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Basic Drug Info
Drug Name:Mirena
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Other Info:

The following are serious but uncommon side effects of Mirena: Pelvic inflammatory disease (PID).

Some IUD users get a serious pelvic infection called pelvic inflammatory disease.

PID is usually sexually transmitted.

You have a higher chance of getting PID if you or your partner have sex with other partners.

PID can cause serious problems such as infertility, ectopic pregnancy or constant pelvic pain.

PID is usually treated with antibiotics.

More serious cases of PID may require surgery.

A hysterectomy (removal of the uterus) is sometimes needed.

In rare cases, infections that start as PID can even cause death.

Tell your health care provider right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, or fever.

Life-threatening infection.

Life-threatening infection can occur within the first few days after Mirena is placed.

Call your health care provider if you develop severe pain within a few hours after placement.

Embedment.

Mirena  may adhere to the uterine wall.

This is called embedment.

If embedment occurs, Mirena may no longer prevent pregnancy and you may need surgery to have it removed.Perforation.

Mirena may go through the uterus.

This is called perforation.

If your uterus is perforated, Mirena may no longer prevent pregnancy.

It may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have Mirena removed.

Common side effects of Mirena include:Discomfort during placement.

Dizziness, faintness, bleeding or cramping may occur during placement.

This is common.

Let your health care provider know if the cramping is severe.

Expulsion.

Mirena may come out by itself.

This is called expulsion.

You may become pregnant if Mirena comes out.

If you notice that Mirena has come out, use a backup birth control method like condoms and call your health care provider.Missed menstrual periods.

About 2 out of 10 women stop having periods after 1 year of Mirena use.

The periods come back when Mirena is removed.

If you do not have a period for 6 weeks during Mirena use, contact your health care provider.Changes in bleeding.

You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months.

Sometimes the bleeding is heavier than usual at first.

However, the bleeding usually becomes lighter than usual and may be irregular.

Call your health care provider if the bleeding remains heavier than usual or if the bleeding becomes heavy after it has been light for a while.

Cyst on the ovary.

Approximately 12% (12 out of 100) of women using Mirena develop a cyst on the ovary.

These cysts usually disappear on their own in a month or two.

However, cysts can cause pain and sometimes cysts will need surgery.

This is not a complete list of possible side effects with Mirena.

For more information, ask your health care provider.

Call your doctor for medical advice about side effects.

You may report side effects to the manufacturer at 1-888-842-2937, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.When should I call my health care provider? Call your health care provider if you have any concerns about Mirena.

Be sure to call if you think you are pregnant have pelvic pain or pain during sex have unusual vaginal discharge or genital sores have unexplained fever might be exposed to sexually transmitted diseases (STDs) cannot feel Mirena 's threads develop very severe or migraine headaches have yellowing of the skin or whites of the eyes.

These may be signs of liver problems.

have a stroke or heart attack or your partner becomes HIV positive have severe vaginal bleeding or bleeding that lasts a long time miss a menstrual period General advice about prescription medicines Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

This leaflet summarizes the most important information about Mirena.

If you would like more information, talk with your health care provider.

You can ask your health care provider for information about Mirena that is written for health providers.© 2008, Bayer HealthCare Pharmaceuticals Inc.

All rights reserved.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470This patient information booklet was updated July 2008.Fill out the following checklist.

