"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"...
Implanon Consumer (continued)
Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. If bleeding is prolonged (more than 8 days) or unusually heavy, contact your doctor. If you miss 2 periods in a row, contact your doctor for a pregnancy test.
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.
The rod must be removed after 3 years. This is usually a simple procedure done in your doctor's office. Rarely (for example, if the rod has been placed too deeply or can't be felt), the rod may require surgery to remove.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as new/worsening depression), lump in the breast, unwanted facial/body hair, severe stomach/abdominal/pelvic pain, unusual tiredness, dark urine, yellowing eyes/skin.
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of body, sudden vision changes.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 Implanon (etonogestrel implant) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using etonogestrel, tell your doctor or pharmacist if you are allergic to it; or to other progestins (such as norethindrone, desogestrel); or to any anesthetics or antiseptics that might be used in the procedure; 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, personal or family history of cancer (especially breast or cervical cancer), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, gall bladder problems, severe headaches/migraine, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), kidney disease, liver disease (including tumors), stroke, swelling (edema), unexplained vaginal bleeding.
Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, implant, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.
Tell your doctor at least 4 weeks beforehand if you will be having surgery or will be confined to a chair or bed for a long time (such as on a long plane flight). You may need to have this medication removed for a time or take special precautions.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Etonogestrel may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.
If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.
This product must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. A certain serious pregnancy problem (ectopic pregnancy) may be more likely if you become pregnant while using this product.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Additional Implanon 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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