SKYLA Intrauterine By BAYER HEALTHCARE PHARM
Generic Name: Levonorgestrel
SKU
SKYLA-Intrauterine
This product is a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. It is used by women who want to use a reversible birth control method that works for a long time (up to 3 years). The device slowly releases a hormone (levonorgestrel) that is similar to a hormone that women normally make. This device helps prevent pregnancy by making cervical fluid thicker, interfering with sperm movement, and reducing sperm survival to prevent sperm from reaching an egg (fertilization). It also changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This device may also stop the release of an egg from your ovary (ovulation), but this is not the way it works in most women. Using this product does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
Pain, bleeding, or dizziness during and after placement of the device may occur. Cramps, irregular menstrual periods, and vaginal bleeding between periods (spotting) may occur, especially during the first few weeks of use. Headache, nausea, breast tenderness, acne, or weight gain may also occur. If any of these effects persist or worsen, tell your doctor promptly. After your body adjusts to this product, it is normal to have fewer bleeding days during your menstrual periods, and some women stop having periods altogether. This will not affect your ability to become pregnant after stopping use of this product. 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 device do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: stomach/abdominal pain, vomiting, lumps in the breast, mental/mood changes (such as new/worsening depression), unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches). Using an intrauterine device (IUD) may increase your risk for a rare but serious pelvic infection (pelvic inflammatory disease-PID), which can cause permanent damage to sex organs and infertility. The risk is greater in women who have multiple sexual partners, or infection with a sexually transmitted disease (STD), or who have had PID in the past (see also Precautions section). Tell your doctor right away if you experience symptoms of PID, including: unexplained fever/chills, lower abdominal/pelvic pain, pain during sexual intercourse, genital sores, unusual vaginal discharge. 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 or at www.fda.gov/medwatch.
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