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Generic Name: Ethinyl Estradiol and Levonorgestrel with Folate (ETH in il es tra DYE ole & LEE voe nor jes trel with FOE late)
Brand Name: FaLessa Kit
- Do not smoke while taking FaLessa Kit (ethinyl estradiol and levonorgestrel with folate). Cigarette smoking raises the chance of very bad heart problems. This chance is higher with age (older than 35 years of age) and with heavy smoking (15 or more cigarettes per day).
Uses of FaLessa Kit:
- It is used to prevent pregnancy.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take FaLessa Kit?
- If you have an allergy to ethinyl estradiol, levonorgestrel, or any other part of FaLessa Kit (ethinyl estradiol and levonorgestrel with folate).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer or other cancer where hormones make it grow, diseased blood vessels in the brain or heart, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, liver disease, liver tumor, very bad headache or migraine, or diabetes that affects blood flow.
- If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
- If you have surgery and need bedrest.
- If you are a heavy smoker (more than 15 cigarettes per day) and older than 35 years of age.
- If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
- If you are pregnant or may be pregnant. Do not take FaLessa Kit (ethinyl estradiol and levonorgestrel with folate) if you are pregnant.
This is not a list of all drugs or health problems that interact with FaLessa Kit (ethinyl estradiol and levonorgestrel with folate).
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take FaLessa Kit (ethinyl estradiol and levonorgestrel with folate) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take FaLessa Kit?
- Tell all of your health care providers that you take FaLessa Kit (ethinyl estradiol and levonorgestrel with folate). This includes your doctors, nurses, pharmacists, and dentists.
- This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
- If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
- Have your blood pressure checked often. Talk with your doctor.
- Have your blood work checked. Talk with your doctor.
- Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take FaLessa Kit (ethinyl estradiol and levonorgestrel with folate).
- Certain drugs, herbal products, or health problems could cause FaLessa Kit (ethinyl estradiol and levonorgestrel with folate) to not work as well. Be sure your doctor knows about all of your drugs and health problems.
- This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
- Do not use in children who have not had their first menstrual period.
- If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (FaLessa Kit) best taken?
Use FaLessa Kit (ethinyl estradiol and levonorgestrel with folate) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Follow how to use as you have been told by the doctor or read the package insert.
- Take FaLessa Kit (ethinyl estradiol and levonorgestrel with folate) at the same time of day.
- Take with or without food. Take with food if it causes an upset stomach.
- Do not skip doses, even if you do not have sex very often.
- If you throw up or have diarrhea, FaLessa Kit (ethinyl estradiol and levonorgestrel with folate) may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
- If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it and go back to your normal time.
- If a dose is missed, check the package insert or call the doctor to find out what to do. If using FaLessa Kit (ethinyl estradiol and levonorgestrel with folate) to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Coughing up blood.
- Shortness of breath.
- Chest pain or pressure.
- Very bad dizziness or passing out.
- Very upset stomach or throwing up.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Very bad headache.
- Low mood (depression).
- Feeling very tired or weak.
- Very bad belly pain.
- Not able to pass urine or change in how much urine is passed.
- A lump in the breast, breast soreness, or nipple discharge.
- Vaginal itching or discharge.
- Spotting or vaginal bleeding that is very bad or does not go away.
- Bulging eyes.
- Change in eyesight.
- Change in how contact lenses feel in the eyes.
What are some other side effects of FaLessa Kit?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling more or less hungry.
- Weight gain.
- Upset stomach or throwing up.
- Enlarged breasts.
- Breast soreness.
- Hair loss.
- Pimples (acne).
- Period (menstrual) changes. These include spotting or bleeding between cycles.
- Lowered interest in sex.
- This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
See also: Side effects (in more detail)
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out FaLessa Kit?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Consumer information use
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about FaLessa Kit (ethinyl estradiol and levonorgestrel with folate), please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Review Date: March 7, 2018