Generic Name: drospirenone/ethinyl estradiol/levomefolate (droe-SPYE-re-none/ETH-i-nil ES-tra-DYE-ol/LEE-voe-me-FOE-late)
Brand Name: Safyral
Cigarette smoking increases the risk of serious heart problems associated with use of drospirenone/ethinyl estradiol/levomefolate. This risk increases with age and with heavy smoking. Women who are over 35 years old are at greater risk. Women who are over 35 years old and smoke should not use drospirenone/ethinyl estradiol/levomefolate.
Drospirenone/ethinyl estradiol/levomefolate is used for:
Preventing pregnancy. It is also used to increase folate levels in order to decrease the risk of certain birth defects in women who become pregnant while taking drospirenone/ethinyl estradiol/levomefolate or shortly after stopping drospirenone/ethinyl estradiol/levomefolate. It may also be used for other conditions as determined by your doctor.
Drospirenone/ethinyl estradiol/levomefolate is a progesterone and estrogen combination birth control pill. It also contains a folate. It works by preventing ovulation. It may also change cervical mucus to prevent the sperm from reaching the egg, and change the lining of the uterus to prevent a fertilized egg from implanting in the uterus.
Do NOT use drospirenone/ethinyl estradiol/levomefolate if:
- you are allergic to any ingredient in drospirenone/ethinyl estradiol/levomefolate
- you are pregnant or think you may be pregnant
- you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), or certain blood vessel problems (eg, in the brain or heart, bleeding in the brain, a heart attack, a stroke)
- you have a history of breast cancer, or other estrogen- or progestin-dependent growths
- you have certain heart problems (eg, heart valve problems, certain types of irregular heartbeat); certain types of headaches or migraines; endometrial, cervical, or vaginal cancer; undiagnosed abnormal vaginal bleeding; or uncontrolled high blood pressure
- you have kidney disease; adrenal disease; diabetes that affects circulation, nerves, eyes, or kidneys; liver disease or liver tumors; or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use
- you have had surgery and are or will be confined to a bed or a chair for an extended period of time
- you are over 35 years old and you smoke
- you have been through menopause
Contact your doctor or health care provider right away if any of these apply to you.
Before using drospirenone/ethinyl estradiol/levomefolate:
Some medical conditions may interact with drospirenone/ethinyl estradiol/levomefolate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of endometriosis, growths in the uterus, an abnormal mammogram, irregular menstrual periods, abnormal vaginal bleeding, a lump in the breast, fibrocystic breast disease, or if a family member has had breast cancer
- if you have a history of diabetes or high blood sugar, gallbladder problems, migraines or severe or persistent headaches, heart problems (eg, angina), high blood pressure, high blood cholesterol or lipid levels, kidney or liver problems, blood or bleeding problems, mental or mood problems (eg, depression), thyroid problems, lupus, high blood calcium or potassium levels, chloasma (dark skin patches), chorea (jerky, involuntary movements of the face, arms, or legs), varicose veins, yellowing of the eyes or skin, pancreas problems, seizures, or a condition called hereditary angioedema
- if you smoke, are very overweight, have not yet had your first menstrual period, have certain types of anemia (eg, pernicious anemia), have certain blood problems (eg, porphyria), or have fluid retention or swelling problems
- if you will be having surgery or will be confined to a bed or a chair for a long period of time
- if a family member has a history of high blood triglyceride levels
- if you are taking a folate (folic acid) supplement
Some MEDICINES MAY INTERACT with drospirenone/ethinyl estradiol/levomefolate. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aldosterone blockers (eg, eplerenone), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin-receptor blockers (eg, losartan), heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, naproxen), potassium-sparing diuretics (eg, spironolactone), or potassium supplements because the risk of high blood potassium levels may be increased
- Acetaminophen, ascorbic acid (vitamin C), atorvastatin, or tranexamic acid because they may increase the risk of drospirenone/ethinyl estradiol/levomefolate's side effects
- Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, efavirenz, nevirapine) because they may decrease drospirenone/ethinyl estradiol/levomefolate's effectiveness, resulting in pregnancy or breakthrough bleeding, or they may increase the risk of drospirenone/ethinyl estradiol/levomefolate's side effects
- Aprepitant, armodafinil, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, oxcarbazepine, penicillins (eg, ampicillin), phenylbutazone, rifamycins (eg, rifampin), rufinamide, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease drospirenone/ethinyl estradiol/levomefolate's effectiveness, resulting in breakthrough bleeding or pregnancy
- Certain antiseizure medicines, cholestyramine, methotrexate, or sulfasalazine because they may decrease the effectiveness of the folate in drospirenone/ethinyl estradiol/levomefolate
- Corticosteroids (eg, prednisolone), theophylline, tizanidine, or troleandomycin because the risk of their side effects may be increased by drospirenone/ethinyl estradiol/levomefolate
- Certain antiseizure medicines (eg, phenytoin, valproic acid), lamotrigine, methotrexate, pyrimethamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by drospirenone/ethinyl estradiol/levomefolate
This may not be a complete list of all interactions that may occur. Ask your health care provider if drospirenone/ethinyl estradiol/levomefolate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use drospirenone/ethinyl estradiol/levomefolate:
Use drospirenone/ethinyl estradiol/levomefolate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with drospirenone/ethinyl estradiol/levomefolate. Talk to your pharmacist if you have questions about this information.
