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|Drospirenone/Ethinyl Estradiol

Drospirenone/Ethinyl Estradiol

Drospirenone/Ethinyl Estradiol is used for:

Preventing pregnancy.

Drospirenone/Ethinyl Estradiol is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries, thereby preventing pregnancy.

Do NOT use Drospirenone/Ethinyl Estradiol if:

• you are allergic to any ingredient in this medicine
• you have blood disorders (eg, porphyria); blood clots in the legs, eyes, or lungs; or a history of developing blood clots in your legs
• you are pregnant or think you may be pregnant
• you have heart disease, including a history of heart attack; severe high blood pressure; kidney or liver disease; a liver tumor; adrenal disease; or a history of stroke
• you have breast cancer or possible cancer of the uterus, cervix, or vagina; abnormal vaginal bleeding; or endometriosis
• you are taking nevirapine, rifampin, or St. John"s wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using Drospirenone/Ethinyl Estradiol :

Some medical conditions may interact with Drospirenone/Ethinyl Estradiol . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a family history of breast cancer, or have ever had an abnormal breast x-ray or mammogram
• if you have a history of depression or migraine headaches
• if you smoke, or have high blood pressure, seizures, diabetes, obesity, high cholesterol or high triglycerides, pancreatitis, or gallbladder disease
• if you have a history of scanty or irregular menstrual periods
• if you are scheduled for surgery or will be on bed rest

Some MEDICINES MAY INTERACT with Drospirenone/Ethinyl Estradiol . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, ketoconazole), aprepitant, bosentan, barbiturates (eg, phenobarbital), carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, indinavir), hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), rifampin, St. John"s wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Drospirenone/Ethinyl Estradiol "s effectiveness
• Beta-adrenergic blockers (eg, metoprolol), corticosteroids (eg, prednisone), cyclosporine, lamotrigine, selegiline, succinylcholine, theophyllines (eg, aminophylline), or troleandomycin because their actions and the risk of their side effects may be increased by Drospirenone/Ethinyl Estradiol
• Acetaminophen or anticoagulants (eg, warfarin) because their actions may be decreased and the risk of their side effects may be increased by Drospirenone/Ethinyl Estradiol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Drospirenone/Ethinyl Estradiol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Drospirenone/Ethinyl Estradiol :

Use Drospirenone/Ethinyl Estradiol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Drospirenone/Ethinyl Estradiol . Talk to your pharmacist if you have questions about this information.
• Take Drospirenone/Ethinyl Estradiol by mouth with or without food.
• To achieve maximum effectiveness of Drospirenone/Ethinyl Estradiol , it must be taken every day (every 24 hours) and at the same time each day.
• Remember to take all of the pills in the pack. Do not skip any doses.
• Be sure to have an extra full pack of this medication available at all times.
• If you miss 1 tablet during the first 3 weeks of the pack, take the tablet as soon as you remember. If you miss 2 tablets during the first or second week of the pack, take 2 tablets the day you remember and 2 tablets the next day; then continue to take 1 pill every day until you finish the pack. You should use a backup method (additional type) of birth control if you have sex in the 7 days after missing a pill. If you miss 2 pills during the third week of the pack or if you miss 3 pills in a row during any of the first 3 weeks of the pack, you should continue to take a pill every day until Sunday. On Sunday, you should throw the rest of the pack and start a new pack that same day. Be sure to use a backup method (additional type) of birth control if you have sex in the 7 days after missing a pill. If you have any questions, contact your doctor, nurse, or pharmacist.

Ask your health care provider any questions you may have about how to use Drospirenone/Ethinyl Estradiol .

Important safety information:

• Drospirenone/Ethinyl Estradiol may cause dizziness or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Drospirenone/Ethinyl Estradiol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.
• Additional monitoring of your dose or condition may be needed if you are taking an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril), carvedilol, pioglitazone, certain "water pills" (eg, spironolactone, triamterene), or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen).
• Drospirenone/Ethinyl Estradiol may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
• Follow your doctor"s instructions for examining your own breasts, and report any lumps immediately.
• Drospirenone/Ethinyl Estradiol may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Drospirenone/Ethinyl Estradiol .
• If you will be having surgery or will be confined to a chair or bed for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks beforehand. Special precautions may need to be taken in these circumstances while you are taking Drospirenone/Ethinyl Estradiol .
• Bleeding or spotting may occur while taking Drospirenone/Ethinyl Estradiol . Do not stop taking Drospirenone/Ethinyl Estradiol if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
• Smoking cigarettes while using Drospirenone/Ethinyl Estradiol may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.
• Vomiting, diarrhea, or taking certain antibiotics or anticonvulsants while you are using Drospirenone/Ethinyl Estradiol may decrease the effectiveness of Drospirenone/Ethinyl Estradiol . To prevent pregnancy, use an additional form of birth control (eg, condoms, spermicide, diaphragm) until your next period. If you have any questions, contact your doctor, nurse, or pharmacist.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• Use of Drospirenone/Ethinyl Estradiol will not prevent the spread of sexually transmitted diseases (STDs).
• Lab tests will be performed while you are taking Drospirenone/Ethinyl Estradiol . You will need to have follow-up exams at least once per year. Be sure to keep all doctor and lab appointments.
• Drospirenone/Ethinyl Estradiol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Drospirenone/Ethinyl Estradiol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Continue to use another method of birth control (eg, condoms). Drospirenone/Ethinyl Estradiol is found in breast milk. Do not breast-feed while you are taking Drospirenone/Ethinyl Estradiol . Do not take Drospirenone/Ethinyl Estradiol soon after delivery of a baby, even if you are not breast-feeding. You should wait 4 weeks after delivery if you are not breast-feeding or 4 weeks after a second trimester abortion.

Possible side effects of Drospirenone/Ethinyl Estradiol :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in appetite; bleeding or spotting between menstrual periods; breast tenderness; change in or absence of menstrual flow; loss of scalp hair; nausea; nervousness or mental depression; reduction of breast milk when given right after childbirth; spotty darkening of the skin, especially the face; stomach cramps or bloating; weight change.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf/leg pain or swelling; changes in vision; chest pain or heaviness in the chest; coughing up blood; dark urine or light-colored bowel movements; difficulty wearing contact lenses; dizziness or fainting; fever; headache or migraine; loss of appetite; lumps in the breast; missed menstrual period; mood/mental changes; numbness of an arm or leg; persistent or recurrent abnormal vaginal bleeding; severe pain or tenderness in the stomach area; sleeplessness; slurred speech; sudden severe headache (migraine); sudden shortness of breath; swelling of fingers or ankles; trouble breathing or shortness of breath; vaginal infections; vomiting; weakness or fatigue; weakness or numbness in the arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include nausea; vaginal withdrawal bleeding; vomiting.

Store Drospirenone/Ethinyl Estradiol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Drospirenone/Ethinyl Estradiol out of the reach of children and away from pets.

General information:

• If you have any questions about Drospirenone/Ethinyl Estradiol , please talk with your doctor, pharmacist, or other health care provider.
• Drospirenone/Ethinyl Estradiol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Drospirenone/Ethinyl Estradiol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.