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ethinyl estradiol and norelgestromin (transdermal)

Pronunciation: EH thi nil ESS tra DYE ol and nor ell JESS tro min

Brand: Xulane

What is the most important information I should know about this medicine?

Do not use this medicine if you are pregnant or think you might be pregnant.

You should not use this medicine if you have: uncontrolled high blood pressure, heart problems, coronary artery disease, health problems caused by diabetes, undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches (especially if you are older than 35), if you have a BMI of 30 or higher, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not use this medicine if you smoke and are older than 35 years of age.

What is ethinyl estradiol and norelgestromin transdermal?

Ethinyl estradiol and norelgestromin transdermal (skin patch) is a combination birth control that is used to prevent pregnancy.

Ethinyl estradiol and norelgestromin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using this medicine?

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using birth control. Your risk is also high when you restart this medicine after not using for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use this medicine if you smoke and are over 35 years old.

Your risk of serious blood clot may be higher with the use of birth control skin patches than with the use of birth control pills.

Do not use if you are pregnant, if you become pregnant, or if you've had a baby in the past 4 weeks.

You should not use hormonal birth control if you have:

  • untreated or uncontrolled high blood pressure;
  • heart problems (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
  • an increased risk of having blood clots due to a hereditary blood disorder;
  • health problems caused by diabetes (such as damage to your kidneys, eyes, nerves, or blood vessels);
  • a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
  • unusual vaginal bleeding that has not been checked by a doctor;
  • liver disease or liver cancer;
  • severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
  • if you are overweight and have a BMI (body mass index) of 30 or higher; or
  • if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Viekira).

Tell your doctor if you have ever had:

  • heart problems, high blood pressure, or if you are prone to having blood clots;
  • depression;
  • migraine headaches;
  • liver disease;
  • jaundice caused by pregnancy or birth control pills; or
  • diabetes, gallbladder disease, underactive thyroid.

This medicine may not be as effective if you weigh more than 198 pounds (90 kilograms). If you are overweight, your doctor may recommend another form of birth control for you.

This medicine can slow breast milk production. You should not breastfeed while using ethinyl estradiol and norelgestromin.

How should I use this medicine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not wear more than one skin patch at a time. Never cut a skin patch.

Apply a new skin patch every 7 days for 3 weeks in a row (21 days). Change your patch on the same day of the week, and wear each patch for 7 full days. On Day 22, remove the patch and wait 7 days before applying a new patch. Your patch-free week should not be longer than 7 days.

Apply the patch to clean, dry skin that is not broken or irritated and won't be rubbed by tight clothing (such as a waistband).

You may need to use back-up birth control (such as a condom/diaphragm with spermicide) when you first start using this medicine, or if a patch has become loose or has been off for longer than 1 day. Read and carefully follow all instructions about what to do if a patch gets loose or falls off, or if you forget to change your patch on time.

If you need major surgery or will be on long-term bed rest, do not use wear a skin patch for at least 4 weeks ahead of time and 2 weeks afterward.

You may have breakthrough bleeding, especially during the first few months. Tell your doctor if this bleeding is very heavy, or if you miss 2 or more regular periods.

Store patches in the foil pouch at room temperature away from moisture and heat. Do not freeze or refrigerate. After removing a skin patch fold it in half, sticky side in, and throw it away in a place where children and pets cannot get to it. Do not flush a used patch down the toilet.

What happens if I miss a dose?

During your patch-free week, do not go without wearing a patch for longer than 7 days. Missing a dose increases your risk of becoming pregnant and you may need to use back-up birth control. Call your doctor if you miss a period for 2 months in a row.

If you forget to apply a patch at the start of a new cycle:

  • Apply a patch as soon as you remember and start a new cycle on that day (3 weeks wearing a weekly patch, 1 week off). Use back-up birth control such as a condom/diaphragm with spermicide during the first week of your new cycle.

If you forget to change your patch during the 3-week wearing time:

  • If it has been 24-48 hours since your scheduled patch change, apply a new patch and change it on your regular change day.
  • If it has been more than 48 hours since your scheduled patch change, apply a new patch and start a new cycle on that day (3 weeks wearing a weekly patch, 1 week off). Use back-up birth control during the first week.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using this medicine?

Do not smoke while using this medicine, especially if you are older than 35 years of age.

Grapefruit may interact with this medicine and lead to unwanted side effects. Avoid the use of grapefruit products.

This medicine may cause darkening of your facial skin (chloasma), especially if you've ever had chloasma during a pregnancy. Avoid sunlight or tanning beds. Use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid applying makeup, lotions, powders, or oils to the skin where you apply a skin patch.

What are the possible side effects of this medicine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), severe headache, problems with vision or speech;
  • signs of a blood clot --sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or pain in an arm or leg;
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • severe headache, pounding in your neck or ears;
  • jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • a change in the pattern or severity of migraine headaches; or
  • symptoms of depression --sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • breast pain or swelling;
  • nausea;
  • menstrual cramps, breakthrough bleeding;
  • headache, anxiety, mood changes; or
  • skin reactions where a patch was worn --redness, irritation, itching, rash, pain, or swelling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

Some drugs can make this medicine less effective, which may result in pregnancy. Use a barrier form of birth control (condom, diaphragm, cervical cap, contraceptive sponge) if you also take:

  • aprepitant, bosentan, griseofulvin, rifabutin, rifampin, St. John's wort;
  • antiviral medicine to treat HIV --nelfinavir, nevirapine, ritonavir; or
  • seizure medicine --carbamazepine, felbamate, oxcarbazepine, phenobarbital, phenytoin, rufinamide, or topiramate.

Many other drugs can affect ethinyl estradiol and norelgestromin, especially:

  • acetaminophen, ascorbic acid (vitamin C), lamotrigine, levothyroxine;
  • antifungal medicine --fluconazole, itraconazole, ketoconazole, voriconazole;
  • certain HIV medicines --atazanavir, etravirine, indinavir; or
  • cholesterol medicine --atorvastatin, rosuvastatin.

This list is not complete and many other drugs may affect ethinyl estradiol and norelgestromin. Tell your doctor about all your current medicines. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norelgestromin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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