Mirena

This device is placed inside the uterus by your doctor within 7 days after the start of your period. Your doctor will most likely perform a gynecological examination before the device is inserted to examine your uterus for correct placement and to rule out pregnancy or other gynecological conditions that would make using levonorgestrel undesirable.

The device is inserted during a routine office visit with your doctor and only takes a few minutes. You may have to go back to your doctor's office about 4 to 12 weeks after the device is inserted to ensure it is in the right position, and then once a year thereafter or as directed by your doctor. The device can be left in place for up to 5 years, after which a decision must be made whether to replace the device with a new one or simply to remove the old device.

It is important to use this contraceptive device exactly as prescribed by your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause pimples (acne); it may cause headaches; it may cause stomach ache; it may affect menstruation (irregular or absence of menses); it may cause nausea or, rarely, vomiting; it may cause your breasts to feel swollen and tender. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Mirena® is supplied as a soft, flexible, T-shaped device about the size of a quarter. It contains 52 mg of levonorgestrel in a cylindrical-shaped reservoir. The reservoir is mounted on a T-shaped frame and covered with a rate-controlling membrane of polydimethylsiloxane and silica. The T-frame is coloured with barium sulfate. The polyethylene removal threads attached to the T-frame are coloured with black iron oxide.

The levonorgestrel IUD should not be used by anyone who:

• is allergic to levonorgestrel or to any of the ingredients or components of the device
• is or may be pregnant
• has a bacterial infection of the heart valves
• has a genital infection
• has a poorly functioning immune system
• has abnormal cells in the cervix
• has abnormalities of the uterus (e.g., fibroids) that distort the shape of the uterus
• has acute liver disease or a liver tumour
• has cancer of the uterus or cervix
• has current or recurrent pelvic inflammatory disease
• has had an abortion complicated by an infection within the past 3 months
• has inflammation of the cervix
• has inflammation of the endometrium (lining of the uterus) after pregnancy
• has Leukemia or other cancers affecting the blood
• has recently had an abnormal growth of cells inside the uterus
• has unexplained bleeding of the uterus
• has a progestin-dependent cancer, including Breast Cancer

There may be an interaction between the levonorgestrel IUD device and any of the following:

• anticoagulants (e.g., Dalteparin, Enoxaparin, Warfarin, Apixaban, dabigatran, Rivaroxaban)
• Aprepitant
• "azole" antifungal medications (e.g., fluconazole, itraconazole, Voriconazole)
• Bosentan
• cannabis
• carfilzomib
• Cladribine
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• Dabrafenib
• diabetes medications (e.g., Canagliflozin, chlorpropamide, Glyburide, insulin, Linagliptin, Metformin Rosiglitazone)
• efavirenz
• Flibanserin
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• Modafinil
• mycophenolate
• Octreotide
• retinoic acid medications (e.g., etretinate, Isotretinoin)
• rifabutin
• rifampin
• St. John's wort
• seizure medications (e.g., Clobazam, Carbamazepine, Lamotrigine, Oxcarbazepine, Phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid)
• Selegiline
• thalidomide
• tipranavir
• Tranexamic acid
• Triazolam

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than the ones listed above may interact with Mirena (Levonorgestrel-intra-uterine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, Nicotine from cigarettes, and street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Mirena (Levonorgestrel-intra-uterine).

Blood pressure: Levonorgestrel can cause an increase in blood pressure. If you have high blood pressure, discuss with your doctor how Mirena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mirena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you experience an increase in your blood pressure after having this device inserted, contact your doctor.

Breast cancer: Cases of breast cancer have been reported by women using levonorgestrel-releasing IUDs. However, some studies have shown that progestin-only forms of birth control do not appear to increase the risk of breast cancer. Discuss any concerns you have with your doctor.

Depression: Hormones, such as progestins, are known to contribute to mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Mirena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mirena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Mirena (Levonorgestrel-intra-uterine), contact your doctor as soon as possible.

