In the U.S.—

• Contraceptive, female

Drospirenone and Ethinyl Estradiol (draw-SPEER-a-none and ETH-in-il es-tra-DYE-ole) This medicine is known also as the Pill, OCs, BCs, BC tablets, or birth control pills. This medicine usually contains two types of hormones, estrogens ( ES-troh-jenz ) and progestins (proh-JES-tins) and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented. Although oral contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Drospirenone and Ethinyl Estradiol
  • Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For drospirenone and ethinyl estradiol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to estrogens or progestins. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Pregnancy—Drospirenone and ethinyl estradiol is not recommended for use during pregnancy and should be discontinued if you become pregnant or think you are pregnant. Women who are not breast-feeding may begin to take oral contraceptives four weeks after having a baby.

Breast-feeding—Drospirenone and ethinyl estradiol pass into the breast milk and can change the content or lower the amount of breast milk. Also, they may shorten a woman's ability to breast-feed. It may be necessary for you to use another method of birth control or to stop breast-feeding while taking drospirenone and ethinyl estradiol.

Children—This medicine is not designed for girls that have not reached menarche.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking drospirenone and ethinyl estradiol, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Angiotensin-converting enzyme (ACE) inhibitors (e.g., Accupril, Aceon, Altace, Capoten, Lotensin, Mavik, Monopril, Prinivil, Univasc, Vasotec, and Zestril)—Potassium in the blood may be increased by drospirenone
• Carbamazepine (e.g., Tegretol) or
• Phenobarbital (e.g., Barbita) or
• Phenytoin (e.g., Dilantin) or
• Rifampin (e.g., Rifadin)—These medicines may cause reduced birth control effect of drospirenone and ethinyl estradiol and increased irregular menstrual bleeding

• Cyclosporine (e.g., Neoral) or
• Theophylline (e.g., Elixophyllin)—Oral contraceptives may increase the effects of these medicines and increase the chance of problems occurring
• Griseofulvin (e.g., Fulvicin)—May cause unplanned pregnancy; using additional birth control methods while taking griseofulvin

• Smoking tobacco— Smoking may decrease the effect of oral contraceptives and increase the chance of causing serious blood clot, vein, or heart problems

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Abnormal changes in menstrual or uterine bleeding or
• Fibroid tumors of the uterus—Oral contraceptives usually improve these female conditions but sometimes they can make them worse or make the diagnosis of these problems more difficult

• Adrenal insufficiency or
• Liver problems or
• Kidney problems—these conditions may increase the risk of retaining too much potassium in the blood

• Blood clots (or history of) or
• Heart or circulation disease or
• Stroke (or history of)—If these conditions are already present, oral contraceptives may have a greater chance of causing blood clots or circulation problems, especially in women who smoke tobacco. Otherwise, oral contraceptives may help prevent circulation and heart disease if you are healthy and do not smoke

• Cancer, including breast cancer (or history of or family history of)—Oral contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of oral contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, oral contraceptives may still be a good choice but you may need to be tested more often

• Gallbladder disease or gallstones (or history of) or
• High blood cholesterol or
• High blood potassium or
• Liver disease (or history of, including jaundice during pregnancy) or
• Mental depression (or history of)—Oral contraceptives may make these conditions worse or, rarely, cause them to occur again. Oral contraceptives may still be a good choice but you may need to be tested more often

• High blood pressure (hypertension) or
• Migraine headaches—Oral contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use oral contraceptives

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of oral contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.

When you begin to use oral contraceptives, your body will require at least 7 days to adjust before a pregnancy will be prevented. You will need to use an additional birth control method for at least 7 days. Some doctors recommend using an additional method of birth control for the first cycle (or 3 weeks) to ensure full protection. Follow the advice of your doctor or other health care professional.

Try to take the doses no more than 24 hours apart to reduce the possibility of side effects and to prevent pregnancy. Since one of the most important factors in the proper use of oral contraceptives is taking every dose exactly on schedule, you should never let your tablet supply run out. When possible, try to keep an extra month's supply of tablets on hand and replace it monthly.

It is very important that you keep the tablets in their original container and take the tablets in the same order that they appear in the container. The containers help you keep track of which tablets to take next. Different colored tablets in the same package contain different amounts of hormones or are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken out of order

Dosing—

The dosing schedule is monophasic. You will be taking tablets of one strength (color) for 21 days. You will also take an additional 7 inactive tablets, which are another color. Taking the last 7 tablets is not required for full protection against pregnancy but they do help to replace estrogen.

