Generic Name: levonorgestrel/ethinyl estradiol (LEE-voe-nor-JES-trel/ETH-i-nil ES-tra-DYE-ol & FOE-late)
Brand Name: Falessa Kit
Smoking cigarettes while using Falessa Kit increases your chance of having heart problems. Do not smoke while using Falessa Kit. The risk of heart problems increases with age and with frequent smoking. Women older than 35 years old and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems.
Falessa Kit is used for:
Preventing pregnancy. It may be used for other conditions as determined by your doctor.
Falessa Kit is a combination birth control pill and folate supplement kit. The birth control pill works by preventing ovulation, altering the cervical mucus, and changing the lining of the uterus. The folate supplement works by improving nutrition status.
Do NOT use Falessa Kit if:
- you are allergic to any ingredient in Falessa Kit
- 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), certain blood vessel problems (eg, bleeding in the brain, heart attack, stroke), or breast cancer
- you are at risk for developing severe blood clots or have certain heart problems (eg, certain heart valve problems, certain types of irregular heartbeat)
- you have chest pain caused by angina; certain types of headaches or migraines with aura; severe or uncontrolled high blood pressure; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; or undiagnosed abnormal vaginal bleeding; or diabetes that affects circulation
- you have liver disease, liver tumors or cancer, 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 older than 35 years old and you smoke 15 or more cigarettes per day
Contact your doctor or health care provider right away if any of these apply to you.
Before using Falessa Kit:
Some medical conditions may interact with Falessa Kit. 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 endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, heart problems, diabetes, headaches or migraines, gallbladder problems, high blood cholesterol or lipid levels, high blood pressure, kidney problems, blood problems (eg, porphyria), blood in the urine, depression or other mental/mood problems, lupus, chorea, high blood calcium levels, yellowing of the eyes or skin, pancreas problems (eg, pancreatitis), seizures (eg, epilepsy), or a history of cancer
- if you are overweight, you have not yet had your first menstrual period, or you use tobacco
- if you have given birth or otherwise ended a pregnancy within the past 4 weeks
Some MEDICINES MAY INTERACT with Falessa Kit. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Atorvastatin, indinavir, or troleandomycin because they may increase the risk of Falessa Kit's side effects
- Aprepitant, azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), phenylbutazone, primidone, rifabutin, rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Falessa Kit's effectiveness, resulting in breakthrough bleeding or pregnancy
- Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, or theophylline because the risk of their side effects may be increased by Falessa Kit
- Clofibric acid, lamotrigine, morphine, salicylic acid, or temazepam because their effectiveness may be decreased by Falessa Kit
This may not be a complete list of all interactions that may occur. Ask your health care provider if Falessa Kit 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 Falessa Kit:
Use Falessa Kit as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Falessa Kit. Talk to your pharmacist if you have questions about this information.
- Take Falessa Kit by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Begin taking Falessa Kit on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking Falessa Kit on that day. Try to take Falessa Kit at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
- For Falessa Kit to be effective it must be taken every day. Do not skip doses.
- If you miss a dose of Falessa Kit and remember it on the same day, take it as soon as possible and go back to your regular dosing schedule. If you do not remember until the next day or if you miss more than 1 dose of Falessa Kit, see the additional patient information leaflet that comes with Falessa Kit or contact your doctor for further instructions. You may need to use an extra form of birth control (eg, condoms). If you are not sure about how to handle missed doses of Falessa Kit, use an extra form of birth control (eg, condoms) until you talk with your doctor.
Ask your health care provider any questions you may have about how to use Falessa Kit.
Important safety information:
- Falessa Kit may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Falessa Kit with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.
- If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking Falessa Kit.
- You should usually not take Falessa Kit within 4 weeks after giving birth or otherwise ending a pregnancy. Discuss any questions or concerns with your doctor.
- Falessa Kit 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.
- Use of Falessa Kit will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs).
- Bleeding or spotting may occur while taking Falessa Kit. Do not stop taking Falessa Kit if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
- Smoking while using Falessa Kit may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.
- Falessa Kit may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Falessa Kit.
- Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using Falessa Kit may decrease the effectiveness of Falessa Kit. To prevent pregnancy, use an extra form of birth control (eg, condoms) until your next period.
- If you wear contact lenses and you develop problems with them, contact your doctor.
- If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.
- Falessa Kit may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping Falessa Kit. Discuss any concerns with your doctor or pharmacist.
- Lab tests, such as PAP tests, may be performed while you use Falessa Kit. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Falessa Kit should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
- PREGNANCY AND BREAST-FEEDING: Do not use Falessa Kit if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Falessa Kit is found in breast milk. Do not breast-feed while taking Falessa Kit.
Possible side effects of Falessa Kit:
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:
Acne; breast tenderness or enlargement; changes in appetite; changes in sexual interest; changes in weight; dizziness; hair loss; headache; nausea; stomach cramps or bloating; unusual spotting or bleeding; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in amount of urine produced; change in vaginal secretions; changes in vision or speech; confusion; coughing of blood; crushing chest pain or heaviness in the chest; dark-colored urine; depression; difficulty sleeping; difficulty wearing contact lenses; fainting; fluid retention (swelling of the fingers and ankles); lack of energy; light-colored bowel movements; mental or mood changes; missed menstrual period; numbness of an arm or leg; one-sided weakness; persistent headache or migraines; persistent or recurrent abnormal vaginal bleeding; persistent or severe dizziness; severe pain or tenderness in the stomach; shortness of breath; sudden partial or complete loss of vision; sudden severe headache or vomiting; tiredness; vaginal irritation or discharge; weakness; yellowing of the skin or eyes.
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.Proper storage of Falessa Kit:
Store Falessa Kit at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Falessa Kit out of the reach of children and away from pets.
- If you have any questions about Falessa Kit, please talk with your doctor, pharmacist, or other health care provider.
- Falessa Kit 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 Falessa Kit 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 Falessa Kit. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Falessa Kit. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Falessa Kit.
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.