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


 

Have You Missed Your Daily Natazia® Pill?

In order to be sure your birth control pill is going to be most effective, it’s important to remember to take your pill every day, as directed. The power is in your hands. If you miss one or more pills, you could get pregnant. This includes starting your pill pack late. If you do miss a pill, here’s what you should do:


If you are less than 12 hours late taking your pill:


If you miss ONE PILL for more than 12 hours:

Days 1–17

Days 18–24

Days 25–28


If you miss TWO PILLS in a row:

Days 1–17 (if you miss the pills for Days 17 and 18, follow the instructions for Days 17–25 instead)

Days 17–25 (if you miss the pills for Days 25 and 26, follow the instructions for Days 25–28 instead)

Days 25–28

You may already be pregnant or COULD BECOME PREGNANT if you had sex on the days after the pills were missed. The more pills missed and the closer they are to the end of the cycle, the higher the risk of a pregnancy. You should call your healthcare provider if you are unsure whether you are already pregnant.


If you are still not sure of what to do about the pills you have missed:

For more information about what to do if you miss a pill and about Natazia in general, please see the What Should I Do if I Miss Any Pills section of the FDA-approved Patient Guide for Using Natazia. This information is also included in each pack of Natazia you will receive.

Advice for Taking Natazia

Whether you’re a first-time user or have been on the pill before, it’s important to remember that the pill is most effective when taken as directed. That means taking one pill consistently at the same time every day. You should never skip a pill or delay taking your daily pill for more than 12 hours.

For more information on starting Natazia, refer to the How Do I Take Natazia section of the FDA-approved Patient Guide for Using Natazia.

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).

Important Safety Information about Natazia

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.

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.

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

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

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.

Please see full Prescribing Information about Natazia, including boxed warning.

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

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