Estradiol, Levonorgestrel Transdermal patch - weekly
What is this medicine?
ESTRADIOL; LEVONORGESTREL (es tra DYE ole; LEE voh nor jes trel) is used as hormone replacement in menopausal women who still have their uterus. This medicine is used to relieve the symptoms of menopause. It also helps to prevent osteoporosis in postmenopausal women.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
blood vessel disease or blood clots
breast, cervical, endometrial, or uterine cancer
heart disease or recent heart attack
high blood cholesterol
high blood pressure
high level of calcium in the blood
systemic lupus erythematosus (SLE)
an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for external use only. Follow the directions on the prescription label. Tear open the pouch, do not use scissors. Remove the stiff protective liner covering the adhesive. Try not to touch the adhesive. Apply the patch, sticky side to the skin, to an area that is clean, dry and hairless. Avoid injured, irritated, calloused, or scarred areas. Do not apply the skin patches to your breasts or around the waistline. Use a different site each time to prevent skin irritation. Do not cut or trim the patch. Do not stop using except on the advice of your doctor or health care professional. Do not wear more than one patch at a time unless you are told to do so by your doctor or health care professional.
Contact your pediatrician regarding the use of this medicine 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, apply it as soon as you can. If it is almost time for your next dose, apply only that dose. Do not apply double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone
This medicine may also interact with the following medications:
barbiturates, like phenobarbital
certain antibiotics used to treat infections
medicines for fungus infections like itraconazole and ketoconazole
raloxifene or tamoxifen
rifabutin, rifampin, or rifapentine
St. John's Wort
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 medicine?
Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests.
This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.
If you have any reason to think you are pregnant, stop taking this medicine right away and contact your doctor or health care professional.
Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine, especially if you are more than 35 years old. You are strongly advised not to smoke.
If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye doctor or health care professional.
If you are going to have surgery or an MRI, you may need to stop taking this medicine. Consult your health care professional for advice before you schedule the surgery.
You may bathe or participate in other activities while wearing your patch. If the patch pulls loose or falls off, you may reapply it if the patch is sticky enough to stay on the skin. You should reapply the patch in a different area. Use a fresh patch if it will no longer stick.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
breakthrough bleeding and spotting
breast tissue changes or discharge
leg, arm or groin pain
severe stomach pain
sudden shortness of breath
yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
changes in sexual desire
mood changes, anxiety, depression, frustration, anger, or emotional outbursts
increased or decreased appetite
skin rash, acne, or brown spots on the skin
symptoms of vaginal infection like itching, irritation or unusual discharge
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.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not store any patches that have been removed from their protective pouch. Throw away any unused medicine after the expiration date. Dispose of used patches properly. Since used patches may still contain active hormones, fold the patch in half so that it sticks to itself prior to disposal.
March 21, 2017
U.S. FDA-approved Package Insert