FaLessa Kit

Name: FaLessa Kit

How is this medicine (FaLessa Kit) best taken?

Use FaLessa Kit (ethinyl estradiol and levonorgestrel) 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) 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 also take colesevelam, take it at least 4 hours before or after you take FaLessa Kit (ethinyl estradiol and levonorgestrel).
  • After starting FaLessa Kit (ethinyl estradiol and levonorgestrel), you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about using a non-hormone type of birth control.
  • If you throw up or have diarrhea, FaLessa Kit (ethinyl estradiol and levonorgestrel) may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
  • If your monthly cycle is 28 days and you miss 2 periods in a row, take a pregnancy test before starting a new dosing cycle.
  • If you have a cycle longer than 91 days and you miss one period, take a pregnancy test before starting a new dosing cycle.

What do I do if I miss a dose?

  • 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) 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.
  • Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • 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.
  • Mood changes.
  • Low mood (depression).
  • Feeling very tired or weak.
  • Very bad belly pain.
  • Swelling.
  • 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.
  • Loss of eyesight.
  • Change in how contact lenses feel in the eyes.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

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.
  • Dizziness.
  • Weight gain.
  • Headache.
  • Upset stomach or throwing up.
  • Cramps.
  • Bloating.
  • 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.

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.
  • Protect from light.
  • 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.
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