Important Safety Information

What special precautions should I follow?

Before taking oral contraceptives, tell your doctor and pharmacist if you are allergic to estrogen, progestin, or any other medications. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: acetaminophen (APAP, Tylenol); antibiotics such as ampicillin (Principen), clarithromycin (Biaxin),erythromycin (E.E.S., E-Mycin, Erythrocin), isoniazid (INH, Nydrazid), metronidazole (Flagyl),minocycline (Dynacin, Minocin), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), tetracycline (Sumycin), and troleandomycin (TAO) (not available in the U.S.); anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as griseofulvin (Fulvicin, Grifulvin, Grisactin), fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); atorvastatin (Lipitor); clofibrate (Atromid-S); cyclosporine (Neoral, Sandimmune); bosentan (Tracleer); cimetidine (Tagamet); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); fluoxetine (Prozac, Sarafem, in Symbyax); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), felbamate (Felbatol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), primidone (Mysoline), and topiramate (Topamax); modafinil (Provigil); morphine (Kadian, MS Contin, MSIR, others); nefazodone; rifampin (Rimactane, in Rifadin, in Rifater); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone); temazepam (Restoril); theophylline (Theobid, Theo-Dur); thyroid medication such as levothyroxine (Levothroid, Levoxyl, Synthroid); verapamil (Calan, Covera, Isoptin, Verelan); vitamin C; and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. If you are taking oral contraceptives that contain drosperinone (Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah) tell your doctor and pharmacist if you are taking any of the medications listed above or any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), enalapril (Vasotec), and lisinopril (Prinivil, Zestril); angiotensin II antagonists such as irbesartan (Avapro), losartan (Cozaar), and valsartan (Diovan); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); diuretics ('water pills') such as amiloride (Midamor), spironolactone (Aldactone), and triamterene (Dyrenium); eplerenone (Inspra); heparin; or potassium supplements. Before taking Beyaz or Safyral, also tell your doctor or pharmacist if you are taking cholestyramine (Locholest, Prevalite, Questran), a folate supplement, methotrexate (Trexall), pyrimethamine (Daraprim), sulfasalazine (Azulfidine), or valproic acid (Depakene, Stavzor). Tell your doctor what herbal products you are taking, especially St. John's wort. Tell your doctor if you have or have ever had blood clots in your legs, lungs, or eyes; thrombophilia (condition in which the blood clots easily); coronary artery disease (clogged blood vessels leading to the heart); cerebrovascular disease (clogging or weakening of the blood vessels within the brain or leading to the brain); stroke or mini-stroke; an irregular heartbeat; heart disease; a heart attack; chest pain; diabetes that has affected your circulation; headaches that come along with other symptoms such as vision changes, weakness, and dizziness; high blood pressure; breast cancer; cancer of the lining of the uterus, cervix, or vagina; liver cancer, liver tumors, or other types of liver disease; yellowing of the skin or eyes during pregnancy or while you were using hormonal contraceptives (birth control pills, patches, rings, implants, or injections); unexplained abnormal vaginal bleeding; adrenal insufficiency (condition in which the body does not produce enough of certain natural substances needed for important functions such as blood pressure); or kidney disease. Also tell your doctor if you have recently had surgery or have been unable to move around for any reason. Your doctor may tell you that you should not take certain types of oral contraceptives or that you should not take any type of oral contraceptive if you have or have had any of these conditions. Also tell your doctor if anyone in your family has had breast cancer, if you are overweight, and if you have or have ever had problems with your breasts such as lumps, an abnormal mammogram (breast x-ray), or fibrocystic breast disease (swollen, tender breasts and/or breast lumps that are not cancer); high blood cholesterol or fats; diabetes; asthma; toxemia (high blood pressure during pregnancy); heart attack; chest pain; seizures; migraine headaches; depression; gallbladder disease; jaundice (yellowing of the skin or eyes); and excessive weight gain and fluid retention (bloating) during the menstrual cycle. Do not take oral contraceptives if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking oral contraceptives, call your doctor immediately. If you miss periods while you are taking oral contraceptives, you may be pregnant. If you are using a 91-tablet packet and you miss one period, call your doctor. If you are using another type of packet according to the directions and you miss one period, you may continue to take your tablets. However, if you have not taken your tablets as directed and you miss one period or if you have taken your tablets as directed and you miss two periods, call your doctor and use another method of birth control until you have a pregnancy test. If you are using a 28-tablet packet that contains only active tablets, you will not expect to have periods on a regular basis, so it may be hard to tell if you are pregnant. If you are using this type of oral contraceptive, call your doctor and have a pregnancy test if you experience symptoms of pregnancy such as nausea, vomiting, and breast tenderness, or if you suspect you may be pregnant. If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking oral contraceptives. You should know that oral contraceptives may cause a spotty darkening of the skin, especially on the face. If you have experienced changes in your skin color during pregnancy or while you were taking oral contraceptives in the past, you should avoid exposure to real or artificial sunlight while you are taking oral contraceptives. Wear protective clothing, sunglasses, and sunscreen. Tell your doctor and pharmacist if you wear contact lenses. If you notice changes in vision or ability to wear your lenses while taking oral contraceptives, see an eye doctor.

What side effects can this medication cause?

Oral contraceptives may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
  

• vomiting
  

• stomach cramps or bloating

• diarrhea
  

• constipation
  

• gingivitis (swelling of the gum tissue)
  

• increased or decreased appetite
  

• weight gain or weight loss
  

• brown or black skin patches
  

• acne

• hair growth in unusual places
• bleeding or spotting between menstrual periods
• changes in menstrual flow
• painful or missed periods
• breast tenderness, enlargement, or discharge
• swelling, redness, irritation, burning, or itching of the vagina
• white vaginal discharge
  

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• severe headache
  
• severe vomiting
  
• speech problems
  
• dizziness or faintness
  
• weakness or numbness of an arm or leg
• crushing chest pain or chest heaviness
• coughing up blood
• shortness of breath
• leg pain
• partial or complete loss of vision
• double vision
• bulging eyes
• severe stomach pain
• yellowing of the skin or eyes
• loss of appetite
• extreme tiredness, weakness, or lack of energy
• fever
• dark-colored urine
• light-colored stool
• swelling of the hands, feet, ankles, or lower legs
• depression, especially if you also have trouble sleeping, tiredness, loss of energy, or other mood changes
• unusual bleeding
• rash
• menstrual bleeding that is unusually heavy or that lasts for longer than 7 days in a row
  

Oral contraceptives may increase the chance that you will develop liver tumors. These tumors are not a form of cancer, but they can break and cause serious bleeding inside the body. Oral contraceptives may also increase the chance that you will develop breast or liver cancer, or have a heart attack, a stroke, or a serious blood clot. Talk to your doctor about the risks of using oral contraceptives.

Some studies show that women who take oral contraceptives that contain drosperinone (Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah) may be more likely to develop deep vein thrombosis (a serious or life-threatening condition in which blood clots that form in the veins, usually in the legs and may move through the body to the lungs) than women who take oral contraceptives that do not contain drosperinone. However, other studies do not show this increased risk. Before you begin taking oral contraceptives, talk to your doctor about the risk that you will develop blood clots and about which oral contraceptive or other method of birth control may be the best choice for you.

Oral contraceptives may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include nausea and vaginal bleeding.