Your health care professional may begin your dose on the first day of your menstrual period (called Day 1 start) or on Sunday after your period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even when you miss a dose. Do not change your schedule on your own. If the schedule that you have been put on is not convenient, check with your health care professional about changing schedules. For Sunday start you need to use another form of birth control for the first 7 days.

• For oral dosage form (tablets):
  • For contraception:
    • Adults and teenagers:
      • Take 1 tablet a day for twenty-eight days. Then repeat the cycle.

Missed dose—

Follow your doctor's orders or the directions on the label if you miss a dose of this medicine.

• If you miss 1 tablet during the cycle—Take it as soon as you remember and then take the next tablet at the normal time. You may take 2 tablets in one day. Then continue your regular dosing schedule.
• If you miss 2 tablets in a row in the first or second week—Take 2 tablets on the day you remember and 2 tablets the next day. Then continue taking 1 tablet a day and use another form of birth control for seven days after the last missed dose.
• If you miss 2 tablets in a row in the third week or
• If you miss 3 or more tablets in a row (during the first three weeks)—
  • Using Day 1 start: Throw out your current cycle and begin a new cycle on the same day. Also, use another birth control method for the next seven days after the last missed dose. You may not have a menstrual period this month. But if you miss two menstrual periods in a row, call your health care professional.
  • Using Sunday start: Keep taking 1 tablet a day from your current pack until Sunday. Then, on Sunday, throw out your old pack and begin a new pack. Also use another birth control method for the next seven days after the last missed dose. You may not have a menstrual period this month. But if you miss two menstrual periods in a row, call your health care professional.

If you miss any of the last 7 (inactive) tablets, there is no danger of pregnancy. However, the first tablet (active) of the next month's cycle must be taken on the regularly scheduled day, in spite of any missed doses, if pregnancy is to be avoided. The active and inactive tablets are colored differently for your convenience.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat and moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:

• Continue on your regular dosing schedule.
• The bleeding usually stops within 1 week.
• Check with your doctor if the bleeding continues for more than 1 week.
• After you have been taking oral contraceptives on schedule and for more than 3 months and bleeding continues, check with your doctor.

Missed menstrual periods may occur:

• If you have not taken the medicine exactly as scheduled. Pregnancy must be considered as a possibility.
• If the medicine is not the right strength or type for your needs.
• If you stop taking oral contraceptives, especially if you have taken oral contraceptives for 2 or more years.

Check with your doctor if you miss any menstrual periods so that the cause may be determined.

If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.

Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives.

The following side effects may be caused by blood clots. Get emergency help immediately if any of the following side effects occur:

• Rare
  • Abdominal or stomach pain (sudden, severe, or continuing);  anxiety;  burning pain in lower abdomen ;  changes in skin color;  chill;  coughing up blood;  convulsions;  fever;  feeling of heat;  feeling of warmth in lips and tongue;  headache (severe or sudden);  loss of coordination (sudden);  loss of vision or change in vision (sudden);  nervousness;  numbness of the fingertips;  pain in lower back, pelvis, or stomach;  pains in chest, groin, or leg (especially in calf of leg);  ringing in th ears;  shortness of breath (sudden or unexplained);  slurring of speech (sudden);  sudden loss of consciousness ;  swelling of foot or leg;  weakness, numbness, or pain in arm or leg (unexplained) 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common—usually less common after the first 3 months of oral contraceptive use
  • Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes 
  
  

• Less common
  • Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse);  increased blood pressure;  vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge  
  
  

• Rare
  • Mental depression;  swelling, pain, or tenderness in upper abdominal area 
  
  
  • For women who smoke tobacco
    • Pains in stomach, side, or abdomen;  yellow eyes or skin 
    
    
  • For women with a history of breast disease
    • Lumps in breast 
    
    

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Abdominal cramping or bloating;  acne (usually less common after first 3 months and may improve if acne already exists);  breast pain, tenderness, or swelling;  dizziness;  nausea;  swelling of ankles and feet;  unusual tiredness or weakness;  vomiting 
  
  

• Less common
  • Brown, blotchy spots on exposed skin;  gain or loss of body or facial hair;  increased or decreased interest in sexual intercourse;  weight gain or loss 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.