Important Safety Information

WARNING TO WOMEN WHO SMOKE: Do not use Natazia if you smoke cigarettes and are over age 35. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and number of cigarettes smoked.
See additional Important Safety Information below


 

How well does Natazia work to help treat heavy periods?

When taken as directed, prescription Natazia is highly effective at preventing pregnancy. But that's not all. Natazia is also highly efective at reducing heavy periods that are not caused by any diagnosed conditions of the uterus.

About the clinical studies

Two clinical studies compared Natazia with placebo (inactive hormone-free pill) in women experiencing irregular bleeding symptoms: heavy, frequent, and/or prolonged bleeding not caused by any diagnosed conditions. The effectiveness of Natazia was evaluated during a 90-day assessment phase (efficacy phase).

For women taking Natazia during this 90-day phase, 29.2% in one study and 29.5% in the other reported “complete symptom relief” (defined as having no more irregular bleeding symptoms and who met up to 8 strictly defined criteria for success). In comparison, 2.9% and 1.2% of women who were given a placebo reported “complete symptom relief”.

Patients experiencing complete symptom relief over a 90-day assessment phase


Average Reduction in Bleeding

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.


Results in women with heavy periods

Average reduction in menstrual blood volume at cycle seven

Most women in the two studies described above experienced heavy bleeding specifically (about 85%). For those women with heavy periods who took Natazia, menstrual bleeding at Cycle 7 was reduced by an average of 90% in one study and 87% in the other. In comparison, for women treated with placebo, menstrual bleeding at Cycle 7 was reduced by an average of 14% and 32%, respectively.

Average Reduction in Bleeding

What are the Most Serious Risks of Taking Birth Control Pills?

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.
It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

  • Legs (deep vein thrombosis)
  • Lungs (pulmonary embolus)
  • Eyes (loss of eyesight)
  • Heart (heart attack)
  • Brain (stroke)

A few women who take birth control pills may get:

  • High blood pressure
  • Gallbladder problems
  • Rare cancerous or noncancerous liver tumors

All of these events are uncommon in healthy women.

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 eyeballs

What are the Common Side Effects of Birth Control Pills?

The most common side effects of birth control pills are:

  • Spotting or bleeding between menstrual periods
  • Nausea
  • Breast tenderness
  • Headache

These side effects are usually mild and usually disappear with time.

Less common side effects are:

  • Acne
  • Less sexual desire
  • Bloating or fluid retention
  • Blotchy darkening of the skin, especially on the face
  • High blood sugar, especially in women who already have diabetes
  • High fat levels in the blood
  • Depression, especially if you have had depression in the past.

Call your healthcare provider immediately if you have any thoughts of harming yourself.

  • Problems tolerating contact lenses
  • Weight changes

This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.

IMPORTANT SAFETY INFORMATION ABOUT NATAZIA, INCLUDING BOXED WARNING

INDICATIONS FOR NATAZIA
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
Who should not take Natazia?

WARNING TO WOMEN WHO SMOKE
Do not use Natazia if you smoke cigarettes and are over age 35. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and number of cigarettes smoked.

Do not use Natazia if you have liver disease, or 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 disorders, 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.

Natazia does not protect against HIV infection (AIDS) or other sexually transmitted diseases (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, including Boxed Warning and Patient Information for Natazia.

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