drospirenone, ethinyl estradiol, and levomefolate

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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 medicine?

Do not use if you are pregnant or if you recently had a baby.

You should not take this medicine if you have any of the following conditions: kidney disease, uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes, an adrenal gland disorder, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, a history of breast or uterine cancer, or if you ever had a heart attack, stroke, or blood clot.

You should not take birth control pills if you smoke and are older than 35 years of age. Smoking can increase your risk of blood clot, stroke, or heart attack while taking 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 pregnancy occurs while taking birth control pills or shortly after stopping them.

Drospirenone, ethinyl estradiol, and levomefolate is a combination medicine used as contraception to prevent pregnancy. The Beyaz brand of this medicine 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 medicine?

Smoking can increase your risk of blood clots, stroke, or heart attack while taking birth control pills, especially if you are older than 35 years of age. Your risk increases the more you smoke. You should not take birth control pills if you smoke and are older than 35 years of age.

Do not use birth control pills 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 recently had a baby, wait at least 4 weeks before taking this medicine.

You should not take this medicine if you have:

  • heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack or stroke);
  • a history of blood clots;
  • untreated or uncontrolled high blood pressure;
  • a blood-clotting disorder or circulation problems;
  • kidney disease;
  • an adrenal gland disorder;
  • problems with your eyes, kidneys, or circulation caused by diabetes;
  • liver disease or liver cancer;
  • severe migraine headaches (with aura, numbness, weakness, or vision changes);
  • abnormal vaginal bleeding that has not been checked by a doctor; or
  • a history of hormone-related cancer such as breast or uterine cancer.

To make sure this medicine is safe for you, tell your doctor if you have:

  • high levels of potassium in your blood;
  • high cholesterol or triglycerides, or if you are overweight;
  • underactive thyroid, diabetes, gallbladder disease; or
  • a history of jaundice caused by pregnancy or birth control pills.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast feeding.

How should I take this medicine?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control (such as condoms and spermicides) when you first start using this medicine. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You could get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

You must take the pills in the right order for this medicine to be effective in preventing pregnancy. Follow the arrows shown on each row of pills in your blister pack. The last few pills you will take contain only levomefolate and not the contraceptive (birth control) medicines.

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

Use back-up birth control if you are sick with severe vomiting or diarrhea.

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

Store 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 pill during Week 1, 2, or 3, 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 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 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 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.

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 levomefolate pill in Week 4, throw it away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a levomefolate pill.

What happens if I overdose?

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 medicine?

Do not smoke while taking birth control pills, especially if you are older than 35 years of age.

Birth control pills 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 medicine?

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

Stop using this medicine and call your doctor at once if you have:

  • a change in the pattern or severity of migraine headaches;
  • swelling in your hands, ankles, or feet;
  • symptoms of depression --sleep problems, weakness, tired feeling, mood changes;
  • 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 in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
  • liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • light vaginal bleeding or spotting;
  • breast pain or tenderness;
  • nausea; or
  • headache.

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 medicine?

Some drugs can make birth control pills less effective, which may result in pregnancy. Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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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