Important Safety Information About Natazia
Prescribing Information, including Boxed WARNING

WARNING TO WOMEN WHO SMOKE: Do not use Natazia if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This risk increases with age and number of cigarettes smoked.
See additional important risk information below


 

Natazia®, the First and Only Birth Control Pill Clinically Proven to Help Heavy Monthly Periods

Do you experience heavy monthly periods?

There’s a birth control pill that’s clinically proven to help. Have you ever wondered whether your heavy periods are “normal”—and whether there’s anything you can do about them? If so, talk to your healthcare provider—help may be available.

Prescription Natazia is effective at preventing pregnancy when taken as directed. But that’s not all. If you choose the Pill for birth control, Natazia is the only birth control pill approved by the FDA to help lighten heavy monthly periods not caused by another condition of the uterus, such as fibroids or polyps.

IMPORTANT SAFETY INFORMATION ABOUT NATAZIA®, INCLUDING BOXED WARNING

What is Natazia® prescribed for?
Natazia is a birth control pill approved to prevent pregnancy. Natazia can also be used for the treatment of heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb) in women who decide to use the Pill for birth control.

Natazia has not been studied for pregnancy prevention in women who are obese (body mass index >30).

Who should not take Natazia?

Do not use Natazia if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This risk increases with age and number of cigarettes smoked.

Do not use Natazia if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant.

What are the most serious risks of taking Natazia?
Natazia increases the risk of serious conditions including blood clots, stroke, and heart attack. The risk of blood clots is highest during the first year of use. This risk is greatest when first starting the Pill and when restarting the same or a different Pill after a 4 week or greater break.

Call your healthcare provider right away if you have:
Persistent leg pain; sudden shortness of breath; sudden blindness, partial or complete; severe pain in your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking; yellowing of the skin or eyes.

What are the most common side effects in Natazia clinical trials?
The most common side effects were headache/migraine, breast pain/discomfort/tenderness, menstrual irregularities, nausea/vomiting, acne, mood changes, and weight gain.

Tell your healthcare provider about all medicines and herbal products you take including daily long-term treatment for chronic conditions such as seizures or cardiovascular disease.

Natazia does not protect against HIV infection (AIDS) or other STDs.

Please see full Prescribing Information about Natazia (estradiol valerate and estradiol valerate/dienogest) tablets, including boxed warning.

Bayer®, the Bayer Cross®, and Natazia® are trademarks of Bayer. All other trademarks are the property of their respective owners.

Copyright ©2013 Bayer. All rights reserved.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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