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|Pronunciation:||droe SPYE re none, ETH in il ES tra DYE ol, and LEE voe me FOE late|
|Do not use this medication if you are pregnant.|
|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.|
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.
|Do 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).|
|Do not use this medication if you have any of the following conditions:|
To make sure you can safely take drospirenone, ethinyl estradiol, and levomefolate, tell your doctor if you have any of these other conditions:
|FDA 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.|
|The 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.|
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).
|Use 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.
|You 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.
|Store this medication at room temperature away from moisture and heat.|
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.
|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 one of the reminder pills in week four, skip that dose and take the next one as directed.
|Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.|
|Do 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.
|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:|
Less serious side effects may include:
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.
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:
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.
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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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