Estrogen and Progestin (Oral Contraceptives)

IMPORTANT WARNING:

Cigarette smoking increases the risk of serious side effects from oral contraceptives, including heart attacks, blood clots, and strokes. This risk is higher for women over 35 years of age and heavy smokers (15 or more cigarettes per day). If you take oral contraceptives, you should not smoke.

WHY is this medicine prescribed?

Oral contraceptives (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Oral contraceptives are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

Some brands of oral contraceptives are also used to treat acne in certain patients. Oral contraceptives treat acne by decreasing the amounts of certain natural substances that can cause acne.

Some oral contraceptives (Beyaz, Yaz) are also used to relieve the symptoms of premenstrual dysphoric disorder (physical and emotional symptoms that occur before the menstrual period each month) in women who have chosen to use an oral contraceptive to prevent pregnancy.

Are there OTHER USES for this medicine?

Oral contraceptives are also sometimes used to treat heavy or irregular menstruation and endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Oral contraceptives come in packets of 21, 28, or 91 tablets to take by mouth once a day, every day or almost every day of a regular cycle. To avoid nausea, take oral contraceptives with food or milk. Take your oral contraceptive at the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take your oral contraceptive exactly as directed. Do not take more or less of it, take it more often, or take it for a longer time than prescribed by your doctor.

Oral contraceptives come in many different brands. Different brands of oral contraceptives contain slightly different medications or doses, are taken in slightly different ways, and have different risks and benefits. Be sure that you know which brand of oral contraceptives you are using and exactly how you should use it. Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient and read it carefully.

If you have a 21-tablet packet, take 1 tablet daily for 21 days and then none for 7 days. Then start a new packet.

If you have a 28-tablet packet, take 1 tablet daily for 28 days in a row in the order specified in your packet. Start a new packet the day after you take your 28th tablet. The tablets in most 28-tablet packets may have different colors. Many 28-tablet packets have certain color tablets that contain different amounts of estrogen and progestin, but also may have other color tablets which contain an inactive ingredient or a folate supplement.

If you have a 91-day tablet packet, take 1 tablet daily for 91 days. Your packet will contain three trays of tablets. Start with the first tablet on the first tray and continue taking 1 tablet every day in the order specified on the packet until you have taken all of the tablets on all of the trays. The last set of tablets are a different color. These tablets may contain an inactive ingredient, or they may contain a very low dose of estrogen. Start your new packet the day after you take your 91st tablet.

Your doctor will tell you when you should start taking your oral contraceptive. Oral contraceptives are usually started on the first or fifth day of your menstrual period or on the first Sunday after or on which bleeding begins. Your doctor will also tell you whether you need to use another method of birth control during the first 7 to 9 days that you take your oral contraceptive and will help you choose a method. Follow these directions carefully.

You will probably experience withdrawal bleeding similar to a menstrual period while you are taking the inactive tablets or the low dose estrogen tablets or during the week that you do not take your oral contraceptive. If you are taking the type of packet that only contains active tablets, you will not experience any scheduled bleeding, but you may experience unexpected bleeding and spotting, especially at the beginning of your treatment. Be sure to start taking your new packet on schedule even if you are still bleeding.

You may need to use a backup method of birth control if you vomit or have diarrhea while you are taking an oral contraceptive. Talk to your doctor about this before you begin to take your oral contraceptive so that you can prepare a backup method of birth control in case it is needed. If you vomit or have diarrhea while you are taking an oral contraceptive, call your doctor to find out how long you should use the backup method.

If you have recently given birth, wait until 4 weeks after delivery to begin taking oral contraceptives. If you have had an abortion or miscarriage, talk to your doctor about when you should begin taking oral contraceptives.

Oral contraceptives will work only as long as they are taken regularly. Continue to take oral contraceptives every day even if you are spotting or bleeding, have an upset stomach, or do not think that you are likely to become pregnant. Do not stop taking oral contraceptives without talking to your doctor.

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.

• 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 SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss doses of your oral contraceptive, you may not be protected from pregnancy. You may need to use a backup method of birth control for 7 to 9 days or until the end of the cycle. Every brand of oral contraceptives comes with specific directions to follow if you miss one or more doses. Carefully read the directions in the manufacturer's information for the patient that came with your oral contraceptive. If you have any questions, call your doctor or pharmacist. Continue to take your tablets as scheduled and use a backup method of birth control until your questions are answered.

What SIDE EFFECTS can this medicine 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. The following symptoms are uncommon, but if you experience any of them, 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).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the packet it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of 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
• vaginal bleeding

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination every year, including blood pressure measurements, breast and pelvic exams, and a Pap test. Follow your doctor's directions for examining your breasts; report any lumps immediately.

Before you have any laboratory tests, tell the laboratory personnel that you take oral contraceptives.

If you wish to stop taking oral contraceptives and become pregnant, your doctor may tell you to use another method of birth control until you begin to menstruate regularly again. It may take a long time for you to become pregnant after you stop taking oral contraceptives, especially if you have never had a baby or if you had irregular, infrequent, or complete absence of menstrual periods before taking oral contraceptives. However, it is possible to become pregnant within days of stopping certain oral contraceptives. If you want to stop taking oral contraceptives but do not want to become pregnant, you should begin using another type of birth control as soon as you stop taking oral contraceptives. Discuss any questions that you may have with your doctor.

Oral contraceptives may decrease the amount of folate in your body. Folate is important for the development of a healthy baby, so you should talk to your doctor if you want to become pregnant soon after you stop taking oral contraceptives. Your doctor may recommend that you take a folate supplement or an oral contraceptive that contains a folate supplement (Beyaz, Safyral).

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.