levonorgestrel-releasing implant - intrauterine, Mirena (cont.)

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before this medication device is inserted and each time it is re-inserted. The leaflet contains very important information about side effects and when it is important to call your doctor. If you have any questions, consult your doctor or pharmacist.This product is inserted into your uterus by a properly trained health care professional, usually once every 5 years or as determined by your doctor. The medication in the device is slowly released into the body over a 5-year period.If you still desire birth control after 5 years, the medication device may be replaced with a new one. The medication device may also be removed at any time by a properly trained health care professional.Learn all the instructions on how and when to check this product and its proper positioning in your body, and make sure you understand the problems that may occur with this product. See also Precautions section.

SIDE EFFECTS: Irregular vaginal bleeding (e.g., spotting), cramps, headache, nausea, breast pain, acne, rash, hair loss, weight gain, or decreased interest in sex may occur. If any of these effects persist or worsen, tell your doctor promptly.Remember that your doctor has prescribed this medication device because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication device do not have serious side effects.Tell your doctor immediately if any of these serious side effects occur: lack of menstrual period, unexplained fever, chills, trouble breathing, mental/mood changes (e.g., depression, nervousness), vaginal swelling/itching, painful intercourse.Tell your doctor immediately if any of these unlikely but serious side effects occur: migraine/severe headache, vomiting, tiredness, fast/pounding heartbeat.Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: prolonged or heavy vaginal bleeding, unusual vaginal discharge/odor, vaginal sores, abdominal/pelvic pain or tenderness, lumps in the breast, yellowing eyes/skin, dark urine, persistent nausea, trouble urinating.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

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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