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

Prevents pregnancy. Also treats premenstrual dysphoric disorder (PMDD) and acne.

Brand Name(s):

Gianvi, Jasmiel, Lo-Zumandimine, Loryna, Nikki, Ocella, Syeda, Vestura, YAZ, Yasmin, Yaz 28, Zarah, Zumandimine

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Each brand of birth control pills has specific directions. Follow the patient instructions for your prescribed brand. Talk to your doctor or pharmacist if you have any questions.
• Take this medicine at the same time each day, preferably after your evening meal or at bedtime with water, as needed. Birth control pills work best when there is no more than 24 hours between doses. Take the pills in the order they appear in the container.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.
• Missed dose:
  • This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.
  • Use a second form of birth control for the next 7 days after you miss a dose.
  • You could have light bleeding or spotting any time you do not take a pill on schedule. The more pills you miss, the more likely you are to have bleeding.
  • If you miss a pill or change your schedule, you may not have a period that month. Tell your doctor if you miss your period 2 months in a row, because you may be pregnant.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
• Some foods and medicines can affect how drospirenone/ethinyl estradiol works. Tell your doctor about all other medicines that you are using.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

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. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have given birth within 4 weeks before you start using this medicine. Tell your doctor if you have inherited angioedema, diabetes, heart or blood vessel disease, high blood pressure, high cholesterol, migraines, jaundice during pregnancy, or a history of depression, cervical cancer, or chloasma gravidarum (skin disorder during pregnancy). Tell your doctor if you smoke or wear contact lenses.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of breast or cervical cancer
  • Liver problems (including liver tumor or cancer)
  • High blood pressure
  • Gallbladder disease
  • High cholesterol in the blood
• This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases. Talk with your doctor if you have questions.
• You may have light bleeding or spotting when you first take the pill.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Breast lumps, tenderness, pain, swelling, or discharge
• Chest pain or tightness, trouble breathing, coughing up blood
• Confusion, weakness, uneven heartbeat, numbness in your hands, feet, or lips
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Irregular, late, or missed menstrual period
• Numbness or weakness on one side of your body, pain in your lower leg (calf), sudden or severe headache, problems with vision, speech, or walking
• Severe stomach pain, nausea, vomiting
• Unusual moods or behavior, depression
• Unusual or unexpected vaginal bleeding or heavy bleeding

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

• Headache
• Mild nausea, bloating
• Mood changes, depression, nervousness
• Vaginal spotting, light bleeding, itching, discharge

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