Ethinyl Estradiol/Drospirenone/Levomefolate Calcium, Oral

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KEY POINTS

• This medicine is taken by mouth to prevent pregnancy, treat acne, or treat premenstrual dysphoric disorder. Take it exactly as directed.
• Birth control pills increase the risk of serious blood clots, especially if you are obese, over age 35, or if you smoke.
• Keep all appointments for tests to see how this medicine affects you. Do not take this medicine for longer than 1 year without a complete physical exam.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: hormone/B vitamin combination

Generic and brand names: ethinyl estradiol/drospirenone/levomefolate calcium, oral; Beyaz; Safyral

What is this medicine used for?

This medicine combines birth control medicines and folate (a B vitamin). It is taken by mouth to:

• Prevent pregnancy
• Prevent pregnancy and supplement folate
• Treat premenstrual dysphoric disorder (PMDD) as well as prevent pregnancy
• Treat acne as well as prevent pregnancy

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Addison's disease or adrenal gland problems
• Angioedema (swelling)
• Asthma
• Blood clots or a blood clotting disorder
• Breast cancer or cancer of the lining of the uterus, cervix, or vagina
• Breast lumps, breast cysts, or abnormal mammograms
• Chest pain (angina)
• Chloasma (darkening of the skin on the face)
• Depression
• Diabetes
• Heart valve or heart rhythm problems
• Gallbladder or kidney disease
• Headaches along with symptoms such as vomiting, double vision, unsteadiness, weakness, or personality changes
• Heart attack, heart disease, or stroke
• High blood pressure
• High cholesterol or high triglycerides
• Irregular periods
• Liver disease or liver tumor
• Porphyria (nerve pain or sensitivity to sunlight)
• Problems with high level of potassium in your blood
• Seizures
• Thyroid problems
• Unexplained vaginal bleeding, uterine fibroids, or abnormal Pap smears
• Yellowing of the eyes or skin (jaundice) during pregnancy or during past use of birth control pills

Tell your healthcare provider if you have recently had a long period of bed rest after a major surgery or illness, or a broken bone in a cast, or you have recently delivered a baby. You may be at a risk of developing blood clots. Also, tell your healthcare provider if you are scheduled for surgery.

Tell your provider if you have a family history of heart disease, heart attack, high cholesterol, blood clots, strokes, breast cancer, or other conditions.

Tell your healthcare provider if you smoke. Smoking while you are using this medicine increases the risk of serious side effects such as heart attack, stroke, and blood clots. The risk increases with age and the number of cigarettes smoked a day. Talk to your healthcare provider about ways to quit smoking.

Females of childbearing age: DO NOT use this product if you are pregnant or breast-feeding because it may harm the baby. Stop taking this medicine at the first sign you may be pregnant and contact your healthcare provider right away.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as prescribed by your healthcare provider.

Check with your healthcare provider before using this medicine in children who have not reached puberty.

You may take this medicine with or without food, but you should take it at the same time each day. Use the special packaging to keep track of doses. Read the information sheet that comes in the medicine package for more information.

What if I miss a dose?

If you miss a dose at your normal time, take it as soon as you remember. If you do not remember until the next day, take 2 tablets that day. If you miss 2 or more doses in a row, see the information sheet that comes in the medicine package or ask your healthcare provider what to do. You may need to use another method of birth control (such as a condom or spermicide) as a back-up method for 7 days.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, vaginal bleeding.

What should I watch out for?

You need to see your provider at least once a year for checkups while you are taking this medicine. Do not take this medicine for longer than 1 year without a complete physical exam.

Because this medicine may harm an unborn baby, contact your healthcare provider if:

• You have symptoms of pregnancy such as morning sickness or breast tenderness.
• You miss a period and did not take this medicine every day.
• You miss 2 periods in a row.

If you have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The symptoms will usually go away. If symptoms continue, check with your healthcare provider.

Birth control pills increase the risk of serious blood clots, especially if you are obese, over age 35, or if you smoke. Talk with your provider about this.

Your healthcare provider may recommend that you use a second method of birth control when you first start taking this medicine.

This medicine only prevents pregnancy. It does not prevent sexually transmitted diseases (STDs) such as HIV or herpes.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. If you need any lab tests, tell your healthcare provider you are using this medicine. Birth control hormones may change some blood test results.

Severe vomiting or diarrhea and certain other medicines may make this medicine less effective. Tell all healthcare providers who treat you that you are taking this medicine. You may need to use another method of birth control if you have vomiting or diarrhea or if your healthcare provider prescribes a medicine that might reduce the effectiveness of the birth control pills.

This medicine may increase the amount of potassium in your blood to a dangerous level. Your healthcare provider may want you to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you notice a change in your vision or wear contacts and it becomes difficult to wear your lenses, contact your healthcare provider.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.):

• Allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing)
• Severe chest pain or pressure, coughing blood, or sudden shortness of breath
• Sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking

Serious (Report these to your healthcare provider right away.):

• Yellowing of the skin or eyes, especially with fever, tiredness, loss of appetite, dark urine, or light-colored bowel movements
• Pain, redness, or swelling in the leg
• Severe pain, swelling, or tenderness in the abdomen
• Breast lumps or tenderness
• Irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than 7 days
• Swelling of your hands or ankles
• Discomfort from contact lenses or vision changes
• Trouble sleeping, weakness, lack of energy, fatigue, or depression

Other: Vaginal or urinary infection, vaginal discharge, weight changes, nausea, vomiting, dizziness, nervousness, bloating, darkening of skin on the face, headache, hair loss, change in sexual desire.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Acetaminophen and medicines that contain acetaminophen
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as amoxicillin (Amoxil, Moxatag), ampicillin, clarithromycin (Biaxin), demeclocycline, dicloxacillin, doxycycline (Doryx, Monodox, Vibramycin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, minocycline (Dynacin, Minocin, Solodyn), oxacillin (Bactocill), penicillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), and nortriptyline (Pamelor)
• Antifungal medicines such as fluconazole (Diflucan), griseofulvin (Grifulvin V, Gris-PEG), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), felbamate (Felbatol), fosphenytoin (Cerebyx), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend)
• Artemether/lumefantrine (Coartem)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bosentan (Tracleer)
• Cancer medicines such as anastrozole (Arimidex), dabrafenib (Tafinlar), enzalutamide (Xtandi), exemestane (Aromasin), and letrozole (Femara)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), and lomitapide (Juxtapid) (Take this medicine 4 hours before or 4 hours after you take cholestyramine (Prevalite), colesevelam, or colestipol.)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diabetes medicines such as exenatide (Bydureon, Byetta), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, spironolactone (Aldactone), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Eplerenone (Inspra)
• Heparin
• HIV medicines such as efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), and ritonavir (Norvir)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Medicines to treat breathing or lung problems such as aminophylline and theophylline
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natural remedies such as alfalfa, black cohosh, bloodroot, chasteberry, dong quai, ginseng, hops, licorice, red clover, saw palmetto, St. John's wort, and yucca
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Pimozide (Orap)
• Potassium supplements or salt substitutes that contain potassium
• Propranolol (Hemangeol, Inderal, InnoPran)
• Pyrimethamine (Daraprim)
• Retinoid medicines such as alitretinoin (Panretin) and isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane)
• Selegiline (Eldepryl, Emsam, Zelapar)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Sulfasalazine (Azulfidine)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Vitamins A, B, and C, and minerals such as zinc, iron, and magnesium
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.