Ethinyl Estradiol; Norelgestromin skin patches

What is this medicine?

ETHINYL ESTRADIOL;NORELGESTROMIN (ETH in il es tra DYE ole; nor el JES troe min) skin patch is used as a contraceptive (birth control method). This medicine combines two types of female hormones, an estrogen and a progestin. This patch is used to prevent ovulation and pregnancy.

How should I use this medicine?

This patch is applied to the skin. Follow the directions on the prescription label. Apply to clean, dry, healthy skin on the buttock, abdomen, upper outer arm or upper torso, in a place where it will not be rubbed by tight clothing. Do not use lotions or other cosmetics on the site where the patch will go. Press the patch firmly in place for 10 seconds to ensure good contact with the skin. Change the patch every 7 days on the same day of the week for 3 weeks. You will then have a break from the patch for 1 week, after which you will apply a new patch. Do not use your medicine more often than directed.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in female children who have started having menstrual periods.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions such as skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat

• breast tissue changes or discharge

• dark patches of skin on your forehead, cheeks, upper lip, and chin

• depression

• high blood pressure

• migraines or severe, sudden headaches

• missed menstrual periods

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• skin reactions at the patch site such as blistering, bleeding, itching, rash, or swelling

• stomach pain

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• breast tenderness

• irregular vaginal bleeding or spotting, particularly during the first 3 months of use

• headache

• nausea

• painful menstrual periods

• skin redness or mild irritation at site where applied

• weight gain (slight)

What may interact with this medicine?

Do not take this medicine with the following medications:

• dasabuvir; ombitasvir; paritaprevir; ritonavir

• ombitasvir; paritaprevir; ritonavir

This medicine may also interact with the following medications:

• acetaminophen

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and possibly penicillins or tetracyclines

• aprepitant or fosaprepitant

• armodafinil

• ascorbic acid (vitamin C)

• barbiturate medicines, such as phenobarbital or primidone

• bosentan

• certain antiviral medicines for hepatitis, HIV or AIDS

• certain medicines for cancer treatment

• certain medicines for seizures like carbamazepine, clobazam, felbamate, lamotrigine, oxcarbazepine, phenytoin, rufinamide, topiramate

• certain medicines for treating high cholesterol

• cyclosporine

• dantrolene

• elagolix

• flibanserin

• grapefruit juice

• lesinurad

• medicines for diabetes

• medicines to treat fungal infections, such as griseofulvin, miconazole, fluconazole, ketoconazole, itraconazole, posaconazole or voriconazole

• mifepristone

• mitotane

• modafinil

• morphine

• mycophenolate

• St. John's wort

• tamoxifen

• temazepam

• theophylline or aminophylline

• thyroid hormones

• tizanidine

• tranexamic acid

• ulipristal

• warfarin

What if I miss a dose?

You will need to replace your patch once a week as directed. If your patch is lost or falls off, contact your health care professional for advice. You may need to use another form of birth control if your patch has been off for more than 1 day.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep the patch in its pouch until time of use. Throw away any unused medicine after the expiration date.

Dispose of used patches properly. Since a used patch may still contain active hormones, fold the patch in half so that it sticks to itself prior to disposal. Throw away in a place where children or pets cannot reach.

What should I tell my health care provider before I take this medicine?

They need to know if you have or ever had any of these conditions:

• abnormal vaginal bleeding

• blood vessel disease or blood clots

• breast, cervical, endometrial, ovarian, liver, or uterine cancer

• diabetes

• gallbladder disease

• having surgery

• heart disease or recent heart attack

• high blood pressure

• high cholesterol or triglycerides

• history of irregular heartbeat or heart valve problems

• kidney disease

• liver disease

• migraine headaches

• protein C deficiency

• protein S deficiency

• recently had a baby, miscarriage, or abortion

• stroke

• systemic lupus erythematosus (SLE)

• tobacco smoker

• an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine.

Use an additional method of contraception during the first cycle that you use this patch.

If you have any reason to think you are pregnant, stop using this medicine right away and contact your doctor or health care professional.

If you are using this medicine for hormone related problems, it may take several cycles of use to see improvement in your condition.

Smoking increases the risk of getting a blood clot or having a stroke while you are using hormonal birth control, especially if you are more than 35 years old. You are strongly advised not to smoke.

This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

In some women, tenderness, swelling, or minor bleeding of the gums may occur. Notify your dentist if this happens. Brushing and flossing your teeth regularly may help limit this. See your dentist regularly and inform your dentist of the medicines you are taking.

If you are going to have elective surgery or a MRI, you may need to stop using this medicine before the surgery or MRI. Consult your health care professional for advice.

This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.