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Xulane

Generic Name: Ethinyl Estradiol and Norelgestromin (ETH in il es tra DYE ole & nor el JES troe min)
Brand Name: Ortho Evra, Xulane

  • Smoking cigarettes while using Xulane (ethinyl estradiol and norelgestromin) raises the chance of very bad heart and blood-related side effects. This chance is raised with age (mainly in women older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this medicine if you smoke and are older than 35 years of age.
  • You will get more estrogen if you use Xulane than if you use some other birth control pills. This may raise the risk of side effects like blood clots. Talk with your doctor.

Uses of Xulane:

  • 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 Xulane?

  • If you have an allergy to ethinyl estradiol, norelgestromin, or any other part of this medicine.
  • 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, diseased arteries in the brain, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, high cholesterol, a pancreas problem (pancreatitis) due to high blood triglycerides, liver disease, liver tumor, very bad headache or migraine, diabetes that affects blood flow, or tumor where estrogen makes it grow.
  • 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 pregnant or may be pregnant. Do not take Xulane if you are pregnant.
  • If you are breast-feeding or plan to breast-feed.
  • If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).

This is not a list of all drugs or health problems that interact with this medicine.

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 Xulane 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 Xulane?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If Xulane is stopped, your doctor will tell you when to start taking this medicine again after your surgery or procedure.
  • This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
  • Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
  • If you weigh 198 pounds (90 kilograms) or more, Xulane may not work as well to prevent pregnancy. Talk with your doctor.
  • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by 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 this medicine.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • Certain drugs, herbal products, or health problems could cause Xulane 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.

How is this medicine (Xulane) best taken?

Use this medicine 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.
  • Put patch on once a week for 3 weeks. Put it on the same day each week. Do not use patch on the 4th week.
  • Put patch on clean, dry, healthy skin on the buttock, belly, upper arm, or back.
  • Do not put on the breast.
  • Do not put the patch on the waistline.
  • Move the site with each patch.
  • Do not put on skin that is irritated or damaged. Do not put on an area with skin folds or skin that will be rubbed by tight clothes.
  • Do not use patches that are cut or do not look right.
  • Do not use adhesives or wraps to hold the patch in place.
  • Do not put on skin where you have just used creams, oils, lotions, powder, or other skin products. The patch may not stick as well.
  • Avoid sunlight on treated area.
  • Do not skip doses, even if you do not have sex very often.
  • Do not put on more than 1 patch at a time.
  • If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.
  • If Xulane (ethinyl estradiol and norelgestromin) has not been used the right way and 1 monthly period is missed, take a pregnancy test.
  • Put the same patch on the same place if it falls off and has been off for less than 24 hours.
  • Put on a new patch if the patch being used is no longer sticky or if it is sticking to itself or some other surface.
  • If a patch has been off for more than 1 day, you may not be protected from pregnancy. Put a new patch on to start a new 4 week cycle. Use another type of birth control like a condom during the first week of the new 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 this medicine to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

Dosage Information (in more detail)

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 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 skin irritation.
  • Very bad belly pain.
  • Swelling.
  • Not able to pass urine or change in how much urine is passed.
  • Bulging eyes.
  • Change in eyesight.
  • Change in how contact lenses feel in the eyes.
  • 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.

What are some other side effects of Xulane?

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:

  • Weight gain.
  • Headache.
  • Upset stomach or throwing up.
  • Cramps.
  • Bloating.
  • Enlarged breasts.
  • Breast soreness.
  • Period (menstrual) changes. These include lots of bleeding, spotting, or bleeding between cycles.
  • Lowered interest in sex.
  • Skin irritation.
  • 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.

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 Xulane?

  • Store at room temperature. Do not refrigerate or freeze.
  • Store in pouch until ready for use.
  • After you take off a skin patch, be sure to fold the sticky sides of the patch to each other.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • 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 Xulane, 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Xulane. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Xulane.

Review Date: November 1, 2017

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