lamotrigine because their effectiveness may be decreased by Femhrt . If you are taking lamotrigine, stopping Femhrt needs to be done under close monitoring. When Femhrt is stopped, it may cause increased levels of lamotrigine, which may lead to toxic effects, including nausea, dizziness, and visual disturbances.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Femhrt may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Femhrt :
Use Femhrt as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with this
medicine. Talk to your pharmacist if you have questions about this information.
- Take Femhrt by mouth with or without food.
- Take Femhrt at the same time every day.
- If you miss a dose, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Femhrt , refer to the patient information that came with Femhrt or contact your health care provider or pharmacist.
Ask your health care provider any questions you may have about how to use Femhrt .
Important safety information:
- Your health care provider should reevaluate you every 3 to 6 months to make sure you still need to take Femhrt .
- You should have a complete physical exam, including blood pressure measurement, a Pap test, and breast and pelvic exams at least once per year.
- You should have regular breast examinations by a health care provider and examine your breasts monthly. Report any lumps to your doctor immediately. Ask your doctor to show you how to do a breast exam yourself. If you are over 50 years of age you should have a mammogram every year.
- If you are scheduled for surgery or you will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor 3 to 4 weeks beforehand. Special precautions may need to be taken in these circumstances while you are taking Femhrt .
- If you take calcium supplements as part of your treatment to help prevent bone thinning (osteoporosis), ask your doctor about the recommended amount. A daily intake of 1,500 milligrams of calcium is often recommended for women past menopause. Vitamin D (400 Units) may help your body absorb and use more calcium.
- Femhrt does not stop the spread of HIV or sexually transmitted diseases
(STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.
- Diabetes patients - Femhrt may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Femhrt may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Femhrt .
- Lab tests, including liver function, kidney function, lung function, blood pressure, fasting blood glucose, and blood cholesterol, may be performed while you use Femhrt . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Femhrt with caution in the ELDERLY; they may be more sensitive to its effects
- Femhrt should not be
used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Femhrt while you are pregnant. Femhrt is found in breast milk. Do not breast-feed while taking Femhrt .
Possible side effects of Femhrt :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast tenderness or enlargement; absence of menstrual flow; back pain; breakthrough bleeding; changes in menstrual flow; depression; headache; joint pain; muscle aches; nausea and vomiting; rash; reddening of the skin; runny nose; spotting; spotty darkening of the skin (especially on the face);
stomach pain; swelling of the fingers or ankles; urinary tract infection; vaginal inflammation or infection; virus infection; weight change.
Severe allergic reactions (rash; hives; itching; difficulty breathing;
tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; chest pain; confusion; coughing up blood; dark urine or light-colored bowel movements; dizziness or fainting; fever; heaviness in the chest; lack of energy or fatigue; loss of appetite; mood change; numbness in arm or leg;
pain or tenderness in the calf; partial or complete loss of vision; persistent or recurrent abnormal vaginal bleeding; shortness of breath; sleeping problems; speech problems; stomach pain or tenderness;
sudden or severe headache or vomiting; swelling of the fingers or ankles;
vision problems or changes; weakness or one-sided
weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088
(1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include vaginal bleeding; vomiting.
Proper storage of Femhrt :
Store Femhrt at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Femhrt out
of the reach of children and away from pets.
- If you have any questions about Femhrt , please talk with your doctor, pharmacist, or other health care provider.
- Femhrt is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Femhrt . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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