copper 380 square mm intrauterine device

Generic name:
Copper-containing system - intrauterine

Brand name(s)
Paragard

This product is a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. It is used by people who want a reversible birth control method that works for a long time (up to 10 years). This device helps prevent pregnancy.

Using this product does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Read the Patient Information Leaflet if available from your pharmacist before you start using this product. 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 10 years. After the device is placed, schedule a follow-up visit after your first menstrual period to make sure it is still in the proper position.

This device may sometimes move out of place or come out by itself. It is a good habit to check once a month 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 backup 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 10 years, the used device may be removed and replaced with a new one. Either way, the used device should be removed after 10 years. Your health care provider can remove this device whenever you want to stop using this method of birth control.

Temporary pain, bleeding, or dizziness during and soon after placement of the device may occur. Your periods may become heavier and longer. You may also have frequent vaginal bleeding (spotting) between periods. If any of these effects last or get worse, tell your doctor promptly.

Remember that this medication device has been prescribed because your doctor 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:

• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods)

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 people 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 have 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 or at www.fda.gov/medwatch.

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

Before using this medication device, tell your doctor or pharmacist if you are allergic to copper; 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
• cancer (especially uterine or cervical cancer)
• unexplained vaginal bleeding
• uterus problems (such as fibroids, pelvic inflammatory disease-PID)
• Wilson's disease (a disorder in how the body handles copper)
• 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(s) get a sexually transmitted disease (including HIV, gonorrhea, chlamydia), contact your doctor right away. Ask your doctor if you should continue to use this device for birth control.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Also, if you are going to have a medical procedure using heat therapy or an MRI test, tell your healthcare provider and testing personnel that you are using this device. Your procedure or MRI test may need to be adjusted.

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

It is unknown if the copper in this device passes into breast milk. However, it is unlikely to pass into breast milk. Consult your doctor before breastfeeding.

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.

This medication device may be harmful if swallowed. If someone has swallowed it and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Keep all regular medical and lab appointments. You should have regular complete physical exams including pelvic exam and screening for cervical cancer (Pap smear). Consult your doctor for more details.

Not applicable.

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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.