Women's Healthcare

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 prescribing information

Important Safety Information about Climara Pro

What is CLIMARA PRO used for?

CLIMARA PRO is used after menopause to:

• Reduce moderate to severe hot flashes.
• Help prevent osteoporosis (thin weak bones).

When prescribing solely for osteoporosis, other treatments should be considered.

Who should not use CLIMARA and CLIMARA PRO? Do not use CLIMARA PRO if you have had your uterus removed (hysterectomy).

Do not start using CLIMARA if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to CLIMARA or CLIMARA PRO or any of its ingredients, or think you may be pregnant.

What are the warnings of less common but serious side effects of CLIMARA or CLIMARA PRO?

Warnings of less common but serious side effects of CLIMARA or CLIMARA PRO include breast lumps, unusual vaginal bleeding, dizziness and faintness, changes in speech, severe headaches, chest pain, shortness of breath, pains in your legs, changes in vision, and vomiting. Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

What are common side effects of CLIMARA or CLIMARA PRO?

Common side effects of CLIMARA include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, and hair loss.

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 prescribing information

Important Safety Information about Mirena

Mirena (levonorgestrel-releasing intrauterine system) is a hormone-releasing system placed in your uterus to prevent pregnancy for up to 5 years. Mirena also treats heavy periods in women who choose intrauterine contraception.

Only you and your healthcare provider can decide if Mirena is right for you. Mirena is recommended for women who have had a child.

• Don't use Mirena if you have a pelvic infection, get infections easily or have certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. Talk to your healthcare provider about problems related to this condition.
• Mirena may attach to or go through the wall of the uterus and cause other problems. If Mirena comes out, use back-up birth control and call your healthcare provider.
• In the uncommon event you get pregnant while using Mirena, seek emergency care because pregnancy with an intrauterine device may result in loss of pregnancy or loss of fertility.
• Pelvic and/or abdominal pain may occur. Talk to your healthcare provider if the pain is persistent.
• Ovarian cysts may occur and usually disappear.
• Bleeding and spotting may increase in the first few months and continue to be irregular. Periods may become shorter, lighter or even stop.

Mirena does not protect against HIV or 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.

For important risk and use information, please see the patient prescribing information

Important Safety Information about YAZ and Yasmin

YASMIN® (drospirenone & ethinyl estradiol) is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive

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.
1. 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
1. 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.

Important Safety Information About YAZ® and YASMIN®

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 or YASMIN? YAZ and YASMIN each contain drsp®, a different kind of hormone that for some may increase potassium too much. Therefore, you should not take YAZ or YASMIN 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 or YASMIN.

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 YASMIN, that were present during the YASMIN clinical trials included: headache, menstrual disorder, breast pain, abdominal pain, nausea, leukorrhea, flu syndrome, acne, vaginal moniliasis, depression, diarrhea, asthenia, dysmenorrhea, back pain, infection, pharyngitis, intermenstrual bleeding, migraine, vomiting, dizziness, nervousness, vaginitis, sinusitis, cystitis, bronchitis, gastroenteritis, allergic reaction, urinary tract infection, pruritus, emotional lability, surgery, rash, upper respiratory infection.

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 prescribing information