Drospirenone

Drospirenone is a type of birth control pill that contains only progestin, and it is used to prevent pregnancy.

Drospirenone may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Drospirenone comes in a pack of pills that are different colors. Take a white (active) pill every day for 24 days in a row, and then take a green (inactive) pill for the next 4 days in a row. Then start a new pack and repeat this daily cycle.

Take your first pill on the first day of your period. If you are switching to drospirenone from another form of birth control, follow the Instructions for Use about when you start taking drospirenone.

Each time you start a new pack, start with the first tablet in the first row of pills. Your medicine may come with stickers to mark your weekday schedule on the pack.

Take drospirenone at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

You may need to use back-up birth control, such as condoms with spermicide, when you first start using drospirenone.

If you vomit or have diarrhea within 3 to 4 hours after taking drospirenone, take your next daily tablet as soon as possible or within 12 hours of the usual time you take your pill. Then keep taking 1 pill every day in order at the usual time.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using drospirenone.

Store at room temperature away from moisture and heat.

Follow all instructions on your medicine label and package. Inform all your healthcare providers about all your medical conditions, allergies, and every medicine you are taking.

You should not use drospirenone if you are allergic to it, or if you have:

• an adrenal gland disorder;
• kidney disease;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Tell your doctor if you have ever had:

• high levels of potassium in your blood;
• a heart attack, stroke, or blood clot;
• diabetes (drospirenone may increase your blood sugar);
• depression; or
• liver or kidney disease.

Tell your doctor if you are pregnant or breastfeeding. Stop taking drospirenone if you become pregnant.

Drospirenone is not approved for any female who has not yet had a menstrual period.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor or get emergency medical help if you experience severe pain in your lower stomach or side. This could indicate a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

Drospirenone may lead to serious side effects. Contact your doctor immediately if you experience:

• severe or persistent nausea, vomiting, or diarrhea;
• high potassium levels—nausea, weakness, tingling sensations, chest pain, irregular heartbeats, loss of movement;
• signs of a stroke—sudden numbness or weakness (especially on one side of your body), sudden severe headache, slurred speech, issues with vision or balance;
• signs of a blood clot—sudden vision loss, sharp chest pain, shortness of breath, coughing up blood, pain or warmth in one or both legs;
• liver issues—loss of appetite, upper stomach pain, fatigue, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• symptoms of depression—sleep disturbances, weakness, fatigue, changes in mood.

Common side effects of drospirenone may include:

• vaginal bleeding, menstrual cramps;
• breast pain or tenderness;
• headache;
• nausea;
• acne;
• weight gain; or
• decreased sex drive.

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice regarding side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow the patient instructions that come with your medicine. If you do not understand these instructions, ask your doctor or pharmacist for help. Missing a pill increases your risk of becoming pregnant.

If you miss 1 active pill, take the pill as soon as you remember. Then take 1 pill each day for the rest of the pack.

If you miss 2 or more active pills in a row, take only the last of the missed pills as soon as you remember. Starting the next day, take 1 pill each day for the rest of the pack (throw away the other missed pills). Use back-up birth control for at least 7 days after missing the pills.

If you miss a period, call your doctor because you might be pregnant.

If you miss an inactive pill, skip the missed pill(s) and continue taking 1 inactive pill each day until the pack is finished.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose may cause vomiting or vaginal bleeding.

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect drospirenone, especially:

• St. John's wort;
• an antibiotic or antifungal medicine; or
• antiviral medicine to treat HIV or hepatitis C.

This list is not complete, and many other drugs may also affect drospirenone. Some drugs can make drospirenone less effective, which may result in pregnancy. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.