Drospirenone/ethinyl estradiol (By mouth)

Warnings While Using This Medicine

• Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have high blood pressure, high cholesterol, diabetes, breast lumps, family history of breast cancer, migraine headaches, history of depression, gallbladder disease, heart disease, kidney disease, irregular monthly periods, or have recently been pregnant.
• If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.
• You should see your doctor on a regular basis while taking birth control pills.
• If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
• Check with your eye doctor if you wear contact lenses and you have vision problems or eye discomfort.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Heavy vaginal bleeding.
• Irregular, late, or missed menstrual period.
• Lumps in breast.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Rapid weight gain.
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Breast tenderness, pain, swelling, or discharge.
• Changes in appetite.
• Contact lens discomfort.
• Depression or mood changes.
• Mild headache.
• Mild skin rash or itching, or change in skin color.
• Sensitivity to sunlight.
• Stomach cramps or bloated feeling.
• Vaginal spotting or light bleeding, itching, or discharge.
• Weight changes.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Drospirenone (droe-SPYE-re-none), Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol)

Used to prevent pregnancy. Also used to treat premenstrual dysphoric disorder (PMDD; severe emotional and physical symptoms before menstrual flow starts) and acne. This medicine is an oral contraceptive (birth control pill).

Brand Name(s)

YAZ, Ocella, Zarah, Yasmin, Syeda, Yaz 28, Gianvi, Loryna, Vestura

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to drospirenone or ethinyl estradiol, or if you are pregnant. Do not use this medicine if you have kidney disease, liver disease, adrenal gland disease, breast cancer, liver tumor, cancer of the uterus, diabetes, blood vessel disorder, heart disease, high blood pressure, or a history of blood clots, heart attack, or stroke. Do not use this medicine if you have ever had jaundice caused by pregnancy or birth control, unusual vaginal bleeding, certain types of headache, if you are having a surgery that needs bedrest, or if you smoke and are over 35 years old.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• You may take this medicine with or without food.
• Keep your pills in the container you receive from the pharmacy. Take the pills in the order they appear in the container.
• Take your pill at the same time every day. Swallow the tablet whole. Do not crush, break, or chew it.

If a dose is missed:

• This medicine needs to be taken every day on a fixed schedule. If you miss a dose or forget to take your medicine, take it as soon as you can. Then take your next pill at the regular time. This means you may take two pills in one day.
• If you miss two or more pills in a row, see your patient instructions or call your doctor or pharmacist if you need to use another kind of birth control.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using acetaminophen (Tylenol®), ascorbic acid (Vitamin C), rifampin (Rifadin®), St. John's Wort, atorvastatin (Lipitor®), blood pressure medicine (such as Accupril®, Avapro®, Capoten®, Cozaar®, Diovan®, Hyzaar®, Prinivil®, Teveten®, Vasotec®, Zestril®), pain or arthritis medicine (such as aspirin, ibuprofen, naproxen, phenylbutazone, Advil®, Aleve®, Feldene®, Motrin®, Orudis®, Relafen®, Voltaren®), diuretics or "water pills" (such as amiloride, spironolactone, triamterene, Aldactone®, Moduretic®), medicine for seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Luminal®, Tegretol®), or antibiotics (such as ampicillin, griseofulvin, tetracycline, Grifulvin V®, Omnipen®, Sumycin®).
• Tell your doctor if you are also using potassium supplements, heparin, cyclosporine (Gengraf®, Neoral®, Sandimmune®), morphine (Astramorph PF®), prednisolone (Delta Cortef®), temazepam (Restoril®), theophylline (Theo-Dur®), salicylic acid, or clofibric acid.