Important Safety Information about YAZ    Prescribing Information, including Boxed WARNING
YAZ is associated with increased risks of several serious 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. In addition, YAZ contains drospirenone, a different kind of hormone that for some may increase potassium too much. continue reading below
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Frequently asked questions

Below is a list of frequently asked questions about birth control and YAZ®.

Q

A

YAZ is a low-dose birth control pill that is 99% effective at preventing pregnancy when taken as directed. YAZ is the only Pill with a 24/4-day dosing schedule (you take active pills for 24 days, followed by inactive pills for 4 days) and the unique progestin, drsp®, or drospirenone.

Q

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PMDD, or Premenstrual Dysphoric Disorder, is a recognized medical condition that causes women to experience a combination of emotional and physical premenstrual symptoms that occur regularly before menstruation starts and go away within a few days following the start of the period. These symptoms are severe enough to impact daily activities, school, work or personal relationships.

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You should only use YAZ for treatment of PMDD if you:

  • Have already decided to use oral contraceptives for birth control, and
  • Have been diagnosed with PMDD by your healthcare provider.

YAZ has not been shown to be effective for the treatment of premenstrual syndrome (PMS), a less serious cluster of symptoms occurring before menstruation. If you or your healthcare provider believes you have PMS, you should only take YAZ if you want to prevent pregnancy; and not for the treatment of PMS.

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YAZ, a combination pill, contains 2 types of hormones, an estrogen and a progestin. Combination pills are the type of birth control pills most commonly prescribed by healthcare providers. They work in 3 possible ways:

  • The body is "tricked" into thinking it is pregnant. This prevents the release of an egg (ovulation). Without an egg to be fertilized, you can't become pregnant.
  • The cervical mucus is thickened, making it hard for sperm to travel toward the egg and fertilize it, in case an egg is released.
  • The lining of the uterus (endometrium) is altered in a way that reduces the likelihood of implantation of the egg.
Q

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In most cases, the answer is no, you do not need to take a blood test if you're taking YAZ. Only those women on daily long-term treatment with certain cardiovascular or anti-inflammatory drugs for chronic conditions - should talk to their healthcare provider about whether or not they should have their potassium level checked in the first month of taking YAZ. Please check Safety Information for further details.

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When taken correctly and consistently, YAZ is 99% effective at preventing pregnancy. This means that your chance of becoming pregnant is one in 100, if you take YAZ as instructed by your doctor or healthcare provider.

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Low dose refers to the amount of estrogen in a pill. A birth control pill is considered low dose if it has 0.035 mg or less of estrogen. Years ago, when birth control pills were introduced in the United States, doctors thought the amount of estrogen had to be high in order to prevent pregnancy. Over the years, however, scientists found that lower doses of estrogen were just as effective for pregnancy prevention.

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All combination birth control pills use estrogen, but they do not all use the same progestin. YAZ contains the estrogen, ethinyl estradiol, and the unique progestin, drsp, or drospirenone. Whereas other combination pills have a progestin that is derived from the male sex hormone testosterone, the drsp in YAZ is derived from spironolactone. Ask your healthcare provider about the unique properties of drsp and what that may mean for you.

YAZ contains a hormone that for some may increase potassium too much, so don't take YAZ if you have kidney, liver, or adrenal disease as this could cause serious heart and health problems.

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YAZ has a 24/4-day dosing schedule (you take active pills for 24 days, followed by four inactive pills). What this means is that YAZ gives you 3 additional days of active "hormone" pills. Plus, it has the unique hormone, drsp (drospirenone). To learn more about what the only 24/4-day dosing schedule with drsp could mean for you, please talk with your healthcare provider.

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You have a choice for which day to start taking your first pack ofpills. Decide with your healthcare provider which is the best day foryou. Pick a time of day which will be easy to remember.

DAY 1 START:

  1. Take the first light pink "active" pill of the first pack during the first 24 hours of your period.
  2. You will not need to use a back-up method of birth control, since you are starting the Pill at the beginning of your period.

SUNDAY START:

  1. Take the first light pink "active" pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
  2. Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).
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When switching from another birth control pill, YAZ should bestarted on the same day that a new pack of the previous birthcontrol pills would have been started.

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YAZ is 99% effective in preventing pregnancy when taken as directed. In addition, it's the only birth control pill that's also approved to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life, for women who choose the Pill for contraception. In addition, YAZ has been proven to help treat moderate acne, but should only be taken by patients who desire an oral contraceptive for birth control.

