Important Safety Information About YAZ®

What is YAZ Prescribed For?
YAZ® (drospirenone & ethinyl estradiol) is indicated for:

• The prevention of pregnancy in women who elect to use an oral contraceptive.
• Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception.
  • The effectiveness of YAZ for PMDD when used for more than 3 menstrual cycles has not been evaluated. YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).
• Treatment of moderate acne vulgaris
  • In women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of moderate acne only if the patient desires an oral contraceptive for birth control.

Who Shouldn’t Take Any Oral Contraceptives (OCs)?
Some women should not use OCs, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

In Addition, Who Shouldn’t Take YAZ?
YAZ contains drsp®, a different kind of hormone that for some may increase potassium too much. Therefore, you should not take YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Tell your doctor if you are on daily long-term treatment for a chronic condition such as cardiovascular disease or chronic inflammatory disease. Women who take certain drugs (see below) should have their potassium levels checked in the first month of taking YAZ.

What Drugs May Increase Potassium?
NSAIDs-ibuprofen (Motrin®, Advil®), naproxen (Naprosyn®, Aleve®, and others) when taken long-term and daily for arthritis or other diseases or conditions, Potassium-sparing diuretics (spironolactone and others), Potassium supplementation, ACE inhibitors (Capoten®, Vasotec®, Zestril®, and others), angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®, and others), aldosterone antagonists, and heparin.

What Are The Risks Involved With Taking Any Oral Contraceptive (OC)?
OCs can be associated with an increased risk of several serious cardiovascular side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. OCs do not protect against HIV infection or other STDs..

The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were present in all YAZ clinical trials included: upper respiratory infection, headache, breast pain, vaginal moniliasis, nausea, abdominal pain, dysmenorrhea, urinary tract infection, accidental injury, sinusitis, emotional lability, suspicious Papanicolaou smear, weight gain, depression, menstrual disorder, and asthenia.

The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were either unique to each trial type or occurred in only two types of clinical trials included:

• In the contraception trial: leukorrhea, diarrhea, vomiting, vaginitis, flu syndrome, moniliasis, allergic reaction, cystitis, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, dyspepsia, rhinitis, acne, gastroenteritis, bronchitis, pharyngitis, skin disorder, intermenstrual bleeding, decreased libido, pain, increased cough, dizziness, pain in extremity, and pelvic pain.
• In the PMDD trials: intermenstrual bleeding, decreased libido, nervousness, menorrhagia, pain in extremity, migraine, vaginitis, hyperlipidemia, back pain, diarrhea, increased appetite, enlarged abdomen, and acne.
• In the acne trials: metrorrhagia, flu syndrome, menorrhagia, gastroenteritis, tooth disorder, infection, vomiting, pharyngitis, sore throat, arthralgia, bronchitis, rhinitis, amenorrhea, and urine abnormality.

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.

For Important risk and use information, please see the full patient prescribing information.

BAYER®, the Bayer Cross®, YAZ®, Aleve®, drsp® and Beyond Birth Control are trademarks of Bayer. All other trademarks are the property of their respective owners.