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drospirenone, ethinyl estradiol, and levomefolate

Pronunciation: droe SPYE re none, ETH in il ES tra DYE ol, and LEE voe me FOE late

Brand: Beyaz, Safyral

What is the most important information I should know about this medication?

Multum nopreg

Do not use birth control pills if you are pregnant or if you have recently had a baby.

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You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

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Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of birth control pills.

You may need to use back up birth control, such as condoms or a spermicide, when you first start using this medication or if you miss a dose. Follow your doctor's instructions.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your birth control pills.

What is drospirenone, ethinyl estradiol, and levomefolate?

Drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. Levomefolate is a type of B vitamin that helps prevent a rare birth defect that could occur in a baby if the pregnancy occurs while taking birth control pills or shortly after stopping them.

Drospirenone, ethinyl estradiol, and levomefolate is used as contraception to prevent pregnancy. The Beyaz brand of this medication is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills.

Beyaz is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.

Drospirenone, ethinyl estradiol, and levomefolate may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medication?

Multum nopreg

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

Multum donot

You should not take birth control pills if you have:

  • untreated or uncontrolled high blood pressure, heart disease, or a history of heart attack, stroke, or blood clot;
  • a blood-clotting disorder or circulation problems;
  • problems with your eyes, kidneys or circulation caused by diabetes;
  • a history of hormone-related cancer such as breast or uterine cancer;
  • unusual vaginal bleeding that has not been checked by a doctor;
  • severe migraine headaches, especially if you are older than 35;
  • liver disease or liver cancer, a history of jaundice caused by pregnancy or birth control pills; or
  • if you smoke and are over 35 years old.

To make sure you can safely take birth control pills, tell your doctor if you have any of these other conditions:

  • high blood pressure, high cholesterol or triglycerides, or if you are overweight;
  • underactive thyroid, diabetes, gallbladder disease;
  • seizures or epilepsy; or
  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
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The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

How should I take this medication?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. You will take your first pill on the first day of your period or on the first Sunday after your period begins. Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

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

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions. Use a back-up birth control if you are sick with severe vomiting or diarrhea.

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If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

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Store this medication at room temperature away from moisture and heat.

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 one active pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss three active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

Multum donot

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant. If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking this medication?

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Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of birth control pills.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What are the possible side effects of this medication?

Multum emt

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

Multum donot

Stop using birth control pills and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, sudden and severe headache, confusion, problems with vision or speech;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • a change in the pattern or severity of migraine headaches;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious side effects may include:

  • mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
  • breast tenderness or swelling, nipple discharge;
  • freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
  • problems with contact lenses; or
  • vaginal itching or discharge, changes in your menstrual periods.

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 this medication?

Some drugs can make birth control pills less effective, which may result in pregnancy. Other drugs may be affected by drospirenone, ethinyl estradiol, and levomefolate. Tell your doctor about all other medicines you use, especially:

  • folic acid or potassium supplements;
  • phenobarbital (Solfoton) and other barbiturates;
  • St. John's wort;
  • an antibiotic, antifungal, or tuberculosis medication;
  • drugs to treat hepatitis C, HIV, or AIDS; or
  • seizure medications.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about drospirenone, ethinyl estradiol, and levomefolate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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