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Important Safety Information About YAZ®
What Is Yaz Prescribed For? YAZ® (drospirenone 3 mg / ethinyl estradiol 20 mcg) 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 drospirenone, 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 level 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 disease 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.
What Side Effects Were Reported In The YAZ® Clinical Trials?
Frequent (greater than 1%) side effects, which may or may not be related to YAZ, reported in all three types of YAZ clinical trials included: upper respiratory infection, headache, breast pain, vaginal yeast infection, nausea, stomach pain, painful menstrual period, urinary tract infection, accidental injury, sinus infection, mood swings, suspicious Pap smear, weight gain, depression, menstrual disorder, and weakness.
Other frequent (greater than 1%) side effects, which may or may not be related to YAZ, reported in either one or two types of YAZ clinical trials included:
- Contraception trial: white or yellow vaginal discharge, diarrhea, vomiting, vaginal infection, flu syndrome, yeast infection, allergic reaction, bladder infection, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, indigestion, inflamed nasal passage, acne, inflammation of the intestines and stomach (eg, stomach flu), bronchitis, skin disorder, bleeding between menstrual periods, decreased libido, pain, increase cough, dizziness, pain in extremity, and pelvic pain.
- PMDD trials: bleeding between menstrual periods, decreased libido, nervousness, heavy menstrual bleeding, pain in extremity, migraine, vaginal infection, elevated cholesterol or triglycerides, back pain, diarrhea, increased appetite, enlarged belly, and acne.
- Acne trials: irregular uterine bleeding, flu syndrome, heavy menstrual bleeding, inflammation of the intestines and stomach (eg, stomach flu), tooth disorder, infection, vomiting, sore throat, joint pain, bronchitis, inflamed nasal passage, absence of menstrual periods, 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.
Please see the full prescribing information including boxed warning.
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.
©2010 Bayer HealthCare Pharmaceuticals Inc., 6 West Belt, Wayne, NJ 07470 All rights reserved.
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
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
Simple lifestyle changes for PMDD
Lifestyle changes alone may not be enough to eliminate the severe emotional and physical symptoms associated with premenstrual dysphoric disorder (PMDD), but they may help lessen them.
Consider trying a few of these steps to learn what works best for you.
Take control: Rethink your diet
- Reduce caffeine to help you feel less tense, irritable, and jittery
- Eat less salt to reduce bloating—this isn't just the salt you add to food, but the sodium content listed on packaged foods
- Eat more complex carbohydrates and fiber found in foods such as whole-grain breads, pasta, cereals, fruits, and vegetables
- Include a source of protein at each meal
- Reduce the amount of sugar and fat in your diet to help improve your energy and stabilize your moods
- Cut back or cut out alcohol
Vitamins and minerals can play a role
Vitamins and minerals are not a treatment for severe premenstrual emotional and physical symptoms, but they can be good for your overall health. While you can choose to eat foods that are rich in these elements, you may decide to take them in pill form. Talk to your healthcare provider if you are currently taking or are planning to take supplements to determine if it's appropriate.
Exercise—move toward better health
Believe it or not, exercise can make you feel better.
- Try to work up to 30 minutes of aerobic exercise, 4 to 6 times a week. It will improve your general health, cardiovascular fitness and muscle tone
- Try forms of exercise that help relax the mind and body, such as yoga or tai chi. Their calming effects can help relieve stress, anxiety and depression
Adjust your schedule
- Try to keep to a regular schedule of meals, bedtime and exercise. And get plenty of rest.
- Get to know your "curve." Use Your Body Diary to track your symptoms and learn when your symptoms are the most severe. Then, see if you can schedule major events or appointments to fall on the week after your period, rather than during your most stressful time
- Make time to pamper yourself. Take a relaxing bubble bath, enjoy a massage or anything else that makes you feel relaxed
Go beyond birth control with YAZ
For women who choose the Pill for contraception, YAZ is the ONLY birth control proven to treat PMDD, a condition with emotional and physical premenstrual symptoms severe enough to impact your life.
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.
Important Safety Information About YAZ®
What Is Yaz Prescribed For? YAZ® (drospirenone 3 mg / ethinyl estradiol 20 mcg) 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 drospirenone, 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 level 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 disease 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.
What Side Effects Were Reported In The YAZ® Clinical Trials?
Frequent (greater than 1%) side effects, which may or may not be related to YAZ, reported in all three types of YAZ clinical trials included: upper respiratory infection, headache, breast pain, vaginal yeast infection, nausea, stomach pain, painful menstrual period, urinary tract infection, accidental injury, sinus infection, mood swings, suspicious Pap smear, weight gain, depression, menstrual disorder, and weakness.
Other frequent (greater than 1%) side effects, which may or may not be related to YAZ, reported in either one or two types of YAZ clinical trials included:
- Contraception trial: white or yellow vaginal discharge, diarrhea, vomiting, vaginal infection, flu syndrome, yeast infection, allergic reaction, bladder infection, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, indigestion, inflamed nasal passage, acne, inflammation of the intestines and stomach (eg, stomach flu), bronchitis, skin disorder, bleeding between menstrual periods, decreased libido, pain, increase cough, dizziness, pain in extremity, and pelvic pain.
- PMDD trials: bleeding between menstrual periods, decreased libido, nervousness, heavy menstrual bleeding, pain in extremity, migraine, vaginal infection, elevated cholesterol or triglycerides, back pain, diarrhea, increased appetite, enlarged belly, and acne.
- Acne trials: irregular uterine bleeding, flu syndrome, heavy menstrual bleeding, inflammation of the intestines and stomach (eg, stomach flu), tooth disorder, infection, vomiting, sore throat, joint pain, bronchitis, inflamed nasal passage, absence of menstrual periods, 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.
Please see the full prescribing information including boxed warning.
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.
©2010 Bayer HealthCare Pharmaceuticals Inc., 6 West Belt, Wayne, NJ 07470 All rights reserved.
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