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Drugs & Medications

Mirena intrauterine

LEVONORGESTREL-RELEASING 3 YEAR SYSTEM - INTRAUTERINE

GENERIC NAME(S): LEVONORGESTREL

Uses

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 thins the lining of the uterus (womb). 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).

How to use Mirena intrauterine

Read the Patient Information Leaflet provided by your pharmacist before you start using this product. The leaflet contains very important information about this device. If you have any questions, ask your doctor or pharmacist.

This device is placed in your uterus by a health care provider during an in-office visit. It is left in place for up to 3 years. Schedule a follow-up visit 4 to 6 weeks after the device is placed to make sure it is still in the proper position.

This device may sometimes move out of place or come out by itself. After each menstrual period, check to make sure it is in the proper position. Learn how to carefully check the position of this device from the Patient Information Leaflet and/or your health care provider. If it comes out or if you cannot feel the threads, contact your doctor promptly and use an additional form of non-hormonal birth control (such as condoms, spermicide) to prevent pregnancy until otherwise directed by your doctor.

If you wish to continue this method of birth control after 3 years, the used device may be removed and replaced with a new one. Either way, the used device should be removed after 3 years. Your health care provider can remove this device whenever you want to stop using this method of birth control.

Side Effects

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, 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this medication device, tell your doctor or pharmacist if you are allergic to levonorgestrel, or to any other progestins (such as norethindrone, desogestrel); 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 product, tell your doctor or pharmacist your medical history, especially of: recent pregnancy, current breastfeeding, bleeding/blood disorders, high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), depression, diabetes, severe headaches/migraines, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), liver disease (including tumors), previous pregnancy outside the uterus (ectopic pregnancy), stroke, unexplained vaginal bleeding, uterus problems (such as fibroids, pelvic inflammatory disease-PID), conditions that weaken the immune system/increase the risk of infection (such as HIV, leukemia, IV drug abuse).

If you or partner have other sexual partners, this device may not be the best birth control method for you. If you or your partner get a sexually transmitted disease (including HIV, gonorrhea, chlamydia), contact your doctor immediately. Ask your doctor if you should continue to use this device for birth control.

If you are going to have an MRI test, tell testing personnel and all your doctors that you are using this device. This device can be safely scanned only under specific conditions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This device should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

Levonorgestrel passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

Overdose with this device is highly unlikely. However, if overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Keep all regular medical and laboratory appointments. You should have regular complete physical exams which include laboratory and medical tests (such as blood pressure, breast exam, pelvic exam, Pap smear) to check for side effects. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Consult your doctor for more details.

Missed Dose

Not applicable.

Storage

Before use, store at room temperature. Keep all medications and medical devices away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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