Dosage Forms:

• Device

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Uses of This Medicine:

Intrauterine copper contraceptive is a device that contains the copper. It is placed in the uterus where it slowly releases the hormone to prevent pregnancy for up to 10 years. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of intrauterine copper contraceptive in teenage females. This medicine may be used for birth control in teenage females but is not recommended before the start of menstruation.

Older adults—

Appropriate studies on the relationship of age to the effects of intrauterine copper contraceptive have not been performed in the geriatric population. This medicine is not recommended for use in elderly women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Abnormally-shaped uterus or uterine fibroids or
• Cancer of the uterus or cervix, known or suspected or
• Genital tract infections (eg, bacterial vaginosis, cervicitis, endometritis, vaginitis), acute and untreated or
• IUD that has not been removed, previous or
• Pelvic infection (active or untreated), history of or
• Pelvic inflammatory disease (a serious pelvic infection) or endometritis, or history of or
• Wilson's disease (disorder in how the body handles copper)—Should not be used in patients with these conditions.

• Bradycardia (slow heartbeat) or
• Dizziness or
• Infection (eg, HIV or AIDS) or
• Seizures—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Your doctor will give you this medicine in a hospital or clinic. This intrauterine device (IUD) is inserted into your uterus.

This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor may want to do tests to make sure you do not have an infection before putting in an IUD. The IUD is usually inserted during your monthly period, immediately after a miscarriage or an abortion in the first trimester of your pregnancy, or after giving birth.

Your IUD has a thread. You cannot see this string, and it will not cause problems when you have sex. Check your IUD after each monthly period. You may not be protected against pregnancy if you cannot feel the thread Do the following to check the placement of your IUD:

• Wash your hands with soap and warm water.
• Check by reaching up to the top of your vagina with clean fingers to feel the 2 threads. Never pull on the string.

You will need to have your device replaced every 10 years or sooner if it comes out of your uterus unexpectedly.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects.

There is a small chance that you could get pregnant when using an IUD, just as there is with any birth control. If you get pregnant, your doctor may remove your IUD to lower the risk of miscarriage or other problems.

Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy (occurs outside the uterus) if you get pregnant while your IUD is in place. This can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

An IUD can slip partly or all the way out of your uterus without you knowing. If this happens, you will have no protection against getting pregnant or you may have an increased risk for serious problems. This is more likely during the first year that you have your IUD, but it can happen at any time. Regularly checking the string of your IUD can tell you if it is still in place.

Using this device can increase your risk for severe infections, including sepsis. This is a rare and life-threatening condition that requires immediate medical attention. Talk to your doctor if you have concerns about this risk.

An IUD can increase your risk of having a serious infection of the female organs, called pelvic inflammatory disease (PID) or endometritis, which can be serious, even life threatening. This infection could cause scarring of the female organs, which may make it hard for you to become pregnant in the future, and can increase your risk of ectopic pregnancy.

Call your doctor right away if you have flu-like symptoms, fever, chills, cramps, pain, bleeding, or fluid leaking from your vagina. These may be signs of an infection.

This medicine may cause perforation (hole in the wall of your uterus), embedment (attached to the wall of the uterus), or expulsion (partially or completely fall out of the uterus) which can damage other organs. Check with your doctor right away if you have excessive pain, vaginal bleeding, pain or bleeding that gets worse after inserting the IUD, or not being able to feel the threads of the IUD.

You may have heavier and longer periods with spotting in between. Check with your doctor right away if it still continues.

You could have less bleeding or even stop having periods by the end of the first year. Call your doctor if you have a change from your regular bleeding pattern after you have had your IUD for awhile, including more bleeding or if you miss a period (and you were having periods even with your IUD).

You may have dizziness, slow heart rate, or seizures immediately after placing or removing Paragard®. Tell your doctor if you had these conditions before.

This device will not protect you from getting HIV/AIDS, herpes, or other sexually transmitted diseases. Tell your doctor if you or your partner begins to have sexual intercourse with other people, or you or your partner tests positive for a sexually transmitted disease. If this is a concern for you, talk with your doctor.

It is important to tell your doctor that you are using this medicine before you have a medical procedure, such as magnetic resonance imaging or MRI.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Absent, missed, or irregular menstrual periods

blistering, peeling, or loosening of the skin

chills

confusion

cough

diarrhea

difficulty in breathing or swallowing

dizziness, lightheadedness

dull or aching stomach pain

fainting

fast heartbeat

fast ,weak pulse

fever

foul-smelling vaginal discharge

full or bloated feeling

increased urge to urinate

joint or muscle pain

pale, cold clammy skin

pressure in the stomach

rapid, shallow breathing

red irritated eyes

red skin lesions, often with a purple center

shivering

skin itching, rash, or redness

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stomach cramps

stopping of menstrual bleeding

sudden increase in stomach or shoulder pain

sweating

swelling of the face, throat, or tongue

swelling of the stomach area

unusual or large amount of vaginal bleeding

unusual tiredness or weakness

unusual vaginal bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Muscle spasms

nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.