- Take drospirenone/ethinyl estradiol/levomefolate by mouth with or without food. It is preferable to take drospirenone/ethinyl estradiol/levomefolate after the evening meal or at bedtime with liquid.
- Talk with your doctor about how you should start to take your first pack of drospirenone/ethinyl estradiol/levomefolate. If you begin to take drospirenone/ethinyl estradiol/levomefolate during the first 24 hours of your period, you do not need to use an extra form of birth control. If you begin to take drospirenone/ethinyl estradiol/levomefolate after the first 24 hours of your period or on the Sunday after your period starts, you will need to use an extra form of birth control (eg, condoms) for 7 days after you start taking drospirenone/ethinyl estradiol/levomefolate.
- If you are switching from another birth control pill to drospirenone/ethinyl estradiol/levomefolate, start drospirenone/ethinyl estradiol/levomefolate on the same day that you would have started a new pack of your previous birth control pills. If you are switching to drospirenone/ethinyl estradiol/levomefolate from another type of hormonal birth control (eg, patch, vaginal ring), ask your doctor or pharmacist about when to start taking drospirenone/ethinyl estradiol/levomefolate.
- Take drospirenone/ethinyl estradiol/levomefolate at the same time each day. After taking the last pill in the pack, start taking the first pill from the new pack the very next day.
- Severe vomiting or diarrhea may decrease drospirenone/ethinyl estradiol/levomefolate's effectiveness. Talk with your doctor about what to do if severe vomiting or diarrhea occurs while you take drospirenone/ethinyl estradiol/levomefolate. If you vomit within 3 to 4 hours after you take drospirenone/ethinyl estradiol/levomefolate, this should be considered a missed dose.
- For drospirenone/ethinyl estradiol/levomefolate to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
- If you miss 1 dose of drospirenone/ethinyl estradiol/levomefolate, take it as soon as possible. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup form of birth control if you only miss 1 pill. If you miss more than 1 dose, read the extra patient leaflet that comes with drospirenone/ethinyl estradiol/levomefolate or contact your doctor for instructions. You must use a backup form of birth control (eg, condom, spermicide) if you miss more than 1 dose. If you are not sure how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.
Ask your health care provider any questions you may have about how to use drospirenone/ethinyl estradiol/levomefolate.
Important safety information:
- Drospirenone/ethinyl estradiol/levomefolate may increase the risk of a stroke, a heart attack, blood clots, high blood pressure, or similar problems. The risk is greater if you smoke. Do not smoke or use other tobacco products while taking drospirenone/ethinyl estradiol/levomefolate.
- Bleeding or spotting may occur while you are taking drospirenone/ethinyl estradiol/levomefolate, especially during the first 3 months. Do not stop taking drospirenone/ethinyl estradiol/levomefolate if this occurs. If bleeding or spotting is persistent, or if it occurs after menstrual cycles that were previously regular, contact your doctor.
- If you miss more than 2 periods in a row or if you miss 1 period when you have not taken your pills correctly, contact your doctor. Also, if you have morning sickness or unusual breast tenderness, contact your doctor. You may be pregnant if any of these occur.
- Certain antibiotics, anticonvulsants, and other medicines may decrease the effectiveness of drospirenone/ethinyl estradiol/levomefolate. Ask your pharmacist if you have questions about which medicines may decrease drospirenone/ethinyl estradiol/levomefolate's effectiveness. To prevent pregnancy while taking these medicines, use an extra form of birth control (eg, condoms). You may also need to use an extra form of birth control for a period of time after you stop taking these medicines. Check with your doctor for more information.
