Drospirenone (droe-SPYE-re-none), Estetrol (es-TE-trol)

Prevents pregnancy.

Brand Name(s):

Nextstellis

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.
• Carefully follow your doctor's instructions about when to start taking your medicine. You will begin taking the pills on the first day of your menstrual period. If you cannot start taking the pills on the first day of your menstrual period, you need to use another form of birth control (including condom, spermicide) for the first 7 days.
• Take your pill at the same time every day. Birth control pills work best when there is no more than 24 hours between doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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.
  • If you miss 1 pink pill, 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. Continue taking 1 pill every day until you finish the pack.
  • If you miss 2 or more pink pills on week 1 or 2, take a pill as soon as you can. Then take your next pill at the regular time. This means, you may take two pills in one day. Throw away the other missed pills. Continue taking 1 pill every day until you finish the pack. Use a second form of birth control (including condom, spermicide) for 7 days after you miss a dose.
  • If you miss 2 or more pink pills on week 3, take a pill as soon as you can. Then take your next pill at the regular time. This means, you may take two pills in one day. Throw away the other missed pills. Continue taking 1 pill every day until you finish the pink pills in the pack. Throw out the rest of the white pills in the pack and start a new pack the next day. Use a second form of birth control (including condom, spermicide) for 7 days after you miss a dose.
  • If you miss 1 or more white pills, skip the missed pill and continue taking 1 pill every day until you finish the pack.
  • If you vomit or have diarrhea within 3 to 4 hours of taking the pills, treat this as a missed dose and take a new pill as soon as you can. Then take your next pill within 12 hours of the regular time. If you miss 2 or more pills, follow the instructions in the patient leaflet or call your doctor or you may use another form of birth control.
• 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 medicines can affect how drospirenone/estetrol works. Tell your doctor if you are using St John's wort, diabetes medicine, diuretic (water pill), medicine to treat an infection, potassium supplement, seizure medicine (including lamotrigine), steroid medicine, or thyroid medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an 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 gallbladder disease, high blood pressure, high cholesterol, diabetes, hereditary angioedema, or a history of depression, chloasma, jaundice (yellow skin or eyes) during pregnancy, or irregular monthly periods. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  • Increased risk of blood clots, heart attack, or stroke
  • Eye or vision problems
  • High blood pressure
  • Migraine headaches
  • Increased risk of cervical cancer
  • Liver problems (including liver cancer or tumors)
  • High cholesterol in the blood
  • Gallbladder disease
• 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 might have some light bleeding or spotting, especially during the first 4 months of using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.
• If you miss a menstrual period, call your doctor for a pregnancy test before you take any more pills.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. Tell your doctor if you are having a surgery that requires inactivity for a long time.
• 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
• Blurred vision, slow or fast heartbeat, lightheadedness, dizziness
• Breast lumps, tenderness, pain, swelling, or discharge
• Chest pain, trouble breathing, coughing up blood
• Confusion, weakness, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips
• Dark urine or pale stools, loss of appetite, nausea, vomiting, stomach pain, yellow skin or eyes
• Irregular, late, or missed menstrual period
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg, sudden or severe headache, problems with vision, speech, or walking
• Unusual or unexpected vaginal bleeding or heavy bleeding

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

• Acne, mild skin rash, or darkened skin on your face
• Headache
• Loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse
• Mood changes, depression, nervousness
• Vaginal spotting, light bleeding, itching, discharge
• Weight gain

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