Like other oral contraceptives,YAZ can also provide other noncontraceptive health benefits, such as:

  • Shorter, lighter periods
  • More regular periods
  • Fewer menstrual cramps
  • Reduced risk of ovarian cancer (cancer of the ovaries)
  • Reduced risk of endometrial cancer (cancer of the endometrium or lining of the uterus)
  • Reduced risk of ectopic pregnancy (a pregnancy that occurs outside the uterus and can be life-threatening)
  • Reduced risk of noncancerous breast cysts or lumps
  • Reduced risk of ovarian cysts

The non-contraceptive health benefits that may also come from using a combination birth control pill are supported by studies that mostly used oral contraceptive formulations containing high doses of estrogen. However, the same benefits are believed to be associated with birth control pills containing low doses of estrogen.

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Yes. YAZ is clinically proven to treat moderate acne in women who choose to use the Pill for birth control. YAZ should only be used to treat acne if you are at least 14 years old, have started having menstrual periods, and your healthcare provider says it is safe for you to use the Pill.

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Women taking combination birth control pills, such as YAZ, may experience side effects. 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. The most frequent (>1%) treatment-emergent adverse events, which may or may not be drug-related, common to all three types of 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.

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Birth control pills can be used safely by most healthy women. However, certain women should not take the Pill. Serious risks include blood clots, stroke, and heart attack. Smoking increases these risks, especially if you're over 35. Don't take the Pill if you've had any of these, certain cancers, or could be pregnant. The Pill does not protect against HIV or STDs.

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If you miss a YAZ® (drospirenone & ethinyl estradiol) pill, don't panic. Review the information below to determine what to do next. Contact your healthcare provider if you have any questions.

Missed 1 pill
If you miss one (1) active pill (pink):

  • Take it as soon as you remember. Take the next pill at your regular time
  • This means you may take 2 pills in 1 day
  • You do not need to use a backup birth control method if you have sex

Missed 2 pills
If you miss two (2) active pills (pink) in a row in Week 1 or Week 2 of your pack:

  • Take two (2) pills on the day you remember and two (2) pills the next day
  • Then take one (1) pill a day until you finish the pack
  • You MAY BECOME PREGNANT if you have sex in the 7 days after you restart your pills
  • You MUST use another birth control method (such as condoms or spermicides) as a backup for those 7 days

If you miss two (2) active pills (pink) in a row in Week 3 or Week 4 of your pack:

  • If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day
  • If you are a Sunday Starter: Keep taking one pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day
  • You MAY BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use another birth control method (such as condoms or spermicides) as a backup for those 7 days
  • You may not have your period this month, but this is expected. However, if you miss your period two months in a row, call your healthcare provider or clinic because you might be pregnant

Miss 3 pills or more
If you miss three (3) or more active pills (pink) in a row during any week:

  • If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day
  • If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day
  • You MAY BECOME PREGNANT if you have sex in the seven days after you restart your pills. You MUST use another birth control method (such as condoms or spermicides) as a backup for those 7 days
  • You may not have your period this month, but this is expected. However, if you miss your period two months in a row, call your healthcare provider or clinic because you might be pregnant

If you miss any of the 4 reminder pills (white) in Week 4:

  • THROW AWAY the pills you missed
  • Keep taking one pill each day until the pack is empty
  • You do not need a backup method of birth control

If you are not sure if you've taken your pills properly or still are not sure what to do about the pills you have missed

  • Use a backup method (e.g., condoms or spermicides) any time you have sex

Keep taking one active pink pill each day until you can reach your healthcare provider or clinic

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Some women gain weight when they take the Pill. And some lose weight, while others don't fluctuate at all. Weight can be affected by such a wide range of factors—changes in your lifestyle, diet, exercise routine, or stress level—that it's hard to pinpoint just one. Bloating, which is caused by water retention, can also give the appearance of weight gain. For those women who do experience weight gain or bloating, simple adjustments in diet and activity can help.

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The hormones used in combination birth control pills do not accumulate in the body over time. Although there is no scientific evidence indicating the need to take a break from the Pill, it is important to consult your healthcare provider before discontinuing YAZ.

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In general, you will want to talk about the effectiveness, potential side effects and the additional benefits of YAZ.

For more information, go to Talking to Your Healthcare Provider and Important Things to Discuss, where you'll find a list of possible questions to get your discussion started.

Q

A

YAZ E-Reminders and text messages are easy-to-use tools that can help you stay on track. If you no longer wish to receive reminders or text messages, click here to unsubscribe and click edit.

You can also unsubscribe to text messages by responding directly to the communication that you receive. Simply hit Reply and text "stop" to unsubscribe.



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 reported 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.

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

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