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  • Generic Name: (drospirenone/ethinyl estradiol/levomefolate calcium)
    Other Brands: N/A
  • Last Revised: 06/2015
    • What is this medication and its most common uses?

      Safyral is a birth control pill used to prevent pregnancy. Safyral is also used to raise folate levels in women who want to use the pill for birth control.

    • What should I know when beginning and continuing on this medication?

      How does this medication work?

      Safyral delivers hormones to block ovulation. If ovulation does not occur, your egg is not released, thereby preventing you from becoming pregnant. Safyral also provides extra folate to lower your risk of having a pregnancy with a rare type of birth defect (known as a neural tube defect).

      What are the beneficial effects of this medication and when should I begin to have results?

      What: 

      Birth Control: When Safyral is taken correctly without missing any pills, the chance of becoming pregnant is approximately 1 in 100 women per year.

      Folate Supplementation: Safyral has been shown to increase the amount of folate in the blood.

      When: 

      Birth Control: The effects of pregnancy prevention are different depending on the day you start your first pack of pills. If you start on the Sunday after your period begins, then it may take 7 days for the pills to take effect (and you should therefore use another method of birth control as a back-up method during this time). If you start on the first day of your period, the pill should be effective right away, and you therefore will not need a back-up method of birth control.

      Folate Supplementation: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Safyral exactly as your healthcare provider has prescribed.

      How do I know it is working?

      If you are taking the pill as directed by your healthcare provider and not missing any doses, you should be protected from becoming pregnant. Your healthcare provider may also order tests to check your folate levels.

    • What are the possible side effects of this medication?

      The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

      Cigarette smoking increases the risk of serious heart-related side effects from use of birth control pills. This risk increases with age (especially if you are >35 years old) and heavy smoking. Do not smoke while you are taking birth control pills.

      More common side effects may include: nausea, vomiting, spotting or bleeding between your menstrual periods, breast tenderness, headache.

      Less common side effects may include: acne, decreased sexual desire, bloating or fluid retention, blotchy darkening of the skin (especially on the face), high blood sugar levels, high fat levels in the blood, depression, problems tolerating contact lenses, weight changes.

      Blood clots are one of the most serious side effects of taking birth control pills. Blood clots can occur in your legs, lungs, or eyes. Call your healthcare provider right away if you experience sharp chest pain, coughing up blood, sudden shortness of breath, pain in your calf, or sudden partial or complete loss of vision, as these may be signs of a possible blood clot.

      Birth control pills may increase your risk of developing a stroke, angina (chest pain), or a heart attack. Smoking greatly increases the possibility of suffering a heart attack or stroke. Call your healthcare provider right away if you develop crushing chest pain or heaviness in your chest, sudden severe headache or vomiting, dizziness or fainting, changes in your vision or speech, weakness, or numbness in an arm or leg, as these may be signs of a possible heart attack or stroke.

      Birth control pills increase your risk of developing gallbladder disease.

      Birth control pills can cause noncancerous but dangerous liver tumors. These tumors can rupture and cause life-threatening internal bleeding. Call your healthcare provider right away if you experience severe pain or tenderness in your stomach area, or yellowing of your skin or the whites of your eyes, often accompanied by fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements, as these may be signs of a possibly ruptured liver tumor or other liver problems.

      Birth control pills can slightly increase your chance of developing breast cancer. You should have regular breast examinations by your healthcare provider and examine your own breasts monthly. Call your healthcare provider right away if you feel a lump when you are examining your breasts. Tell your healthcare provider if you have a family history of breast cancer.

      Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding, which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of taking the pills, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. Tell your healthcare provider if the bleeding occurs in more than one cycle or lasts for more than a few days.

      Birth control pills can cause fluid retention with swelling of your fingers or ankles and increase your blood pressure and blood potassium levels.

      There may be times when you may not have regular menstrual periods after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle, but be sure to inform your healthcare provider. If you have not taken the pills daily as instructed and missed a menstrual period, or if you missed two consecutive menstrual periods, you may be pregnant.

    • Who should not take this medication?

      Do not take Safyral if you are allergic to it or any of its ingredients.

      Do not take Safyral if you have a history of a blood clot in your legs, lungs, or eyes; stroke; heart attack; certain kinds of severe migraine headaches with aura, numbness, weakness, or changes in vision; or breast cancer.

