What is the most important information I should know about Mirena?

· Avoid smoking cigarettes while using Mirena. Smoking increases the risk of developing a heart attack, stroke, or blood clot.

· Mirena does not protect you from sexually transmitted diseases--including HIV and AIDS.


What is Mirena?

· Mirena is a form of progesterone, which is a female hormone involved in conception. Mirena is used to prevent pregnancy by inhibiting ovulation (the release of an egg from an ovary) and by causing the cervical mucous to thicken, which makes it harder for sperm to move toward the uterus.

· Mirena is used to prevent pregnancy for up to 5 years.

· Mirena may also be used for purposes other than those listed in this medication guide.


What should I discuss with my healthcare provider before taking Mirena?

· Before using Mirena, tell your doctor if you have     ·high blood pressure, angina, or heart disease;     ·had a stroke;     ·a bleeding or blood-clotting disorder;     ·liver disease;     ·breast cancer, uterine, or another hormone-related cancer;     ·undiagnosed, abnormal vaginal bleeding;     ·a history of intracranial hypertension (increased blood pressure inside the head);     ·diabetes;     ·an increased level of cholesterol in your blood;     ·migraines;     ·asthma; or     ·seizures or epilepsy.

· You may not be able to use Mirena or you may require special monitoring during treatment if you have any of the conditions listed above.

· Mirena is in the FDA pregnancy category X. This means that Mirena is known cause birth defects in an unborn baby. Hormonal changes during pregnancy can have very serious negative effects on a developing baby. The use of Mirena during early pregnancy is not always harmful to a developing baby. Notify your doctor immediately if you think you might be pregnant.

· The hormones in Mirena pass into breast milk. Talk to your doctor before using Mirena if you are breast-feeding a baby.


How should I use Mirena?

· Use Mirena exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

· To use the Norplant system, your doctor or health care provider will surgically implant six capsules containing Mirena under the skin of your upper arm.

· Following insertion of the capsules, keep the area clean and dry and avoid heavy lifting with that arm for 2 to 3 days. The incision should be healed in about 3 days. Follow your doctor's instructions regarding proper wound care.

· Use another method of birth control for at least 7 days after insertion of the Mirena capsules.

· Have a complete physical examination at least once a year while using a Mirena implant.

· The capsules will continue to work for 5 years and should be removed by the end of the fifth year. New capsules may be inserted at that time if desired.


What happens if I miss a dose?

· Since the implanted capsules continuously release a low dose of Mirena, missing a dose does not occur when using this form of Mirena.


What happens if I overdose?

· An overdose of Mirena can result only if more than six capsules are implanted at once, which is unlikely to occur.


What should I avoid while using Mirena?

· Avoid smoking. Smoking increases the risk of developing a heart attack, stroke, or blood clot.

· Mirena does not protect you from sexually transmitted diseases--including HIV and AIDS.


What are the possible side effects of Mirena?

· If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:     ·an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);     ·possible blood clot in the lung (shortness of breath or pain in the chest);     ·possible blood clot in an arm or leg (pain, redness, swelling, or numbness of an arm or leg);     ·headaches with a change in pattern, severity, or length, or that are unending in nature or accompanied by changes in vision;      ·high blood pressure (severe headache, flushing, blurred vision); or     ·liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).     ·infection at the insertion site;     ·pain, numbness, or tingling in the arm with the implanted capsules; or     ·movement of the capsules under the skin.

· Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience     ·breakthrough, heavy, or prolonged menstrual bleeding;     ·lack of menstrual bleeding;     ·pain, swelling, or bruising at the insertion site;     ·headache or dizziness;     ·nausea;     ·breast tenderness;     ·changes in weight or appetite;     ·oily skin or acne; or     ·changes in hair growth.

· Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Mirena?

· Other medications may decrease the effectiveness of Mirena. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, while using Mirena.


Where can I get more information?

· Your pharmacist has additional information about Mirena written for health professionals that you may read.