Safety Information for Lysteda (tranexamic acid)

Fertility

About LYSTEDA®
LYSTEDA is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. LYSTEDA does not contain any hormones and is taken only during your period. It does not treat premenstrual symptoms, does not affect your fertility, and cannot be used as birth control. It does not protect against sexually transmitted diseases.


Important Safety Information
You should not take LYSTEDA if you currently have or have ever had a blood clot, have been told you are at risk for having a blood clot, or are allergic to LYSTEDA or tranexamic acid.

LYSTEDA can cause serious side effects, including: The risk of serious blood clots may be increased when LYSTEDA is taken with hormonal contraceptives, especially if you are taking higher than your normal dose of birth control, are overweight, or if you smoke cigarettes. Risk of serious blood clots may also be increased if you take LYSTEDA with medicines used to help your blood clot or some medicines used to treat leukemia. Be sure to tell your health care provider if you take any of these medicines.

Stop taking LYSTEDA if you experience any eye changes, and promptly report any eye problems to your healthcare provider.

If you have an allergic reaction (have shortness of breath and your throat feels tight), stop taking LYSTEDA and get medical help right away.

The most common side effects of LYSTEDA include: headaches, sinus and nasal problems, back pain, pain in your abdomen, pain in your muscles or joints, anemia, and fatigue.

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition.

You are encouraged to report side effects of prescription drugs. Contact Ferring at 1-888-FERRING (1-888-337-7464) or call 1-800-FDA-1088 or visit fda.gov/medwatch. Please see full Prescribing Information here: www.lysteda.com/assets/pdf/PI_FERRING2010.pdf

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