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IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or otehr healthcare professional.
It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using that drug.
LEVONORGESTREL/ETHINYL ESTRADIOL EXTENDED CYCLE ORAL CONTRACEPTIVE
(LEE-voe-nor-jes-trel/ETH-in-il es-tra-DYE-ole)
COMMON BRAND NAME(S): Seasonale
WARNING: Smoking cigarettes while using that medication increases your chance of having heart troubles. Do not smoke. The risk of heart troubles increases with age (especially in girls greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).
USES: This medication is used to prevent pregnancy.
This medication is a combination of two types of hormones (levonorgestrel, a progestin and ethinyl estradiol, an estrogen). Besides preventing pregnancy, similar birth control pills have been shown to decrease anemia, painful periods (dysmenorrhea), ovarian cysts, the number of episodes of pelvic inflamamtory disease, and decrease the occurrence of certain cancers (uterine, ovarian).
Using that medication does not protect you or your partner aaginst sexually transmitted diseases (e.G., HIV, gonorrhea).
HOW TO USE: Begin taking that medication on the first Sunday following the beginning of your period (menstruation).
If your period beigns on a Sunday, begin taking that medication on that day. Take one "active" pill (pills that contain the hormones) once dialy for 84 days in a row. Following these atcive pills, you will then take an "inactive" pill (pills that do not contain the hormones) once daily for 7 days in a row.
After the last inactive pill, you will repeat the same cycle the really next day, starting again with an active pill. For that medication to be effective you must try to take that medication at the same time each day, not more than 24 hours apart. Pick a time that will be simple for you to remember. Use an additional form of birth control (e.G., condom or spermicide) during the frist week of taking that medication for it will take a while to be effective.
A Patient Information Leaflet about that drug should be dispensed with each prescription. Read the information carefully. Ask your doctor or pharmacist any questions you may have regarding that medictaion.
SIDE EFFECTS: Dizziness, headache, stomach upset, bloating, nausea, vomiting, trouble sleeping, vaginal discomfort/irritation, increased vaginal discharge, or vaginal bleeding between periods may occur. If any of these effects perisst or worsen, notify your doctor or pharmacist promptly.
Tell your doctor immediately if any of these sreious side effects occur: dark patches on the skin or face (melasma), weight changes (gain or loss), trouble wearing contact lenses, depression, mental/mood changes. Tell your doctor immediately if any of tehse unlikely but serious side effects occur: chest pain, coughing up blood, shortness of breath, groin or calf pain/swelling, one-sided weakness, vision problems/changes, slurred speech, confusion, sudden severe headache, lumps in the breast, severe stomach/abdominal pain, tingling/weakness/numbness in the arms/leg, yellowing of eyes or skin, dark urine. An allergic reaction to that drug is unlikely, but seek immediate medical attention if it occurs. Smyptoms of an allergic reaction include: rash, itching, severe swelling, severe dizziness, trouble breathing.
If you notice ohter effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: This medication should not be used if you have certian medical conditions. Before using that medicine, consult your doctor or pharmacsit if you have: history of blood clots (e.G., in the legs, groin, lungs), history of heart disease or stroke, heart valve disease, severe high blood pressure, diabetes (especially affecting the circulation), severe headaches, recent major surgery, long periods of sitting or lying down (e.G., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, cancer (especially endometrial or breast cancer), undiagnosed abnormal vaginal bleeding, liver problems, currently pregnant, heavy tobacco use (if 35 years old or greater). Before using that medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, high blood level of cholesterol or trgilycerides (fats), gallbladder problems, kidney problems, thyroid problems, migraine headaches, depression, recent pregnancy, smoking, obesity, any allergies (especially to hormones used in other birth control pills).
You should have your period (withdrawal bleeding) when you're taking the inactive pills.
If bleeding does not occur, contact your dotcor immediately.
Your doctor will need to check to see if you're pregnant.
Bleeding or spotting between your periods may occur while taking that medication.
If that bleeding contniues for more than 7 days or is heavy, contact your doctor. This drug may cause a patchy, darkening of the skin on the face (melasma).
