Medications and Drugs

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Brand Names: Beyaz, Safyral

Generic Name: drospirenone, ethinyl estradiol, and levomefolate (Pronunciation: droe SPYE re none, ETH in il ES tra DYE ol, and LEE voe me FOE late )

• What is drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?
• What are the possible side effects of drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?
• What is the most important information I should know about drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?
• What should I discuss with my healthcare provider before taking drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?
• How should I take drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?
• What happens if I miss a dose (Beyaz, Safyral)?
• What happens if I overdose (Beyaz, Safyral)?
• What should I avoid while taking drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?
• What other drugs will affect drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?
• Where can I get more information?

What is drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?

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 are the possible side effects of drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?

Get 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.

Stop 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 is the most important information I should know about drospirenone, ethinyl estradiol, and levomefolate (Beyaz, Safyral)?

Do 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.

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