Xulane transdermal

Ethinyl estradiol and norelgestromin contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norelgestromin transdermal (skin patch) is used as contraception to prevent pregnancy.

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

Skin irritation at the application site, nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change may occur. Vaginal bleeding between periods (spotting) may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the patch has not been used properly), talk to your doctor about a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using this medication patch, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or norelgestromin; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression, diabetes, family medical history (especially angioedema), gallbladder problems, severe headaches/migraines, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), liver disease (including tumors), stroke, swelling (edema), thyroid problems, unexplained vaginal bleeding.

If you weigh more than 198 pounds (90 kilograms), this patch may not work well for you. Make sure your doctor knows your current weight, and ask about which form of birth control will work best for you.

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

This medication may decrease breast milk production. A small amount passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Applies to ethinyl estradiol / norelgestromin: transdermal patch extended release

Along with its needed effects, ethinyl estradiol / norelgestromin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / norelgestromin:

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Anxiety
• changes in skin color
• chest pain or discomfort
• confusion
• dark urine
• diarrhea
• dizziness
• eye pain
• fainting
• inability to speak
• itching
• lack or loss of appetite
• light-colored stools
• lightheadedness
• nausea
• numbness in the hands
• pain in the abdomen or stomach
• pain in the chest, groin, or legs, especially the calves
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pounding in the ears
• rash
• seizures
• slow or fast heartbeat
• slurred speech
• sudden headache
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg on one side of the body
• sudden, unexplained shortness of breath
• sweating
• swelling, pain, or tenderness in the upper abdominal or stomach area
• temporary blindness
• unpleasant breath odor
• vision changes
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking ethinyl estradiol / norelgestromin:

• Unusual vaginal bleeding in women
• vomiting

Some side effects of ethinyl estradiol / norelgestromin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, itching, or redness of the skin
• menstrual cramps
• pain, soreness, swelling, or discharge from the breast or breasts
• swelling or soreness at the patch site

• Abdominal or stomach cramps or bloating
• absent, missed, or irregular menstrual periods
• bloody vaginal discharge
• brown, blotchy spots on exposed skin
• change in amount of vaginal discharge
• change in menstrual flow
• decreased amount of breast milk
• discouragement
• dry mouth
• feeling sad or empty
• increase or decrease in weight
• increased hunger or thirst
• increased urination
• irritability
• itching of the vagina or outside of the genitals
• light vaginal bleeding between periods and after sexual intercourse
• loss of interest or pleasure
• pain during sexual intercourse
• stopping of menstrual bleeding
• swelling
• thick, white curd-like vaginal discharge without odor or with mild odor
• trouble concentrating
• trouble sleeping