Drospirenone/ethinyl estradiol (By mouth)

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

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.

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: Carefully follow the patient instructions if you miss a dose. You may need to use a second form of birth control for the first 7 days of your first pill cycle.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the pills in the original container.

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

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

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

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 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

• Tell your doctor right away if you become pregnant. This medicine could harm your unborn baby if you take it while you are 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 or chloasma. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  • Increased risk of blood clots, which may cause a stroke or heart attack
  • Possible increased risk of breast or cervical cancer
  • Liver problems
  • 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.
• 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 check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.