Generic Name: Drospirenone

  • What is Safyral?

    Safyral tablets are birth control pills used to prevent pregnancy. Safyral is also used to provide folic acid supplementation in women who choose to use birth control. The amount of folate contained in Safyral supplements folate in the diet to lower your risk of having a pregnancy with a rare type of birth defect, in case you become pregnant while taking this medicine or shortly after stopping it.

  • What is the most important information I should know about Safyral?

    Cigarette smoking increases the risk of serious heart-related side effects, such as blood clots, stroke, and heart attack from birth control pill use, such as Safyral. The risk increases with age (especially if you are >35 years old and smoke). Do not smoke while you are taking birth control pills.

    Birth control pill use is associated with increased risk of heart attack, clotting disorders, stroke, liver tumors, and gallbladder disease. These risks increase in people with a history of high blood pressure, high cholesterol, obesity, diabetes, clotting disorders, heart attack, stroke, chest pain, cancer of the breast or sex organs, or liver tumors.

    Birth control pills may increase cholesterol levels. Women with high cholesterol should be monitored closely.

    Safyral does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

    You can experience breakthrough bleeding or spotting while taking birth control pills, especially during the first 3 months of use. You may also have irregular periods. If you have missed more than two periods in a row, take a pregnancy test to determine if you are pregnant. Do not use Safyral if you are pregnant.

    Safyral is different from other birth control pills because it contains the progestin drospirenone. Drospirenone may increase your potassium levels. During the first month that you take Safyral, your doctor will order a blood test to check your potassium levels.

  • Who should not take Safyral?

    Do not use Safyral if you are >35 years old and smoke cigarettes. Do not use Safyral if you have a history of heart attack or stroke; heart disease; blood clots in the legs, lungs, or deep veins of your legs; angina (chest pain); diabetes (including associated circulation problems); known or suspected breast cancer; cancer of the lining of the uterus, cervix, or vagina; unexplained vaginal bleeding; jaundice (yellowing of the skin or whites of the eyes) during pregnancy or during previous use of birth control pills; liver tumors; kidney disease; adrenal disease; very high blood pressure; certain types of headaches; are allergic to any of the ingredients in Safyral; or if you plan to have surgery with prolonged bed rest. Do not take Safyral if you think you may become pregnant. Do not take Safyral if you have not had your first period.

  • What should I tell my doctor before I take the first dose of Safyral?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Safyral. Also, talk to your doctor about your complete medical history, especially if you have ever had any of the health conditions listed above; have or have had breast nodules, fibrocystic disease of the breast (lumpy and painful breasts), an abnormal breast x-ray or mammogram; high triglycerides; water retention; depression; migraines or other headaches; seizures; gallbladder disease; history of irregular menstrual bleeding or periods; if you wear contact lenses; smoke; will undergo surgery with prolonged bed rest; are already taking daily folic acid supplements; or if you are pregnant, plan to become pregnant, or are breastfeeding.

  • What is the usual dosage?

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

    Adults: Safyral may be taken in one of two ways: On the Sunday after your period begins or within 24 hours of the start of your period, as outlined below.

    Sunday Start: Take the first orange "active" tablet on the Sunday after your period begins, even if you are still bleeding. Take one orange "active" tablet daily for 21 days, followed by one light orange "reminder" tablet daily for 7 days. After taking all 28 tablets, start a new course the next day (Sunday).

    Day 1 Start: Take the first orange "active" tablet during the first 24 hours of your period. Take one orange "active" tablet daily for 21 days, followed by one light orange "reminder" tablet daily for 7 days. After taking all 28 tablets, start a new course the next day.

  • How should I take Safyral?

    Before you start taking Safyral, be sure to read the directions. Take Safyral once a day, at the same time every day, until the pack is empty. When you finish a pack, start the next pack on the day after taking your last light orange "reminder" tablet of the first pack. Do not wait any days between packs. If you are switching from another birth control pill, start Safyral on the same day that a new pack of the previous pills should have been started.

    For the first cycle of a Sunday Start regimen, use another method of birth control (such as condoms or spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until you have been taking the pills for 7 days. You will not need to use a back-up method of birth control for the first cycle of a Day 1 regimen, since you are starting the pill at the beginning of your period.

  • What should I avoid while taking Safyral?

    Do not smoke or become pregnant 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 possible food and drug interactions associated with Safyral?

    If Safyral is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Safyral with the following: acetaminophen; antibiotics; blood pressure/heart medications in a class called angiotensin-converting enzyme (ACE) inhibitors (such as captopril, enalapril, or lisinopril), or a class called angiotensin-II receptor antagonists (such as losartan, valsartan, or irbesartan); bosentan; griseofulvin; heparin; nonsteroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen and naproxen) when taken long-term and daily; potassium-sparing diuretics (water pills) (such as spironolactone); potassium supplements; rifampin; seizure medications (such as carbamazepine, felbamate, phenobarbital, topiramate, or phenytoin); St. John's wort; or vitamin C.

  • What are the possible side effects of Safyral?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: acne (pimples), bloating or fluid retention, blotchy darkening of the skin (especially on the face), breast tenderness, depression, gallbladder problems, headache, high blood pressure, less sexual desire, nausea, problems tolerating contact lenses, spotting or bleeding between menstrual periods, weight changes

  • Can I receive Safyral if I am pregnant or breastfeeding?

    Do not use Safyral if you are pregnant or breastfeeding. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

  • What should I do if I miss a dose of Safyral?

    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 the same day. You do not need a back-up birth control method if you have sex. If you miss two or more pills, consult the patient information that accompanied your prescription, or call your pharmacist or doctor for advice.

  • How should I store Safyral?

    Store at room temperature.