Drospirenone (droe-SPYE-re-none)

Prevents pregnancy.

Brand Name(s):

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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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.
• Take your pill at the same time every day. Birth control pills work best when there is no more than 24 hours between doses.
• 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:
  • If you miss one white 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 two or more white pills, 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. Continue taking 1 pill every day until you finish the pack. One or more missed white pills will remain in the blister pack. Use a second form of birth control until you have been taking white pills for seven days in a row.
  • If you miss your pills and change your schedule, you may not have a period for that month. Make sure your doctor knows if you miss your period two 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.

• Some medicines can affect how drospirenone works. Tell your doctor if you are using any of the following:
  • Aprepitant, boceprevir, bosentan, carbamazepine, clarithromycin, efavirenz, felbamate, griseofulvin, heparin, indinavir, itraconazole, ketoconazole, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampicin, rufinamide, St John's wort, voriconazole
  • Blood pressure medicine (including ACE inhibitors, ARBs)
  • Diuretic (water pill)
  • Potassium supplement
  • NSAID pain or arthritis medicine

Warnings While Using This Medicine:

• 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 diabetes, bone problems, a history of depression or blood clots. Tell your doctor if you smoke or if you are having a surgery that requires inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk of blood clots, heart attack, or stroke
  • Loss of bone mineral density
  • Increased risk of cervical cancer
  • Liver problems (including liver cancer or tumors)
  • Increased risk of ectopic pregnancy (pregnancy outside the uterus)
  • High blood sugar level
  • Changes in mood or behavior
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases.
• You might have some light bleeding or spotting, especially during the first 3 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 two periods in a row, call your doctor for a pregnancy test before you take any more pills.
• 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
• Bone pain, decrease in height
• Chest pain that may spread, trouble breathing, unusual sweating, fainting, coughing up blood
• Confusion, weakness, uneven heartbeat, numbness or tingling in your hands, feet, or lips
• Dark urine or pale stools, loss of appetite, nausea, vomiting, yellow skin or eyes
• Increased hunger, thirst, or urination, sweating, weight loss
• 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
• Rapid weight gain, swelling in your hands, ankles, or feet
• 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:

• Vaginal spotting or 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