drospirenone

What is the most important information I should know about drospirenone?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is drospirenone?

Drospirenone is a progestin-only birth control pill that is used to prevent pregnancy.

Drospirenone may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking drospirenone?

• 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.

How should I take drospirenone?

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 this medicine 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.

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.

What happens if I miss a dose?

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. 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 per 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. From the next day forward, take 1 pill per day for the rest of the pack (throw out the other missed pills). Use back-up birth control for at least 7 days following the missed pills.

If you miss an inactive pill, skip the missed pill(s) and keep keep taking 1 inactive pill per day until the pack is empty.

What happens if I overdose?

What should I avoid while taking drospirenone?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of drospirenone?

• severe or ongoing nausea, vomiting, or diarrhea;
• high potassium level --nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot --sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• liver problems --loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• symptoms of depression --sleep problems, weakness, tired feeling, mood changes.

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

What other drugs will affect drospirenone?

Tell your doctor about all your current medicines. 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 affect drospirenone. Some drugs can make this medicine 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.

Where can I get more information?

Your pharmacist can provide more information about drospirenone.