"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Ortho Evra Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), unwanted facial/body hair (hirsutism), dark patches on the skin (melasma), mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), swelling of the ankles/feet, weight changes (gain or loss), problem wearing contact lenses.
This medication may rarely cause serious (sometimes fatal) blood clot problems (e.g., thrombosis, pulmonary embolism, stroke, heart attack). The risk for blood clots may be higher for the birth control patch than for the pill. Seek immediate medical attention if you experience: tingling/weakness/numbness in the arms/legs, pain/swelling/warmth in the groin/calf, chest/jaw/left arm pain, confusion, coughing up blood, sudden shortness of breath, sudden dizziness/fainting, weakness on one side of the body, vision problems/changes, slurred speech, sudden severe headaches, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse).
Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, yellowing eyes/skin, unusual tiredness, dark urine.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Ortho Evra (norelgestromin, ethinyl estradiol transdermal) Side Effects Center for a complete guide to possible side effects »
PRECAUTIONS: See also Warning section.
Before using this medication patch, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, breathing problems (e.g., asthma), cancer (especially endometrial or breast cancer), blood clotting disorders (such as protein C or protein S deficiency), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, kidney problems, liver problems (e.g., liver tumor), current or suspected pregnancy, seizure, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high cholesterol or triglyceride (blood fat) levels, depression, diabetes, high blood pressure, fluid retention (edema), gallbladder problems, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems.
Do not smoke cigarettes. Hormonal birth control (e.g., pills, injections, devices) products combined with smoking cigarettes significantly increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist or consult the Patient Information Leaflet that comes with this product.
Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions in these circumstances while you are using this drug.
The drugs in this patch may cause blotchy, dark areas on your skin (melasma). Sunlight may intensify this effect. If this occurs, avoid prolonged sun exposure, use a sunscreen, and wear protective clothing when outdoors.
If you are nearsighted or wear contact lenses, you may develop vision problems or may have problems wearing your contact lenses. Contact your eye doctor if these problems occur.
This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.
The medication from this patch passes into breast milk and may have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.
Additional Ortho Evra Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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