Safyral contains a combination of 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 the pregnancy occurs while taking birth control pills or shortly after stopping them.
Safyral is used as contraception to prevent pregnancy. Safyral is also used to raise folate levels in women who choose to use a birth control pill for contraception.
Safyral may also be used for purposes not listed in this medication guide.
Important information
Do not use Safyral if you are pregnant or if you have recently had a baby. You should not take Safyral if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease 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 attack, a stroke, or a blood clot.
Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Safyral may be more likely to cause blood clots than other 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 Safyral or if you miss a dose. 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 Safyral.
Before taking this medicine
Safyral can cause birth defects. Do not use 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 Safyral. You should not take Safyral if you have:
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untreated or uncontrolled high blood pressure, heart disease, or a history of heart attack, stroke, or blood clot;
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a blood-clotting disorder or circulation problems;
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problems with your eyes, kidneys or circulation caused by diabetes;
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a history of hormone-related cancer such as breast or uterine cancer;
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unusual vaginal bleeding that has not been checked by a doctor;
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severe migraine headaches, especially if you are older than 35;
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liver disease or liver cancer, a history of jaundice caused by pregnancy or birth control pills; or
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if you smoke and are over 35 years old.
To make sure you can safely take Safyral, tell your doctor if you have any of these other conditions:
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high blood pressure, high cholesterol or triglycerides, or if you are overweight;
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underactive thyroid, diabetes, gallbladder disease;
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seizures or epilepsy; or
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a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
The hormones in Safyral (drospirenone and ethinyl estradiol) can pass into breast milk and may harm a nursing baby. Safyral may also slow breast milk production. Do not use if you are breast feeding a baby.
How should I take Safyral?
Take Safyral 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. Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.
You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using Safyral. 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 tests or if you will be on bed rest, you may need to stop using Safyral for a short time. Any doctor or surgeon who treats you should know that you are using Safyral.
Store Safyral at room temperature away from moisture and heat.
What happens if I miss a dose?
Follow the patient instructions supplied with your Safyral prescription. 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 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 following 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, 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 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, 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 reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder 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?
Smoking can increase your risk of blood clots, stroke, or heart attack caused by Safyral, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of birth control pills.
Safyral 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.
Safyral side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Safyral: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Safyral and call your doctor at once if you have a serious side effect such as:
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sudden numbness or weakness, sudden and severe headache, confusion, problems with vision or speech;
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chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
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sudden cough, wheezing, rapid breathing, coughing up blood;
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pain, swelling, warmth, or redness in one or both legs;
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a change in the pattern or severity of migraine headaches;
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nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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swelling in your hands, ankles, or feet;
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a breast lump; or
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symptoms of depression (sleep problems, weakness, tired feeling, mood changes).
Less serious Safyral side effects may include:
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mild nausea (especially when you first start taking Safyral), vomiting, bloating, stomach cramps;
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breast tenderness or swelling, nipple discharge;
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freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
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problems with contact lenses; or
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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 report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Safyral?
Some drugs can make Safyral less effective, which may result in pregnancy. Other drugs may be affected by Safyral. Tell your doctor about all other medicines you use, especially:
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folic acid or potassium supplements;
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phenobarbital (Solfoton) and other barbiturates;
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St. John"s wort;
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an antibiotic, antifungal, or tuberculosis medication;
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drugs to treat hepatitis C, HIV, or AIDS; or
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seizure medications.
This list is not complete and other drugs may interact with Safyral. 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.
