Levonorgestrel IUD

Levonorgestrel IUD is used for:

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Preventing pregnancy for up to 5 years in certain women.

Levonorgestrel IUD is a progestin intrauterine device (IUD). It works by preventing ovulation. It also alters the lining of the uterus to prevent implantation should fertilization occur.

Do NOT use Levonorgestrel IUD if:

• you are allergic to any ingredient in Levonorgestrel IUD
• you are pregnant or suspect that you are pregnant
• you have an abnormally shaped uterus or uterine fibroids
• you have a history of pelvic inflammatory disease (PID), ectopic pregnancy, endometritis, or a condition that puts you at risk of ectopic pregnancy or pelvic infections
• you have had an inflamed lining of the uterus after pregnancy or an infected abortion within the past 3 months
• you have an abnormal Pap smear of unknown cause; vaginal bleeding of unknown cause; inflammation of the cervix or vagina; an infection of the vagina that has not been treated; any sexually transmitted diseases (eg, chlamydia, gonorrhea); known or suspected tumors of the uterus or cervix; or genital, vaginal, or cervical infection
• you or your partner has more than one sex partner
• you have a condition that makes you prone to infection (eg, leukemia), immune system problems, HIV infection, or intravenous (IV) substance abuse
• you have a previously inserted IUD that has not been removed
• you have a history of breast cancer or you suspect that you have breast cancer
• you are taking nevirapine, troleandomycin, or St. John's wort
• you have liver disease or liver tumors

Contact your doctor or health care provider right away if any of these apply to you.

Before using Levonorgestrel IUD:

Some medical conditions may interact with Levonorgestrel IUD. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have recently had a baby or an abortion
• if you have ever had an ectopic pregnancy
• if you have a history of diabetes, migraine headaches, heart disease or other heart problems (eg, heart attack), blood pressure problems, blood vessel problems, stroke or bleeding in the brain, blood clotting problems, or anemia
• if you take anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), or insulin
• if you have never given birth to a child or are premenstrual
• if you have infections or pelvic problems (eg, persistent pelvic pain or infections), endometriosis, genital lesions, painful sexual intercourse, bleeding of the uterus, or vaginal discharge

Some MEDICINES MAY INTERACT with Levonorgestrel IUD. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, indinavir), hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Levonorgestrel IUD's effectiveness
• Anticoagulants (eg, warfarin) because the risk of their side effects may be increased or decreased by Levonorgestrel IUD
• Beta-adrenergic blockers (eg, metoprolol), corticosteroids (eg, prednisone), insulin, selegiline, theophylline, or troleandomycin because the risk of their side effects may be increased by Levonorgestrel IUD
• Lamotrigine because its effectiveness is decreased, and when levonorgestrel is stopped, toxic effects, such as nausea, dizziness, and vision problems, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levonorgestrel IUD may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Levonorgestrel IUD:

Use Levonorgestrel IUD as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Levonorgestrel IUD. Talk to your pharmacist if you have questions about this information.
• Before using this product, read the patient insert and discuss the information, as well as other birth control methods, with your health care provider.
• This product will be inserted by a qualified health care provider in a medical setting.
• Your period may be irregular during the first 3 to 6 months of use.
• Check after each menstrual period to make sure you can locate the thread from the IUD that extends through the cervix. Do not pull on the thread. Contact your doctor if you cannot locate the thread.
• Levonorgestrel IUD must be replaced every 5 years.
• If you miss a dose of Levonorgestrel IUD, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Levonorgestrel IUD.

Important safety information:

• This product does not protect against HIV or other sexually transmitted diseases.
• Contact your doctor immediately if either you or your partner develops HIV infection or a sexually transmitted disease.
• Diabetes patients - Levonorgestrel IUD may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• If you experience severe pain within hours after the device is inserted, contact your doctor right away.
• Lab tests, including a complete physical exam, pelvic examination, Pap smear, uterine ultrasound, pregnancy tests, liver function tests, x-ray, and blood counts, may be performed while you use Levonorgestrel IUD. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Levonorgestrel IUD with caution in the ELDERLY; they may be more sensitive to its effects.
• Levonorgestrel IUD should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Levonorgestrel IUD if you are pregnant. If you think you may be pregnant, contact your doctor right away. Levonorgestrel IUD is found in breast milk. If you are or will be breast-feeding while you use Levonorgestrel IUD, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Levonorgestrel IUD:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; back pain; breast pain; breast tenderness; changes in sex drive; cramps; depression; hair loss; headache; irregular bleeding; lack of menstrual bleeding; nausea; nervousness; skin problems; stomach pain; vomiting; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; changes in vision; chills; dizziness; fever; genital sores; lack of menstrual period; mental or mood changes; numbness of an arm or leg; painful sexual intercourse; prolonged heavy menstrual bleeding; severe headache or dizziness; severe pain or tenderness in the abdomen or pelvis; sharp or crushing chest pain; spotting instead of your usual period; sudden leg pain; sudden severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; unusual or odorous vaginal discharge; unusual vaginal swelling or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Levonorgestrel IUD is usually handled and stored by a health care provider. Keep Levonorgestrel IUD out of the reach of children and away from pets.

General information:

• If you have any questions about Levonorgestrel IUD, please talk with your doctor, pharmacist, or other health care provider.
• Levonorgestrel IUD is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Levonorgestrel IUD. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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