Diabetes: Low-dose contraceptives such as this device have very little effect on blood sugar control. However, people with diabetes or those with a family history of diabetes should monitor their blood sugar closely to detect any worsening of blood sugar control.

Ectopic Pregnancy: If you have a history of ectopic pregnancy (when a fertilized egg implants itself outside of the uterus), have had surgery on the fallopian tubes, or have had a pelvic infection, you should speak to your doctor or pharmacist before using this device. If you experience lower abdominal pain along with a missed period or unexpected bleeding while using Mirena (Levonorgestrel-intra-uterine), contact your doctor.

Expulsion of device: Bleeding or pain may indicate that the device has either moved out of position or has been expelled from the uterine cavity. A device that is out of position is less effective and should be removed and replaced by a new device.

Eye problems: Some women may experience a change in vision or contact lens tolerance. If this occurs, contact your eye doctor.

Headache: Levonorgestrel, like other hormones, may cause severe headache or migraine. If you have a history of migraines, discuss with your doctor how Mirena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mirena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you notice increasing numbers or severity of headaches after the device has been inserted, contact your doctor as soon as possible.

Heart disease: Levonorgestrel may increase the risk of developing Blood Clots, causing reduced blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. Discuss with your doctor how Mirena (Levonorgestrel-intra-uterine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mirena (Levonorgestrel-intra-uterine), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Heart valve disorders: Mirena (Levonorgestrel-intra-uterine) can increase your risk of getting an infection in your heart valves if you were born with or have acquired a heart valve defect. You may need to take antibiotics before the insertion and removal of Mirena (Levonorgestrel-intra-uterine) to prevent the infection.

Insertion and removal of the device: Some women may experience some pain and bleeding when the device is inserted or removed. The procedure may also cause fainting or a seizure for someone with a seizure disorder.

Liver disease: If you develop signs of a liver problem (yellow skin or eyes, dark urine, pale stools, abdominal pain, or itchy skin), talk to your doctor about whether you should have the device removed.

Menstrual bleeding: Some women may experience some pain and bleeding when the device is inserted or removed. Irregular menstrual bleeding is common for the first few months after the device is inserted. Over time, menstrual bleeding decreases and may stop completely while the device is inserted.

Ovarian cysts: Mirena (Levonorgestrel-intra-uterine) can cause the development of ovarian cysts. Most of these don't have any symptoms and disappear on their own within 2 to 3 months. However, if you experience pain in the pelvic area, contact your doctor.

Perforation: The chance of the device puncturing the cervix or uterus is very rare (between 1 in 1,000 and 1 in 10,000). If it were to occur, it would most likely be when the device is being inserted. If this happens, the device should be removed as soon as possible.

Removal of the device: If you experience any of the following, check with your doctor to see if you should have your device removed:

• confirmed or suspected breast or endometrial cancer
• migraines or severe headaches
• recurrent inflammation of the lining of the uterus
• recurrent pelvic infections
• significantly elevated blood pressure
• stroke or heart attack

Return to fertility: Your usual level of fertility should return soon after the device is removed. Nearly 90% of women wishing to become pregnant conceive within 24 months after removal of the device.

Sexually transmitted infections (STIs): This device does not protect against STIs, including HIV/AIDS. For protection against STIs, use latex condoms.

Pregnancy: This device should not be used during pregnancy. You should have this device removed if you become pregnant. Any device in the uterus during pregnancy can result in an increased risk of miscarriage or early labour. There is no evidence of birth defects when the device remains in the uterus for the full term. However, there is no conclusive evidence of this because of limited experience.

Breast-feeding: Hormonal birth control, such as this device, is not the first choice of birth control for women who are breast-feeding. Mirena (Levonorgestrel-intra-uterine) passes into breast milk. If you are a breast-feeding mother and are using levonorgestrel, it may affect your baby. Some women using Mirena (Levonorgestrel-intra-uterine) have reported decreased milk production. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Mirena (Levonorgestrel-intra-uterine) have not been established for children under 18 years of age. This contraceptive device is not the first option of contraception for women that have not been pregnant before.

The intra-uterine device must be inserted by a doctor.