Paragard T 380A Intrauterine Copper Contraceptive ®

What if I become pregnant while using Paragard ?

® If you think you are pregnant, contact your healthcare professional right away. If you are pregnant and Paragard is in your uterus, you may get a severe

® infection or shock, have a miscarriage or premature labor and delivery, or even die. Because of these risks, your healthcare provider will recommend that you have Paragard removed, even though removal may cause miscarriage.

® If you continue a pregnancy with Paragard in place, see your healthcare pro

® vider regularly. Contact your healthcare provider right away if you get fever, chills, cramping, pain, bleeding, flu-like symptoms, or an unusual, bad smelling vaginal discharge. A pregnancy with Paragard in place has a greater than usual chance of being

® ectopic (outside your uterus). Ectopic pregnancy is an emergency that may require surgery. An ectopic pregnancy can cause internal bleeding, infertility, and death. Unusual vaginal bleeding or abdominal pain may be signs of an ectopic pregnancy. Copper in Paragard does not seem to cause birth defects.

®

What side effects can I expect with Paragard ?

® The most common side effects of Paragard are heavier, longer periods and

® spotting between periods; most of these side effects diminish after 2-3 months. However, if your menstrual flow continues to be heavy or long, or spotting continues, contact your healthcare provider. Infrequently, serious side effects may occur:

® • Pelvic inflammatory disease (PID): Uncommonly, Paragard and other IUDS are associated with PID. PID is an infection of the uterus, tubes, and nearby organs. PID is most likely to occur in the first 20 days after placement. You have a higher chance of getting PID if you or your partner have sex with more than one person. PID is treated with antibiotics. However, PID can cause serious problems such as infertility, ectopic pregnancy, and chronic pelvic pain. Rarely, PID may even cause death. More serious cases of PID require surgery or a hysterectomy (removal of the uterus). Contact your healthcare provider right away if you have any of the signs of PID: abdominal or pelvic pain, painful sex, unusual or bad smelling vaginal discharge, chills, heavy bleeding, or fever. • Difficult removals: Occasionally Paragard may be hard to remove because

® it is stuck in the uterus. Surgery may sometimes be needed to remove Paragard .

® • Perforation: Rarely, Paragard goes through the wall of the uterus, especially

® during placement. This is called perforation. If Paragard perforates the

® uterus, it should be removed. Surgery may be needed. Perforation can cause infection, scarring, or damage to other organs. If Paragard perforates the

® uterus, you are not protected from pregnancy. • Expulsion: Paragard may partially or completely fall out of the uterus. This

® is called expulsion. Women who have never been pregnant may be more likely to expel Paragard than women who have been pregnant before. If you

® think that Paragard has partly or completely fallen out, use an additional

® birth control method, such as a condom and call your healthcare provider. You may have other side effects with Paragard . For example, you may have

® anemia (low blood count), backache, pain during sex, menstrual cramps, allergic reaction, vaginal infection, vaginal discharge, faintness, or pain. This is not a complete list of possible side effects. If you have questions about a side effect, check with your healthcare provider.

When should I call my healthcare provider? Call your healthcare provider if you have any concerns about Paragard . Be

® sure to call if you: • Think you are pregnant • Have pelvic pain or pain during sex • Have unusual vaginal discharge or genital sores • Have unexplained fever • Might be exposed to sexually transmitted diseases (STDS) • Cannot feel Paragard ’s threads or can feel the threads are much longer

® • Can feel any other part of the Paragard besides the threads

® • Become HIV positive or your partner becomes HIV positive • Have severe or prolonged vaginal bleeding • Miss a menstrual period

Teva Women’s Health, Inc. A Subsidiary of Teva Pharmaceuticals USA, Inc. North Wales, PA 19454

This brief summary is based on Paragard Fda-approved patient labeling,

® Rev. 9/2014.