Your answers will help you and your health care provider decide if Mirena is a good choice for you.Do you have any of these conditions? YesNoDon’t know— will discuss with my health care provider Abnormalities of the uterus ??? Acquired immune deficiency syndrome (AIDS) ??? Anemia or blood clotting problems ??? Bleeding between periods ??? Cancer of the uterus or cervix ??? History of other types of cancer ??? Steroid therapy (for example, prednisone)??? Possible pregnancy ??? Diabetes ??? Ectopic pregnancy in the past ??? Fainting attacks ??? Genital sores ??? Heart disease ??? Heart murmur ??? Heavy menstrual flow ??? Hepatitis or other liver disease ??? Infection of the uterus or cervix ??? IUD in place now or in the past ??? IV drug abuse now or in the past ??? Leukemia ??? More than one sexual partner ??? A sexual partner who has more than one sexual partner ??? Pelvic infection ??? Abortion or miscarriage in the past 2 months ??? Pregnancy in the past 2 months ??? Severe menstrual cramps ??? Severe Headache??? Sexually transmitted disease (STD), such as gonorrhea or chlamydia ??? Stroke??? Abnormal Pap smear ??? Unexplained genital bleeding ??? Uterine or pelvic surgery ??? Vaginal discharge or infection ??? HIV infection ??? Breastfeeding ??? High blood pressure??? Manufactured for:Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470Manufactured in Finland1-866-647-3646© 2008, Bayer HealthCare Pharmaceuticals Inc.All rights reserved.

6705102         July 2008



Clinical Trials:


Indications and Usage

Mirena is indicated for intrauterine contraception for up to 5 years.

Thereafter, if continued contraception is desired, the system should be replaced.Mirena is recommended for women who have had at least one child.
Contraindications

Mirena is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy.

Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity.

Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy.

Postpartum endometritis or infected abortion in the past 3 months.

Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear.

Genital bleeding of unknown etiology.

Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled.

Acute liver disease or liver tumor (benign or malignant).

Conditions associated with increased susceptibility to pelvic infections.

A previously inserted IUD that has not been removed.Hypersensitivity to any component of this product.

Known or suspected carcinoma of the breast.
Fibroid Tumor -- A benign tumor derived from smooth muscle tissue, also known as a fibroid tumor. They rarely occur outside of the UTERUS and the GASTROINTESTINAL TRACT but can occur in the SKIN and SUBCUTANEOUS TISSUE, probably arising from the smooth muscle of small blood vessels in these tissues.

Uterine Fibroids -- A benign smooth muscle neoplasm arising from the body of the uterus. It is characterized by the presence of spindle cells with cigar-shaped nuclei, interlacing fascicles, and a whorled pattern.

PELVIC INFLAMMATORY DISEASE ACUTE --

Pelvic Inflammatory Disease -- A spectrum of inflammation involving the female upper genital tract and the supporting tissues. It is usually caused by an ascending infection of organisms from the endocervix. Infection may be confined to the uterus (ENDOMETRITIS), the FALLOPIAN TUBES; (SALPINGITIS); the ovaries (OOPHORITIS), the supporting ligaments (PARAMETRITIS), or may involve several of the above uterine appendages. Such inflammation can lead to functional impairment and infertility.

Abortion, Septic -- Any type of abortion, induced or spontaneous, that is associated with infection of the UTERUS and its appendages. It is characterized by FEVER, uterine tenderness, and foul discharge.

Cervical Neoplasm -- new abnormal cervical tissue that grows by excessive cellular division and proliferation more rapidly than normal and continues to grow after the stimuli that initiated the new growth cease.

Acute Cervicitis --

Vaginitis -- Inflammation of the vagina characterized by pain and a purulent discharge.

Bacterial Vaginosis -- Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Liver diseases -- Pathological processes of the LIVER.

acute disease/disorder -- Disease having a short and relatively severe course.

Liver neoplasms -- Tumors or cancer of the LIVER.

Pelvic Infection -- Infection involving the tissues or organs in the PELVIS.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Warnings

Evaluate women who become pregnant while using Mirena for ectopic pregnancy.

Up to half of pregnancies that occur with Mirena in place are ectopic.

The incidence of ectopic pregnancy in clinical trials that excluded women with risk factors for ectopic pregnancy was about 1 ectopic pregnancy per 1000 users per year.

Tell women who choose Mirena about the risks of ectopic pregnancy, including the loss of fertility.

Teach them to recognize and report to their physician promptly any symptoms of ectopic pregnancy.

Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy.

The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use Mirena is unknown.

Clinical trials of Mirena excluded women with a history of ectopic pregnancy.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.