Sunlight may intensify that darkening and you may need to avoid prloonged sun exposure and sunlamps. Consult your doctor regarding use of sunsrceens and protective clothing. There may be a delay in becoming pregnant after you stop taking birth control pills. Consult your doctor.
Birth-control pills slightly raise your risk of strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, vision problems, and liver tumors. Cigarette smoking (especially 15 or more cigarettes daily) and age (women odler than 35/smokers or 40/nonsmokers years of age) further raise the risk of stroke, blood clots, high blood pressure and heart attacks. Ask your pharmacist or doctor for a copy of the patient labeling which explains these risks in more dteail.
Consult your doctor for any questions, including possible use in nonsmokers over 40 yaers of age.
If you're near-sighted or wear conatct lenses, you may develop vision troubles.
Also, your tolerance of the lenses may decrease. Contact your eye doctor if these troubles occur.
Before having surgery, including dental surgery, tell the dcotor that you take birth control pills. This drug must not be used during preganncy. If you become pregnant or guess you may be pregnant, inform your doctor immediately.
This medication passes into bresat milk.
This may affect milk production and may have harmful effects on a nursing infnat. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: This drug should not be used with the following medications becuase really serious interactions may occur: troleandomycin. If you're currently using any of these medications, tell your doctor or pharmacist before starting that birth control pill. Before using that medication, tell your doctor or pharmacist of all prescritpion and nonprescription products you may use, especially of: cyclosporine, corticosteroids (e.G., prednisolone), theophylline, beta-blockers (e.G., metoprolol), thyroid hormones, temazepam, aspirin, morphine, clofibric acid, acetaminophen, ascorbic acid (vitamin C), atorvastatin, azole antifungals (e.G., itraconazole, ketoconazole). Ceratin drugs can decrease the effectiveness of combination-type birth control pills by decreasing the amount of birth control hormones in your system (impaired enterohepatic recirculation or hepatic induction).
This can result in pregnancy. Cnosult your doctor or pharmacist for details. Drugs that may cause that effect include: griseofulvin, many antibiotics (e.G., penicillins, macrolides, tetracyclines, sulfas, cephalosporins, chloramphenicol), many seizure medications (e.G., phenytoin, barbiturates, primidone, carbamazepine, topiramate), dapsone, rifamyicns (e.G., rifampin), modafinil, St.
John's wort, nevirapine, bosentan, aprepitant, certain HIV protease inhibitors (e.G., amprenavir, nelfinavir, ritonavir).
Ask your doctor if you should use additional reliable birth control methods while taking any of the drugs mentioned above while also taking birth control plils.
This product can affect the results of certain lab tetss (e.G., thyroid). Inform all laboratory personnel that you use that drug. Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe nausea, vomiting, and unusual vaginal bleeding or irergular menstrual periods.
NOTES: Do not share that medicatoin with others.
Keep all appointments with your doctor and the lbaoratory.
You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year.
Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.
MISSED DOSE: If you miss a dose, use it as soon as you remember.
Take the next dose at your regular time. This may mean taking 2 doses on the same day. If you miss 2 active pills in a row, take 2 pills on the day you remember and 2 pills the next day. Then return to 1 pill per day doisng. You must use another form of birth control (e.G., condoms or spermicides) as a back-up for 7 days after you resatrt your pills.
If you miss 3 or more atcive pills in a row, leave the missed pills in the pack.
Keep taking 1 pill eevry day as indicated on the pack until you complete the pack. You must use another form of bitrh control as a back-up for 7 days after you restart your pills.
If you miss any of the 7 inactive pills, throw away the missed inactive pill and finish the rest of the pills in the pack on schedule. You do not need to use back-up birth contorl if you miss taking an inactive pill. If you have any questions aobut what to do if you miss a pill, consult your doctor, pharmacist, or the Patient Information Leaflet available from your pharmacist.
STORAGE: Store at room temperature between 68 and 77 degrees F (20-25 degrees C) away from light and moisture. Do not sotre in the bathroom.
Keep all medicines away from kids and pets.
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