drospirenone, ethinyl estradiol, and levomefolate

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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 drospirenone, ethinyl estradiol, and levomefolate?

nopregDo not use this medication if you are pregnant.
donotDo not use if you have any of the following conditions: a history of stroke or blood clot, history of heart attack, circulation problems (especially if caused by diabetes), a blood-clotting disorder, a heart valve disorder, coronary heart disease, breast or uterine cancer, unusual vaginal bleeding, kidney or liver disease, an adrenal gland disorder, uncontrolled high blood pressure, severe migraines, a history of jaundice caused by pregnancy, or if you are 35 or older and you smoke.

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 is normally found in foods. Levomefolate 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 to prevent pregnancy.

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. Beyaz will not treat symptoms of premenstrual syndrome (PMS).

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

What should I discuss with my healthcare provider before taking drospirenone, ethinyl estradiol, and levomefolate?

nopregDo not use this medication 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 (or until you stop breast-feeding).
donotDo not use this medication if you have any of the following conditions:
  • a heart valve disorder, blood-clotting disorder, uncontrolled high blood pressure, coronary heart disease, or severe migraine headaches;
  • a history of heart attack, stroke, or blood clot (especially in your leg, lung, or eye);
  • problems with your eyes, kidneys, or circulation caused by diabetes;
  • kidney disease or adrenal gland disorder;
  • liver disease or liver cancer;
  • unusual vaginal bleeding;
  • any type of breast, uterine, or hormone-dependent cancer;
  • a history of jaundice caused by pregnancy; or
  • if you are 35 or older and you smoke.

To make sure you can safely take drospirenone, ethinyl estradiol, and levomefolate, tell your doctor if you have any of these other conditions:

  • high blood pressure or heart disease;
  • high cholesterol or triglycerides;
  • high levels of potassium in your blood;
  • gallbladder disease;
  • diabetes;
  • seizures or epilepsy; or
  • a history of depression.
nopregFDA pregnancy category X. Do not use this medication if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant.
nobrfeedThe hormones in this medicine 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 drospirenone, ethinyl estradiol, and levomefolate?

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 (follow your doctor's instructions).

donotUse back-up birth control (condoms or spermicide), for the first 7 days of using this medication.

The 28-day birth control pack contains reminder pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

Take one pill with every evening meal or at bedtime, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.

emtYou may have breakthrough bleeding. Tell your doctor if this bleeding continues or is very heavy.

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 (starting 4 weeks before a surgery). Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

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

What happens if I miss a dose?

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.

If you miss two active pills in a row in week 3, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one 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 one that day.

donotIf 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 one of the reminder pills in week four, skip that dose and take the next one as directed.

What happens if I overdose?

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

What should I avoid while taking drospirenone, ethinyl estradiol, and levomefolate?

smokingDo not smoke while using this medication, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Drospirenone, ethinyl estradiol, and levomefolate 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 drospirenone, ethinyl estradiol, and levomefolate?

emtGet emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
donotStop using this medicine and call your doctor at once if you have a serious side effect such as:
  • sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • jaundice (yellowing of the skin or eyes); or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

  • breast pain, tenderness, or swelling;
  • mild headache, feeling tired or irritable;
  • bloating, stomach pain, mild nausea;
  • weight gain, swelling of your hands or feet;
  • problems with contact lenses;
  • loss of interest in sex; or
  • 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 drospirenone, ethinyl estradiol, and levomefolate?

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:

  • bosentan (Tracleer);
  • folic acid or potassium supplements;
  • heparin;
  • St. John's wort;
  • antibiotics such as griseofulvin (Fulvicin) or rifampin (Rifadin, Rifater, Rifamate);
  • heart or blood pressure medication, including diuretics (water pills);
  • HIV or AIDS medications;
  • antifungal medicines;
  • NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), celecoxib (Celebrex), and others;
  • phenobarbital (Solfoton) and other barbiturates; or
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenytoin (Dilantin), and others.

This list is not complete and there are many other drugs that can interact with drospirenone, ethinyl estradiol, and levomefolate. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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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