The first and only contraceptive with 3 i ndications For women who choose an oral contraceptive for birth control, YAZ is indicated for¹:

1 99% contraceptive efficacy when used correctly

2

Treatment of emotional and physical premenstrual symptoms severe enough to impact women’s lives

3 Treatment of moderate acne

DAY 1

DAY 24

DAY 28

BEYOND BIRTH CONTROL^™

INDICATIONS

1. YAZ is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. 2. YAZ is also indicated for the treatment of 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. 3. YAZ is indicated for the 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 acne only if the patient desires an oral contraceptive for birth control.

IMPORTANT SAFETY INFORMATION

YAZ contains 3 mg of the progestin drospirenone that has AntiMineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone.

YAZ should not be used in patients with conditions that predispose to hyperkalemia (ie, renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs.

The most frequent (>1%) treatment-emergent adverse events, listed in descending order, reported with the use of YAZ in the contraception clinical trials, which may or may not be drug related, included: upper respiratory infection, headache, breast pain, vaginal moniliasis, leukorrhea, diarrhea, nausea, vomiting, vaginitis, abdominal pain, flu syndrome, dysmenorrhea, moniliasis, allergic reaction, urinary tract infection, accidental injury, cystitis, tooth disorder, sore throat, infection, fever, surgery, sinusitis, back pain, emotional lability, migraine, suspicious Papanicolaou smear, dyspepsia, rhinitis, acne, gastroenteritis, bronchitis, pharyngitis, skin disorder, intermenstrual bleeding, decreased libido, weight gain, pain, depression, increased cough, dizziness, menstrual disorder, pain in extremity, pelvic pain, and asthenia.

The most frequent (>1%) treatment-emergent adverse events, listed in descending order, reported with the use of YAZ in the PMDD clinical trials, which may or may not be drug related, included: intermenstrual bleeding, headache, nausea, breast pain, upper respiratory infection, asthenia, abdominal pain, decreased libido, emotional lability, suspicious Papanicolaou smear, nervousness, menorrhagia, pain in extremity, depression, menstrual disorder, migraine, sinusitis, weight gain, vaginal moniliasis, vaginitis, hyperlipidemia, back pain, diarrhea, increased appetite, enlarged abdomen, accidental injury, acne, dysmenorrhea, and urinary tract infection.

The most frequent (>1%) treatment-emergent adverse events, listed in descending order, reported with the use of YAZ in the acne clinical trials, which may or may not be drug related, included: upper respiratory infection, metrorrhagia, headache, suspicious Papanicolaou smear, nausea, sinusitis, vaginal moniliasis, flu syndrome, menorrhagia, depression, emotional lability, abdominal pain, gastroenteritis, urinary tract infection, tooth disorder, infection, vomiting, pharyngitis, breast pain, dysmenorrhea, menstrual disorder, accidental injury, asthenia, sore throat, weight gain, arthralgia, bronchitis, rhinitis, amenorrhea, and urine abnormality.

Patients should be counseled that OCs do not protect against HIV infection and other sexually transmitted diseases. The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension. Cigarette smoking increases the risk of serious cardiovascular side effects; women who take OCs are strongly advised not to smoke.

Reference: 1. YAZ [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; 2007. Visit www.YAZ-us.com for more information.