      Do not take Safyral if you have certain heart valve problems or heart rhythm abnormalities; an inherited problem with your blood that makes it clot more than normal; high blood pressure that medicine cannot control; diabetes with kidney, eye, nerve, or blood vessel damage; liver disease, including liver tumors; kidney or adrenal disease.

      Do not take Safyral if you smoke and are over 35 years old.

      Do not take Safyral if you are or think you may be pregnant.

    • What should I tell my healthcare provider before I take the first dose of this medication?

      Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Safyral. Tell your healthcare provider if you have ever had any of the health conditions listed above. Also, talk to your healthcare provider about your complete medical history, especially if you have or have had breast cancer; high blood potassium levels; diabetes; high cholesterol or triglyceride (fats in your blood) levels; high blood pressure; migraines or other headaches; seizures; depression; gallbladder, liver, heart, or kidney disease; irregular menstrual periods; hereditary angioedema (a very rare genetic condition that causes swelling of various parts of the body, including the hands, feet, face, and airway, as well as abdominal cramping); chloasma (tan or dark skin discoloration); or if you are planning to have surgery.

    • What is the usual dosage?

      The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

      Women and adolescents who have had their first menstrual period: There are 21 orange "active" pills and 7 light-orange "reminder" pills in the pill pack.

      Sunday Start: Take the first orange "active" pill of the first pack on the Sunday after your period begins, even if you are still bleeding. If your period begins on a Sunday, start the pack that same day. Take the orange "active" pills once a day for 21 days followed by one light-orange "reminder" pill per day for 7 days. After all 28 pills have been taken, start a new course the next day (Sunday).

      Day 1 Start: Take the first orange "active" pill of the first pack during the first 24 hours of your period. Take the orange "active" pills once a day from the 1st day through the 21st day of the menstrual cycle (counting the day your period starts as Day 1) followed by one light-orange "reminder" pill per day for 7 days. Take the pills without interruption for 28 days. After all 28 pills have been taken, start a new course the next day.

    • How should I take this medication?

      Before you start taking your pills, be sure to read the directions. Take one pill at the same time every day until the pack is empty. You may take Safyral with or without meals. It is preferable to take the pill after the evening meal or at bedtime, with some liquid, as needed.

      When you finish a pack, start the next pack on the day after your last light orange "reminder" pill. It is important to take the light-orange pills because they contain folate. Do not wait any days between packs. If you are switching from another brand of pills, start Safyral on the same day that a new pack of the previous pills should have been started. If you are switching from another birth control method, talk to your healthcare provider about what you should do.

      For the first cycle of a Sunday Start regimen, use another method of birth control (such as condoms and spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).

      You will not need to use a back-up method of birth control for the first cycle of a Day 1 Start regimen, since you are starting the pill at the beginning of your period.

      If you have vomiting or diarrhea, your birth control pills may not work as well. If you vomit within 3 to 4 hours after taking your pill, please refer to the "What should I do if I miss a dose of this medication?" section.

    • What should I avoid while taking this medication?

      Do not smoke cigarettes while you are taking Safyral.

      Do not skip pills, even if you are spotting or bleeding between monthly periods, feel sick to your stomach (nausea), or if you do not have sex very often.

       

    • What are the possible food and drug interactions associated with this medication?

      If Safyral is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Safyral may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.

    • May I receive this medication if I am pregnant or breastfeeding?

      Do not take Safyral if you are pregnant or breastfeeding. Safyral can be found in your breast milk if you take it while breastfeeding. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

    • What should I do if I miss a dose of this medication?

      If you miss one orange "active" pill, take it as soon as you remember. Take the next pill at your regular time. This means you can take two pills in one day. You do not need a back-up birth control method if you have sex.

      If you miss two or more orange "active" pills, consult the patient information that accompanied your prescription or call your healthcare provider or pharmacist for advice.

      If you miss any of the 7 light-orange "reminder" pills, throw away the missed pills. Continue taking the scheduled pills until the pack is finished. You do not need a back-up method of birth control.

       

    • How should I store this medication?

      Store at room temperature.

    • Who should I contact in case of emergency or overdose?
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      In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
      National Poison Control#: Call 1-800-222-1222

      This PDR+ drug information has been developed by the Physicians’ Desk Reference Network (PDRN), a source of medication information trusted by doctors for over 65 years.

      This monograph summarizes the most important information about your medication and does not cover all the information you may need. If you have any questions or concerns or want to learn more about your medication, ask your healthcare provider; he/she will be able to provide answers to your questions. This medication should only be used by the patient for whom it was prescribed and should not be shared with other people.
    • Additional patient resources.
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