IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ETHINYL ESTRADIOL/DROSPIRENONE - ORAL

(ETH-in-il ess-tra-DYE-ole/droh-SPYE-re-none)

COMMON BRAND NAME(S): Yasmin 28

WARNING: Smoking cigarettes while using this medication increases your chance of having heart problems. Do not smoke while using this medication. The risk of heart problems increases with age (in women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).

USES: This combination medication is used to prevent pregnancy. This medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).

OTHER USES: This drug may also be used to regulate your menstrual cycle.

HOW TO USE: Take this medication by mouth once daily, or as directed by your doctor. The manufacturer recommends that you take this product after your evening meal or at bedtime to help you remember to take it and to minimize any stomach upset or nausea you may have. You may, however, choose to take this medication at another time of the day instead. No matter what dosing schedule you use, it is important to take this medication at the same time each day. It is recommended to start taking this medication on the first day of your period (menstrual cycle). If it is not possible to start this treatment at the start of your period, consult the product information and/or your doctor or pharmacist for proper instructions. It is recommended that you use an alternative method of birth control during the first week of taking this medication until the full benefit of this drug takes effect.

SIDE EFFECTS: Nausea, vomiting, headache, diarrhea, bleeding between menstrual periods (spotting), weight gain, acne, stomach cramps, rash, swelling or bloating, skin spots, breast tenderness, or difficulty wearing contact lenses may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: dizziness, flu-like symptoms (e.g., fever, cough, unusual weakness/fatigue, sore throat, muscle aches), mental/mood changes, trouble sleeping, hair loss, vaginal infections. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe headache, pain in the lower legs or groin, trouble breathing, chest pain, vision changes, severe stomach pain, one-sided weakness, yellowing eyes or skin, lumps in the breast. If you notice any other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: heart problems, stroke, gallbladder disease, diabetes, high cholesterol or triglyceride levels, high blood pressure, migraines, seizures, irregular vaginal bleeding, depression, any allergies. This medication is not recommended for use if you have the following medical conditions: liver problems, kidney or adrenal gland problems, history of blood clots (thrombophlebitis), blood vessel problems (e.g., cerebral vascular disease, coronary artery disease), history of certain cancers (especially endometrial or breast cancer), heavy smoking (especially if older than 35 years of age). If you are near-sighted or wear contact lenses, you may develop vision problems or have trouble wearing your contact lenses. Contact your eye doctor if this occurs. If you stop taking this birth control medicine and want to become pregnant, it may take a longer time than is usually seen with women not taking birth control medicine. Consult your doctor. Do not smoke cigarettes. Birth control pills combined with smoking cigarettes, especially in women older than 35 years of age, puts you at a much higher risk of developing serious health problems than with birth control pills alone. Consult your doctor or pharmacist for more information. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk and has had undesirable effects on nursing infants. Consult your doctor before breast- feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: ACE inhibitors (e.g., enalapril, lisinopril), angiotensin receptor blockers (e.g., losartan, valsartan), potassium-sparing "water pills" (e.g., spironolactone, triamterene), potassium supplements, heparin, NSAIDs (e.g., ibuprofen, naproxen), atorvastatin, cyclosporine, corticosteroids (e.g., prednisone, prednisolone) theophylline, ascorbic acid (vitamin C), acetaminophen, morphine, temazepam, clofibric acid. Tell your doctor if you take certain drugs that may decrease the effectiveness of this medication, such as: antibiotics (e.g., tetracyclines, penicillins, cephalosporins), griseofulvin, rifampin, certain anti-seizure drugs (e.g., carbamazepine, phenobarbital, phenytoin), St John's wort, phenylbutazone. This product can affect the result of certain lab tests (e.g., liver function tests, blood tests). Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea and vomiting.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., potassium levels, breast exams, pelvic exams) may be performed to monitor for potential side effects to this medication. A manufacturer's fact sheet about this drug should be dispensed with each prescription. Read the information carefully; if any of the information is unclear, consult your doctor or pharmacist.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, take the missed dose and resume your usual dosing schedule; this may mean taking two tablets in one day. If you miss two or more doses in a row, use an alternate birth control method (e.g., condoms, spermicides) for at least 7 days and consult the product information or your doctor for a new dosing schedule.

STORAGE: Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.

Developed by First DataBank, Inc., San Bruno, CA
Copyright 2004 by First DataBank, Inc.