- Drospirenone/ethinyl estradiol/levomefolate contains drospirenone. The risk of developing a blood clot may be greater with birth control that contains drospirenone than with other birth control pills. Talk with your doctor about the benefits and risks of drospirenone/ethinyl estradiol/levomefolate or other birth control pills.
- Tell your doctor or dentist that you take drospirenone/ethinyl estradiol/levomefolate before you receive any medical or dental care, emergency care, or surgery. If possible, drospirenone/ethinyl estradiol/levomefolate should be stopped at least 4 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (eg, long plane flight, bedrest, lengthy illness).
- You should usually not take drospirenone/ethinyl estradiol/levomefolate within 4 weeks after giving birth or after a second-trimester abortion. Talk with your doctor about how to start taking drospirenone/ethinyl estradiol/levomefolate in these instances.
- If you start to take drospirenone/ethinyl estradiol/levomefolate after giving birth and you have not yet had a period, use an extra form of birth control for 7 days after you start to take drospirenone/ethinyl estradiol/levomefolate.
- Drospirenone/ethinyl estradiol/levomefolate may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
- If you wear contact lenses and you develop problems with them or experience other vision changes, contact your doctor.
- You may experience a delay in being able to become pregnant after stopping drospirenone/ethinyl estradiol/levomefolate. This effect may be greater in patients who had irregular periods before starting drospirenone/ethinyl estradiol/levomefolate. Discuss any concerns with your doctor or pharmacist.
- Drospirenone/ethinyl estradiol/levomefolate does not stop the spread of HIV and other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not run out of medicine. Your chance of becoming pregnant may be increased if you do not take drospirenone/ethinyl estradiol/levomefolate every day as directed.
- Diabetes patients - Drospirenone/ethinyl estradiol/levomefolate may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Examine your breasts monthly as directed by your doctor. Report any lumps right away.
- Drospirenone/ethinyl estradiol/levomefolate has folic acid in it. Before you start any new medicine, check the label to see if it has folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Drospirenone/ethinyl estradiol/levomefolate may interfere with certain lab tests, such as cholesterol or diabetes. Be sure your doctor and lab personnel know you are taking drospirenone/ethinyl estradiol/levomefolate.
- Lab tests, including breast exams, Pap, physicals, and blood pressure, may be performed while you use drospirenone/ethinyl estradiol/levomefolate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Drospirenone/ethinyl estradiol/levomefolate should not be used in CHILDREN who have not yet had their first menstrual period; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not take drospirenone/ethinyl estradiol/levomefolate if you are pregnant. If you think you may become pregnant, contact your doctor right away. Drospirenone/ethinyl estradiol/levomefolate is found in breast milk. Do not breast-feed while you are taking drospirenone/ethinyl estradiol/levomefolate.
Possible side effects of drospirenone/ethinyl estradiol/levomefolate:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Breast tenderness; bleeding or spotting between menstrual periods; headache; nausea; PMS-like symptoms (eg, irritability); vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); breast pain, lump, or discharge; calf or leg pain, swelling, or tenderness; change in the amount of urine produced; chest pain or heaviness; confusion; coughing of blood; fainting; irregular heartbeat; left-sided jaw, neck, shoulder, or arm pain; mental or mood changes (eg, depression); migraines; missed menstrual period; muscle cramps or weakness; numbness of an arm or leg; one-sided weakness; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; red, swollen, blistered, or peeling skin; severe or persistent trouble sleeping; severe stomach pain or tenderness; shortness of breath; slurred speech; sudden, severe vomiting; swelling of the fingers, hands, legs, or ankles; symptoms of liver problems (eg, yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite); unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation or discharge; vision changes (eg, sudden vision loss, double vision).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe nausea; unexplained vaginal bleeding.Proper storage of drospirenone/ethinyl estradiol/levomefolate:
Store drospirenone/ethinyl estradiol/levomefolate at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep drospirenone/ethinyl estradiol/levomefolate out of the reach of children and away from pets.
- If you have any questions about drospirenone/ethinyl estradiol/levomefolate, please talk with your doctor, pharmacist, or other health care provider.
- Drospirenone/ethinyl estradiol/levomefolate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take drospirenone/ethinyl estradiol/levomefolate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about drospirenone/ethinyl estradiol/levomefolate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to drospirenone/ethinyl estradiol/levomefolate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using drospirenone/ethinyl estradiol/levomefolate.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.