DROSPIRENONE, ETHINYL ESTRADIOL, AND LEVOMEFOLATE

(droe SPYE re none, ETH in il ES tra Paint ol, and LEE voe me FOE late ) Brand: Beyaz, Safyral

What is the most significant information I must know about this medication?

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

• You must not take birth control pills if you have any of the next conditions: uncontrolled tall blood pressure, heart malady, a blood-clotting mess, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver malady 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 onslaught, a stroke, or a blood clot.

• Smoking can magnify your risk of blood clots, stroke, or heart onslaught caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to reason blood clots than another 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 medicine or if you miss a doze. 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?

• estradiol-23486.htm'>Drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) and also reason 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 child 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 medicine is also used to treat temperate 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 mess (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 medicine guide.

What must I discuss with my healthcare provider till taking this medication?

• This medicine can reason birth defects. Do not use if you are pregnant. Speak your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a child, wait at least 4 weeks till taking birth control pills.

• You must not take birth control pills if you have:

· untreated or uncontrolled tall blood pressure, heart malady, or a history of heart onslaught, stroke, or blood clot;

· a blood-clotting mess 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 malady 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 create certain you can safely take birth control pills, speak your doctor if you have any of these another conditions:

· tall blood pressure, tall cholesterol or triglycerides, or if you are overweight;

· underactive thyroid, diabetes, gallbladder disease;

· seizures or epilepsy; or

· a history of fibrocystic breast malady, lumps, nodules, or an emergency mammogram.

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

How must I take this medication?

• Take exactly as predesigned by your doctor. Do not take in larger or less 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 each day, no more than 24 hours separately. When the pills run out, start a new pack the next day. You may get pregnant if you do not take one pill daily. Get your prescription refilled till you run out of pills completely.

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

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

• If you need surgery or medical trials 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 must know that you are using birth control pills.

• Store this medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

• Follow the patient instructions provided with your medication. 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 for day for the rest of the pack.

• If you miss two active pills in a row in Week 1 or 2, take two pills for day for two days in a row. Then take one pill for day for the rest of the pack. Use back-up birth control for at least 7 days next 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, hold taking a pill each day before 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, hold taking a pill each day before 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 reminder pill, throw it away and hold taking one reminder pill for day before the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

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

What must I avoid while taking this medication?

• This medicine 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?

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

• 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 hard feeling, pain spreading to the hand or shoulder, nausea, sweating, common 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, weary feeling, mood changes).

• Smaller 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, heighten 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect this medication?

• Some drugs can create birth control pills smaller effective, which may result in pregnancy. Other drugs may be affected by drospirenone, ethinyl estradiol, and levomefolate. Speak your doctor about all another medicines you use, especially:

· folic acid or potassium supplements;

· phenobarbital (Solfoton) and another 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 another drugs may interact with birth control pills. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

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

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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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