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Yasmin Consumer Information

YASMIN

Generic Name: drospirenone and ethinyl estradiol (drow SPIH reh known and EH thi nill ess tra DYE ole)

Brand Names: Yasmin

What is the most important information I should know about drospirenone and ethinyl estradiol?

• Drospirenone and ethinyl estradiol does not offer protection from sexually transmitted diseases--including HIV or AIDS. Using a condom is the only way to obtain protection from these diseases.
• Take one pill every day, no more than 24 hours after the last dose. Try to take the pills at a time that you will remember every day--for example, just before bed, with a meal, or first thing in the morning.
• Avoid smoking cigarettes while taking drospirenone and ethinyl estradiol. Smoking greatly increases the risk of heart attack, stroke, and blood clot.
• Some other medicines may decrease the effectiveness of drospirenone and ethinyl estradiol, which may result in unintended pregnancy. Talk to your doctor before taking any other medicines while taking drospirenone and ethinyl estradiol to determine if an additional form of birth control may be needed temporarily.

What is drospirenone and ethinyl estradiol?

• Drospirenone is a form of progesterone and ethinyl estradiol is a form of estrogen. These are both female hormones involved in conception. Together, drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) from occurring.
• Drospirenone and ethinyl estradiol are used to prevent pregnancy.
• Drospirenone and ethinyl estradiol may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking drospirenone and ethinyl estradiol?

• Drospirenone may increase potassium in the body. The following list of conditions and medications may also affect potassium levels in the body. Do not take drospirenone and ethinyl estradiol without first talking to your doctor if you have or are taking:
• liver disease or a history of yellowing of the skin or eyes due to pregnancy or previous use of birth control pills;
• kidney disease;
• adrenal insufficiency;
• a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, others), naproxen (Aleve, Naprosyn, Anaprox, others), and others;
• a potassium-sparing diuretic such as spironolactone (Aldactone, others), triamterene (Dyrenium, Dyazide, Maxzide, others), amiloride (Midamor, others), or eplerenone (Inspra);
• a potassium supplement such as Klor-Con, K-Dur, K-Tab, Kaon, others;
• an ACE inhibitor such as benazepril (Lotensin), lisinopril (Prinivil, Zestril), enalapril (Vasotec), and others;
• an angiotensin II receptor antagonist such as candesartan (Atacand), losartan (Cozaar), telmisartan (Micardis), and others; or
• heparin.
• Also, do not take drospirenone and ethinyl estradiol without first talking to your doctor if you have
• had a stroke, heart attack, or blood clot;
• high blood pressure, angina, or heart disease;
• a bleeding or blood-clotting disorder;
• breast, uterine, or another hormone-related cancer; or
• undiagnosed, abnormal vaginal bleeding.
• Before taking drospirenone and ethinyl estradiol, also tell your doctor if you have diabetes; high cholesterol; gallbladder disease; migraines or other headaches; epilepsy; a history of depression; a history of scanty or irregular menstrual periods; smoke cigarettes; or need an extended period of bed rest due to surgery or illness.
• Drospirenone and ethinyl estradiol is in the FDA pregnancy category X. This means that it has been reported to cause birth defects in an unborn baby. Hormonal changes during pregnancy can have very serious negative effects on a developing baby. Do not take drospirenone and ethinyl estradiol if you are pregnant or if you think you might be pregnant.
• Drospirenone and ethinyl estradiol passes into breast milk and may decrease milk production. Do not take drospirenone and ethinyl estradiol without first talking to your doctor if you are breast-feeding a baby.

How should I take drospirenone and ethinyl estradiol?

• Take drospirenone and ethinyl estradiol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take the first pill in a package on the first day of your period or on the first Sunday after your period begins as directed by your doctor.
• Take one pill every day, no more than 24 hours after the last dose. Try to take the pills at a time that you will remember every day.
• Taking the pill at night may reduce noticeable side effects such as headache or nausea.
• If you are on a 28-day cycle, take one pill every day. When the pack runs out, throw it away. Begin a new pack the following day. The 28-day cycle contains seven pills that are placebos (with no active ingredients). These are "reminder" pills to keep you on a regular cycle. They are taken while you are menstruating.
• Follow your doctor's instructions about using a second form of birth control when you first start taking drospirenone and ethinyl estradiol, when you are taking other medications, or if you miss a pill. If you are unsure what to do in any of these cases, talk to your pharmacist, nurse, or doctor about how to ensure that you will not become pregnant.
• Have yearly physical exams and examine your breasts for lumps monthly while taking drospirenone and ethinyl estradiol. Your doctor may also want you to have blood tests to monitor potassium levels in your blood.
• Store drospirenone and ethinyl estradiol at room temperature away from moisture and heat.

