SAFETY INFORMATION

ParaGard® T 380A does not protect against HIV/AIDS or other sexually transmitted diseases. ParaGard® is recommended for women who have had at least one child, are in a stable, mutually monogamous relationship, and have no history of pelvic inflammatory disease (PID). Women with a history of PID should not use ParaGard®.

Some serious complications that have been associated with intrauterine contraceptives, including ParaGard®, are:

• Pelvic inflammatory disease (PID)
• Perforation of the uterus
• Expulsion (where the contraceptive falls completely or partially out of the uterus)

The highest risk of PID is shortly after placement in the uterus, usually within the first 20 days. PID can cause permanent blockage of the tubes, sterility, ectopic pregnancy, or, in infrequent cases, death. A decision to use ParaGard® T 380A must include consideration of these and other possible risks. If you currently have or have ever had PID, you must not use ParaGard®.

The most common side effects of ParaGard® T 380A are heavier, longer periods with increased cramping for a few months after placement; some women have spotting between periods. For most women, this typically subsides after a few months. If you ever miss a period, call your healthcare professional without delay.

Prescribing Information
Patient Package Insert

 

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