Class Name(s):

• 32:00 Nonhormonal Contraceptives

Brand Name(s):

• CU-7^®¶
• Miudella^®
• Paragard T 380A^®
• Tatum-T¶

IMPORTANT WARNING:

Copper intrauterine system (Miudella^®) may cause infection, perforation, abnormal bleeding, pregnancy loss (if pregnancy occurs once in), and device expulsion if copper intrauterine system is not inserted properly. Copper intrauterine system should only be inserted by a trained health care professional. To make sure health care professionals are properly trained, copper intrauterine system (Miudella^®) is only available through a Miudella REMS program.

WHY is this medicine prescribed?

Copper intrauterine system is used to prevent pregnancy. Copper intrauterine system is in a class of medications called nonhormonal contraceptives. It works by slowly releasing copper into the uterine cavity which interferes with sperm transport and egg fertilization.

Copper intrauterine system is an effective method of birth control but it does not prevent the spread of AIDS and other sexually transmitted diseases.

HOW should this medicine be used?

Copper intrauterine system comes as a small flexible t-shaped device to be inserted into the uterus by a healthcare provider. It is left in place for up to 3 or up to 10 years depending on the product being used.

Your doctor will determine the best time to have copper intrauterine system inserted.

You will need to have your copper intrauterine system inserted in your health-care provider's office or clinic. Your health-care provider may tell you to take a nonprescription pain reliever prior to your appointment to help decrease cramping during and after the placement. You may experience some of these symptoms during and after the placement: sweating, pale skin, fast heartbeat, fainting, dizziness, cramping, and bleeding. Tell your health-care provider if your cramping is severe or if these symptoms continue. Your health-care provider will check you to be sure that your system has been placed correctly.

Your health-care provider will place your intrauterine system into your uterus, but will leave two threads dangling through your cervix. You should check for these threads once a month so that you will know whether your intrauterine system is still in place. To check for the threads, you should wash your hands with soap and water. Then, reach up to the top of your vagina with clean fingers to feel the threads. If you cannot feel the threads or if you feel any part of the intrauterine system other than the threads, your intrauterine system may not be in place and may not prevent pregnancy. If this happens, call your doctor and use a non-hormonal birth control method such as condoms and spermicide to prevent pregnancy until you are seen by your doctor.

You will need a follow-up appointment with your health-care provider after your first menses after the copper intrauterine system is inserted to be sure that your system is properly in place. After this appointment, you will need to be examined once every year or more often if you have any problems or concerns.

Your doctor will determine the right time in your menstrual cycle to have your intrauterine system removed. You will need to have your intrauterine system removed in your health-care provider's office or clinic. You may experience some of these symptoms during and after the removal: sweating, pale skin, fast heartbeat, fainting, dizziness, cramping, and bleeding.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using copper intrauterine system,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have any condition that affects the shape of the inside of your uterus including fibroids (growths in or on the uterus that may cause heavy menstrual bleeding, pain, and other symptoms); cancer of the uterus or cervix; unexplained abnormal vaginal bleeding; an untreated infection of the vagina or cervix; pelvic inflammatory disease (PID; an infection of the reproductive organs); any condition that affects your immune system such as leukemia (cancer that begins in the white blood cells) or AIDS (acquired immunodeficiency syndrome); Wilson's Disease or liver disease or a tumor of the liver. Also tell your doctor if you had a serious infection after pregnancy or abortion in the past 3 months, if you have had PID in the past and have not had a normal pregnancy since your PID got better, if you inject street drugs, if you have more than one sexual partner, or if your partner has more than one sexual partner. Your doctor will probably tell you can't receive copper intrauterine system.
• tell your doctor if you have or have ever had an ectopic pregnancy (a pregnancy that develops outside the uterus), surgery to treat a problem with your fallopian tubes (tubes that transport eggs that have been released by the ovaries to the uterus), or an abnormal Pap smear (test to detect cancer of the cervix).
• tell your doctor if you already have an intrauterine system in place.
• you should not have a copper intrauterine system put in place if you are pregnant or plan to become pregnant. Your doctor will give you a pregnancy test before placing your intrauterine system if there is a chance that you might be pregnant.
• you should know about the risks of becoming pregnant while you have an intrauterine system. It is unlikely that you will become pregnant while your intrauterine system is in place, but if you do become pregnant, there is a risk that your pregnancy will be ectopic. Ectopic pregnancies may be life-threatening and may cause internal bleeding or loss of fertility. If your pregnancy is not ectopic, there is a risk that you will develop a severe infection, miscarry, begin labor prematurely, or die if your pregnancy continues with your intrauterine system in place. If you become pregnant with a copper intrauterine system in place, you and your doctor should discuss the risks of removing the system. If you continue your pregnancy with the intrauterine system in place, it will increase the risk of miscarriage or infection. You will need to see your doctor often and call immediately if you develop signs of pregnancy loss or infection including flu-like symptoms, fever, chills, cramping, pain, bleeding, or vaginal discharge or leaking. Call your doctor right away if you think you may become pregnant or if you experience symptoms of ectopic pregnancy such as unusual vaginal bleeding or pain in your stomach area at any time while your intrauterine system is in place.
• tell your doctor if you are breastfeeding.
• you should expect changes in your menstrual cycle while your intrauterine system is in place. Your periods may become heavier and longer during the first few months and then taper off. You may also have spotting between periods.
• you and your partner will not be able to feel your intrauterine system during intercourse because the system will be placed inside your uterus. However, your partner may feel the threads. Call your doctor if this happens.
• you should know that there is a risk that your intrauterine system will become attached to the wall of your uterus or may move through the wall of your uterus, causing damage or scarring to other organs. If this happens, you might need surgery to remove the system. There is a higher risk that your intrauterine system will move through the wall of your uterus if you are breast-feeding when the intrauterine system is inserted.
• you should know that using an intrauterine system may increase the risk that you will develop PID. PID may cause infertility, ectopic pregnancy, pain that does not go away, and death. Sometimes PID must be treated with surgery, including hysterectomy (surgery to remove the uterus). The risk that you will develop PID is higher if you or your partner have more than one partner. Call your doctor if you experience any of the following symptoms of PID: long-lasting or heavy bleeding, unusual vaginal discharge, stomach area pain, painful sex, chills, or fever.
• you should know that you can use tampons while the intrauterine system is in place but should avoud using menstrual cups or discs.
• if you are having surgery, tell the doctor or dentist that you have a copper intrauterine system.
• if you are having an MRI scan done, tell your doctor or technician that you have a copper intrauterine system.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Copper intrauterine system may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vaginal bleeding
• pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• foul-smelling or unusual vaginal discharge; vaginal pain; pain during sex; sores on the genital area

Copper intrauterine system may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about copper intrauterine system.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2026.