What happens if I miss a dose?

• Missing a pill increases the risk of becoming pregnant. Follow the exact directions on the package information insert concerning missed doses, it may have slightly different instructions in the case of missed pills.
• If you do not have a package information insert, call your pharmacist, doctor, or nurse to find out what to do. In general:
• If you miss one yellow "active" pill, take the dose as soon as you remember or take two pills at the time of your next regularly scheduled dose. You do not need to use backup birth control.
• If you miss two yellow "active" tablets in a row in week one or two, take two tablets each for the next two regularly scheduled doses (one missed tablet plus one regularly scheduled tablet for 2 days in a row). Use another form of birth control for at least 7 days following the missed tablets.
• If you miss two yellow "active" tablets in a row in week three, or if you miss three tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new package on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a 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 not have a period that month, but this is expected. However, if you miss your period 2 months in a row, call your doctor because you might be pregnant. You may become pregnant if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or spermicides) as a back-up for those 7 days.
• If you miss one of the reminder pills in week four, skip that dose and take the next one as directed.

What happens if I overdose?

• Consult a doctor, emergency room, or poison control left for advice if an overdose is suspected.
• Symptoms of an overdose include nausea, vomiting, and menstrual bleeding.

What should I avoid while taking drospirenone and ethinyl estradiol?

• Avoid smoking. Smoking greatly increases the risk of heart attack, stroke, or blood clot formation.
• Drospirenone and ethinyl estradiol does not offer protection from sexually transmitted diseases--including HIV or AIDS. Using a condom is the only way to obtain protection from these diseases.

What are the possible side effects of drospirenone and ethinyl estradiol?

• If you experience any of the following serious side effects, stop taking drospirenone and ethinyl estradiol and seek emergency medical attention or contact your doctor immediately:
• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• sharp chest pain, coughing of blood or shortness of breath (possible blood clot in the lung );
• pain in the calf (possible blood clot in the leg);
• crushing chest pain or heaviness in the chest (possible heart attack);
• sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (possible stroke);
• partial or complete loss of vision (possible clot in the eye);
• stomach pain or tenderness, yellowing of the skin or eyes, fever, fatigue, loss of appetite, dark-colored urine, or light-colored stools (possible liver problems);
• difficulty sleeping, weakness, lack of energy, fatigue , or change in mood (possibly severe depression); or
• new or changing breast lumps.
• Other, less serious side effects may also occur. Continue to take drospirenone and ethinyl estradiol and talk to your doctor if you experience
• headache or dizziness;
• changes in menstrual cycle or breast tenderness;
• changes in weight or appetite;
• water retention;
• intolerance to contact lenses;
• changes in skin color; or
• changes in blood sugar.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect drospirenone and ethinyl estradiol?

• Drospirenone may increase potassium in the body. The following list of medications may also affect potassium levels in the body. More specific examples of these medicines are listed in the section entitled "What should I discuss with my healthcare provider before taking drospirenone and ethinyl estradiol?". Do not take drospirenone and ethinyl estradiol without first talking to your doctor if you are on daily, long-term treatment with:
• a nonsteroidal anti-inflammatory drug (NSAID);
• a potassium-sparing diuretic;
• a potassium supplement;
• an ACE inhibitor;
• an angiotensin II receptor antagonist; or
• heparin.
• Many other drugs may interact with drospirenone and ethinyl estradiol. Some interactions (e.g. with certain antibiotics, protease inhibitors, seizure medications, St. John's wort, and other medications) may result in decreased effectiveness of the medication and therefore increase the risk of unintended pregnancy. Talk to your doctor or pharmacist before taking any other prescription or over-the-counter medications, including vitamins and minerals and herbal products.

Where can I get more information?

• Your pharmacist has additional information about drospirenone and ethinyl estradiol written for health professionals that you may read.
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Limitations of This Canadian Pharmacy Information

Efforts have been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information does not endorse drugs, diagnose patients or recommend therapy. This is an educational resource only intended to supplement but not to replace the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, please check with your doctor, nurse or local pharmacist. This site does not assume any responsibility for any aspect of healthcare administered with the aid of information provided here.

Full public license and copyright information is available separately from Cerner Multum, Inc.

Version: 2.01. Revision date: 6/12/03.